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The iv Watch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear, uncolored infusates, as an adjunctive device to the clinical evaluation in the hospital setting of patients 18 years old or greater with peripherally-inserted IVs (PIVs) on the forearm or dorsal aspect of the hand.

The device is indicated to assess patients for subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by physicians, or under the direction of a physician, who have been trained in the use of the iv Watch Model 400.

The ivWatch Model 400 is a medical device that provides continuous, noninvasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites on the forearm and dorsal aspect of the hand to aid in the early detection of infiltration and extravasation events. The ivWatch Model 400 ("Device") consists of the ivWatch Patient Monitor (IPM), a reusable optical sensor cable, and a single-use sensor receptacle.

The device uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site; the measured changes are processed by proprietary ivWatch signal processing algorithms to determine if an infiltration event may have occurred. The device is indicated for use by medical professionals who are experienced with administering or monitoring peripheral IV therapy.

The IPM mounts to an IV pole, typically above the infusion pump. The sensor is secured in the receptacle and subsequently placed on the patient's skin near the peripheral IV insertion site for the duration of the IV monitoring. The fiberoptic sensor cable follows the IV line back to the pole-mounted IPM.

One end of the sensor cable attaches to the IPM; the other end snaps into the ivWatch sensor receptacle, which secures the sensor to the patient's skin. The sensor cable is a multiple-use disposable with a total useful life of approximately 240 hours of IV monitoring; it is intended to be cleaned between uses.

The ivWatch sensor receptacle is molded out of biocompatible plastics and includes biocompatible adhesives for attaching the receptacle to the patient's skin. The sensor receptacle is a single-use disposable and supplied sterile.

The IPM contains an optical system that generates light signals that are sent to the patient's skin (via the sensor cable) and measures the light returning from the patient's skin (also via the sensor cable). The Device uses low power LEDs as sources of visible and near-infrared (NIR) light. Optical fibers in the sensor cable deliver the light from the IPM to the sensor and transmit reflected light back to the IPM. The IPM also contains the hardware for executing the proprietary ivWatch signal processing algorithm.

If changes in the optical properties of the tissue near the peripheral IV insertion site are consistent with an infusate pooling in the subcutaneous tissue, the IPM emits audible and visual notifications intended to prompt the clinician to inspect the peripheral IV site for a possible infiltration event.

Here's a breakdown of the acceptance criteria and study information for the ivWatch Model 400, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria alongside specific measured device performance metrics (e.g., sensitivity, specificity, PPV, NPV) with numerical thresholds for infiltration detection. Instead, it describes the device's ability to assist clinicians in identifying early stages of PIV infiltration and mentions "sensitivity, false notification rate" as performance aspects assessed in validation studies without providing specific values or targets.

However, based on the description, the primary functional acceptance criterion appears to be:

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

• Test Set Sample Size: "A series of six IRB-approved verification and validation clinical studies were performed." The exact total number of patients or infiltration events across these six studies is not specified in the provided document.
• Data Provenance: The studies were prospective clinical studies given the mention of "IRB-approved verification and validation clinical studies" and active monitoring during IV infusions. The country of origin of the data is not explicitly stated, but the FDA submission suggests it was likely in the USA.

3. 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 of experts used or their qualifications to establish ground truth for the test set. It mentions the device is "adjunctive... to the clinical evaluation" and "intended for use by physicians, or under the direction of a physician, who have been trained in the use of the ivWatch Model 400." This implies that physicians/clinicians were involved in the ground truth assessment, but details are lacking.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set (e.g., 2+1, 3+1, none). Ground truth establishment is only broadly referred to as "clinical evaluation."

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not detailed or mentioned in the provided document. The device is described as "adjunctive" to clinical evaluation, implying it works alongside clinicians, but no study comparing human performance with and without the device is presented.

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

A standalone performance assessment without human intervention was done to some extent. The document states:

• "The ivWatch Model 400 could assist clinicians in identifying the early stages of a PIV infiltration." This implies the device provides an alert based on its algorithm's detection.
• "The device is indicated to assess patients for subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site." This further indicates its primary function is automated detection.
• "If changes in the optical properties of the tissue near the peripheral IV insertion site are consistent with an infusate pooling in the subcutaneous tissue, the IPM emits audible and visual notifications..." This describes the algorithm's standalone output (notifications) without immediate human intervention as part of the detection step.

The validation studies assessed "performance (e.g., sensitivity, false notification rate)" of the device, which are metrics typically associated with standalone algorithm performance.

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

The type of ground truth used for the test set is implicitly clinical evaluation by clinicians/physicians. The "Indications for Use" explicitly states the device is "adjunctive device to the clinical evaluation."

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. It mentions "Computer simulations were used to identify the optimal design for the ivWatch sensor," which might involve simulated data, but no real-world training data size is provided.

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

The document does not explicitly describe how ground truth for a training set (if any real-world data was used for training the proprietary algorithms) was established. It refers to "proprietary ivWatch signal processing algorithms" and "Computer simulations...validated in bench tests using an ex vivo porcine foot model" for sensor design. This suggests a blend of simulation, bench testing, and perhaps prior knowledge/data informing algorithm development, rather than a distinct, described process for establishing ground truth on a specific training dataset from human subjects.

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Use of the Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), pulse wave, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO2), nitrous oxide concentration (N20), oxygen concentration (O2), and anesthetic agent concentration (AG). The target populations of the system are adult, pediatric, and neonatal patients with the exception of the ST segment and arrhythmia analysis, for which the target populations are adult and pediatric only. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-7000 Series Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7000 Series Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

The Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) is meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR, ER, or Recovery areas of the hospital or clinic. An optional Battery Pack operation allows the DS-7210/7210M to be used to monitor patients during intra-hospital transport. Patient ages from neonates to adults can all be monitored. Waveforms, numeric and trend data from these patients are available to the clinician on the systems display or may be printed on the system's recorder.

The DS-7000 Series Patient Monitor allows for the monitoring of ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), plethysmograph, temperature, invasive blood pressure (IBP), and cardiac output. This subject modified DS-7000 Series Patient Monitor extended the NIBP measurement target populations from adult and pediatric to adult. pediatric, and neonatal and the DS-7210/7210M of the DS-7000 Series includes ECG 12 Lead monitoring.

The DS-7000/7000M of the DS-7000 Series Patient Monitor allows for the monitoring of carbon dioxide concentration (CO2), nitrous oxide concentration (N2O), oxygen concentration (O2), and anesthetic agent concentration (AG), which utilizes Criticare Systems technology (K012059), by using the option Multigas Unit (MGU-701/MGU-702) . And, by using the option Unit (HU-71/HU-72/HU-73), invasive blood pressure (up to 6 channels), cardiac output, temperature (up to 3 channels) can be additionally monitored. No new functions for the options are being added and are not the subject of this submission for the DS-7000/7000M.

This subject modified DS-7210/7210M of the DS-7000 series Patient Monitor allows for the monitoring of carbon dioxide concentration (CO2), which utilizes Oridion Medical 1987 Ltd. technology "Microstream"" (K060065), by using the option CO2 measurement unit (MGU-722). Or, by using the option Mainstream CO2 interface Unit (MGU-721), the Capnostat 5 Mainstream CO2 Sensor (K042601) manufactured by Respironics Novametrix, LLC. is allowed to connect to the DS-7210/7210M with serial communication protocol for CO2 monitoring. And, by using the option Unit (HU-71/HU-72/HU-73), invasive blood pressure (up to 5 channels), cardiac output, temperature (up to 3 channels) can be additionally monitored.

For the SpO2 measurement monitoring, the DS-7000 utilizes Nellcor technology (K021090) and the DS-7000M utilizes Masimo one (K033296). No new functions for SpO2 measurement are being added and are not the subject of this submission. This subject modified DS-7210/7210M has the same feature.

The DS-7000 Series Patient Monitor is a self contained monitor which includes a 12.1 inch TFT color LCD display which can display up to 12 (for DS-7000/7000M) or 14 (for DS-7210/7210M) waveforms and up to 20 (for DS-7000/7000M) or 16 (for DS-7210/7210M) numeric displays. Input operation is performed by the touch screen panel, 5 fixed keys (only DS-7000/7000M), or infrared remote-control command (optional). Additional standard features of the DS-7000 Series Patient Monitor include the DS-LAN II connection, which is a proprietary network system based on an Ethernet LAN (K970585), through either a built in Ethernet LAN or external telemetry transmitter (the Fukuda Denshi DS-5000 series telemetry model HLX-501/561, K980728) connection for connection to the Fukuda Denshi Central Station Monitors, a built- in dot matrix thermal printer that can print up to 3 wave forms simultaneously, and an alarm indicator feature on the top of device that alerts to alarm conditions.

The DS-7000/7000M of the DS-7000 Series is small and lightweight at 9.0 kg. The physical dimensions of the device are 324mm (W) x 260mm (H) x 179mm (D). The option Multigas Unit (MGU-701/MGU-702) weight is 1.8 kg. The physical dimensions of the device are 248mm (W) x 138mm (H) x 82mm (D). No weight and physical dimensions are being changed and are not the subject of this submission for the DS-7000/7000M.

The subject modified DS-7210/7210M weight is 9.9 kg. The physical dimensions of the device are 310mm (W) x 351mm (H) x 245mm (D). The option CO2 measurement Unit (MGU-722) weight is 260g and Mainstream CO2 interface unit (MGU-721) weight is 200g. The both physical dimensions of the device are 141.5mm (W) x 41mm (H) x 79mm (D).

For the DS-7000 Series option Unit (HU-71/HU-72/HU-73) weight is 180g. The physical dimensions of the device are 37mm (W) x 99 mm (H) x 90 mm (D). No weight and physical dimensions are being changed and are not the subject of this submission.

The provided text describes the Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor and its substantial equivalence to predicate devices, but it does not contain a detailed study with specific acceptance criteria and reported device performance in the format requested.

The document primarily focuses on:

• Description of the device: Its features, monitored parameters, and intended use.
• Predicate device comparison: Stating that it incorporates identical technology and is substantially equivalent.
• Safety and environmental testing: Mentioning compliance with various general and individual safety standards, and EMC standards.
• Conclusion: Reiterating that it's as safe and effective as predicate devices based on laboratory testing, validation, and risk analysis.

However, it lacks the specific quantitative data, sample sizes, ground truth establishment methods, or expert qualifications that would be detailed in a robust clinical or performance study report.

Therefore, I cannot populate the requested table and answer many of the specific questions directly from the provided text.

Here's a breakdown of what can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Detailed Answers to Specific Questions:

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: Not specified. The document only mentions "various performance tests" and "final testing."
• Data provenance: Not specified. The text indicates "laboratory testing" and testing at an "OEM engineering test facility." This suggests internal testing, but no details on patient data, if any, are provided. It does not mention if the data was retrospective or prospective.

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 applicable. The document describes compliance with technical standards and performance specifications, not diagnostic accuracy requiring expert ground truth in a clinical setting.

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

• Not applicable. This type of adjudication is typically for subjective assessments or discrepancy resolution in clinical studies, which is not described here.

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. This device is a patient monitor, not an AI-assisted diagnostic tool. The submission focuses on device safety and performance as a monitoring system.

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

• Not applicable in the context of an "algorithm only" study. The performance testing mentioned is for the integrated patient monitor system.

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

• For a patient monitor, the "ground truth" for performance testing typically refers to validated reference standards or simulated physiological signals that mimic real patient data with known values (e.g., a calibrated simulator for vital signs, or direct physical measurement for electrical safety parameters). The document does not explicitly state the specific type of ground truth used, but it would be based on these established engineering and physiological reference systems.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that would have a separate "training set."

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

• Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as:

• ECG: Heartrate, Respiration Rate ・
• Invasive Blood Pressure: systolic, diastolic and mean pressure -
• Temperature: temperature ー
• Non Invasive Blood Pressure: systolic, diastolic and mean pressure -
• CO2, etCO2 and CO2ins -
• SpO2: SpO2 and pulse rate -

There is alarm handling for all parameters except temperature.

The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input.

The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.

The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as: ECG, Invasive Blood Pressure, Temperature, Non Invasive Blood Pressure, CO2, etCO2, CO2ins, SpO2, and pulse rate. There is alarm handling for all parameters except temperature. The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input. The system is intended for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.

The provided document is a 510(k) summary for the SCHILLER AG Argus LCM Monitoring System, comparing it to predicate devices. It states that the device is "as safe and effective as" the predicate devices and passed relevant electrical safety and software quality tests. However, it does not contain the specific information requested about acceptance criteria and a study proving those criteria are met in the format of the output.

Specifically:

• Acceptance Criteria and Reported Device Performance Table: The document lists standards passed for various components (e.g., IEC 60601-1 for System, IEC 60601-2-2 for ECG). However, it does not provide specific acceptance criteria values (e.g., accuracy +/- X%) or numerical reported device performance against those criteria. Instead, it generally states "All tests are passed" or refers to compliance with standards.
• Sample size and data provenance for test set: Not available. The document states "B2 Clinical Tests: n.a." (not applicable), indicating no clinical tests were performed for this submission. The non-clinical tests mentioned are electrical safety and software quality.
• Number of experts and qualifications for ground truth: Not applicable, as no clinical study with ground truth established by experts is described.
• Adjudication method for test set: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm-only) performance: Not applicable, as the device is a monitoring system and the performance evaluation focuses on hardware components and electrical safety, not an algorithm's standalone diagnostic performance.
• Type of ground truth used: Not applicable, as no clinical study is described. The "ground truth" for the non-clinical tests would be the specifications and requirements of the standards themselves.
• Sample size for training set: Not applicable, as no machine learning algorithm development is described in detail that would require a 'training set'. The software quality section refers to software requirements, development, verification, validation, and testing, but not in the context of a machine learning model.
• How ground truth for training set was established: Not applicable.

Therefore, since the document pertains to a medical device submission primarily focused on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, the requested clinical study-centric details are not present.

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The CAS 740 Series Vital Signs Monitor is indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adult, pediatric and neonatal patients, in the care of health professionals.

The CAS 740 Monitor is a replacement monitor based on the existing 9303 Vital Signs Monitor, and the CAS 9001 or 9002 EMS monitors. The 740 are primarily a repackaging of these monitors. The primary parameter is non-invasive blood pressure, which is included in all models. Blood pressure measurement is based on oscillometric technology. The additional two parameters are pulse oximetry and temperature. A purchaser has pulse oximetry choices that include modules manufactured by Masimo, Nellcor or Nonin. The temperature parameter utilizes predictive technology from SureTemp (Welch Allyn Inc.). The monitor is a rugged, portable and lightweight unit widely adaptable for many applications and mounting schemes. Used for spot-checking or continuous monitoring, features include an easily replaceable Nickel Metal Hydride rechargeable battery pack, wireless infrared printer communication, and many more.

The provided document describes the CAS 740 Series Monitor, a vital signs monitor, and details its equivalence to predicate devices, not an AI/ML powered device. Therefore, the questions related to AI/ML specific studies, such as multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for training sets, are not applicable.

However, the document does provide information regarding acceptance criteria and a study for the Non-Invasive Blood Pressure (NIBP) component.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that the clinical studies for NIBP were conducted in accordance with AAMI SP10:2002. The AAMI SP10 standard (now ISO 81060-2) typically requires a minimum of 85 subjects for clinical validation to ensure a statistically robust evaluation of NIBP device accuracy. The document does not specify the exact number of subjects or the country of origin, nor whether the data was retrospective or prospective, beyond stating "clinical studies."

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

For Non-Invasive Blood Pressure measurements validated against a standard like AAMI SP10, the "ground truth" is typically established by simultaneously taken reference blood pressure measurements (e.g., intra-arterial measurements or trained auscultatory measurements using a mercury sphygmomanometer) by qualified healthcare professionals. The document does not specify the exact number or qualifications of these professionals beyond implying adherence to the AAMI SP10 standard, which mandates specific protocols for reference measurements.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method in the context of expert consensus, as this is not typically applicable for NIBP accuracy studies where direct physiological measurements serve as the reference. Adherence to AAMI SP10 implies a standardized method for obtaining reference measurements.

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

No. This is not applicable as the CAS 740 Series Monitor is a vital signs monitor and not an AI/ML powered device requiring interpretation of medical images or data by multiple readers.

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

Yes, for the Non-Invasive Blood Pressure component, standalone performance was assessed. The document states: "CAS has tested and demonstrated ND Plus performance equivalent to the NB module in bench test simulations." This refers to the algorithm's performance in simulation without human interaction to interpret the NIBP readings. Additionally, the clinical studies, while involving patients, assess the device's ability to accurately measure blood pressure on its own.

7. The Type of Ground Truth Used

For the Non-Invasive Blood Pressure (NIBP) component, the ground truth was based on reference blood pressure measurements obtained according to the AAMI SP10:2002 standard during clinical studies. These are direct physiological measurements.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/ML algorithm. The NIBP measurement relies on oscillometric technology and algorithms that were likely developed and refined using physiological data, but the term "training set" with specific size is not mentioned for this type of device.

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

As there is no mention of a "training set" in the AI/ML context, this question is not directly applicable. The underlying algorithms for oscillometric NIBP would have been developed and validated against a combination of empirical data and theoretical models of blood pressure oscillations, with accuracy verified through extensive testing against established reference methods.

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The Propaq LT 802 series monitors are highly portable devices intended to be used by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of ambulatory and non-ambulatory neonate, pediatric and adult patients. These monitors are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by this device are hospital general medical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services and other healthcare applications. The monitors may be used as standalone devices or as devices networked to an Acuity " central station through wireless communication over Welch Allyn's FlexNet™ network.

This device is available for sale only upon the order of a physician or licensed health care professional.

The Propaq LT 802 Series of monitors are small, lightweight patient monitoring devices intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive Interious bo adou by cirite, ECG, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) in ambulatory, non-ambulatory and transport environments

This document is a 510(k) summary for the Welch Allyn Propaq LT 802 Series vital signs monitor. It describes the device, its intended use, and provides a statement of its substantial equivalence to predicate devices. However, it does not contain the detailed performance study results, acceptance criteria, or ground truth information typical for an AI/ML device submission.

Therefore, I cannot fully complete the requested table and sections based on the provided text.

Here's what I can infer and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical acceptance criteria for each vital sign parameter (ECG, NIBP, Respiration, SpO2).
• Quantified performance results (e.g., mean absolute difference for NIBP, accuracy percentages for heart rate, SpO2 accuracy over specific ranges).

Study Related Information (Based on what can be inferred/is missing):

• Study That Proves the Device Meets Acceptance Criteria: The document mentions that the device "will be tested in accordance with the [test methods mentioned elsewhere in the submission] using production equivalent units prior to release to market." This indicates that verification and validation testing was planned or executed, but the details of these studies are not present in this summary. The summary focuses on regulatory compliance and substantial equivalence rather than detailed performance study reports.

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

  • Not specified in the document. The document does not provide details on specific test sets, sample sizes, or data provenance.

• 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 applicable/Not specified. For a vital signs monitor, ground truth is typically established by reference devices (e.g., a highly accurate NIBP simulator, a SpO2 simulator, or a known ECG waveform generator) rather than expert consensus on medical images or diagnoses. The document does not mention experts for ground truth establishment.

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

  • Not applicable/Not specified. Adjudication methods are typically used in studies involving subjective interpretation (e.g., image reading). For vital sign measurements, accuracy is usually determined against a validated reference.

• 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. This is a vital signs monitor, not an AI-powered diagnostic device. MRMC studies are not relevant in this context.

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

  • Yes, implicitly. The device itself is a standalone vital signs monitor. Its performance would be evaluated as an algorithm/device-only performance against reference standards. This is the primary mode of evaluation for such devices.

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

  • Likely a combination of physical simulators and clinical studies against reference devices. While not explicitly stated, for vital signs monitors, ground truth typically comes from:
    • For NIBP: Cuff inflation measurements against a reference manometer or invasive arterial pressure measurements.
    • For ECG: Standardized ECG waveforms, or simultaneous recordings with a highly accurate reference ECG device.
    • For SpO2: Controlled hypoxia studies against a CO-oximeter, or testing with calibrated SpO2 simulators.
  • The document mentions "production equivalent units," implying testing against established standards.

• 8. The sample size for the training set:

  • Not applicable/Not specified. This is not an AI/ML device that requires a "training set" in the conventional sense. The device's algorithms for processing vital signs are likely based on established physiological principles and signal processing, not statistical learning from a large training dataset.

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

  • Not applicable/Not specified. As it's not an AI/ML device relying on a training set, this question is not relevant.

Summary of Device and Regulatory Context:

This 510(k) summary is for a traditional medical device (vital signs monitor). The regulatory pathway focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness compared to the predicate. The performance data, while crucial for the submission, is usually summarized or referenced rather than detailed in the public 510(k) summary.

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The VSM series of monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature. noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients.

The most likely locations for patients to be monitored are general med/surg, floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

The model 53000 Series of monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpOz), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients.

The most likely locations for patients to be monitored are general med/surg. floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

The provided text is a 510(k) summary for a medical device cleared through substantial equivalence, not a detailed study report with specific acceptance criteria and performance metrics. Therefore, much of the requested information (such as specific performance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods) is not explicitly stated in this document.

However, based on the available text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the 510(k) summary. The document states that the device "will be tested in accordance with the Test Plan / Report, #831-0719-00, and Clinical Validation Report #831-0752-00 included with the submission," but the content of these reports, including specific acceptance criteria and performance data, is not summarized here. Instead, it relies on substantial equivalence to predicate devices, implying that its performance should be comparable.

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

This information is not explicitly provided. The document mentions a "Clinical Validation Report #831-0752-00," which would contain this data, but the summary does not detail it.

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

This information is not explicitly provided.

4. Adjudication Method for the Test Set

This information is not explicitly provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size

This information is not explicitly provided. The document focuses on substantial equivalence based on technical specifications and performance compared to predicate devices, not on a comparative study with human readers for improved effectiveness.

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

This information is not explicitly provided. Given the device is a vital signs monitor, its core function is to produce readings directly, which implies a standalone performance would be inherent. However, specific details about such testing are not in this summary.

7. The Type of Ground Truth Used

This information is not explicitly provided. For vital signs monitors, ground truth would typically come from reference standards for each measurement (e.g., arterial line measurements for NIBP, co-oximetry for SpO2, calibrated thermometers for temperature), but this is not detailed in the summary.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is a vital signs monitor that likely uses established algorithms and hardware for measurement, not a machine learning or AI-based device requiring a "training set" in the typical sense.

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

This information is not applicable/provided for the same reasons as point 8.

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The Nellcor Puritan Bennett Suzanne is intended for use in collecting and recording physiological data to be used in diagnosing sleep disorders. A pediatric through adult patient population is intended for the Suzanne, which can be used in either home or hospital environments.

The Suzanne System is composed of a data recorder that contains the electronics and software necessary to capture the physiological information of each sensor and to store this information in a Flash card or to send it to a computer via a serial communication port. The information that can be recorded by the Suzanne System is : - · EEG signals - · ECG signals - · Pressure signals - · Thoracic movements - Abdominal movements - Breath detection (through bucco-nasal thermistor) . - Flow (through pneumotachometer) - Envelope of ambient sound . - Body position . - Ambient light detection . - Arterial oxyhemoglobin saturation (SpO2) . - Pulse rate . The signals are amplified by different amplifiers contained in elements of the system known as headboxes. When used in a home environment, the data is recorded in the flash card and the clinician uses a setup unit to check that the system works correctly and to set the recording starting time. When used in a clinical environment, the system can be used as described above or data can be recorded to a computer with the use of a PC application software. The system is powered by an internal battery or by a DC power supply.

This document is a 510(k) summary for the Nellcor Puritan Bennett Suzanne Polysomnograph System. It describes the device, its intended use, and compares it to a legally marketed predicate device. The primary change in the modified device is the addition of new pulse oximetry technology. This document asserts that the modifications do not raise new questions of safety or effectiveness.

However, the provided document does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, number of experts, adjudication methods, or ground truth for a test set.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance.
• The type of ground truth used for a study.
• Sample size and ground truth establishment for a training set.

The document states that "Clinical and non-clinical tests were performed to support the determination of substantial equivalence" and that "The technological characteristics of the modified Suzanne and the results of clinical and non-clinical tests do not raise any new questions of safety or effectiveness when compared to the legally marketed (unmodified) device." However, it does not provide the specifics of these tests or their results.

Therefore, based solely on the provided text, I cannot complete your request. The document describes the regulatory submission process and the determination of substantial equivalence, but it does not detail the specific performance studies and their results.

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