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Radius VSM:

The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities.

The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults.

The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions.

The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults.

The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers.

The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVI as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PV i measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.

Devices with Masimo technology are only indicated for use with Masimo accessories.

Radius VSM Accessories:

Radius VSM ECG Electrodes are disposable, single-patient ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact.

Radius VSM Blood Pressure Cuffs are accessories intended to be use with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions.

The Radius VSM and Accessories is a wearable, multi-modular patient monitoring platform that allows for the ability to scale and tailor the use of monitoring technologies based upon the hospital's and clinician's assessment of what technologies are appropriate. The purpose of this submission is the premarket notification for the introduction of Masimo Radius VSM and Accessories, including its use with the previously cleared Root (K191882) and Masimo Patient SafetyNet (K071047).

The Radius VSM and Accessories system comprises of the Radius VSM Wearable Monitor, Radius VSM ECG Module and Electrodes, and the Radius VSM NiBP Module and Cuff.

The provided text describes the acceptance criteria and study results for the Masimo Radius VSM and Accessories device, focusing specifically on the Non-invasive Blood Pressure (NiBP) feature.

1. Acceptance Criteria and Reported Device Performance (NiBP Feature):

The clinical performance analysis for the NiBP feature supported by the Masimo Radius VSM device had the following acceptance criteria and reported values:

The device met all specified acceptance criteria for the NiBP feature.

2. Sample Size and Data Provenance for the Test Set:

• Sample Size:
  • NiBP Feature: 89 subjects.
  • ECG Waveform Comparison: 31 subjects.
  • Patient Posture, Position, and Activity: 20 subjects.
  • Aggregate Respiration Rate (First Study): 48 subjects.
  • Aggregate Respiration Rate (Second Study): The number of healthy volunteer subjects is not explicitly stated, but it's implied to be a separate group for validation of integration.
• Data Provenance: The document does not explicitly state the country of origin. The studies are described as "clinical studies," implying prospective data collection for the purpose of validating the device. The term "healthy volunteer subjects" used in the fifth study further suggests prospective, controlled data collection.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number or qualifications of experts used to establish ground truth for any of the studies mentioned.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method for the test set data.

5. MRMC Comparative Effectiveness Study:

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human readers improving with AI assistance is made in the provided text. The studies focus on device performance against reference measurements or previously cleared monitors/algorithms, not on human-AI collaboration.

6. Standalone Performance (Algorithm Only):

• For the NiBP feature, the study was conducted to validate the clinical performance of the Radius VSM's NiBP feature against reference blood pressure measurements, implying standalone performance of the algorithm integrated into the device.
• For the ECG waveform comparison, the device's ECG output was compared to an existing FDA-cleared ECG monitor, indicating standalone performance of the device's ECG functionality.
• For the patient posture, position, and activity feature, the testing supported the "correct integration of the algorithm that was previously cleared," suggesting a focus on the device's implementation of an existing standalone algorithm.
• For the Aggregate Respiration Rate, the algorithm's performance was evaluated against manually annotated capnography data, indicating standalone algorithm performance.

7. Type of Ground Truth Used:

• NiBP: Clinical performance was validated through comparison against "reference blood pressure measurements."
• ECG: Comparison against an "FDA cleared ECG monitor."
• Patient Posture, Position, and Activity: Based on the "correct integration of the algorithm that was previously cleared." The original ground truth for this algorithm (K191882) is not detailed here, but the study validates its implementation in the new device.
• Aggregate Respiration Rate: "Reference respiration rate derived from manual annotated capnography data."

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for training sets for any of the algorithms or features. The studies described are validation (test set) studies.

9. How Ground Truth for the Training Set was Established:

As no information regarding training sets is provided, there is no detail on how their ground truth was established. The document focuses on the validation of integrated features, some of which (like PVi, RRa, and position monitoring) leverage previously cleared Masimo technologies, implying that their development and training (if applicable) occurred prior to this submission.

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The Rad-97 and Accessories is a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital, hospital type facilities, mobile and home environments.

The Rad-97 and Accessories can communicate with network systems for supplemental remote viewing (e.g., at a central station).

The Rad-97 and Accessories are indicated for the non-invasive spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions.

The Rad-97 and Accessories are indicated for the continuous monitoring rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions.

In addition, the Rad-97 and Accessories are indicated to provide the non-invasive spot-checking and continuous monitoring data obtained from the Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi-parameter devices for the display on those devices.

The Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The optional NomoLine Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The NomoLine Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatric and infant patients.

The optional non-invasive blood pressure (NiBP) module is indicated for the noninvasive measurement of arterial blood pressure. The NiBP module is designed to messure for patient population described in the following table:

Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older

Devices with Masimo technology are only to be used with Masimo sensors and cables.

The Rad-97 and accessories are indicated for the non-invasive continuous monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions.

PV i may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PV in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of respiratory rate from Pleth (RRp) for adult and pediatric patients during no motion conditions.

The Radical-7 and Accessories are indicated for the non-invasive spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are not intended to be used as the sole basis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospital-type facilities.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

This premarket notification [510(k)] is for the authorization to market the previously cleared Rad-97 (K193626) and Radical-7 (K193242) with an additional indication for spot-checking.

The cleared versions of the subject devices already support both continuous monitoring and spotchecking use through the activation and deactivation of alarms. This submission updates the indications to reflect both uses of the subject devices.

Rad-97: The Rad-97 is a patient monitor capable of providing multiple parameters. The Rad-97 product family provides the integrated ability of noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), Pleth Respiration Rate (RRp), capnography parameters, and noninvasive blood pressure (NiBP) parameters.

Radical-7: The Radical-7 is a noninvasive monitor that measures arterial oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), Pleth Variability Index (PVi), totalhemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), acoustic respiration rate (RRa), and Pleth Respiration Rate (RRp).

The provided text describes a 510(k) premarket notification for the Masimo Radical-7 Pulse CO-Oximeter and Accessories and the Rad-97 and Accessories. The submission's primary purpose is to update the indications for use to explicitly include "spot-checking" functionality, which the devices already supported by allowing alarm deactivation.

The document asserts that the devices are substantially equivalent to their predicate devices (K193626 for Rad-97 and K193242 for Radical-7) because there are no changes to the device's fundamental technology, principle of operation, or performance specifications. The "spot-checking" capability was already inherent in the devices' design, as users could deactivate continuous monitoring alarms to achieve this function. Therefore, the update is primarily a labeling change to reflect existing functionality.

Based on the provided information, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based device is not directly applicable in the way one might expect for a new AI product. This submission is for a traditional medical device (patient monitor/oximeter), and the "study" is demonstrating substantial equivalence to a predicate device, not necessarily proving a new algorithm's performance against specific acceptance criteria for AI.

However, we can infer the "acceptance criteria" not as novel performance thresholds, but as the maintenance of the same performance characteristics as the predicate devices, and the "proof" coming from the assertion that no changes were made to the core technology that would alter these.

Here's an attempt to structure the information according to the requested format, interpreting "acceptance criteria" as maintaining the predicate's performance and "study" as the justification for substantial equivalence.

Acceptance Criteria and Device Performance (Interpreted)

The core "acceptance criteria" in this 510(k) submission are that the subject devices (Rad-97 and Radical-7) maintain substantial equivalence to their predicate devices (Rad-97 K193626 and Radical-7 K193242, respectively) and that the expanded "indications for use" to include "spot-checking" does not introduce new questions of safety or effectiveness. This is because the devices already possessed the capability for spot-checking by deactivating alarms.

The "study" that proves the device meets these criteria is an assertion of no change in fundamental technological characteristics, principles of operation, or performance specifications compared to the predicate devices, supported by software verification and validation that confirm the integrity of the existing as-cleared software.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim for a traditional device with an expanded indication based on existing functionality, the "acceptance criteria" are implicitly the already cleared performance specifications of the predicate devices. The reported device performance is stated to be identical to these predicate devices. The change is in the stated use (labeling), not in the core performance.

Note: ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- ARMS of the reference measurements in a controlled study.
*Applicable with RD SET Disposable sensors.

2. Sample Size for the Test Set and Data Provenance

No new clinical or non-clinical testing was conducted for this submission (K212161) because the changes were limited to labeling to include existing functionality. The predicate devices' performance data implicitly serve as the "test set" and provenance.

• Sample Size for Test Set: Not applicable for this submission as no new testing was performed. The data and sample sizes supporting the original predicate clearances (K193626 and K193242) would have established these performance metrics. The document states that the devices are "the same as the predicate cleared... with exception of the updated indications for spot-checking."
• Data Provenance: Not explicitly stated for new data. The original predicate device data would have come from clinical studies, often including induced hypoxia studies for oximetry, which typically occur in controlled clinical environments (e.g., US, Europe). The studies for the original clearances would have been prospective to generate the performance data.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable for this submission as no new ground truth was established. The performance specifications are based on the device's technical capabilities, validated against reference standards in prior clearances.
• Qualifications of Experts: N/A for this particular submission. For the original clearances, such validation would involve highly trained clinical professionals and laboratory personnel.

4. Adjudication Method for the Test Set

Not applicable for this submission as no new test set requiring adjudication was generated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI-assisted diagnostic device where human reader improvement with AI assistance would be measured. This is a traditional physiological monitor.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a medical device that measures physiological parameters. Its performance is inherent in its design and sensor technology, not a detached algorithm output. The "algorithm" here refers to the internal processing of physiological signals, which is proven through the device's accuracy specifications.

7. Type of Ground Truth Used

The ground truth for the device's performance (as established for the predicate devices) would typically be:

• Reference Devices/Methods: In a controlled study, the device's measurements (e.g., SpO2) would be compared against a gold standard reference (e.g., co-oximeter for blood gas analysis).
• Controlled Physiological Conditions: For SpO2 and PR, studies often involve inducing a range of oxygen saturation levels and heart rates in human volunteers under controlled conditions.

8. Sample Size for the Training Set

Not applicable in the context of traditional medical device validation. "Training set" is a concept primarily relevant to machine learning/AI models. The device's internal signal processing algorithms are engineered based on principles of physics and physiology, not "trained" on a dataset in the AI sense.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

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The Rad-C Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp).

The Rad-G Pulse Oximeter and Accessories are indicated for noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of adult, pediatric, infant, and neonate patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, transport, and home environments.

The Rad-G Pulse Oximeter and Accessories are indicated for the spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, transport, and home environments.

The Rad-G is a handheld pulse oximeter that provides Masimo SET pulse oximetry and Respiration Rate from the Plethysmograph. The Rad-G is provided with an internal battery and a connection to an external power supply to support continuous monitoring. The technologies supported in the Rad-G are the same as what has been cleared with the Radical-7.

The Masimo Rad-G Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp). The device's performance specifications are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly detail the sample size for a specific clinical test set for the Masimo Rad-G. Instead, it states that "additional clinical testing was not deemed necessary to support the substantial equivalence" because the subject device "utilizes the same monitoring technologies as the predicate (K193242)," the Masimo Radical-7 Pulse Co-Oximeter and Accessories. The performance specifications listed are identical to those of the predicate device.

Therefore, the performance data for the Masimo Rad-G device is based on the data provenance of the predicate device, K193242, which is not detailed in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since "additional clinical testing was not deemed necessary" for the subject device due to its technological similarity to the predicate, this information is not provided for the Masimo Rad-G directly in this document. The ground truth would have been established during the development and clearance process of the predicate device (K193242), but details are not available here.

4. Adjudication Method for the Test Set

As "additional clinical testing was not deemed necessary" for the subject device, details on adjudication methods for a specific test set are not present in this document. This would have been part of the predicate device's (K193242) clinical validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned in the provided text for the Masimo Rad-G. The document focuses on demonstrating substantial equivalence to a predicate device rather than comparing against human readers or assessing improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

The performance specifications listed are for the device's direct measurements (SpO2, PR, RRp). These are standalone algorithms that continuously process physiological signals to output numerical values. The device itself is an automated measurement tool, thus its listed performance is inherently standalone (algorithm-only). The context implies that these are measurements derived directly from the device's sensor and internal processing, rather than requiring human interpretation for the primary output.

7. The Type of Ground Truth Used

Based on the nature of pulse oximetry and respiration rate measurements, the ground truth for establishing the accuracy of the predicate device (and by extension, the Masimo Rad-G) would typically involve:

• Fractional Arterial Oxygen Saturation (SaO2) from a co-oximeter and manual pulse rate counts for SpO2 and PR accuracy studies, often obtained from subjects undergoing induced hypoxia in controlled clinical settings.
• Reference respiration rate measurements (e.g., from capnography, impedance pneumography, or direct observation) for RRp accuracy studies.

The document states that the Masimo Rad-G utilizes the same principles of operation and has the same performance specifications as the predicate device (Masimo Radical-7, K193242). This indicates that the ground truth for the Masimo Rad-G's performance is derived from the ground truth established for the predicate device.

8. The Sample Size for the Training Set

The document does not describe the a "training set" in the context of machine learning, nor does it specify a sample size for such a set. The device utilizes established physiological measurement technologies (Masimo SET pulse oximetry and Respiration Rate from Plethysmograph) rather than a novel machine learning algorithm that would require a dedicated training set. The performance is validated against clinical trials previously conducted for the predicate technology.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a "training set" in the machine learning sense, this information is not applicable. The core technology and its accuracy were established during the development and clinical validation of the Masimo SET Pulse Oximetry and Respiration Rate from Plethysmograph system, which underlies both the predicate and subject devices. This would have involved comparing the device's measurements against accepted clinical reference standards (as described in point 7).

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The Masimo Rad-97 and Accessories are indicated for hospital-type facilities, mobile, and home environments.

The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of pulse rate (PR) of adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions.

In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi-parameter devices for the display on those devices.

The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The optional Nomoline Capnography product family is intended to be connected to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatic and infant patients.

The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure. The NIBP module is designed to measure blood pressure for patient population described in the following table:

Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older

Devices with Masimo technology are only indicated for use with Masimo sensors and cables.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) for adults and pediatics during no motion conditions in hospitals and hospital-type facilities.

PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.

Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the connected monitoring parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery.

The subject device (Rad-97 product family) is the same as the predicate (Rad-97 product family) cleared under K183697. The Rad-97 comprises of the same measurement technologies as cleared in the predicate, which includes the Masimo rainbow SET technology, capnography technology, and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa) and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.

The subject of this submission is the addition of indications for PVi, an index previously cleared as an informational index.

Here's a breakdown of the acceptance criteria and study information for the Masimo Rad-97 Pulse CO-Oximeter and Accessories, specifically for the PVi indication, based on the provided text:

Acceptance Criteria and Reported Device Performance for PVi

Note: The provided text does not explicitly define acceptance criteria as a specific numerical benchmark for AUC. Instead, it states that the "test results supported the ability of PVi to provide an indication of fluid responsiveness."

Study Details for PVi Indication

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: A combined total of 182 subjects were included across 6 highlighted studies that involved mechanically ventilated adult patients.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they involved "undergoing surgeries, where PVi was monitored for fluid responsiveness using volume expansion changes (fluid bolus infusions)."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The ground truth was established by monitoring "cardiac output response" to "fluid bolus infusion," which suggests physiological measurements rather than expert consensus on a subjective interpretation. The text does not mention expert review for establishing ground truth for PVi functionality.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified. The determination of fluid responsiveness based on cardiac output response to fluid bolus infusion is a direct physiological measurement, not an interpretation requiring adjudication by multiple experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. The PVi feature is a non-invasive monitoring parameter, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, this was a standalone performance evaluation. The PVi feature provides a continuous non-invasive measurement (algorithm only) and is intended as an "indicator of fluid responsiveness." The assessment focused on the device's ability to correlate PVi changes with fluid responsiveness, without a human interpretation step being part of the primary evaluation of the PVi's accuracy itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The ground truth was established by monitoring the cardiac output response to fluid bolus infusion. This represents physiological outcomes data (changes in a patient's hemodynamic status).

8. The sample size for the training set

• Not specified. The provided information focuses on the validation of the PVi feature for its updated indications, using published studies. It does not detail the initial development or training phases of the PVi algorithm itself.

9. How the ground truth for the training set was established

• Not specified. As mentioned above, the document focuses on the validation studies for the expanded PVi indication, not the initial development or training.

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Masimo Rad-97 Pulse CO-Oximeter and Accessories:

The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi-parameter devices for the display on those devices.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatic patients during no motion conditions in hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

The optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediativ and infant patients.

The optional non-invasive blood pressure (NiBP) module is indicated for the noninvasive measurement of arterial blood pressure. The NiBP module is designed to measure blood pressure for patient population described in the following Table:

Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older

Devices with Masimo technology are only to be used with Masimo sensors and cables.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

Masimo Radical-7 Pulse CO-Oximeter and Accessories

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radical-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospital-type facilities.

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

Masimo Radius-7 Pulse CO-Oximeter and Accessories:

The Radius-7 Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radius and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoplobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.

The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities.

The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitaltype facilities, home environments, and transport within healthcare facilities.

The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

The subject of the submission is to add Respiration Rate from photoplethysmogram (designated as RRp) feature to the previously cleared Masimo Pulse Oximetry devices. The RRp feature that was previously cleared as part of MightySat fingertip pulse oximeter under K181956. RRp feature determines the patient's respiration rate by analyzing cyclic variations in photoplethysmogram (pleth) to establish respiration measurement. The devices in which the RRp feature is being added as part of this submission are the previously cleared Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, and Masimo Radius-7 Pulse CO-Oximeter.

Rad-97 Pulse CO-Oximeter: Masimo Rad-97 System and Accessories (Rad-97), is a portable monitor that features a touchscreen that provides a display and control user interface for monitored parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery. The Rad-97 comprises of technologies that enable the device to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PV), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or capnography parameters or noninvasive blood pressure (NIBP) parameters which were all previously cleared under K183697.

Radical-7 Pulse CO-Oximeter: Masimo Radical-7 and Accessories, is a pulse co-oximeter that features a touchscreen that provides a display and control user interface for monitored parameters. It can be used either as a handheld or standalone monitor. Radical-7 can interface with a multi-parameter patient monitor and send data in order to display on the monitor. The Radical-7 comprises of technologies that enable the Radical-7 to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), and acoustic respiration rate (RRa) parameters which were all previously cleared under K171121.

Radius-7 Pulse CO-Oximeter: Masimo Radius-7 and Accessories, is a wearable Pulse CO-Oximeter. Radius-7 can interface with a multi-parameter patient monitor and send data in order to display on the monitor via Bluetooth or WiFi. The Radius-7 comprises of technologies that enable the Radius-7 to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PV), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), and acoustic respiration rate (RRa) parameters which were all previously cleared under K171121.

The document provided explains the regulatory clearance of Masimo Rad-97, Radical-7, and Radius-7 Pulse CO-Oximeters with the addition of a Respiration Rate from photoplethysmogram (RRp) feature. The acceptance criteria and the studies proving the device meets these criteria are detailed below, focusing on the newly added RRp feature.

Acceptance Criteria and Device Performance

The core acceptance criterion for the RRp feature is its accuracy (ARMS) and mean error when compared to a gold-reference capnography.

Table of Acceptance Criteria and Reported Device Performance (RRp Feature):

Note: The document states the performance specification of RRp is "ARMS of ≤ 3.0RPM and mean error of 1", which is explicitly met by the reported performance.

Study Details Proving Device Meets Acceptance Criteria

1. Sample Sizes Used for the Test Set and Data Provenance:

• Prospective Clinical Study (Healthy Adults):
  • Number of Data Points: 7,751
  • Data Provenance: Not explicitly stated but implied to be from a controlled clinical setting, likely in the US (given FDA submission). It's a prospective study.
• Retrospective Clinical Validation Study (Hospitalized Adults):
  • Number of Data Points: 119,174
  • Data Provenance: Collected from hospitalized adults. Retrospective study. Country of origin not explicitly stated, but common for such studies to be multi-site or from a single clinical institution, likely in the US.
• Retrospective Clinical Validation Study (Hospitalized Pediatrics):
  • Number of Data Points: 35,390
  • Data Provenance: Collected from hospitalized pediatrics. Retrospective study. Country of origin not explicitly stated.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• The document does not specify the number or qualifications of experts involved in establishing the ground truth. The ground truth method relies on an FDA-cleared capnography device (Oridion Capnostream20, K060065) as the "gold-reference method." This suggests that the ground truth is derived from instrumental measurements rather than human expert interpretation of raw data.

3. Adjudication Method for the Test Set:

• Not applicable as the ground truth is established by a medical device (capnography) and not human consensus or adjudication. The comparison is between the device's RRp measurement and the capnography's measurement.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. The study focuses on the accuracy of the device's RRp measurement against a reference standard, not on how human readers' performance improves with or without AI assistance. The device is a monitor, not an AI-assisted diagnostic tool that requires human interpretation.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, the studies conducted demonstrate the standalone performance of the RRp algorithm. The device produces a directly measurable respiration rate (RRp) which is then compared to a reference standard (capnography). Human interpretation is not part of the RRp measurement process itself.

6. The Type of Ground Truth Used:

• The ground truth used is an instrumental reference standard: an FDA-cleared capnography device (Oridion Capnostream20, K060065), which is considered a "gold-reference method" for respiration rate measurement. This is a direct physiological measurement, not expert consensus or pathology.

7. The Sample Size for the Training Set:

• The document does not explicitly state the sample size for the training set. It mentions that the "technological characteristics of the RRp feature is the same as that of previously cleared reference predicate MightySat (K181956)." This implies that the RRp algorithm was likely developed and potentially trained using data before this specific submission, possibly on data sets contributing to the MightySat clearance. The presented studies are validation studies for the implementation of this existing feature on new devices.

8. How the Ground Truth for the Training Set was Established:

• The document does not provide details on how the ground truth for the training set was established. Given that the RRp feature's technology is stated to be the same as a previously cleared predicate device (MightySat K181956), it can be inferred that the validation and potentially the training of the original algorithm would have followed similar rigorous methods, likely involving comparison to golden standards such as capnography. However, specific details for the training set's ground truth establishment are not present in this submission.

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The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of Methadone Metabolite in human urine. The cutoff for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL for methadone metabolite. The assay is designed for prescription use on automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GCMS or (2) permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or liguid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Methadone Metabolite (EDDP) (100 and 300) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Methadone Metabolite (EDDP) Enzyme Immunoassay at the cutoff values of 100 ng/mL and 300 ng/mL.

The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between EDDP in the sample and EDDP labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the EDDP concentration in the sample is measured in terms of enzyme activity. In the absence of EDDP in the sample, EDDP-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free EDDP is present in the sample, antibody would bind to free EDDP; the unbound EDDP-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.

The Ri solution contains mouse monoclonal anti-methadone metabolite antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with methadone metabolite in buffer with sodium azide (0.09 %) as a preservative.

The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay calibrators and controls designated for use at the 100 ng/mL cutoff contain 0, 50, 75, 100, 125, 250, 500 ng/mL of methadone metabolite (EDDP) in human urine with sodium azide (0.09 %) as a preservative. These five calibrators and two controls are sold as individual bottles.

The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay calibrators and controls designated for use at the 300 ng/mL cutoff contain 0, 150, 225, 300, 375, 600, and 1000 ng/mL of methadone metabolite (EDDP) in human urine with sodium azide (0.09 %) as a preservative. These five calibrators and two controls are sold as individual bottles.

The provided document is a 510(k) premarket notification for the LZI Methadone Metabolite (EDDP) Enzyme Immunoassay and Calibrators. It focuses on demonstrating substantial equivalence to a predicate device, rather than establishing acceptance criteria and proving conformance to them in the same way a de novo or PMA submission might.

Therefore, the acceptance criteria are largely implied by the comparison to the predicate device and the analytical performance data presented. The study aims to show that the new device performs comparably to the predicate and provides accurate results for methadone metabolite detection.

Here's an attempt to extract the requested information based on the provided text, with notable limitations due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

• 0, 25, 50, 75 ng/mL: 100% Negative (Within Run N=22, Total N=88)
• 100 ng/mL (Cutoff): Within Run: 11 Neg/11 Pos (50%); Total: 40 Pos/48 Neg (45.5% Pos)
• 125, 150, 175, 200 ng/mL: 100% Positive (Within Run N=22, Total N=88)

Qualitative Results:

• 0, 25, 50, 75 ng/mL: 100% Negative (Within Run N=22, Total N=88)
• 100 ng/mL (Cutoff): Within Run: 13 Neg/9 Pos (40.9% Pos); Total: 34 Pos/54 Neg (38.6% Pos)
• 125, 150, 175, 200 ng/mL: 100% Positive (Within Run N=22, Total N=88) |
  | Precision (300 ng/mL Cutoff) | Consistency in qualitative results (Negative/Positive) at various concentrations, particularly near the cutoff, demonstrating minimal variation within and between runs. For concentrations 375 ng/mL, results should be consistently positive. At the 300 ng/mL cutoff, a mix of positive and negative results is expected due to inherent variability, but overall agreement with expected ranges should be demonstrated. | Semi-Quantitative Results:
• 0, 75, 150, 225 ng/mL: 100% Negative (Within Run N=22, Total N=88)
• 300 ng/mL (Cutoff): Within Run: 6 Neg/16 Pos (72.7% Pos); Total: 52 Pos/36 Neg (59.1% Pos)
• 375, 450, 525, 600 ng/mL: 100% Positive (Within Run N=22, Total N=88)

Qualitative Results:

• 0, 75, 150, 225 ng/mL: 100% Negative (Within Run N=22, Total N=88)
• 300 ng/mL (Cutoff): Within Run: 7 Neg/15 Pos (68.2% Pos); Total: 55 Pos/33 Neg (62.5% Pos)
• 375, 450, 525, 600 ng/mL: 100% Positive (Within Run N=22, Total N=88) |
  | Method Comparison - Clinical Samples (100 ng/mL Cutoff) | High concordance with LC/MS results, especially for samples clearly positive or negative relative to the cutoff. Discrepancies should be understood and ideally minimal, particularly for samples significantly above/below the cutoff. The device should demonstrate appropriate sensitivity and specificity compared to a confirmatory method. | Qualitative/Semi-Quantitative Accuracy Study (N=87):
• Agreement for 23 Negative, 11

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The Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 1.0 ng/mL. The assay is intended for use in laboratories for the qualitative analysis of Fentanyl in human urine with automated clinical chemistry analyzers. This assay is calibrated against Fentanyl. This in vitro diagnostic device is for prescription use only.

The Immunalysis SEFRIA Fentanyl Urine Enzyne Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Immunalysis Fentanyl Urine Calibrators:

The Immunalysis Fentanyl Urine Calibrators are used as calibrators in the Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay for the qualitative determination of Fentanyl in urine on automated clinical chemistry analyzers.

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes EA protein and rabbit antibodies to Fentanyl in PIPES buffer with sodium azide as a preservative. The enzyme conjugate reagent includes ED peptide labeled with Fentanyl and CPRG substrate in malic acid buffer with sodium azide as a preservative. Calibrators and controls are included as part of the test system and provided separately. The Fentanyl calibrators consist of a Level 1 calibrator at 1 ng/mL, a Level 2 calibrator at 2 ng/mL, and a Level 3 calibrator at 4 ng/mL. The control set contains a LOW control at 0.5 ng/mL and a HIGH control at 1.5 ng/mL.

Automated clinical chemistry analyzers capable of maintaining a constant temperature, pipetting samples and reagents, mixing reagents, timing the reaction accurately and measuring enzymatic rates at 570nm can be used to perform the assay.

The SEFRIA™ technology is based on artificial fragments of the E. coli enzyme ß-galactosidase. A mutant enzyme, termed Enzyme Acceptor (EA), is created by deletion of 28 amino acids in the amino-terminal region of the sequence. EA is inactive, but can combine with peptides, termed Enzyme Donors (ED's), containing the deleted sequence, to form active B-galactosidase. This process is termed complementation, and the active enzyme formed as a result can be measured by hydrolysis of a chromogenic substrate such as chlorophenolred ß-D-galactopyranoside (CPRG). The ED peptides can be modified by attachment of a derivative of fentanyl, which does not interfere with the formation of active ß-galactosidase. However antibodies to fentanyl bind to the ED-fentanyl conjugate, and block complementation. The assay is based on the competition of fentanyl in a urine sample with the ED-fentanyl conjugate for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the ED-fentanyl conjugate, resulting in inhibition of enzyme formation. As the fentanyl concentration in the sample increases, ED-fentanyl becomes available for complementation, creating a dose response relationship between fentanyl concentration in the urine and enzyme formation. The Bgalactosidase activity is determined spectrophotometrically at 570 nm by the conversion of CPRG (orange) to chlorophenol red (red) and galactose.

Here's a breakdown of the acceptance criteria and study information for the Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay, based on the provided text:

Important Note: This document describes an in vitro diagnostic (IVD) device, not an AI/ML powered device for image analysis. Therefore, some of the requested information (like experts for ground truth, adjudication methods, MRMC studies, effect size of human readers with AI assistance, and standalone algorithm performance) is not applicable or not present in the context of this type of device. I will address only the information that can be extracted from the provided text for this specific device type.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are mainly demonstrated through various performance studies, showing that the device accurately identifies fentanyl in urine at defined concentrations and is not significantly affected by interferences. Since specific numerical acceptance criteria (e.g., "must achieve >95% accuracy") are not explicitly stated in a consolidated table, I've inferred them from the study results presented as "verification" of performance.

Acceptance Criteria & Reported Device Performance for Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay

2. Sample Size Used for the Test Set and Data Provenance

• Precision/Cutoff Characterization/Reproducibility Study:
  • Sample Size: 80 drug-free urine samples, spiked with fentanyl at 9 different concentrations, each tested in replicates of 4 over 10 days (total determinations = 80 per concentration point).
  • Data Provenance: Drug-free urine was spiked with fentanyl. The provenance of the original drug-free urine is not specified (e.g., country of origin). The study is prospective in nature as samples were intentionally prepared for the test.
• Specificity and Cross-Reactivity Study:
  • Sample Size: Not explicitly stated, samples were spiked with various compounds to represent different concentrations.
  • Data Provenance: Not explicitly stated, samples were spiked into drug-free urine.
• Interference (Structurally Unrelated & Endogenous Compounds), Boric Acid, pH, and Specific Gravity Interference Studies:
  • Sample Size: Not explicitly detailed per compound, but samples were spiked into drug-free urine containing fentanyl at ±50% of the cutoff.
  • Data Provenance: Samples were spiked into drug-free urine.
• Method Comparison Study:
  • Sample Size: 80 de-identified, unaltered leftover clinical urine samples.
  • Data Provenance: Obtained from clinical testing laboratories. Specific country of origin is not mentioned, but it implies a retrospective collection of existing clinical samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This device is an in vitro diagnostic immunoassay, not an imaging AI device requiring expert interpretation for ground truth.

• Ground Truth Establishment for Analytical Studies (Precision, Specificity, Interference): The "ground truth" was established by precisely spiking known concentrations of fentanyl or other compounds into drug-free urine, and/or confirming concentrations via mass spectrometry (LC-MS/MS). No human experts are used for this.
• Ground Truth Establishment for Method Comparison Study: The ground truth was established by a confirmatory method, Liquid Chromatography / Mass Spectrometry (LC/MS or LC-MS/MS), which is considered the gold standard for drug quantification. No human experts are mentioned for establishing this ground truth.

4. Adjudication Method for the Test Set

Not applicable for this type of IVD device. Adjudication methods like 2+1 or 3+1 typically apply to human readers interpreting complex data (e.g., medical images) where discrepancies need to be resolved. For an immunoassay, the result is quantitative (absorbance) and then interpreted qualitatively based on a cutoff. Confirmatory testing (e.g., LC-MS/MS) serves as the definitive assessment, not a human adjudication process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this is not applicable. MRMC studies evaluate the performance of human readers, sometimes with and without AI assistance, on a set of cases. This device is an automated laboratory test, not an AI-powered reader for medical images or other data that requires human interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies evaluate the performance of the device itself (the immunoassay) in a standalone fashion. Human involvement is limited to preparing samples, loading them onto the automated clinical chemistry analyzer, and reading the qualitative result (positive/negative) that the instrument provides based on its internal reaction and cutoff. There is no "human-in-the-loop" performance as would be understood in an AI-assisted diagnostic context for interpretation.

7. The Type of Ground Truth Used

• Analytical Studies (Precision, Specificity, Interference): Ground truth was established by known concentrations of spiked analytes in drug-free urine, often confirmed by Mass Spectrometry (MS).
• Method Comparison Study: Ground truth was established by Liquid Chromatography / Mass Spectrometry (LC/MS or LC-MS/MS), which is the preferred confirmatory method mentioned in the "Indications for Use" and is considered the gold standard.

8. The Sample Size for the Training Set

This is not an AI/ML device that requires a "training set" in the traditional sense. The device is a chemical immunoassay based on enzymatic reactions and antibody binding. Its "development" involves chemical formulation and optimization, not machine learning model training.

9. How the Ground Truth for the Training Set was Established

As noted above, there is no "training set" for this immunoassay device in the context of AI/ML. The development and optimization of the immunoassay reagents (antibodies, enzymes, etc.) would have relied on biochemical principles and extensive internal testing with known Fentanyl concentrations. The calibrators themselves have their values assigned based on mass spectrometry, as described in section 10 of the performance characteristics.

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The CEDIA Buprenorphine II Assay is a homogeneous enzyme immunoassay for the qualitative and/or semiquantitative determination for the presence of buprenorphine and its metabolites in human urine at a cut-off concentration of 10 ng/ mL. The assay is intended to be used in laboratories and provides a simple and rapid analytical screening procedure to detect buprenorphine and its metabolites in human urine. The assay is designed for use with a number of clinical chemistry analyzers.

The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid chromatography/tandem mass spectrometry (LC-MS/ MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography/tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

CEDIA Buprenorphine II Calibrators:

The CEDIA Buprenorphine II calibrators and CEDIA Negative Calibrator II are intended for the calibration of the CEDIA Buprenorphine II Assay in human urine. For In Vitro Diagnostic Use Only.

CEDIA Buprenorphine II Control Set:

The CEDIA Buprenorphine II controls are used to validate the CEDIA Buprenorphine II Assay calibration in human urine. For In Vitro Diagnostic Use Only.

The assay consists of buffers (1 and 2) and lyophilized reagents (1a and 2a). The components include mouse monoclonal anti-buprenorphine antibody, recombinant microbial "enzyme donor'' - buprenorphine conjugate, "enzyme acceptor", chlorophenol red ß-Dgalactopyranoside, stabilizers and preservatives. Calibrators and controls are sold separately.

Here's a breakdown of the acceptance criteria and study information for the CEDIA Buprenorphine II Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Immunalysis Barbiturates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Barbiturates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Secobarbital. This in vitro diagnostic device is for prescription use only.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The Immunalysis Barbiturates Urine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or LC-MS/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Immunalysis Multi-Drug Calibrators:

The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the following analytes: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam. The calibrators are designed for prescription use with immunoassays.

The Immunalysis Barbiturates Urine Enzyme Immunoassay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes a recombinant antibody to Secobarbital, a mouse monoclonal antibody to Secobarbital, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with sodium azide as a preservative. The enzyme conjugate reagent includes Barbiturates labeled with glucose-6phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as a preservative.

Immunalysis Multi-Drug Calibrators are included as part of the test system and provided separately. The calibrator kit includes four levels of drugs and a negative calibrator in a ready-touse format. Automated clinical chemistry analyzers capable of maintaining a constant temperature, pipetting samples and reagents, mixing reagents, timing the reaction accurately and measuring enzymatic rates spectrophotometrically at 340nm can be used to perform the assay.

The Immunalysis Barbiturates Urine Enzyme Immunoassay uses barbiturates recombinant and monoclonal antibody. The assay is based on the competition of Barbiturates labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine and enzyme activity. The enzyme G6PDH activity is determined at 340 nm spectrophotometrically by the conversion of NAD to NADH.

Here's a breakdown of the acceptance criteria and study information for the Immunalysis Barbiturates Urine Enzyme Immunoassay:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets within the provided text. However, the studies demonstrate the performance of the device in various metrics, and the conclusion states that the device is "substantially equivalent to the legally marketed predicate device for its intended use." This implies that the performance shown met the, albeit unstated, acceptance criteria for substantial equivalence to the predicate device.

For this analysis, I will infer the acceptance criteria from the context of how the results are presented, specifically the aim of demonstrating that the cutoff serves as a boundary between negative and positive interpretations, demonstrating appropriate cross-reactivity and non-interference, and showing high agreement with LC/MS-MS.

• 200 ng/mL (Cutoff): 33/80 Negative, 47/80 Positive
• 250-400 ng/mL: 80/80 Positive (100%) |
  | Semi-Quantitative Analysis (Precision/Cutoff Characterization) | Clear discrimination around the 200 ng/mL cutoff and mixed results at cutoff. | - 0-150 ng/mL: 80/80 Negative (100%)
• 200 ng/mL (Cutoff): 23/80 Negative, 57/80 Positive
• 250-400 ng/mL: 80/80 Positive (100%) |
  | Specificity and Cross-Reactivity (Structurally Related Compounds) | Detect target compound (Secobarbital) at cutoff with 100% cross-reactivity; minimal or varying cross-reactivity for other barbiturates, with higher concentrations needed for positive results; Negative results for Phenytoin. | - Secobarbital: 100% Cross-Reactivity
• Other Barbiturates: Cross-reactivity % varied from 0.3% (Hexobarbital, Mephobarbital) to 105.3% (Alphenal, Butobarbital)
• Phenytoin (100,000 ng/mL): Negative, 200 ng/mL and 200-300 ng/mL)
• Qualitative Negative: 100% Agreement (for 200 ng/mL and 200-300 ng/mL)
• Semi-Quantitative Negative: 100% Agreement (for

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The ARK™ Oxcarbazepine Metabolite Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy.

The ARK™ Oxcarbazepine Metabolite Calibrator is intended for use in calibration of the ARK Oxcarbazepine Metabolite Assay.

The ARK™ Oxcarbazepine Metabolite Control is an assayed quality control material intended for use in quality control of the ARK Oxcarcarbazepine Metabolite Assay.

For prescription use only. Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.

The ARK Oxcarbazepine Metabolite Assay is a homogeneous immunoassay based on competition between drug in the specimen and Oxcarbazepine Metabolite labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly proportional to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenyzme NAD functions only with the bacterial enzyme used in the assay.

The ARK Oxcarbazepine Metabolite Assay consists of reagents R1 anti-Oxcarbazepine Metabolite polyclonal antibody with substrate and R2 Oxcarbazepine Metabolite labeled with bacterial G6PDH enzyme. The ARK Oxcarbazepine Metabolite Calibrator consists of a six-level set to calibrate the assay, and the ARK Oxcarbazepine Metabolite Control consists of a three-level set used for quality control of the assay.

The provided document describes the performance characteristics of the ARK™ Oxcarbazepine Metabolite Assay, Ark Oxcarbazepine Metabolite Calibrator, and Ark Oxcarbazepine Metabolite Control. This is a 510(k) premarket notification for a medical device (an in-vitro diagnostic assay), not an AI/ML powered device, therefore the information typically requested for AI/ML device studies (such as number of experts, adjudication methods, multi-reader multi-case studies, separate training/test sets with ground truth establishment methods for AI/ML models) are not applicable.

The acceptance criteria and performance data are detailed for several analytical validation studies.

Here's the breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• LOQ: Not explicitly stated how many unique samples, but "mean of six (6) replicate measurements" for recovery at different enantiomer ratios.
• Recovery: Not explicitly stated how many unique samples, but "mean of six (6) replicate measurements" of Oxcarbazepine Metabolite was tabulated as a function of the enantiomer ratio.
• Linearity: Not explicitly stated how many unique samples other than a "60.0 µg/mL serum sample was prepared and dilutions were made proportionally."
• Method Comparison: 190 samples.
• Precision: 3 levels of ARK Control (N=160 each) and 3 human serum pooled specimens (N=160 each). This means for each of the 6 material types, 160 measurements were taken (quadruplicate twice a day for 20 days).
• Interfering Substances: Not explicitly stated the number of unique human serum samples, but substances were tested "in serum with known levels of Oxcarbazepine Metabolite (approximately 3 and 30 µg/mL)."
• Specificity & Drug Interference: Not explicitly stated how many unique human serum samples, but tested with spiked compounds into normal human serum with known Oxcarbazepine Metabolite levels.
• Sample Stability & Calibration Curve Stability: "supporting data" cited, but specific sample sizes are not provided within this document.

Data Provenance: The document does not specify the country of origin of the human serum samples. The studies are analytical validations performed retrospectively in a laboratory setting (e.g., Beckman Coulter AU480® automated clinical chemistry analyzer). It's not a prospective clinical trial with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is an analytical chemistry assay validation, not a diagnostic imaging AI/ML model. Therefore, "experts" in the sense of physicians establishing ground truth for patient cases are not applicable. The "ground truth" for the test set (e.g., concentration of Oxcarbazepine Metabolite) is established by highly accurate reference methods such as LC-MS/MS (for method comparison) or by precise gravimetric/volumetric preparation of controls and calibrators using certified reference materials. The qualifications of the personnel performing these analytical tests are implicitly assumed to be those typical for a laboratory setting conducting such validations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is an analytical validation of an in-vitro diagnostic assay measuring a chemical concentration, not a study involving human readers or subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an analytical validation of an in-vitro diagnostic assay, not an AI-assisted diagnostic device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is an "algorithm only" in the sense that it is an automated chemical assay system. Its performance (quantification of Oxcarbazepine Metabolite) is assessed independently through the various analytical studies (e.g., LOQ, linearity, precision, method comparison against LC-MS/MS). Human "human-in-the-loop" performance is not a direct component of the assay's function, though human operators are involved in running the assay and interpreting the results.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the analytical performance studies is primarily:

• Reference Method: For method comparison, LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) is used as the reference "ground truth" method. LC-MS/MS is a highly accurate and precise analytical technique for quantifying specific compounds in complex mixtures.
• Gravimetric/Volumetric Preparation: For calibrators and controls, the "ground truth" concentrations are established by precise gravimetric addition of certified Oxcarbazepine Metabolite powder to solvents. Purity is determined by NMR and elemental analysis.

8. The sample size for the training set

This is an immunoassay, not a machine learning or AI algorithm in the traditional sense that requires a "training set" for model development. The "training" of the assay refers to its calibration. The calibrators are prepared and value-assigned as described (e.g., "Two calibrated runs are performed using the Master Calibrator. In each run, five replicates of Master Lot (reference) and Test Lot are tested as matched pairs for each calibrator level.").

9. How the ground truth for the training set was established

As described above, for an immunoassay, the "training set" is the calibrator set. The ground truth for the calibrators is established through:

• Traceability to certified powder: The calibrators are traceable to certified Oxcarbazepine Metabolite powder. "The purity of Oxcarbazepine Metabolite in the certified raw material is determined by NMR and elemental analysis as performed by the supplier of the certified powder."
• Gravimetric Addition: "Bulk solutions of the ARK Oxcarbazepine Metabolite Calibrator are prepared volumetrically using a stock solution prepared by gravimetric addition of powder to solvent."
• Value Assignment: "Testing is performed with the ARK Oxcarbazepine Metabolite Assay on the Beckman Coulter AU480® automated analyzer. Two calibrated runs are performed using the Master Calibrator. In each run, five replicates of Master Lot (reference) and Test Lot are tested as matched pairs for each calibrator level. Mean values for ten replicates are calculated." This process ensures consistency and accuracy against a master reference.

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