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The intended use of the Mercury module with Capnostat 5 is to provide:

• spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.

The Mercury module with Capnostat 5 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography in all of these clinical settings. It is intended to serve the same purposes as the Mercury module with Capnostat 5. The submitted Mercury module with Capnostat 5 is identical to the cleared Mercury Module with Capnostat 5 CO2 sensor. except the nominal upper limit for the specification for the neonatal flow and neonatal CO2/flow sensors used with the Mercury module has been increased from 25 to 30 LPM to align with the specification for maximum inspiratory flow for ventilators cleared for use with neonates. The Mercury module with Capnostat 5 is intended to provide continuous monitoring of respiratory flow and pressure, and CO2 during anesthesia and intensive care and in the emergency department. The flow sensors connect to a patient airway circuit and provide physiological information to the Mercury module. The parameters directly measured and computed by the module (when connected to a Capnostat 5 sensor) include airway flow and pressure, volume, and CO2. The monitor calculates flow by measuring the pressure drop across a known resistance placed in the breathing circuit. CO2 is measured as the absorption of a known intensity of infrared light by CO2 molecules in the airway.

This document describes a Special 510(k) for a device modification, specifically an increase in the nominal upper limit for the specification for neonatal flow and neonatal CO2/flow sensors from 25 to 30 LPM on the Mercury Module with Capnostat 5 CO2 sensor. The submission asserts that the device is "identical" to the predicate device except for this specification change, which was made to align with maximum inspiratory flow for ventilators cleared for use with neonates.

Because this is a Special 510(k) for a minor modification, the typical structure of a comprehensive de novo submission with detailed performance studies and acceptance criteria as outlined in your prompt is not present. Special 510(k)s often rely on demonstrating that the change does not significantly affect safety or effectiveness, often by showing that the modified device still meets existing performance standards or by providing limited testing related only to the change.

Therefore, many of the specific details you requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for a full-scale AI/ML device validation are not available in this type of submission.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI/ML context:

Acceptance Criteria and Device Performance Study (K092217)

This submission is a Special 510(k) for a minor modification to an existing device (Mercury Module with Capnostat 5 CO2 sensor). The modification involves increasing the nominal upper limit for the specification for neonatal flow and neonatal CO2/flow sensors from 25 to 30 LPM. This type of submission relies on demonstrating substantial equivalence to a predicate device and that the change does not significantly affect safety or effectiveness.

Due to the nature of this submission (a device modification rather than a new device), the provided text does not contain explicit performance acceptance criteria or detailed study results in the manner one would expect for a novel AI/ML device. Instead, the focus is on the equivalence to the predicate device and the justification for the specification change.

The primary "acceptance criterion" for this Special 510(k) appears to be that the modified device remains substantially equivalent to the cleared predicate device (K080652) and that the change aligns with existing standards for neonatal ventilators.

Based on the provided text, a formal "study" with specific performance metrics and statistical analyses (as would be typical for an AI/ML product) is not described. The manufacturer states that the device is "identical" except for the changed specification.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this Special 510(k), explicit performance acceptance criteria are not detailed in the provided text. The "acceptance" is implied by the FDA's decision of substantial equivalence.

The following points cannot be answered definitively from the provided text as it pertains to a hardware device modification, not an AI/ML algorithm requiring such specific validation details.

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

• Not Applicable/Not Provided: For a hardware modification like this, a "test set" in the context of AI/ML validation (e.g., a dataset of images or patient records) is not relevant. The testing would involve verifying the hardware's performance characteristics. Details on such testing (e.g., number of units tested, conditions) are not in this summary.

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

• Not Applicable/Not Provided: Ground truth in the AI/ML sense (e.g., expert labels for clinical conditions) is not relevant for this hardware modification. The "ground truth" for the modified specification would likely be established through engineering design, material specifications, and performance verification against known physical standards, rather than expert clinical consensus.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not Applicable/Not Provided: This method is used in AI/ML studies to resolve discrepancies in expert annotations. It is not relevant to the validation of a hardware device's technical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• Not Applicable/Not Provided: MRMC studies are specific to evaluating clinical performance of AI/ML tools used by human readers. This submission concerns a physical sensor's performance.

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

• Not Applicable/Not Provided: This pertains to AI/ML algorithm performance independent of human interpretation. It is not relevant for a hardware sensor.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Not Applicable/Not Provided: The "ground truth" for this device's performance would likely be based on physical measurements against calibrated standards, engineering specifications, and established physiological ranges for neonatal respiration, rather than clinical consensus, pathology, or outcomes data in the AI/ML context.

8. The Sample Size for the Training Set

• Not Applicable/Not Provided: "Training set" refers to data used to train an AI/ML model. This device is a hardware sensor, not an AI/ML algorithm.

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

• Not Applicable/Not Provided: As above, this concept refers to AI/ML model development and is not applicable to this hardware device modification.

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The intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.

The Capnostat 5 CO2 sensor is designed for continuous, non-invasive monitoring of carbon dioxide .. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters are already legally marketed as accessories to the predicate device. The Capnostat 5 CO2 sensor is an integrated microprocessor based data acquisition system consisting of CO2 measurement, control circuitry and a high speed serial interface. The Capnostat 5 CO2 sensor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the Capnostat 5 CO2 sensor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for NoO. O2 and barometric pressure.

This 510(k) submission describes a device modification to an existing CO2 sensor, the Capnostat 5 CO2 sensor. The core of the submission is about demonstrating that the modified device is substantially equivalent to its predicate device (Capnostat III sensor in Tidal Wave Sp. Model 710/715 [510(k) K032971]). For devices like this, the "acceptance criteria" are typically related to performance specifications that show the device functions as intended and is safe and effective, similar to the predicate. The study would then demonstrate that these specifications are met.

However, the provided text does not contain a detailed study section with explicit acceptance criteria, results, and specific study parameters like sample sizes, expert qualifications, or ground truth methods. The document is primarily a 510(k) summary, which focuses on describing the device, its intended use, and its technological characteristics in comparison to a predicate device. It confirms substantial equivalence based on these characteristics and mentions that the device is a modification.

Therefore, many of the requested fields cannot be filled directly from the provided text. I will explain why each field cannot be filled, or what can be inferred if any information is available.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document describes the technical function of the CO2 sensor (infrared absorption, beam splitter, pulsed IR source, calibration to a known CO2 concentration) but does not provide specific numerical acceptance criteria or performance results from any studies. For a device modification of this nature, performance data (e.g., accuracy against a known gas mixture, stability over time, performance in different temperature/humidity conditions) would typically be part of the supporting documentation but is not included in this 510(k) 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: Not provided.
• Data Provenance: Not provided.

Explanation: No specific performance study data, including sample sizes or data provenance (e.g., whether a clinical study was performed, and if so, where and when), is mentioned in this summary.

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 provided.
• Qualifications of Experts: Not applicable/Not provided.

Explanation: This type of device (CO2 sensor) typically doesn't use human expert ground truth in the way an imaging AI algorithm would. Its ground truth would be established by reference gas mixtures or another highly accurate, independently verified CO2 measurement device. No details on such a "ground truth" establishment are provided, nor are human experts relevant for this specific device.

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

• Adjudication Method: Not applicable/Not provided.

Explanation: As explained above, human expert adjudication methods are not typically used for establishing ground truth for a CO2 sensor's performance.

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.

Explanation: This is a hardware CO2 sensor, not an AI diagnostic tool that assists human readers with interpretation. Therefore, a MRMC study is not applicable.

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

• Standalone Performance: Partially yes, but specific study details are not provided.

Explanation: The device itself is designed for standalone measurement of CO2. The description focuses on its technical mechanism (IR absorption, calibration) which implies standalone performance is its primary function. However, no specific "standalone study" with quantifiable results is documented in this summary. The device's performance is inherently "standalone" in how it acquires and processes CO2 data.

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

• Type of Ground Truth: Not explicitly stated, but for this type of device, it would typically be a reference gas analyzer or known, certified CO2 gas mixtures.

Explanation: The text mentions "To calibrate, the photodetector's response to a known concentration of CO2 is stored in the monitor at the factory." This implies that the ground truth for calibration (and by extension, for evaluating accuracy) comes from controlled, known CO2 concentrations.

8. The sample size for the training set

• Sample Size: Not applicable/Not provided.

Explanation: This device is a hardware sensor with embedded firmware, not a machine learning model that undergoes a "training set" in the conventional AI sense. Its calibration is done at the factory with known CO2 concentrations, but this is a calibration process, not a machine learning training process.

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

• Ground Truth Establishment: Not applicable/Not provided in terms of a "training set" for AI.

Explanation: As mentioned above, the concept of a "training set" and associated ground truth establishment for AI models does not directly apply to this device. Its accuracy is established through calibration against known CO2 concentrations, which serves a similar function to ground truth validation in a traditional engineering context.

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The intended use of the TidalWave Sp (Models 710/715) is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care. Separate airway adapters are provided for pediatric/adult and neonatal/pediatric use.

The Tidal Wave Models 710/715 handheld combined pulse oximeter/capnograph are designed for continuous, non-invasive monitoring of carbon dioxide and functional oxygen saturation. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters and O2 saturation sensors are already legally marketed as accessories to the Model 610 and Model 510 monitors, respectively. The TidalWave Sp monitor is a microprocessor based data acquisition system consisting of CO2 and SpO2 measurement, control circuitry and a high speed serial interface. The monitor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the TidalWave Sp monitor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for N2O, O2 and barometric pressure.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tidal Wave Sp, Models 710/715 device. It's important to note that the provided document is a 510(k) summary (K032971) which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study report with all the specific data points requested in your prompt. Therefore, some of the information you asked for may not be explicitly stated or not applicable in this type of submission.

Acceptance Criteria and Device Performance for Tidal Wave Sp, Models 710/715

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list quantitative acceptance criteria in a formal table like a performance specification. Instead, it states that "inter-device comparison studies were conducted to establish the TidalWave Sp accuracy and to ensure that the sensors meet their currently published accuracy specifications with the specified predicate devices."

The key performance indicators are implied to be accuracy for CO2 measurement and accuracy for SpO2 and pulse rate measurement.

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

The document does not explicitly state the sample sizes (number of patients or measurements) used for the "inter-device comparison studies."

• Data Provenance: Not explicitly stated, but the submission is from Respironics Novametrix, Inc. in Wallingford, CT, USA. Given the context of a 510(k) submission to the FDA, it is highly likely that the testing was conducted in a controlled environment, potentially with healthy volunteers or clinical patients. The studies were retrospective in the sense that they were comparing the new device's performance against established predicate devices rather than observing real-world outcomes over a long period.

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

This information is not provided in the summary. For devices like pulse oximeters and capnographs, the "ground truth" for accuracy is typically established by using highly accurate, calibrated reference measurement devices (e.g., co-oximeters for SpO2, calibrated gas analyzers for CO2) rather than expert consensus.

4. Adjudication Method for the Test Set

This is not applicable and not mentioned. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret medical images or clinical data, and their interpretations need to be reconciled to establish a ground truth. For objective physiological measurements like CO2 and SpO2, adjudication by experts is not the standard method for establishing ground truth.

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

No, an MRMC comparative effectiveness study was not conducted or reported. MRMC studies are primarily relevant for AI-powered diagnostic tools interpreting complex medical data where human readers are involved. This device is a physiological monitor providing objective measurements, not an interpretative AI tool that assists human readers.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation of the device's algorithms was implied and conducted as part of the "inter-device comparison studies." The device's SpO2 and pulse rate algorithms are explicitly stated to be "identical" to the predicate device (Model 510 Pulse Oximeter). The CO2 algorithm is based on established IR absorption linearity and factory calibration to known concentrations. The "accuracy" reported for these measurements is inherently the standalone performance of the device's algorithms and sensors against reference standards.

7. Type of Ground Truth Used

Based on the description of the devices (pulse oximeter/capnograph):

• For CO2: Ground truth would typically be established using calibrated gas analyzers with known CO2 concentrations. The document mentions "the photodetector's response to a known concentration of CO2 is stored in the monitor at the factory," implying calibration against such standards.
• For SpO2: Ground truth would typically be established using laboratory co-oximetry (or similar invasive arterial blood gas analysis) which is considered the gold standard for measuring fractional oxygen saturation in blood.
• For Pulse Rate: Ground truth would likely be established using simultaneous ECG monitoring or other highly accurate cardiac rhythm detection methods.

8. Sample Size for the Training Set

This information is not provided and is largely not applicable in the context of this device. The Tidal Wave Sp is described as a traditional physiological monitor, not an AI/machine learning device that relies on a "training set" in the modern sense. Its algorithms are based on established biophysical principles (infrared absorption, light absorption by hemoglobin) and fixed factory calibrations, not statistical learning from a large dataset.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of modern AI/ML for this device, this question is not applicable. The device's operational parameters and calibration are set at the factory based on known physical properties and reference standards (e.g., known CO2 concentrations, specific light absorption properties of hemoglobin).

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The Model 512 Handheld Pulse Oximeter is intended to provide non-invasive spot checking of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport.

The Model 513 Handheld Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport.

The monitor and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgment of a licensed medical practitioner.

The Model 512/53 Pulse Oximeters are designed for non-invasive measurement of the functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as successories to the Model 510 monitor. The Model 510 displays digital values of SpO2 and pulse rate. The Model 512/513 consists of a microprocessor based data acquisition system that measures oxygen saturation data. The Model 513 also contains additional circuitry to support battery backed trend data storage and retrieval. Data is stored in a 16Kbyte serial Flash RAM, with time and date retrieved from a separate serial real time clock. The trend data may be transferred serially to a printer or PC via an IRDA compatible chipset.

Acceptance Criteria and Device Performance for Model 512/513 Pulse Oximeter

The provided document describes the predicate device equivalence of the Model 512/513 Pulse Oximeter, rather than a standalone study with defined acceptance criteria and performance metrics for the new device. The core of the submission relies on demonstrating that the Model 512/513 is substantially equivalent to the legally marketed Model 510 Pulse Oximeter and that its sensors meet the currently published accuracy specifications of the Model 510.

Therefore, the "acceptance criteria" for the Model 512/513 can be inferred as meeting or performing comparably to the Model 510's established accuracy specifications. The document does not explicitly state these numerical specifications for the Model 510, nor does it provide specific novel performance data for the Model 512/513 beyond stating that "inter-device comparison studies were conducted to establish the Model 512/513s accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 510."

However, based on the information provided, we can structure the response by inferring the likely acceptance criteria based on standard pulse oximetry requirements and what is typically tested for equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given the lack of explicit numerical acceptance criteria for the Model 512/513 in the provided text, and the reliance on demonstrating equivalence to the Model 510, the table below reflects this approach. The "Reported Device Performance" is derived from the statement that the device meets the predicate's specifications.

Note: The FDA's Oximeter regulation (21 CFR 870.2700) typically requires accuracy testing against arterial blood gas (SaO2) measurements over a range of saturations (e.g., 70-100% SpO2), often using hypoxic challenge studies. The absence of these specific details indicates that the submission focuses on predicate equivalence through comparison studies, implying the Model 510 already met these regulatory standards.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "inter-device comparison studies were conducted," but details on the number of subjects, measurements, or data points are absent.
• Data Provenance: Not explicitly stated. The document does not mention the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of medical device testing for regulatory submission, it is highly probable these were prospective clinical studies, but this is not confirmed in the text.

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

• Number of Experts: Not applicable/not stated in the context of expert review for ground truth in this submission. The ground truth for pulse oximetry accuracy studies is typically established through direct arterial blood gas (SaO2) measurements performed by trained medical personnel, not by a panel of experts reviewing images or other subjective data.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Pulse oximetry accuracy studies generally rely on direct physiological measurements (arterial blood gas analysis) as the gold standard, rather than expert adjudication of subjective assessments.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is assessed. This device is a measurement device, not an interpretive one.

6. Standalone Performance Study (Algorithm only without human-in-the-loop)

• Standalone Study: Yes, in essence, the "inter-device comparison studies" to establish the Model 512/513's accuracy and ensure sensors meet published specifications of the Model 510 represent a standalone performance assessment of the device's measurement capabilities. While not using the explicit term "standalone study," the objective of these comparisons was to verify the device's inherent accuracy in measuring SpO2 and pulse rate, independent of a human interpreting its output.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for pulse oximetry accuracy is typically established by arterial blood gas (SaO2) measurements, which are considered the gold standard for arterial oxygen saturation. While not explicitly stated in the provided text, this is the standard methodology for validating pulse oximeter accuracy.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not stated. The document indicates that the Model 512/513 uses the "identical SpO2 and pulse rate software algorithm" as the predicate device, Model 510. This implies the algorithm was already developed and validated with the Model 510. There is no mention of a new algorithm requiring a separate training set for the Model 512/513, suggesting it leverages the existing, validated algorithm from the predicate device.

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

• How Ground Truth for Training Set Was Established: Not applicable. As the Model 512/513 uses the identical algorithm from the predicate device (Model 510), any "training" would have occurred during the development of the Model 510. The document does not provide details on the training set or ground truth establishment for the Model 510's algorithm development. It focuses solely on the equivalence of the 512/513 to the already-cleared 510.

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The intended use of the NICO with MARS, Model 7300, monitor is to provide:

• cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
• spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
• continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED).

The use of the NICO with MARS, Model 7300, monitor for cardiac output monitoring is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO2 level cannot be tolerated.

The NICO with MARS, Model 7300, is a patient monitor capable of monitoring a patient's cardiac output, spirometry, carbon dioxide, and functional oxygen saturation and pulse rate. In addition, the Model 7300 is capable of communicating with a variety of patient information systems, including the Respironics Esprit ventilator.

The provided text describes a special 510(k) submission for a device modification, specifically an interface for the NICO with MARS, Model 7300 monitor to communicate with the Respironics Esprit ventilator. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical study data to establish acceptance criteria and prove device performance in the same way a new device might.

Therefore, many of the requested elements regarding acceptance criteria, study details, expert involvement, and ground truth are not present or not directly applicable in this specific regulatory submission. The document mainly outlines the device's intended use, technological characteristics, and compares it to a predicate device (K030886 - NICO with MARS, Model 7300).

However, I can extract the information that is present and indicate where the requested information is not available from the provided text.

Acceptance Criteria and Device Performance:

The document does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., accuracy, precision) for the communication interface. Instead, the "acceptance" is based on the demonstration of substantial equivalence to a predicate device, meaning the modified device performs as intended without raising new questions of safety or effectiveness.

The "reported device performance" in this context refers to the inherent performance of the NICO with MARS, Model 7300, for which the communication interface is being added. The document reiterates its original intended uses and technological characteristics.

• Cardiac output via partial rebreathing in adult patients mechanically ventilated during general anesthesia and in ICU.
• Spirometric and CO2 monitoring in neonatal, pediatric, and adult patients during general anesthesia, ICU, and ED.
• Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric, and adult patients during no motion and motion conditions, and for well or poorly perfused patients during general anesthesia, ICU, and ED.

The monitor uses:

• Flow sensors and pneumatics for flow measurement (proportional to pressure drop).
• Infrared absorption (IR) technique for CO2 monitoring.
• Red and infrared light sources in sensors for oxygen saturation and pulse rate (plethysmogram and MARS technology's frequency-based algorithm).
• Non-invasive differential Fick partial re-breathing technique for cardiac output.
• Bidirectional serial communications (ASCII/scaled binary digits) and analog outputs for external devices, including Respironics Esprit Ventilator. |
  | No new questions of safety or effectiveness are raised. | The submission states: "The NICO with MARS, Model 7300, monitor with NICO to Esprit Communications Interface has the same intended use as the predicate monitor [K030886]." This implies that the safety and effectiveness profile is maintained. |

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

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

   • Not provided. This document describes a 510(k) for a device modification, specifically a communication interface. It does not mention a clinical test set or data from a study to establish performance for this particular modification. The focus is on demonstrating substantial equivalence to the predicate device.

2. 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 provided. Since no specific test set or clinical study data is presented for this modification, there's no mention of experts establishing a ground truth for such a set.

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

   • Not applicable / Not provided.

4. 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 medical monitoring device, not an AI-assisted diagnostic tool. No MRMC study or AI components are mentioned.

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

   • Not applicable. This device integrates with human operation as a monitor. The "standalone" performance would refer to the device's function in monitoring, which is described in its technological characteristics, but not as an "algorithm only" in the context of AI. The communication interface itself is a technical component, not a standalone algorithm.

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

   • Not applicable / Not provided for this modification. For the original device, performance would likely have been validated against established reference methods for cardiac output, CO2, spirometry, and pulse oximetry, but this detail is not in the provided modification summary.

7. The sample size for the training set:

   • Not applicable / Not provided. The device does not appear to use machine learning in a way that would require a "training set" in the context of AI development.

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

   • Not applicable / Not provided.

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The Model 509M Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospital, hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units.

The Model 509M Pulse Oximeter Module is designed for continuous, non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as accessories to the Model 2001 monitor. The Model 509M displays digital values of SpO₂ and pulse rate and transmits these values as well as the plethysmogram to a Philips Monitoring System via the VueLink Interface. The Model 509M module consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the primary microprocessor is responsible for handling the user interface and communications with external devices via VueLink interface. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the algorithms which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected.

The provided 510(k) summary for the K032755 (Model 509M Pulse Oximeter) does not contain a specific table of acceptance criteria or detailed results from a study proving device performance against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device (Model 2001 Pulse Oximeter, K993979, K000794) and mentions "inter-device comparison studies" to establish accuracy and sensor compatibility.

However, based on the information provided, we can infer some aspects related to acceptance criteria and the nature of the "study."

Here's an attempt to structure the information, acknowledging the limitations of the provided document:

Acceptance Criteria and Study for K032755 (Model 509M Pulse Oximeter)

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria (e.g., specific SpO2 accuracy ranges with mean absolute difference (MAD) or root mean square (RMS) error). However, it implies that the device is expected to meet the accuracy specifications of its legally marketed sensors, which were previously cleared with the predicate device (Model 2001).

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

• Sample Size: The document does not specify the sample size for the "inter-device comparison studies."
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It just states "inter-device comparison studies were conducted."

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

The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for the "inter-device comparison studies." For pulse oximeters, ground truth for SpO2 typically involves co-oximetry of arterial blood samples, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe any human interpretation or adjudication process for establishing ground truth or evaluating device performance. For pulse oximetry, the ground truth is typically a direct physiological measurement, not an adjudicated expert opinion.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging devices where human readers interpret medical images, and the AI's impact on their performance is being evaluated. The Model 509M is a physiological monitoring device.

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

Yes, a standalone evaluation of the device's accuracy was implicitly done through the "inter-device comparison studies." The summary states these studies were conducted "to establish the Model 509Ms accuracy" and "to ensure that the sensors meet their currently published accuracy specifications with the Model 2001." This refers to the device's ability to accurately measure SpO2 and pulse rate, independent of a human operator's interpretation of its output.

7. The type of ground truth used

The type of ground truth used for pulse oximeter accuracy studies is typically co-oximetry of arterial blood samples. While not explicitly stated in this summary, this is the standard for SpO2 accuracy validation, and it is implied that the "inter-device comparison studies" would have referred to such objective physiological measurements for establishing accuracy reference.

8. The sample size for the training set

The document states: "The Model 509M uses the identical SpO2 and pulse rate software algorithm to process the information from the sensor as the predicate device, Model 2001 Pulse Oximeter, cleared under K993979 and K000794." This implies that the algorithm itself has been previously developed and validated with the predicate device. The summary does not provide any information regarding a training set specifically for the Model 509M, as it utilizes an existing, cleared algorithm.

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

Since the Model 509M uses an "identical" algorithm to the predicate device (Model 2001), the ground truth for any original algorithm development (what might be considered a "training set" for the algorithm itself) would have been established during the development and clearance of the Model 2001 Pulse Oximeter (K993979, K000794). This would typically involve co-oximetry of arterial blood samples across a range of oxygen saturations in human subjects, as per ISO or FDA guidance for pulse oximeters. The current submission does not describe this historical training data or its ground truth establishment, as it primarily relies on demonstrating equivalence and sensor compatibility for the new device variant.

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The intended use of the NICO monitor, Model 7300 is to provide:

• cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
• spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
• continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED).
  The use of the NICO monitor Model 7300 for cardiac output monitoring is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO2 level cannot be tolerated.

The NICO monitor Model 7300 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography and pulse oximetry in all of these clinical settings. As is its predicate device CO2SMO Plus! with NICO, NICO with MARS is designed to use neonatal, pediatric, and adult combined CO2/flow sensors and single patient use or reusable pulse oximetry sensors. It non-invasively calculates cardiac output using established physiological principles by the application and removal of a rebreathed volume in a patient's breathing circuit and the analysis of that response. The NICO with MARS is intended to provide cardiac output monitoring in mechanically ventilated patients in the operating room and intensive care units. It is intended to serve the same purposes as the CO2SMO Plus! with NICO and MARSPO2, Model 2001.

Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as accessories to the Model 2001 monitor. As the Model 2001 monitor, the Model 7300 with MARS consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected.

The Model 7300 can be powered by either an internal power supply operating on AC or by a sealed rechargeable lead-acid gel battery. Audible and visual alarms for high/low saturation and pulse rate are available. There is also a serial port that provides user configurable data output capable of communicating with printers and other devices.

Here's an analysis of the provided text regarding the NICO, Model 7300, focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary, specific acceptance criteria and detailed study results demonstrating performance against these criteria are not explicitly stated or fully detailed. The document primarily focuses on establishing substantial equivalence to predicate devices and describes the device's technological characteristics and intended use.

However, it does mention a specific study for pulse oximetry accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical acceptance criteria. The "Reported Device Performance" is inferred from the description of the study and the claim of meeting specifications.

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

• Sample Size for Pulse Oximetry Accuracy: The document states "controlled hypoxia studies were conducted." It does not specify the sample size (number of subjects) for these studies.
• Data Provenance: The studies were evidently conducted by Respironics Novametrix Inc., likely in the USA (where the company is based). The studies were conducted prospectively for the purpose of demonstrating the device's accuracy.

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

• The document does not specify the number or qualifications of experts used to establish ground truth. For pulse oximetry, the ground truth would likely be established using a co-oximeter or arterial blood gas analysis, which are considered gold standards, overseen by clinical professionals.

4. Adjudication Method for the Test Set

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

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

• No, an MRMC comparative effectiveness study was not mentioned or described. This document does not describe studies comparing human readers' performance with and without AI assistance. The device is a monitor, not an AI-assisted diagnostic tool for human interpretation in the sense of image reading.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was performed for the pulse oximetry component. The "controlled hypoxia studies" were designed to establish the accuracy of the Model 7300's pulse oximetry function and its integrated sensors. This implies assessing the algorithm's performance in measuring oxygen saturation against a known reference in a controlled environment. The document also mentions the "firmware for the second microprocessor... performs the filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction." This directly points to evaluating the algorithm's output.

7. Type of Ground Truth Used

• For pulse oximetry, the ground truth for the "controlled hypoxia studies" would typically be established using a co-oximeter to measure arterial oxygen saturation (SaO2) from arterial blood samples. This is considered the clinical gold standard for arterial oxygen saturation.

8. Sample Size for the Training Set

• The document does not specify a training set sample size. While the pulse oximetry algorithms use "existing algorithms" and mention "additional calculations which analyze the incoming signals and perform noise reduction," there is no mention of a distinct training phase or a specific dataset used for training machine learning models in the context of this 2003 submission. The algorithms are likely based on established physiological principles and signal processing, rather than modern data-driven machine learning with explicit training sets as understood today.

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

• As a training set is not explicitly mentioned in the context of modern machine learning model development, the method of establishing ground truth for a training set is not applicable/not provided in this document. The underlying principles and parameters for the device's algorithms (e.g., ratiometric technique for O2 saturation) are based on fundamental scientific understanding rather than a data-driven training process.

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