(113 days)
The Nihon Kohden PocketCap Pocket CO2 Monitor, model number OLG-1100A, is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. The device is intended as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis. The device will be available for use only by medical personnel within a hospital or other medical facility, at a remote site, or during transport from a remote site to a hospital or other medical facility. This device is not recommended for patients with low tidal volume such as patients younger than three (3) years of age or weighing less 22 pounds or patients with a respiration rate greater than or equal to 60 breaths per minute.
The OLG-1100A PocketCap Pocket CO2 Monitor is classified as Class II by the Division of Anesthesiology Devices and the Anesthesiology Device Classification Panel under 21 CFR Part 868.1400 "Analyzer, Gas, Carbon dioxide, Gaseous-phase" as per part 73 CCK. Common names for the OLG-1100A PocketCap Pocket CO2 Monitor include CO2 Analyzer, CO2 Monitor and CO2 Indicator.
This 510(k) summary for the Nihon Kohden OLG-1100A Pocket CO2 Monitor does not contain the detailed information requested regarding specific acceptance criteria, a study proving those criteria were met, or typical AI/algorithm-related study metrics.
The document is a traditional 510(k) summary from 1997, focusing on substantial equivalence to a predicate device. It predates the era of complex AI device submissions and therefore lacks the detailed performance study information you're asking for.
Here’s a breakdown of what can be extracted and what is missing:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical criteria. The summary generally states "verified the operation of the device" and "performed within specifications." | General Statements: "verified the operation of the device," "performed within specifications," "confirmed that the device performed within specifications." |
Missing: Specific accuracy, precision, or other quantitative performance metrics (e.g., CO2 measurement accuracy range, response time, etc.) that would typically be detailed acceptance criteria.
2. Sample size used for the test set and the data provenance:
Missing. The document does not describe a "test set" in the context of a performance study with human subjects or a large dataset. The testing mentioned appears to be engineering verification and validation of the device's basic functions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Missing. Not applicable as there's no mention of a performance study requiring expert ground truth establishment.
4. Adjudication method for the test set:
Missing. Not applicable.
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:
Missing. This device is a monitor, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Missing. This device is a monitor providing a reading; the "algorithm" is integral to its function, but a standalone performance study in the modern sense (e.g., comparing its output against a reference) is not described in detail. The testing described focuses on functional verification.
7. The type of ground truth used:
Missing. Not applicable, as no external "ground truth" for a performance study is described. The device's internal specifications and expected behavior likely served as the reference for its own functional testing.
8. The sample size for the training set:
Missing. Not applicable; this device is not an AI/machine learning model that undergoes "training."
9. How the ground truth for the training set was established:
Missing. Not applicable.
Summary of what the document does state regarding testing:
The device underwent:
- Electromagnetic testing
- Environmental testing
- Safety testing
- Performance testing (general statement)
- Software validation: "tested the operation of the software functions of acquiring, processing and displaying all functions of the device."
The results of these tests "verified the operation of the device" and "confirmed that the device performed within specifications."
Conclusion:
This 510(k) summary provides a high-level overview of the device and its general testing, but it fundamentally lacks the specific details about quantitative acceptance criteria, dedicated clinical or performance studies, expert involvement, and AI-specific metrics that your request outlines. This is typical for a medical device submission from 1997, particularly for a monitoring device where the focus was on functional equivalence and safety rather than complex diagnostic accuracy studies with expert adjudication.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).