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510(k) Data Aggregation
(345 days)
The intended use of the ETCO2 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 ETCO2 Sensor is comprised of three main components, a sensor with photo detector and light emitter, cable and connector, The CO2 Sensor incorporates an infrared light source, of specified wavelength, and an infrared detector. The photo detector and light emitter end of the CO2 sensor is connected to an airway adapter. The airway adapter is connected between the patient airway and the respirator. As the patient completes an expiratory breath the sensor measures the CO2 levels in the expiratory breath and sends that data to the compatible CO2 monitor. The monitor then reads the data and converts the data so it can be displayed on screen.
This document is a 510(k) premarket notification for an ETCO2 Sensor (Model CTM-RP01), not a study report detailing specific acceptance criteria and performance of an AI/ML device. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is not present in this document.
The document focuses on demonstrating substantial equivalence to a predicate device (Capnostat 5 CO2 sensor, K042601) based on similar technological characteristics and performance specifications for a carbon dioxide gas analyzer.
Here's what can be extracted and what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides the performance specifications of the subject device (ETCO2 Sensor, Model CTM-RP01) and compares them to the predicate device. These specifications serve as de facto "acceptance criteria" through the lens of substantial equivalence.
| Acceptance Criteria (from Predicate Device Specifications) | Reported Device Performance (ETCO2 Sensor, Model CTM-RP01) | Comments |
|---|---|---|
| CO2 Measurement Range: 0 to 150 mmHg, 0 to 19.7% | 0 to 150 mmHg, 0 to 19.7% | Same |
| CO2 Resolution: 0.1 mmHg 0 to 69 mmHg; 0.25 mmHg 70 to 150 mmHg | 0.1 mmHg 0 to 69 mmHg; 0.25 mmHg 70 to 150 mmHg | Same |
| CO2 Accuracy: | Same | |
| 0 - 40 mmHg ± 2 mmHg | 0 - 40 mmHg ± 2 mmHg | |
| 41 - 70 mmHg ± 5% of reading | 41 - 70 mmHg ± 5% of reading | |
| 71 - 100 mmHg ± 8% of reading | 71 - 100 mmHg ± 8% of reading | |
| 101 - 150 mmHg ± 10% of reading | 101 - 150 mmHg ± 10% of reading | |
| Above 80 breath per minute ± 12% of reading | Above 80 breath per minute ± 12% of reading | |
| *NOTE: Gas temperature at 25°C | *NOTE: Gas temperature at 25°C | |
| Respiration Rate Range: 0 to 150 breaths per minute (bpm) | 0 to 150 breaths per minute (bpm) | Same |
| Respiration Rate Accuracy: ± 1 breaths per minute (bpm) | ± 1 breaths per minute (bpm) | Same |
| Voltage Requirements: 5.0 VDC ±5% | 5.0 VDC ±5% | Same |
| Interconnection: Lemo Redel 8-pin plastic | Lemo Redel 8-pin plastic | Same |
| Operating Temperature/Humidity: 0-45°C, 10-90% RH, non-condensing | 0-40°C, 15-85% RH, non-condensing | Similar |
| Storage Temperature/Humidity: -40-70°C, <90% RH, non-condensing | -10-40°C, <90% RH, non-condensing | Similar |
| Water Resistance: IPX4 – Splash-proof (sensor head only) | IPX2 – Splash-proof (sensor head only) | Similar |
| Compliance: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 80601-2-55 (Performance) | IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 80601-2-55 (Performance) | Same |
The following information is NOT available in the provided text:
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 states "Non-clinical test data" were used, including compliance with industry standards. It does not specify a "test set" in the context of data for an AI/ML device, nor does it provide sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as this is a medical device (sensor) and not an AI/ML diagnostic or predictive algorithm based on expert-labeled data. The performance criteria are met through physical measurements and engineering validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device and testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done. This device is a sensor performing direct measurements, not an AI assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device's performance is inherently standalone in its measurement function, but it's a sensor, not an "algorithm only" device in the AI sense. Its output is displayed by a compatible monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device would be established by reference gas standards and engineering measurement techniques for CO2 concentration, flow rates, and timing. The document references compliance with ISO 80601-2-55 (Respiratory gas monitors) which would outline such testing methods.
8. The sample size for the training set
- Not applicable. This is a hardware sensor, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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