(98 days)
Accessory device for use with nitrous oxide / oxygen sedation systems to monitor the medical gas system for a low oxygen pressure condition (less than 40 ps), and activate an audio alarm when this condition exists.
The Guardian™ Low Pressure Monitor Model 34076 will consist of the following major sub-components:
- . Circuit board with battery holder and battery
- . Pressure switch
- Manifold and medical gas fittings (DISS)
- . Protective cover
The intended major functional characteristics of the device are: - . Audibly indicate proper initialization upon insertion of the battery (i.e. power up)
- Audibly indicate low tank pressure
- . Audibly indicate low remaining battery life, as determined by battery voltage
This document describes a medical device, the Guardian™ Low Pressure Monitor Model 34076, designed to monitor low oxygen pressure in nitrous oxide/oxygen sedation systems. The provided text outlines the device's characteristics, intended use, and a regulatory submission (510(k)) to the FDA. However, it does not contain a detailed study demonstrating specific acceptance criteria with reported device performance metrics in the format requested.
The document primarily focuses on regulatory approval (510(k) clearance based on substantial equivalence to a predicate device) rather than a specific performance study with quantitative results against acceptance criteria.
Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC study, standalone performance, ground truth details, training set size, etc.) cannot be addressed from the provided text.
Here's an attempt to extract what is available and highlight what's missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Audibly indicate proper initialization upon battery insertion | Not explicitly reported with quantitative data in the provided text. |
| Audibly indicate low tank pressure (less than 40 psi) | Not explicitly reported with quantitative data in the provided text. |
| Audibly indicate low remaining battery life | Not explicitly reported with quantitative data in the provided text. |
| Meet ADA Acceptance Guidelines for Nitrous Oxide-Oxygen Conscious Sedation Systems | The system is designed and tested to meet these requirements, but specific performance data or a report detailing how it met them is not provided. |
Missing Information: The provided text states the intended functional characteristics, which serve as de-facto acceptance criteria. However, it does not provide quantitative results or specific performance metrics demonstrating that the device actually meets these criteria. It only states that the system is "designed and tested to meet the requirements."
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The text refers to "Non-Clinical Testing" and "rigorous application of a risk management program," but no details on the origin of data (e.g., country, retrospective/prospective) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the provided text. There is no mention of an expert panel or ground truth establishment relevant to a test set's performance.
4. Adjudication method for the test set
- Not specified in the provided text.
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. This device is a low-pressure monitor, not an AI-assisted diagnostic tool for which MRMC studies comparing human readers with and without AI assistance would be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly described as a formal validation study. The device itself is a standalone alarm system. Its performance evaluation would naturally be "standalone" in the sense that the alarm mechanism operates independently of human interpretation of a reading. However, the text does not detail a study specifically validating the "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. For a device like this, the "ground truth" would likely be derived from calibrated pressure gauges and simulated low-pressure conditions. However, the document does not detail how this ground truth was established or used in testing.
8. The sample size for the training set
- Not applicable/Not specified. This device does not appear to involve machine learning or AI that would require a "training set" in the conventional sense. Its function is based on a physical pressure switch and circuit logic.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As there's no mention of a training set, the establishment of ground truth for such a set is not detailed.
Summary of what can be inferred from the provided text:
- The device, a low-pressure monitor, has defined functional requirements (audible alarms for power-up, low pressure
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).