(298 days)
The TABATABA® CO TESTER is for the monitoring of Carbon Monoxide in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It can also be used for ambient air monitoring. It is for use by health professionals.
The TABATABA is a battery operated hand held carbon monoxide monitor for use as an aid in smoking cessation programs. The TABATABA is a complete tool for the prevention of the risks of active or passive smoking. It can be carried in the pocket or on the belt. The device is parametered by an internal menu (time, date, alarm threshold, measurement time of monitoring). It can be connected to a computer via an RS232 port, to record and analyze results.
The provided text describes the TABATABA® CO TESTER, a Carbon Monoxide gas analyzer, and its substantial equivalence to a predicate device (K000962. PiCO Smokerlyzer, Bedfont Scientific Ltd.). The information primarily focuses on a comparison of characteristics rather than a detailed study with specific acceptance criteria and performance metrics typically found for AI/ML devices.
Based on the provided text, a direct table of "acceptance criteria" and "reported device performance" in the context of an AI/ML study is not available. The document is a 510(k) summary for a medical device, which typically establishes substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety/effectiveness data.
Here's an analysis of the provided information, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state "acceptance criteria" in a quantitative manner for performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML studies. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" is implicitly demonstrated through bench, standards, and clinical testing showing it's "as safe and effective" as the predicate.
The table below reflects the comparison of characteristics, which served as the basis for the substantial equivalence claim. The "Acceptance Criteria" here are the characteristics of the predicate device that the TABATABA® CO TESTER needed to meet or be comparable to. The "Reported Device Performance" refers to the TABATABA® CO TESTER's characteristics.
| Acceptance Criteria (from Predicate Device K000962) | Reported Device Performance (TABATABA® CO TESTER) |
|---|---|
| Indications for Use: For the monitoring of Carbon Monoxide in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It can also be used for ambient air monitoring. It is for use by health professionals. | SAME (For the monitoring of Carbon Monoxide in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It can also be used for ambient air monitoring. It is for use by health professionals.) |
| Construction: Hand held battery operated device | SAME (Hand held battery operated device) |
| Display: LCD, 3 digit | LCD, 4 digit |
| Enclosure material: ABS | SAME (ABS) |
| Mouthpiece: Polypropylene, replaceable. | SAME (Polypropylene, replaceable.) |
| Power source: 2-AA Alkaline Batteries | SAME (2-AA Alkaline Batteries) |
| CO Measurement Range: 0-80 ppm and higher | 0-500 ppm |
| Dimensions: 120 x 75 x 45 (mm) | 110 x 70 x 30 (mm) |
| Weight: 200 gm. | 170 gm. |
Study Proving Device Meets Acceptance Criteria:
The document states that "The results of bench, standards, and clinical testing indicates that the new device is as safe and effective as the predicate devices," and thus supports the conclusion of substantial equivalence. However, the details of these tests are not provided in this summary.
Regarding AI/ML specific questions (which are not directly applicable to this device based on the provided information):
- Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device. The document mentions "clinical testing data" without specifying sample size or provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML device.
- 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 as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device. The device is a direct measurement tool.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a CO analyzer, the "ground truth" would typically be established by highly accurate laboratory-grade CO measurement instruments. The document doesn't specify the method, but mentions "bench, standards, and clinical testing."
- The sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.
In summary: The K080278 submission is for a traditional medical device (CO analyzer) and demonstrates substantial equivalence to a predicate device. It does not involve AI/ML technology, and therefore, many of the questions related to AI/ML study design are not applicable to the information provided. The "acceptance criteria" were the characteristics and performance of the predicate device, which the new device aimed to match or improve upon while remaining substantially equivalent. The study mentioned ("bench, standards, and clinical testing") served to demonstrate this equivalence, although specific data from these studies are not detailed in this summary.
§ 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).