(546 days)
The ToxCO® breath Carbon Monoxide monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning.
The ToxCO® is a hand held exhaled breath monitor for the detection of Carbon Monoxide on the breath. The battery powered monitor uses an electrochemical sensor, designed to react specifically to carbon monoxide producing an electrical output. The output is then amplified and a microcontroller processes the signal and converts it to a meaningful displayed result on an LCD touch screen. The sample system for the ToxCO® mimics the predicate device channeling the breath sample directly over the sensor during test ensuring the sensor is exposed to the gas sample for the required length of time to give an accurate reading. The ToxCO® Monitor uses a non-patient contacting D-piece™ sampling system, with integrated bacterial and viral filter and a one-way valve, attached directly to the monitor. A patient contacting, single patient use SteriBreath™ mouthpiece is connected to the D-piece™ sampling system to perform a breath sample. The D-piece™ is designed to have minimal dead space and therefore initial dilution of the sample is reduced. The patient is required to hold their breath for a 15 second countdown. This is displayed on the LCD screen of the device. At the end of the breath hold, the patient shall blow gently but fully into the ToxCO®, exhaling as much of the breath in their lungs as possible. The reading on the display shall rise until the peak reading is held on the display. Use of the breath sampling D-piece™ and disposable SteriBreath™ mouthpiece may be impossible if the patient is unconscious or injured. In this event, a modified sampling technique can be used, which consists of a specially constructed face mask sampling system, which allows exhaled breath to be directed to the instrument's sensor for analysis. The Face mask sampling system is a single-use, pre-assembled adapter to enable a breath sample to be taken with a single use face mask, connected to the ToxCO® breath Carbon Monoxide monitor by means of a breath sampling D-piece™. The face mask sampling procedure does not require a 15 second breath hold to be performed before the test can begin. Sampling will last 60 seconds as the %COHb/ppm levels rise and then hold at the peak level. The result will be shown on the LCD monitor screen. The ToxCO® breath Carbon Monoxide monitor and accessories are used by healthcare professionals in medical institutions and healthcare environments where Carbon Monoxide exposure is suspected.
The provided document is a 510(k) summary for the ToxCO® Carbon Monoxide Monitor, focusing on demonstrating substantial equivalence to a predicate device rather than providing a detailed study demonstrating performance against a set of acceptance criteria. Therefore, most of the information requested in your prompt regarding a study that proves the device meets acceptance criteria (such as sample size, data provenance, expert involvement, MRMC study details, training set information) is not available in this document.
However, based on the provided text, I can extract information related to the device's accuracy and the performance testing conducted.
Here's an attempt to answer your questions based only on the provided document:
Acceptance Criteria and Reported Device Performance
The document states accuracy as an acceptance criterion.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|
| Accuracy (Standard Breath Test) | ≤ ±3ppm/10% - whichever is greater (Operating temperature range 0 to 45°C) |
| Accuracy (Modified Breath Test - Facemask Mode) | "The ToxCO® is able to provide readings within the operating tolerances specified when tested across the detection range." (Implied to be 0-200 ppm range, although the input CO levels for testing reached 605 ppm for the standard test and 50, 158, 605 ppm for facemask mode, with the stated range for facemask being 0-200 ppm). "The face mask testing protocol has been developed for use on patients with a respiration rate of between 12-20 breaths per minute. The manual advises if face mask testing is used outside of these specifications, this may result in decreased accuracy of readings." |
| CO Measurement Range (Standard Breath Test) | 0-500 ppm |
| CO Measurement Range (Modified Breath Test - Facemask Mode) | 0-200 ppm |
| Electrical Safety | Complies with IEC 60601-1 Electrical Safety Standard |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 EMC standards |
| Software (Firmware) Verification and Validation Testing | Performed as recommended by FDA's Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software determined to be a Moderate level of concern. |
| Repeatability | Confirmed within specification (Tested with calibrated CO gases) |
| Device performance across specified Operating (0-45°c) and Storage (0-50°c) temperatures | Confirmed to perform correctly (Carried out with calibrated CO gases) |
| Response to CO gas, calculating and displaying correct PPM and %COHb | Confirmed (Carried out with calibrated CO gases) |
| Biocompatibility | Evaluation performed in accordance with FDA recognized Consensus Standard ISO 10993-1, Part 1: Evaluation and testing within a risk management process. |
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: The document does not specify a "sample size" in terms of subject counts for clinical testing. For bench testing, it mentions "calibrated CO gases (0, 20, 50, 158, 605 ppm)" for accuracy and repeatability, and "calibrated CO gases (0, 20, 50, 158, 500, 605 ppm)" for temperature range testing. For facemask mode, it used "calibrated CO gases (0 (clean air), 50, 158, 605 ppm)". These are gas concentrations, not human subjects or a number of tests/runs.
- Data Provenance: Not specified. The manufacturer is Bedfont Scientific Ltd, located in the United Kingdom. Given the nature of the tests described (bench testing with calibrated gases, electrical safety, EMC, software V&V), these are typically laboratory-based tests rather than human subject clinical studies requiring patient data provenance. The document indicates "non-clinical data" was provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for device performance tests (accuracy, range, etc.) was established using calibrated CO gases and a calibrated Volume/Flow simulator, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. Performance was measured against objective standards and calibrated reference instruments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a CO monitor, not an AI-assisted diagnostic imaging device. No MRMC study was described or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- While the device has software (firmware), the accuracy testing described is on the integrated system (device + sensor + software) measuring CO levels. It's essentially a "standalone" device performance test, as there's no "human-in-the-loop" component determining the CO reading itself (humans interpret the device's output, but the device provides the raw measurement).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the performance testing (accuracy, range, repeatability) was established using calibrated CO gases and a calibrated Volume/Flow simulator representing known concentrations and simulated physiological conditions.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a distinct "training set" for an algorithm. The device functions based on an electrochemical sensor and internal processing, not a trained AI model from external data.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of an AI/machine learning model.
§ 868.1430 Carbon monoxide gas analyzer.
(a)
Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.(b)
Classification. Class II (performance standards).