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ADI Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The ADI Medical Surgical Face Masks are single use, three-layer, flat -folded masks with ear loops and nose clamp. The ADI Medical Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. ADI Medical Surgical Face Masks will be provided in blue. ADI Medical Surgical Face Masks are sold non-sterile and are intended to be single use, disposable devices.

The provided text describes the regulatory filing for a surgical face mask, not an AI-powered diagnostic device. Therefore, the questions related to AI device performance, expert ground truth, MRMC studies, and training/test set sample sizes are not directly applicable.

However, I can extract the information relevant to the device's acceptance criteria and the study proving it meets those criteria based on the provided document.

Device: ADI Medical Surgical Face Mask
Regulatory Filing: K213347

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ADI Medical Surgical Face Mask are defined by various ASTM and EN standards for surgical masks. The performance tests were conducted to demonstrate that the device meets these standards.

Table of Acceptance Criteria and Reported Device Performance:

Details of the Study Proving Device Meets Acceptance Criteria

Given that this is a physical medical device (surgical face mask) and not an AI/software as a medical device (SaMD), many of the typical questions for an AI study are not applicable. Below are the relevant answers based on the provided document.

1. A table of acceptance criteria and the reported device performance: (See table above)

2. Sample size used for the test set and the data provenance:

   • Sample Size: The non-clinical tests were conducted on 3 non-consecutive lots, with each lot containing 32 samples. This means a total of 96 samples (3 lots * 32 samples/lot) were tested for most performance criteria (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability). Biocompatibility testing is typically done on specific extracts or samples, not necessarily a batch of 96.
   • Data Provenance: Not specified in terms of country of origin for the data. The tests are "non-clinical tests" meaning laboratory assessments. The document doesn't indicate if they were prospective or retrospective in the sense of a clinical trial; rather, they are standard product performance verification tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable. The "ground truth" for a surgical mask's performance is established by the specified ASTM/EN standards and test methods, not by human expert interpretation or consensus. The tests involve objective measurements (e.g., pressure, filtration efficiency, flammability rating).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. As described above, the test results are objective measurements against defined standards, not subjective interpretations requiring adjudication.

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 is a physical device, not an AI-driven medical imaging or diagnostic device. No human reader studies (with or without AI assistance) were part of this premarket notification. The document explicitly states: "No clinical study is included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an AI algorithm. Its performance is inherent to its physical properties and material construction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" (or more accurately, the performance benchmark/standard) for this device is based on established national and international performance standards (ASTM F1862, ASTM F2299, ASTM F2101, EN 14683 Annex C, 16 CFR 1610) and recognized biocompatibility standards (e.g., ISO 10993 for Cytotoxicity, Irritation, Sensitization). These standards define the acceptable physical and biological properties of surgical masks.

8. The sample size for the training set:

   • Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable. Since there is no training set for an AI model, there is no "ground truth" for it to be established.

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