(309 days)
The Rescue Breather is intended to separate the patient and the rescuer during cardiopulmonary resuscitation (CPR) on adults and children. It is a single use device and is not sold sterile.
The device is a flat sheet measuring 6" by 11" which has integral ear loops to hold it in position during use. The mask provides separation between the skin, mucous membranes and oral secretions of the patient and the rescuer. There is a one-way valve in the middle of the mask which directs breathing flow to the patient.
Since the provided text describes a 510(k) summary for a CPR mask and not an AI/ML medical device, most of the requested information (like acceptance criteria for AI performance, sample sizes for test/training sets in an AI study, expert ground truth, MRMC studies, etc.) is not applicable. The document focuses on demonstrating substantial equivalence to a predicate device based on material composition and adherence to a specific ASTM standard for non-rebreathing valves.
Therefore, I will provide the relevant information based on the text and explicitly state when a requested field is not applicable due to the nature of the device.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device meets all specifications relevant to its features as delineated in ASTM Standard F 920-93 (Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans). | The device "meets all specifications relevant to its features" as per ASTM Standard F 920-93. |
1. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The testing refers to adherence to an ASTM standard, which typically outlines test methods rather than the sample size of a patient population for performance evaluation.
- Data Provenance: Not applicable. The testing described is for a physical device's performance against a standard, not analysis of patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for a CPR mask's performance is objective compliance with engineering and safety standards (ASTM F 920-93), not a subjective assessment by medical experts for a diagnostic task.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically relevant for human interpretation tasks or clinical endpoints requiring expert consensus, not for testing a physical device's adherence to an ASTM standard.
4. 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 physical CPR mask, not an AI/ML diagnostic tool. Therefore, an MRMC study and the concept of "human readers improving with AI assistance" are irrelevant.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical CPR mask, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or more accurately, the conformance standard) used is the technical specifications and performance requirements outlined in ASTM Standard F 920-93. This standard sets objective criteria for resuscitators.
7. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
8. How the ground truth for the training set was established:
- Not applicable. This is a physical device, not an AI/ML model.
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).