(50 days)
The GaleMed CPAP masks are intended to be used in a home, hospital or institutional environment for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be used under the specific direction of a physician. Disposable and Single patient, multi-use styles.
The proposed CPAP masks incorporate a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.
- . Full face and Nasal style
- . Integral anti-asphyxia valve
- Headgear for attachment .
- . Single use disposable and Single patient, multi-use
The provided document is a 510(k) premarket notification for a medical device (GaleMed CPAP mask). Such notifications typically aim to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way a clinical trial for a novel drug or a high-risk device would.
Based on the information provided, here's an analysis of the "acceptance criteria" and "study" as they relate to this type of submission:
Acceptance Criteria and Reported Device Performance
For a 510(k) submission, the "acceptance criteria" are generally met by demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as the predicate device. In this specific case, the submission asserts that the proposed device is identical to the predicate device (Hsiner K063268) in features, indications for use, environment of use, patient population, contraindications, single patient/multi-use, components, anti-asphyxia valve, and materials.
The "study" that proves this substantial equivalence is described as "Comparative testing for safety and efficacy" including "Flow vs. Leak / Pressure" and "Dead space." The report states these tests are "Identical" to those performed for the predicate. This implies that the GaleMed CPAP mask performed equivalently to the predicate device on these established engineering and performance tests relevant to CPAP masks.
Here's how to frame the information, even though it's not a typical "acceptance criteria" table from a clinical study:
Table: Acceptance Criteria and Reported Device Performance (as demonstrated by Substantial Equivalence)
| Acceptance Criteria Category (based on predicate device) | Specific Criteria (Implicitly met by "Identical" or "Same") | Reported Device Performance (from comparison) |
|---|---|---|
| Indications for Use | Same as Predicate Hsiner K063268 | Identical |
| Environment of Use | Same as Predicate Hsiner K063268 | Same |
| Patient Population | Same as Predicate Hsiner K063268 | Same |
| Contraindications | Same as Predicate Hsiner K063268 | None (Same as Predicate) |
| Single patient, Multi-use | Yes (Same as Predicate Hsiner K063268) | Yes |
| Components | Headgear, Anti-asphyxia valve (Same as Predicate) | Headgear, Anti-asphyxia valve |
| Anti-asphyxia valve | Yes (Same as Predicate Hsiner K063268) | Yes |
| Materials | Polycarbonate, Silicone (Same as Predicate K063268) | Identical K063268 |
| Safety and Efficacy Testing | Flow vs. Leak / Pressure performance | Identical to Predicate |
| Dead space measurements | Identical to Predicate |
Additional Information based on the provided document:
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document mentions "Comparative testing for safety and efficacy" including "Flow vs. Leak / Pressure" and "Dead space." However, it does not specify the sample size for these tests. It simply states that they were "Identical" to the testing for the predicate device.
- The data provenance is not specified regarding the "Comparative testing." Given that the applicant is from Taiwan (GaleMed, Taiwan), it's plausible the testing was conducted there, but this is not explicitly stated. The nature (retrospective/prospective) of these engineering tests is also not detailed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This question is generally not applicable to a 510(k) submission for a device like a CPAP mask, especially when the claim is substantial equivalence based on engineering and material comparisons. "Ground truth" in the clinical sense (e.g., expert consensus on medical images or diagnoses) is not established or discussed here. The "ground truth" for the performance claims rests on the technical specifications and engineering test results being "identical" to a legally marketed device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is used in clinical studies involving human interpretation (e.g., reading medical images) to resolve discrepancies. The provided document details engineering tests comparing a new device to a predicate, not a clinical study requiring expert adjudication of results.
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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. This is a question relevant to AI-powered diagnostic aids, not a CPAP mask. The submission does not involve AI or human "readers" in the context of comparative effectiveness.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This question relates to AI algorithms operating independently. The GaleMed CPAP mask is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the performance claims, the "ground truth" is based on engineering performance specifications and measurements (e.g., flow, leak, pressure, dead space) which are asserted to be identical to those of the predicate device. There is no mention of clinical outcomes data, expert consensus on patient outcomes, or pathology results being used as ground truth for this submission.
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The sample size for the training set:
- Not applicable. This refers to the training of machine learning models. The submission is for a physical medical device and does not involve a training set for an algorithm.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an algorithm in this submission.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).