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The Spin Care Disposable Protective Mask is 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 to blood and body fluids. This is a single use, disposable device, provided non-sterile.

The Spin Care Disposable Protective Mask is a single use multi-layer level 2 surgical mask. It houses a meltblown polypropylene filter between an outer and inner layer of Spunbond polypropylene that covers the nose and mouth of the end user and held in place by a pliable nose piece and ear loops. Contact duration is less than 24 hours.

This document describes the acceptance criteria and performance of the "Spin Care Disposable Protective Mask". Since this is a medical device, the acceptance criteria are based on non-clinical performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

The device is designed to meet the ASTM 2100 Level 2 standard for medical face masks. The table below summarizes the key performance criteria and the results for the Spin Care Disposable Protective Mask, compared to its predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., how many masks were tested for fluid resistance or BFE). However, the tests are performed in accordance with recognized international standards (ASTM, EN, ISO, CFR) which typically define appropriate sample sizes for robust testing.

The data provenance is from non-clinical tests performed to assess the device's physical and biological properties. The country of origin of the data is not specified in the provided text, but it's generated by the manufacturer, SpinTech LLC, for their submission to the U.S. FDA. The data is prospective in the sense that it was generated specifically for the premarket notification to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For non-clinical device testing like this, the "ground truth" is established by adherence to standardized testing protocols and validated measurement techniques as outlined in the referenced standards (e.g., ASTM F2100, ISO 10993, etc.). The expertise lies in:

• Standard Development Bodies: The organizations (ASTM, ISO, CEN) that develop and maintain these standards rely on panels of experts in materials science, microbiology, engineering, and medical device design.
• Testing Laboratories: The testing itself would be conducted by qualified laboratory personnel with expertise in performing these specific tests and interpreting their results according to the standard. The document doesn't mention the specific number or qualifications of these laboratory experts, but their work is governed by the principles of Good Laboratory Practice (GLP) or similar quality systems.

4. Adjudication Method for the Test Set

There's no explicit adjudication method described in the sense of multiple independent reviewers assessing the test results. For non-clinical performance tests, the method is typically based on:

• Objective Measurement: The tests yield quantitative results (e.g., percentage filtration, pressure differential) that are objectively measured.
• Standard Conformance: The results are then compared directly against the quantitative thresholds defined by the relevant standards (e.g., "Pass" if BFE is ≥98%). Deviations or borderline results might necessitate retesting or further investigation by a single expert/team in the lab.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic or imaging devices where human interpretation of results (e.g., reading an X-ray) is involved, and the goal is to assess the impact of AI assistance on human performance. This submission is for a physical medical device (a mask), and thus, this type of clinical study is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance assessment was not done. This device does not involve an algorithm or AI component; it is a physical product designed for infection control. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Spin Care Disposable Protective Mask is based on established objective performance standards for medical face masks, including:

• Physical and Chemical Standards: ASTM F2100-19 (general performance), ASTM F1862-17 (fluid resistance), ASTM F2299-03 (particle filtration), ASTM F2101-19 (bacterial filtration), 16 CFR 1610 (flammability), and EN 14683 (differential pressure).
• Biocompatibility Standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization).

These standards define the acceptable range or threshold for each performance characteristic.

8. The Sample Size for the Training Set

This device does not involve machine learning or AI, so there is no "training set" in the conventional sense. The "training" for such a device is in its design and manufacturing processes to ensure it consistently meets the established performance specifications.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set for an AI algorithm, this question is not applicable. The design "ground truth" for the device's manufacturing and quality control would be based on the established performance criteria from recognized standards, ensuring that each produced unit meets those specifications.

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