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The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOV, E-sCAiOVX) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric patients.

When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy.

These modules are intended for use by qualified medical personnel only.

The CARESCAPE Respiratory Modules E-sCO, E-sCOV, EsCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate), ventilatory parameters (airway pressure, flow and breathing volumes) and gas exchange parameters (oxygen consumption and carbon dioxide production) of hospital patients.

Parameters measured by the CARESCAPE Respiratory Modules are CO2, N2O, O2, Anesthetic agents, Agent ID, Spirometry, oxygen consumption (VO2) and carbon dioxide production (VCO2) depending on the model used. The CARESCAPE Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPE Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE Respiratory Modules acquire the signals detected by the module sensors, calculate the parameter values and communicate them to the host device. The CARESCAPE Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system.

The CARESCAPE Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host devices based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.

This Special 510(k) introduces two new spirometry accessories: 2104297-001 D-lite++ Patient Spirometry Set. 2m/7ft and 2104297-002 D-lite++ Patient Spirometry Set, 3m/10ft. The design of the D-lite++ Patient Spirometry Sets is based on the design of previously cleared accessories 8004381 D-lite+ Spirometry Kit, adult, 2m/7ft and 8004382 D-lite+ Spirometry Kit, adult, 3m/10ft (510(k) K171028) used for spirometry, gas exchange and gas measurement and owned by GE Healthcare Finland Oy. The main modifications are in the design of the spirometry sensor part of the product; the gas sampling line connector shape and location have been modified and spirometry connector internal volumes have been expanded. The only new material introduced is cyanoacrylate glue CB 2011 used for attaching the spirometry connector to the sensor body. The only new manufacturing method introduced is ultrasonic welding used for attaching the gas sampling line connector to the sensor body. The CARESCAPE Respiratory Module measurement specifications are unaffected except for a minor decrease in gas exchange VO2 and VCO2 accuracy specifications with respiration rates above 30 breaths/min when the measurement is performed using the D-lite++ Patient Spirometry Sets. The specification change does not raise different questions of safety or effectiveness of the CARESCAPE Respiratory Modules.

There are no changes to indications for use, hardware, software, mechanics or electrical safety of the CARESCAPE Respiratory Modules due to the D-lite++ Patient Spirometry Sets. The introduction of the D-lite++ Patient Spirometry Sets does not add or change the functionality or fundamental scientific technology of the CARESCAPE Respiratory Modules. The D-lite++ Patient Spirometry Sets employ the same fundamental scientific technology as the existing accessories 8004381 D-lite+ Spirometry Kit, adult, 2m/7ft and 8004382 D-lite+ Spirometry Kit, adult, 3m/10ft used for spirometry, gas exchange and gas measurement with the CARESCAPE Respiratory Modules.

The provided text describes a Special 510(k) submission for the CARESCAPE Respiratory Modules, focusing on the introduction of new spirometry accessories (D-lite++ Patient Spirometry Sets). The crucial aspect for this request is that no clinical studies were conducted, as noted in "Summary of Clinical Tests: The subject of this premarket submission... did not require clinical studies to support substantial equivalence."

Instead, the submission relies on bench testing to demonstrate that the modified device performs as intended and within specifications, particularly concerning spirometry, gas exchange, and gas accuracy measurements when the new accessories are used. The report explicitly states, "Bench testing supports the substantial equivalence determination of the modified CARESCAPE Respiratory Modules when compared to the predicate device."

Therefore, many of the requested elements, such as the number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for a clinical test set, are not applicable to this submission because no clinical study was performed.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "The CARESCAPE Respirator Module measurement specifications are unaffected except for a minor decrease in gas exchange VO2 and VCO2 accuracy specifications with respiration rates above 30 breaths/min when the measurement is performed using the new accessories." It also states that the device "perform[s] as intended and within specification." However, specific quantitative acceptance criteria and their corresponding reported performance values for spirometry, gas exchange, and gas accuracy are not detailed in the provided text. The text implies that the device meets its own specifications with the minor adjustment mentioned.

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

• Sample Size for Test Set: Not specified, as "bench testing" was performed rather than a human-patient-based clinical test set. The testing involved verification of spirometry, gas exchange, and gas accuracy measurements, and tightness of ultrasonic welding.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory or manufacturing environment, likely in Finland where GE Healthcare Finland Oy is located. It is retrospective in the sense that it evaluates the modified device's performance against existing specifications.

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

• Not applicable. No clinical test set requiring expert ground truth was performed.

4. Adjudication method for the test set:

• Not applicable. No clinical test set requiring adjudication was performed.

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. No MRMC comparative effectiveness study was done. This device is a respiratory module and accessories, 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:

• Not applicable in the typical sense of an algorithm's standalone performance. The testing performed was related to the device's measurement accuracy and physical integrity. The device itself (CARESCAPE Respiratory Modules) operates in conjunction with a host device and is intended for use by qualified medical personnel, but its primary function is measurement, not algorithmic interpretation requiring human-in-the-loop comparison.

7. The type of ground truth used:

• For the bench testing, the "ground truth" would be the known, precise values generated by calibration equipment or reference standards against which the device's measurements (spirometry, gas exchange, gas concentrations) were compared. This is a scientific, instrument-based ground truth.

8. The sample size for the training set:

• Not applicable. This submission describes modifications to an existing device and its accessories, not a new AI/ML algorithm that requires a training set.

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

• Not applicable. No training set was used.

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The CARESCAPE Respiratory Modules (E-SCO, E-SCOV, E-SCOVX, E-sCAIO, ESCAIOV, E-SCAIOVX) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric patients.
When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy.
These modules are intended for use by qualified medical personnel only.

The CARESCAPE Respiratory Modules E-sCO, E-sCOV, EsCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories measure respiratory parameters (concentrations of Carbon Dioxide. Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate), ventilatory parameters (airway pressure, flow and breathing volumes) and gas exchange parameters (oxygen consumption and carbon dioxide production) of hospital patients.
Parameters measured by the CARESCAPE Respiratory Modules are CO2. N2O. O2. Anesthetic agents, Agent ID, Spirometry, oxygen consumption (VO2) and carbon dioxide production (VCO2) depending on the model used. The CARESCAPE Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPE Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE Respiratory Modules acquire the detected signals from the sensors of the modules, calculate the parameter values and communicate them to the host device. The CARESCAPE Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system.
The CARESCAPE Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host devices based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.

The provided document is a 510(k) premarket notification for the GE Healthcare CARESCAPE Respiratory Modules. This document describes the device, its intended use, and its substantial equivalence to a predicate device (K150245). It does not contain information about acceptance criteria and study data for the device's performance that would typically be found in a clinical study report.

Here's a breakdown of why the requested information cannot be fully provided from this document:

1. A table of acceptance criteria and the reported device performance: This document states that "The CARESCAPE Respiratory Modules and accessories is as safe and effective as the predicate device" and that "Performance testing (Verification)" was conducted. However, it does not explicitly list quantitative acceptance criteria or the specific performance results against those criteria (e.g., accuracy, precision, bias for gas measurements). It only indicates that "an evaluation was performed to account for gas return connection and gas return filter impact on the gas measurement accuracy, sample flow measurement accuracy as well as pump and filter lifetime."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document states that no clinical studies were required, and non-clinical tests were performed. It does not provide details on sample sizes for these tests 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): This information is not present as the document focuses on device modifications and compliance with standards rather than clinical validation involving expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as expert adjudication for a test set is not described.

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: This is not applicable. The device is a respiratory gas module, 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: The document describes a medical device, not an AI algorithm in the context of standalone performance studies for AI. Its performance is inherent to its sensors and processing of physiological parameters.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, ground truth would typically refer to established reference measurements or calibrated standards. The document doesn't explicitly detail the "ground truth" methods used for the non-clinical evaluations but implies standard metrological practices for testing medical devices.

8. The sample size for the training set: Not applicable, as there's no mention of a machine learning or AI training set.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary based on the provided document:

The document focuses on demonstrating substantial equivalence to a predicate device (K150245) for premarket notification, particularly highlighting that recent modifications do not introduce new technology or software. The changes mainly involve the addition of a "sample gas return feature."

Here's what can be extracted regarding the study that proves the device meets the acceptance criteria (though specific criteria and results are generalized):

Study Type: Non-clinical testing and evaluation were performed. No clinical studies were required.

Purpose of the Study: To ensure that the addition of the sample gas return feature and ongoing product maintenance activities do not affect product safety and performance, and that the device remains substantially equivalent to its predicate.

Specific Evaluations Mentioned:

• Evaluation of gas return connection and gas return filter impact on:
  • Gas measurement accuracy
  • Sample flow measurement accuracy
  • Pump and filter lifetime
• System level Volatile Organic Component (VOC) and particulate matter testing for new components and materials in the dry gas path.

Table of Acceptance Criteria and Reported Device Performance (Generalized based on the document):

Data Provenance and Sample Size:

• Sample Size (Test Set): Not specified in the document. The testing was non-clinical (laboratory/bench testing).
• Data Provenance: Implied to be from GE Healthcare's internal testing facilities (Finland, given the company's address).
• Retrospective/Prospective: Non-clinical verification and validation testing would typically be prospective (designed to verify specific requirements).

Ground Truth: For non-clinical tests, ground truth would be established through calibrated reference instruments and known gas concentrations. Specific details are not provided.

Training Set: Not applicable as this is not an AI/ML device in the context of self-learning algorithms.

In essence, this document serves as a regulatory submission arguing for equivalence based on adherence to standards and internal non-clinical evaluations, rather than a detailed report of a clinical performance study with specific acceptance criteria and outcome data as one might expect for a novel device or AI algorithm.

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The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOV, E-sCAiOVX) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric patients.
When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy. These modules are intended for use by qualified medical personnel only.

The CARESCAPE Respiratory Modules, E-sCO, E-sCOV, sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate), ventilatory parameters (airway pressure, flow and breathing volumes) and gas exchange parameters (oxygen consumption and carbon dioxide production) of hospital patients.
Parameters measured by the CARESCAPE Respiratory Modules are CO2, N2O, O2, Anesthetic agents, Agent ID, Spirometry, oxygen consumption (VO2) and carbon dioxide production (VCO2) depending on the model used. The CARESCAPE Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPE Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE Respiratory Modules acquire the detected signals from the sensors of the modules, calculate the parameter values and communicate them to the host device. The CARESCAPE Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system.
The CARESCAPE Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host monitors based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.

The provided text describes a medical device, the CARESCAPE Respiratory Modules, and its 510(k) submission to the FDA. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested. The document states that "Verification and validation testing was performed according to predetermined acceptance criteria," but it does not list these criteria or the reported device performance against them. Similarly, it mentions "Extensive non-clinical testing was performed to establish substantial equivalence," but doesn't provide the specifics of these tests in a way that would answer the questions about sample size, ground truth, or MRMC studies.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted or inferred, and what cannot:

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

• Cannot be provided. The document states that "Verification and validation testing was performed according to predetermined acceptance criteria," but it does not list these criteria or the reported performance against them.

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

• Cannot be provided. The document mentions "Extensive non-clinical testing," but does not specify sample sizes or data provenance for any test sets.

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)

• Cannot be provided. The document does not describe the establishment of a ground truth by experts for the test set.

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

• Cannot be provided. The document does not describe any adjudication methods for a test set.

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

• Cannot be provided. This is not an AI device in the context of image interpretation that would typically involve human readers. The text describes a respiratory monitoring module, not an AI-powered diagnostic tool for human interpretation. No MRMC study is mentioned.

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

• No specific details can be provided. The device itself is a measurement and monitoring module. The "performance testing (Verification)" and "Standard compliance testing (Verification)" would inherently involve assessing the algorithm's accuracy in measuring and calculating parameters without human intervention at the measurement level. However, specific details of these standalone tests, their methodology, or results are not included in the provided text.

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

• Cannot be explicitly stated for test sets. For the type of device described (respiratory gas modules measuring parameters like CO2, O2, N2O, anesthetic agents, etc.), ground truth would typically be established through highly accurate reference measurement devices or calibrated gas mixtures. However, the document does not specify how ground truth was established for any specific "test set."

8. The sample size for the training set

• Not applicable / Cannot be provided. The device implements a gas exchange algorithm ("oxygen consumption (VO2) and carbon dioxide production (VCO2)") that was available on a predicate device. This suggests an established algorithm rather than a machine learning model that requires a distinct "training set" in the common sense. The text does not mention any training sets for machine learning.

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

• Not applicable / Cannot be provided. As above, no training set for a machine learning model is mentioned.

Summary of what is present:

• Device: CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX)
• Purpose: Monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, respiratory rate), ventilatory parameters (airway pressure, flow, volume), and gas exchange parameters (VCO2, VO2).
• Indications for Use: Adult, pediatric, and neonatal patients.
• Validation statement: "Verification and validation testing was performed according to predetermined acceptance criteria, which concluded that the module and its applications are substantially equivalent to the predicate devices." and "Extensive non-clinical testing was performed to establish substantial equivalence of the CARESCAPE Respiratory Modules and its applications."
• Clinical studies: "The subject of this premarket submission, CARESCAPE Respiratory Modules... did not require clinical studies to support substantial equivalence."
• Technology change: The current submission adds models E-sCOVX and E-sCAiOVX with gas exchange calculation, leveraging an existing algorithm from a predicate device (Datex-Ohmeda S/5 Compact Airway Module). The software version is 2.
• Quality assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Final acceptance testing (Validation), Performance testing (Verification), Standard compliance testing (Verification).
• Standards compliance: A list of IEC and ISO standards the device was designed and tested for compliance with.

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