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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 multiparameter 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 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 in hospitals, hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:

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

The subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K170168. and has the same indications for use. The Rad-97 comprises 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), Perfusion Index (Pi), 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 Rad-9, an instrument model within the Rad-97 product family, is an embodiment with a simplified configuration. The Rad-9 was also cleared in K170168. The Rad-9 model includes the Masimo SET technology (a subset of Masimo Rainbow SET technology), which provides pulse oximetry parameters of SpO2, PR, Pi, and PVi. The Rad-9 model can be optionally available with NIBP technology.

Masimo's Rad-97 has improved SpO2 measurement accuracy for motion and no motion conditions with RD SET Disposable sensors previously cleared under K170168. Masimo improved its RD SET Disposable sensors through sensor characterization, facilitating a SpO2 measurement accuracy claim of 1.5% Ams during no-motions conditions for patient populations (adults, pediatrics, infants, and neonates) when used with Masimo's MX/MS-2000 boards. Masimo's SpO2 measurement accuracy claim with RD SET Disposable Sensors is 1.5% Arms during motion conditions for patient population (adults, pediatrics, infants, and neonates) when used with Masimo's MX/MS-2000 boards. Although they now include improved sensor characterization, the RD SET Disposable sensors are substantially equivalent to the currently marketed product.

Additionally, this submission includes the following sensors that have non-significant changes: the Multisite Reusable Sensors (K111888), the RD Specialty Sensors (K101896), and the RD reusable sensors (K051212).

Here is a summary of the acceptance criteria and study information for the Masimo Rad-97 and Accessories, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as "Accuracy (ARMS)" specifications in the document.

Note: The clinical study specifically focused on SpO2 accuracy claims for no-motion and motion conditions for adult, pediatric, and infant populations. The document states that "Accordingly, the claimed Ams value is 1.5% during no-motion conditions for adults, pediatrics, and infants, and the claimed Arms value is 1.5% during motion conditions for adult, pediatrics, and infants." This implies that the reported study results support these specific claims, which are the acceptance criteria.

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

The document states: "The study was done on healthy adult volunteers".

• Sample Size: Not explicitly stated as a number, but refers to "healthy adult volunteers."
• Data Provenance: Clinical study, likely prospective, conducted on "healthy adult volunteers" at an unspecified location (typically assumed to be U.S. unless otherwise specified in FDA submissions).

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

Not applicable for this type of device and study. The ground truth for SpO2 accuracy is typically established by comparing the device's readings to arterial blood samples analyzed by a laboratory CO-Oximeter (as stated in the document: "in comparison to blood measurements from a laboratory CO-Oximeter"). No human expert "adjudication" of the ground truth is mentioned or implied for SpO2 measurements.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 is directly derived from laboratory CO-Oximeter analysis of blood samples, not from expert adjudication of images or signals that would require an adjudication method like 2+1 or 3+1.

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

No, an MRMC comparative effectiveness study was not done. The study described is a clinical accuracy study comparing the device's measurements directly to a reference standard (laboratory CO-Oximeter). It does not involve human readers or assess their improvement with AI assistance.

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

Yes, the clinical study performed was a standalone performance evaluation of the device (algorithm only) comparing its SpO2 measurements against a reference standard. The "human-in-the-loop" aspect for a device like a pulse oximeter is generally the medical professional interpreting the device's output, but the accuracy study assesses the device's measured values directly.

7. The Type of Ground Truth Used

Laboratory Standards: The ground truth for SpO2 measurements was established by "blood measurements from a laboratory CO-Oximeter."

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. It focuses on the validation study (test set).

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

The document does not provide information on how the ground truth for the training set was established. This information is typically not included in a 510(k) summary for device modifications unless the model itself is novel and the training process is a key part of the submission. The device (Masimo Rad-97) and its underlying Rainbow SET technology are described as substantially similar to a cleared predicate (K170168), even with improved sensor characterization.

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The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.

MATRx plus uses these recordings to produce a report for the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.

The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.

This De Novo request is for an expanded indication (new intended use) for use with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.

The device is an automated temporary oral appliance that manipulates the mandible through multiple protrusion levels during an overnight sleep study in the home. The device uses the same interface as the MATRx plus Home Sleep Apnea Test, also from Zephyr Sleep Technologies, cleared under product code MNR, regulation 21 CFR 868.2375, cleared in K163665. These components include the recorder, tablet, oximeter, effector belt, and nasal cannula. The MATRx plus device for a titration study includes a mandibular positioner to determine an optimal titration position based on inputs of airflow and an oxygen desaturation index (ODI) of less than 10 events per hour. The device analyses the collected information and generates a report to assist the Healthcare Provider in the clinical management of oral appliance therapy for patients with mild to moderate obstructive sleep apnea. From this report, patients may be informed on the future efficaciousness of oral appliance (OA) therapy.

Specifically, the clinical management may be assisted by this type of oral appliance assessment study by prospectively identifying patients that are expected to achieve therapeutic success with oral appliance therapy. The oral appliance assessment study also includes the provision of a recommended target protrusive setting for the mandible through use of a legally marketed intraoral appliance (regulated under 21 CFR 872.5570, product code LQZ). The target protrusive setting is the amount of mandibular protrusion where the patient is expected to achieve efficacious therapy with the intraoral appliance and is used by the HCP to more effectively complete the titration process.

The use of the MATRx plus device for an oral appliance assessment study does not replace the clinical titration process or the need for follow-up testing to determine the initial and ongoing therapy as recommended by clinical practice guidelines.

The MATRx plus test identifies patients as suitable for intraoral therapy if a mandible protrusion level can be found where the patient has an oxygen desaturation index (ODI) of less than 10 events per hour with a 4% desaturation criterion.

Here's a structured breakdown of the acceptance criteria and the study that proves the MATRx plus device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Clinical Endpoints

Bench Performance Testing

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

• Sample Size for Test Set:
  • Clinical Study: The document provides "49" for "Successful Identification of Responders" and "2" for "Failure to Identify Responders" in the "Predictive Success Category," and "3" for "Successful Identification of Responders" and "6" for "Failure to Identify Responders" in the "Predictive Failure Category." This totals 49 + 2 + 3 + 6 = 60 participants in the mild to moderate OSA population for the effectiveness endpoints.
  • Human Factors: 15 patients were recruited for each study.
• Data Provenance: The MATRx plus is by Zephyr Sleep Technology, located in Calgary, Alberta, Canada. The clinical study was conducted in a clinical setting (dental professional's office for deployment, home environment for use). The study is prospective, as it involved recruiting participants, conducting the MATRx plus study, and then following up with custom oral appliance therapy.

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

• Number of Experts:
  • Effectiveness Ground Truth (Oral Appliance Outcome): While not explicitly stated how many individual experts reviewed each case, the process involved a "Sleep Health professional" reviewing baseline HSAT data and a "licensed dentist" conducting intraoral exams and subjective interviews post-study. The final determination of "successful treatment with an oral appliance" (ODI

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The Masimo Disposable Ear Sensors are indicated for single patient use for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an monitoring of tansitional Drygol and pediatric patients, (weighing >30kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

The Masimo Disposable Ear Oximetry Sensors) are fully compatible for use with instruments which include or compatible with the following technologies:

• · Masimo SET technology
• · Masimo Rainbow SET technology
  The E1 Sensors and the predicates (K012992) Masimo Reuseable Ear Sensor (LNOP Sensor) and (K051212) the LNCS Reusable Ear Sensor (LNCS Sensor) have similar indications for use/ intended use. The main difference is that the E1 Sensors are disposable ear sensors.

Here's a breakdown of the requested information based on the provided text, focusing on the study and acceptance criteria for the Masimo Disposable Oximetry Ear Sensors:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance Testing" was applied to the development of the E1 Sensors and that "The E1 Sensors have been validated to the Masimo SET Technology."

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

The document describes a sensor for continuous non-invasive monitoring of physiological parameters (SpO2 and pulse rate). This is a direct measurement device and not an AI-assisted diagnostic tool that would involve "human readers" or an MRMC study in the context of improving human interpretation. Therefore, an MRMC comparative effectiveness study was not applicable and not performed.

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

Yes, a standalone performance evaluation was done. The "Specifications" section directly lists the accuracy of the E1 Sensors for SpO2 and Pulse Rate measurements, which are inherent performance characteristics of the device itself, independent of human interpretation or intervention during measurement. The validation was against "Masimo SET Technology," implying a direct comparison to an established measurement standard rather than human-in-the-loop performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document implies the ground truth for performance validation was likely established through comparison with Masimo SET Technology, which itself would be validated against a recognized gold standard for oxygen saturation and pulse rate measurement (e.g., blood gas analysis for SpO2). However, the specific method for establishing this ground truth (e.g., clinical study with arterial blood gas draws) is not detailed in this summary.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" as this device is a sensor for direct measurement and not a machine learning algorithm that typically requires a distinct training phase. The validation stated is against "Masimo SET Technology."

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

As noted in point 8, the concept of a "training set" and its associated ground truth establishment is not directly applicable to this type of device based on the provided information. The device's performance is validated against an established technology (Masimo SET Technology), which would have its own validated ground truth.

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The LNCS Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, 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 LNCS Oximetry Sensors are to be reprocessed. They are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The LNCS Oximety Sensors are also compatible with Nellcor compatible pulse oximeter monitors. There is no change in the sensor design or performance. The only change is that the sensors are to be reprocessed and subjected to ethylene oxide (EO) sterilization, and are to be supplied as sterile sensors by Masimo.

The provided document is a 510(k) summary for the Masimo LNCS Oximetry Sensors. It focuses on the substantial equivalence of reprocessed and sterilized sensors to previously cleared sensors. Therefore, the information typically found in acceptance criteria and detailed study reports for new device performance (like specific accuracy metrics, sample sizes for test/training sets, expert qualifications, etc.) is not present in this summary.

Here's a breakdown of what can be extracted based on the request, and what cannot:

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

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., accuracy, precision errors for SpO2). The primary acceptance criterion here is "substantial equivalence" to previously cleared predicate devices. This means the reprocessed sensors must perform at least as well as the original, non-reprocessed sensors.
• Reported Device Performance: The document only states: "The results of the performance data demonstrate that the LNCS Oximetery Sensors, after reprocessed and sterilized are as safe and effective as the legally marketed predicate devices." No specific numerical performance values (e.g., SpO2 accuracy, pulse rate accuracy) are provided in this summary.

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 for Test Set: Not specified.
• Data Provenance: The testing was "in-house and laboratory validation testing." No information on country of origin or whether it was retrospective or prospective is provided.

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)

• Number of Experts: Not applicable/not specified. For oximetry sensors, ground truth typically comes from a reference device (e.g., CO-oximeter for SpO2) rather than expert consensus on images.
• Qualifications of Experts: Not applicable/not specified.

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

• Adjudication Method: Not applicable/not specified. Oximetry sensor performance is typically evaluated against reference instruments, not expert adjudication in the way image analysis algorithms are.

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

• MRMC Study: No. This device is an oximetry sensor, not an AI-powered diagnostic tool requiring human reader studies.

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

• Standalone Performance: Not applicable in the context of an "algorithm only" device, as this is a physical sensor. The "performance data" mentioned would be for the sensor itself.

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

• Type of Ground Truth: Not explicitly stated in this summary. For oximetry devices, ground truth for SpO2 accuracy is typically established using a reference CO-oximeter with arterial blood samples. The document refers to "in-house and laboratory validation testing," which would imply such rigorous reference methods.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a sensor, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of available information as per request:

This 510(k) summary is for a device modification (reprocessing and sterilization) of an existing device type, not a new technology introduction. Therefore, the focus is on demonstrating that the reprocessing and sterilization do not negatively impact the established performance and safety of the device, rather than establishing original performance criteria from scratch. Detailed performance metrics and study designs, if required, would typically be found in the full 510(k) submission, not necessarily in the public summary.

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