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The Capnostream®20p combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is also indicated for continuous non-invasive monitoring of carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). It is intended for use with neonatal, pediatric, and adult patients in hospital-type facilities, intra-hospital transport and home environments.

The Capnostream®20p monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

The Capnostream20p bedside monitor is a two parameter monitor consisting of a microMediCO2 capnography module and/or a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed. The device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer with DQA 21 CFR § 870.2700 Pulse Oximeter listed as an additional or alternate classification.

This device has two modules that are classified as follows:

• 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK) .
• . 21 CFR 870.2700 Pulse Oximeter (Classification DQA).

Each module is controlled by dedicated software that is an integral part of the respective module. Each module provides parameters to the host software (the Capnostream20p device software) which then controls the display of the received parameter values and creates alarms when the values cross the preset thresholds.

The microMediCO2 module provides the following inputs to the host monitor: FiCO2, EtCO2 numeric, EtCO2 waveform, Respiratory Rate, IPI (Integrated Pulmonary Index).

The Masimo MX1 SpO2 module, integrated in the Capnostream20 p monitor presented in this submission, provides the following parameters to the host for display: SpO2 (functional oxygen saturation of arterial hemoglobin), pulse rate, SpCO (carboxyhemoglobin saturation in blood), SpMet (methemoglobin saturation in blood) and SpHb (total hemoglobin concentration in blood).

The host monitor will display this data to the user in numerics via a screen, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.

The three measurements will be available both real time and in trend summaries.

In addition, the MX1 board provides a Perfusion Index (PI) indicating the relative pulsatile strength at the sampling site is provided to the host monitor for display.

The host displays the Rainbow SET parameters values on the screen alongside the four IPI (Integrated Pulmonary Index) parameters and the IPI value as presented on the predicate device.

This 510(k) summary describes a device, the Capnostream®20p with Masimo MX1 SpO2 board, which is a combined capnograph/pulse oximeter monitor. The submission seeks to prove its substantial equivalence to predicate devices, particularly concerning the addition of three new parameters: SpCO, SpMet, and SpHb.

Based on the provided text, the device itself is a medical monitor, not an AI or algorithm-based diagnostic tool that would typically undergo studies to demonstrate performance against established acceptance criteria in the manner requested. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria for new functionality.

Therefore, many of the requested categories (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details, and ground truth establishment for training) are not applicable or explicitly mentioned in the provided regulatory submission for this type of medical device.

However, I can extract the relevant information regarding performance, a comparison to predicate devices, and the intended use.

Acceptance Criteria and Device Performance Study Summary

The submission does not present a study with specific acceptance criteria in the format of a diagnostic algorithm or AI performance evaluation. Instead, it asserts substantial equivalence to existing predicate devices based on design, intended use, and adherence to performance and safety standards. The "performance" in this context refers to the device's ability to accurately measure the stated physiological parameters in line with its predicate devices and relevant standards.

The primary document provided is a "Traditional 510(k) Submission," which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is typically achieved through engineering and verification/validation testing against standards, rather than large-scale clinical trials establishing new performance benchmarks.

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

Since specific acceptance criteria for a new clinical performance study (like sensitivity/specificity targets) for this device are not presented, the table below reflects the comparison to predicate device characteristics and adherence to recognized standards, which serve as the "acceptance criteria" for a 510(k) submission of this nature.

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

• The document primarily references software testing and adherence to standards for the Capnostream20p device itself. No specific clinical test set sample sizes for the overall device's performance (beyond the existing Masimo validation for the SpCO/SpMet/SpHb module) are provided in this summary.
• The data provenance for the clinical validation of SpCO, SpMet, and SpHb, if conducted by Masimo, is not detailed in this submission. It relies on the prior clearance (K080238) of the Masimo device.
• The document does not specify whether any de novo clinical studies for this specific integrated device were prospective or retrospective.

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):

• This information is not provided in the summary. For a 510(k) submission showing substantial equivalence for a monitoring device, ground truth established by experts in this manner is not typically required or presented unless new clinical performance (e.g., diagnostic accuracy) is being claimed for a novel algorithm.

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

• This information is not provided, as the submission does not detail a clinical study with expert 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 a medical monitoring device, not an AI diagnostic algorithm, and no MRMC study or AI assistance is mentioned.

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

• Not applicable in the typical sense for an AI algorithm. The device itself is a "standalone" monitor that provides continuous measurements. The "performance" is its intrinsic measurement accuracy against physical standards and clinical correlation, as established by the predicate devices. The new SpCO/SpMet/SpHb parameters are derived from the Masimo MX1 SpO2 board, which would have undergone its own standalone validation.

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

• For the core capnography and pulse oximetry functions, ground truth would typically be established through physical gas standards for CO2, and controlled blood gas analysis and controlled hypoxia/hyperoxia studies for SpO2, matched against invasive measurements, as per ISO standards.
• For the added SpCO, SpMet, and SpHb parameters, the submission states these "have been clinically validated by Masimo Corporation." Such validation would typically involve co-oximetry blood sampling as the ground truth against the non-invasive measurements from the Masimo sensor.

8. The sample size for the training set:

• This information is not applicable and not provided. The device does not appear to employ machine learning that would require a separate "training set" in the context of an AI algorithm.

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

• Not applicable, as no training set for an AI algorithm is mentioned.

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The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital transport and home environments.

The Capnostream20 monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

The Capnostream20 bedside monitor is a two parameter monitor consisting of a CO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed. The device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer with DQA 21 CFR § 870.2700 Pulse Oximeter listed as an additional or alternate classification.

This device has two modules that are classified as follows:

• 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK) .
• 21 CFR 870.2700 Pulse Oximeter (Classification DQA) .

Each module is controlled by dedicated software that is an integral part of the respective module.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a SPECIAL 510(k) submission, indicating that the device (Capnostream20 with microMediCO2 CO2 module) is being submitted for substantial equivalence to a previously cleared predicate device (Capnostream20 with miniMediCO2 CO2 module). In such submissions, the primary "study" is often a demonstration of equivalence to the predicate device, rather than a de novo clinical trial with novel acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" are essentially demonstrating substantial equivalence to the predicate device's established performance and meeting relevant regulatory standards. The device performance is generally stated as being equivalent to or meeting the same standards as the predicate.

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

• Sample Size for Test Set: The document does not provide a specific sample size for a "test set" in the context of clinical data for the new microMediCO2 CO2 module. The submission focuses on design and performance verification/validation against existing predicate standards, rather than new clinical trials with patient data. The "test set" here refers to engineering and bench testing to demonstrate compliance with standards and equivalence.
• Data Provenance: Not applicable in the context of clinical patient data. The provenance of the validation data would be from Oridion's internal testing and compliance activities.

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

• Number of Experts: Not specified or applicable in the context of expert-adjudicated ground truth for a clinical dataset. The "ground truth" for this engineering-focused submission is derived from established international standards (ISO, IEC, UL) and a comparison to the predicate device's performance. Performance testing would likely involve engineers and technicians.
• Qualifications of Experts: Not specified, as it's not a clinical study requiring expert adjudication of patient cases.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This submission doesn't describe a clinical study requiring adjudication of expert interpretations. The verification and validation activities would follow standard engineering and quality assurance protocols, where measurements are compared against specifications and standards, not through expert consensus on medical findings.

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, an MRMC comparative effectiveness study was not done, and it is not relevant to this submission. The device is a monitor providing physiological parameters, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: Not explicitly termed "standalone algorithm performance" as it would be for AI. However, the document states: "Verification and validation of the new module as a standalone and when integrated in the monitor were successfully completed." This indicates that the microMediCO2 CO2 module's performance was evaluated independently before integration into the Capnostream20 monitor. This is essentially demonstrating the technical performance of the module itself.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device, in terms of its performance, is based on:
  • Reference measurements/standards: For CO2 and SpO2 accuracy, this would involve comparing the device's readings against highly accurate reference instruments or calibrated gas mixtures as dictated by ISO standards (ISO 21647, ISO 9919).
  • Predicate device's performance: The fundamental "ground truth" for this 510(k) is that the new module performs equivalently to the previously cleared predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physiological monitor, not a machine learning model that requires a "training set" in the AI sense. Its calibration and operational parameters are determined through engineering design and testing, not by learning from a dataset.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" in this context.

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The Capnostream 20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital transport and home environments.

The Capnostream 20 monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

The Capnostream 20 bedside monitor is a two parameter monitor consisting of a miniMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed. The device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer with DQA 21 CFR § 870.2700 Pulse Oximeter listed as an additional or alternate classification.

This device has two modules that are classified as follows:

• 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK)
• 21 CFR 870.2700 Pulse Oximeter (Classification DQA) .

Each module is controlled by dedicated software that is an integral part of the respective module. Each module provides parameters to the host software (the Capnostream 20 device software) which then controls the display of the received parameter values and creates alarms when the values cross the preset thresholds. The miniMediCO2 capnography module software presented in this submission includes the ability to receive SpO2 and pulse rate values from a pulse oximetry module and to calculate an integrated pulmonary index (IPI) which provides a simple and clear single parameter representation of the patient's ventilatory status. The IPI, is an integer value ranging from 1-10 based on end tidal CO2, respiration rate, SpO2 (oxygen saturation of arterial hemoglobin) and pulse rate. The calculated IPI is then provided to a host device (the Capnostream 20 device in the case of this submission). The host displays the index value on the screen alongside the four parameters presented on the predicate device. The IPI feature is not intended for use in the monitoring of children aged less than one year or neonates and the feature is disabled when neonatal mode is selected by the user. However, the monitor itself may continue to be used, in a manner that is identical to the predicate device in all respects, for all patient populations.

The MiniMediCO2 module software is designed to enable the index to be calculated by accepting SpO2 and heart rate values supplied at the required rate (once a second) by any type of pulse oximetry module implemented in a host device. The miniMediCO2 module with IPI software may be implemented in any other pulse oximetry enabled host monitor after making the required changes to the host software to allow provision of SpO2 and pulse rate values to the module and display of the IPI by the host. The host will continue to display the four reference parameters and any other parameters provided by the monitor with the IPI as an addition.

The provided text describes a 510(k) summary for the Capnostream 20 with Integrated Pulmonary Index (IPI) software. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report as would be found in a comprehensive clinical trial publication.

Based on the provided document, here's an attempt to extract the requested information. It's important to note that many specific details about how the acceptance criteria were met (like sample sizes for specific tests, expert qualifications, or detailed ground truth establishment methods) are not explicitly stated in this type of summary document. The document primarily focuses on asserting that these studies were performed and that the device met the requirements.

Acceptance Criteria and Device Performance for Capnostream 20 with Integrated Pulmonary Index (IPI)

The Capnostream 20 with IPI is primarily compared to its predicate device, the Capnostream 20 (miniMediCO2 software version 2.31), to demonstrate substantial equivalence. The acceptance criteria are implicitly those of safety and performance equivalent to the predicate device, with specific attention to the new IPI functionality.

1. Table of Acceptance Criteria and Reported Device Performance

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The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric and adult patients in hospital type facilities, intra hospital transport and home environments.

The Capnostream20 bedside monitor is a two parameter monitor consisting of a miniMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed. The device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer. This device has two modules that are classified as follows: 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK) . 21 CFR870.2700 Pulse Oximeter (Classification DQA) . Each module is controlled by dedicated software that is an integral part of the respective module. Each module provides parameters to the host software (the Capnostream20 device software) which then controls the display of the received parameter values and creates alarms when the values cross the preset thresholds. The miniMediCO2 capnography module software presented in this submission includes an adaptive averaging algorithm defined as the A Algorithm for calculating the respiration rate from the CO2 waveform introduced in software version 2.31 of the miniMediCO2 capnography module software. The calculated respiration rate parameter is then provided to the host (the Capnostream20 device software). The host makes no modification to the values received from the module. The host triggers an alarm when the respiration rate high or respiration rate low thresholds have been crossed. The algorithm employed in the respiration rate calculation reduces false positive alarms by filtering out noise and instantaneous fluctuations without missing true alarms that may indicate a clinically significant change to respiration rate. By employing the adaptive averaging algorithm, the respiration rate accurately reflects the patient's condition and significantly reduces the generation of nuisance alarms by the host.

The provided text describes a 510(k) summary for the Capnostream20 with A2 (adaptive averaging) software for its miniMediCO2 module. This submission is for an updated software version (2.31) that introduces an adaptive averaging algorithm for calculating respiration rate, aiming to reduce false positive alarms while maintaining accuracy.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for the A2 software's performance in terms of specific sensitivity, specificity, accuracy, or alarm reduction metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

The "reported device performance" related to the new software is described functionally: "The algorithm employed in the respiration rate calculation reduces false positive alarms by filtering out noise and instantaneous fluctuations without missing true alarms that may indicate a clinically significant change to respiration rate. By employing the adaptive averaging algorithm, the respiration rate accurately reflects the patient's condition and significantly reduces the generation of nuisance alarms by the host."

While the device meets the safety and performance standards of the predicate device, it doesn't quantify the improvement of the A2 software against specific targets. The performance metrics are implicitly "reduces false positive alarms" and "accurately reflects the patient's condition."

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

The document states: "Test data are provided to validate the performance of the software and its substantial equivalence to the predicate device." However, specific details regarding the sample size used for the test set and the data provenance (e.g., country of origin, retrospective or prospective) are NOT provided in this summary.

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. The text does not describe how ground truth was established for evaluating the performance of the new algorithm.

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 an 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 is NOT mentioned in the document. The new algorithm is for an automated respiration rate calculation, not an AI-assisted human reading task.

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

Yes, the study described is a standalone (algorithm only) performance evaluation. The focus is on the "adaptive averaging algorithm" (A2 software) for calculating respiration rate, which operates autonomously within the miniMediCO2 module. The output (respiration rate) is then provided to the host device. The document states: "The host makes no modification to the values received from the module." This confirms it's an algorithm-only evaluation.

7. The Type of Ground Truth Used

The type of ground truth used is NOT explicitly stated. Given that the algorithm calculates respiration rate from the CO2 waveform, it is most probable that the ground truth would involve:

• Manual, expert review and calculation of respiration rate from raw CO2 waveforms or
• Comparison to another highly accurate, validated respiration rate measurement method.

8. The Sample Size for the Training Set

The document does NOT provide any information about a training set or its sample size. This is a software update described as an "adaptive averaging algorithm," but details on its development or any training data are not included in this 510(k) summary.

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

As no training set is mentioned, information on how its ground truth was established is NOT provided.

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The Capnostream20 is intended for CO2 and SpO2 indications. The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.

The Capnostream10 is intended for CO2 indications only. The Capnostreamso is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and insoired breath. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.

Capnostream20: The Capnostream20 bedside monitor is a two parameter monitor consisting of an EtCO2 MiniMediCO2 module and a MP100 SpO2 module, displays and alarms.

Capnostream10: The Capnostream ( bedside monitor is a one parameter monitor consisting of a MP100 EtCO2 module displays and alarms.

The provided text describes information about the Capnostream20 and Capnostream10 devices but does not contain a study or data to prove that the devices meet acceptance criteria. Instead, it seems to be part of a 510(k) submission, establishing substantial equivalence to predicate devices. Therefore, I cannot generate the requested table and study summary based on the provided text.

However, I can extract information related to the device descriptions, intended use, and substantial equivalence:

Device Descriptions and Intended Use:

• Capnostream20: A two-parameter monitor consisting of an EtCO2 MiniMediCO2 module and an MP100 SpO2 module. It displays and provides alarms for continuous, non-invasive measurement and monitoring of carbon dioxide concentration of expired and inspired breath and respiration rate, and continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate). Intended for neonatal, pediatric, and adult patients in various healthcare environments.
• Capnostream10: A one-parameter monitor consisting of a MiniMediCO2 EtCO2 module. It provides continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. Intended for neonatal, pediatric, and adult patients in various healthcare environments.

Substantial Equivalence Information (instead of study data):

The devices are presented as substantially equivalent to legally marketed predicate devices.

• CO2 Module (MiniMediCO2) used in Predicate Devices:
  • Oridion Polaris 2004, K040011
  • CAS Medical Systems, Inc Models 750c-2ms, 750cm-2ms, 750c-Nnl, 750cm with MiniMediCO2-V1 K050844
  • Larsen & Toubro Limited Star 50 Monitoring System K051608
• Pulse Oximeter Module, SpO2 Module (MP100) used in Predicate Devices:
  • NPB OxiMax Pulse Oximeter System With N-595 Pulse Oximeter, K012891
  • NPB Oximax N-550, K021090

To fulfill your request for acceptance criteria and a study proving device performance, the document would need to include details of specific performance metrics (e.g., accuracy, precision) tested against predetermined acceptance thresholds, along with the methodology and results of such testing. This information is not present in the provided text, which focuses on regulatory submission details and comparison to predicate devices.

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