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510(k) Data Aggregation
(287 days)
The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is for prescription use.
The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring cardiopulmonary resuscitation (CPR) resuscitator without oxygen port is for overthe-counter use.
The KYOLING CPR mask is used during cardiopulmonary resuscitation procedures, which are used in emergency situations to supply oxygen and produce blood flow in the heart and lungs.
The CPR mask is made of PVC and one-way valve made of medical grade K-resin, the mask is used for mouth-to-mask breathing, it provides a physical barrier between the rescuer and victim, eliminating direct contact of the rescuer's lips with the unknown subject; and also it promotes an airtight seal to the face allowing ventilation through both the mouth and nose simultaneously. The KYOLING CPR Mask includes transparent dome, universal breathing tube, one-way filtered valve, head strap, and with Oxygen Port or without Oxygen Port.
The provided document describes the acceptance criteria and a study to prove that the KYOLING CPR mask with and without an oxygen port meets these criteria.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria | Reported Device Performance (KYOLING CPR Mask with Oxygen Port) | Reported Device Performance (KYOLING CPR Mask without Oxygen Port) |
|---|---|---|---|
| Biocompatibility | Meeting ISO 10993 standards for cytotoxicity, sensitization, and irritation | All tests conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1, with tests for cytotoxicity, sensitization, and irritation completed. Cushion and valve considered surface contacting for < 24 hours. | All tests conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1, with tests for cytotoxicity, sensitization, and irritation completed. Cushion and valve considered surface contacting for < 24 hours. |
| Inspiratory Resistance | < 5 cmH₂O (at 50 L/min) | 3.19~3.24 cmH₂O | 3.19~3.24 cmH₂O |
| Expiratory Resistance | < 5 cmH₂O (at 50 L/min) | 3.31~3.37 cmH₂O | 3.31~3.37 cmH₂O |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" sample size for the resistance testing or biocompatibility. The resistance testing likely refers to a sample of manufactured devices. The data provenance is not explicitly stated as "country of origin," but the manufacturer is Hangzhou Jinlin Medical Appliances Co., Ltd. in China, implying the testing was conducted there or arranged by them. The studies appear to be retrospective in the sense that they are conducted on the finished device to demonstrate compliance.
3. 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 this device's performance is established by objective measurements against international standards (ISO 10993 and AS-4259-1995), not expert consensus.
4. Adjudication method for the test set
Not applicable. As noted above, performance is determined by objective measurements against established standards, not by human adjudication of outcomes.
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 CPR mask, not an AI-powered diagnostic or interpretive tool that would involve multi-reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for this device's performance evaluation is based on:
- International Standards: ISO 10993 for biocompatibility and AS-4259-1995 for inspiratory and expiratory resistance. These standards define the acceptable range for the device's physical and biological properties.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for a training set to be established.
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