(214 days)
Winner Medical facemask / shield are intended to be used by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate matter.
These masks are pleated 3-ply masks with an inner and outer layer that sandwich a polypropylene filter material. On some masks a plastic shield with a non-fog coating is incorporated. The masks are identical to the predicate devices in design, materials used and performance in non-clinical testing. This testing included bacterial filtration efficiency (BFE), pressure differential (Delta P), flammability, ISO skin irritation and sensitization.
The provided document is a 510(k) summary for surgical masks. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. This type of regulatory submission in the medical device field typically does not involve the types of acceptance criteria and studies (e.g., MRMC studies, expert consensus for ground truth on a large dataset, standalone algorithm performance) that you are asking about, which are more common for AI/ML-based diagnostic or clinical decision support devices.
Therefore, much of the requested information cannot be extracted from this document, as it describes a different kind of regulatory submission and testing. However, I can extract what is relevant to the information provided.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance (Non-Clinical)
The device (Winner Medical Facemasks) was compared to predicate devices through non-clinical testing. The document states that the masks are "identical to the predicate devices in design, materials used and performance in non-clinical testing." This implies that the acceptance criteria were met if the performance in these non-clinical tests was equivalent to the predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bacterial Filtration Efficiency (BFE) | Not explicitly quantified, but stated as "identical to the predicate devices in performance." |
| Pressure Differential (Delta P) | Not explicitly quantified, but stated as "identical to the predicate devices in performance." |
| Flammability | Not explicitly quantified, but stated as "identical to the predicate devices in performance." |
| ISO Skin Irritation | Not explicitly quantified, but stated as "identical to the predicate devices in performance." |
| ISO Sensitization | Not explicitly quantified, but stated as "identical to the predicate devices in performance." |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of masks tested or number of trials for each non-clinical test.
- Data Provenance: The testing was "non-clinical testing." The document does not specify the country of origin of the data related to these specific tests, but the submitter is based in China, and the U.S. Agent is in California, USA. It's retrospective in the sense that the data was collected and then submitted.
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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. The "ground truth" for non-clinical performance tests like BFE or flammability is determined by standardized laboratory measurements against established test methods, not by expert consensus in a clinical diagnostic sense.
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Adjudication method for the test set: Not applicable. Laboratory tests have defined protocols, and the results are typically quantitative measurements, not subjective adjudications.
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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 surgical mask, not an AI-powered diagnostic device. No human reader studies (with or without AI assistance) are relevant or mentioned.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (surgical mask), not an algorithm or AI system.
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The type of ground truth used: For the non-clinical tests, the "ground truth" is established by the specified standards and protocols for each test (e.g., standardized methods for measuring BFE, Delta P, flammability, skin irritation, and sensitization). The performance of the predicate device serves as the benchmark for substantial equivalence.
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The sample size for the training set: Not applicable. There is no AI/ML model or "training set" in the context of this device and its regulatory submission.
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How the ground truth for the training set was established: Not applicable. No training set exists for this type of device.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.