(611 days)
The FS-104 CPR mask with oxygen port is indicated for use of mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult and child whose weight exceeds 40kg. It is for prescription use.
The FS-104 CPR mask with oxygen port is intended for single use only.
(1) The CPR mask with oxygen port is composed of foldable cushion mask with Oxygen Port, one- way valve, disposable filter, and elastic head trap. (2) The CPR mask with oxygen port provides a physical barrier between the rescuer and victim, eliminating direct contact of the rescuer's lips with unknown subject. (3) The CPR mask with oxygen port promotes an airtight seal to the face allowing ventilation through both the mouth and nose simultaneously. Proper training in ventilation and CPR should be obtained before using this device. (4) The CPR mask with oxygen port can be functioned in such a way that no any part of device extends into the patient's oral cavity by more than 2 cm. (5) For the device with capability of using oxygen is to sale as prescription device
The provided text is a 510(k) Summary for a CPR Mask (FS-104 CPR Mask). The document discusses the device's substantial equivalence to predicate devices based on non-clinical testing. It does not describe a study involving humans or AI to set and meet acceptance criteria for device performance as a diagnostic or analytical tool.
Therefore, I cannot fulfill the request to provide information based on the specific numbered points (1-9) as they relate to such a study. The document focuses on demonstrating that the new CPR mask is as safe and effective as pre-existing, legally marketed predicate devices through compliance with voluntary standards and similar functional characteristics.
Here's what I can extract regarding the assessment of the device, aligning it as much as possible with the spirit of your request, but highlighting that it's not a clinical AI performance study:
Summary of Device Assessment (Not an AI/Diagnostic Performance Study):
The assessment described in this document is a demonstration of substantial equivalence of the FS-104 CPR Mask to predicate devices, focusing on:
- Indications for Use: Same or similar.
- Technological Characteristics: Same or similar.
- Principles of Operation: Same or similar.
- Performance: Same or similar, as demonstrated by compliance to voluntary standards.
Explanation of Acceptance Criteria and the "Study":
The "study" here is the non-clinical testing performed to establish compliance with recognized voluntary standards and compare the device's performance to predicate devices. The acceptance criteria are implicit in meeting these standards and demonstrating similarity.
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criterion / Standard Reported Device Performance ISO 10993-1 (Biocompatibility) Compliant ISO 10993-5 (Biocompatibility - In vitro cytotoxicity) Compliant ISO 10993-10 (Biocompatibility - Skin irritation & sensitization) Compliant ASTM F920 (Performance of device) Compliant (Similar to predicate devices) Functional Performance (e.g., airtight seal, barrier, 2cm oral cavity limit) Functions as described, similar to predicate devices -
Sample size used for the test set and the data provenance: Not applicable. This was non-clinical (laboratory/bench) testing against standards, not a clinical trial with a test set of patient data. The "data provenance" would be the accredited laboratories or internal testing facilities where the standards were applied.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic performance, is not established by experts for this type of device submission. Compliance with standards and functional equivalence are the "ground truth."
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Adjudication method for the test set: Not applicable.
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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. No MRMC study was mentioned; this device is a mechanical CPR mask, not an AI-powered diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
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The type of ground truth used: For this submission, the "ground truth" is defined by:
- Compliance with established voluntary standards (ISO 10993-1, ISO 10993-5, ISO 10993-10, ASTM F920).
- Demonstrated performance characteristics that are "same or similar" to legally marketed predicate devices.
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The sample size for the training set: Not applicable. This device is not an AI model, so there is no training set.
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How the ground truth for the training set was established: Not applicable.
In conclusion, this document describes a regulatory submission for a Class II medical device (CPR Mask) seeking substantial equivalence to predicate devices, based on non-clinical testing and comparison of characteristics. It does not involve AI, clinical diagnostic performance studies, or the methodologies typically associated with establishing performance for such tools.
§ 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).