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The N95 Surgical Respirator AP0018 and AP0028 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

SHUENN BAO SHING Corp. N95 Surgical Respirator AP0018 and AP0028 are flat pleated 3-ply masks with a center layer of polypropylene meltblown material by inner and outer layers of nonwoven material. The mask has 2 braided synthetic elastic headbands and a flexible wire tie nosepiece that allows the respirator to form to the bridge of the wearer's nose. No fiberglass media is used in this product.

Here's an analysis of the acceptance criteria and the study conducted for the SHUENN BAO SHING Corp. N95 Surgical Respirator (types AP0018 and AP0028), based on the provided 510(k) summary document:

This document is a 510(k) summary for a medical device (N95 Surgical Respirator), which is typically used to demonstrate substantial equivalence to a legally marketed predicate device rather than to rigorously "prove" device performance against a novel set of acceptance criteria through a full-scale clinical trial. Therefore, the "study" referred to here encompasses the non-clinical tests performed to demonstrate equivalency.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for N95 Surgical Respirators are based on established regulatory standards and guidance for such devices, primarily from NIOSH and ASTM. The device's performance is demonstrated by its compliance with these standards, effectively making the performance metrics of the new device equivalent to or better than those of the predicate device for substantial equivalence.

Table 1: Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are the requirements outlined in the specified standards, and "reported device performance" is the statement of compliance to these standards.

Study Details

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

The document does not specify a "sample size" in the context of a clinical test set, as no clinical tests were performed. The testing conducted was non-clinical (bench testing). For these bench tests (e.g., NIOSH, flammability, biocompatibility), the sample sizes would typically be determined by the specific test standards themselves, but these details are not provided in this summary.

Data Provenance: The document originates from SHUENN BAO SHING Co., Ltd. in Taiwan, R.O.C. The tests were performed in compliance with US regulatory standards (NIOSH, CFR, ISO). The data is retrospective in the sense that it represents lab test results conducted on the manufactured device models.

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

Not applicable. This was a non-clinical bench testing study, not requiring expert consensus for a "ground truth" in the way a clinical diagnostic study would. Compliance to engineering and material science standards was assessed.

3. Adjudication Method for the Test Set

Not applicable. As this was non-clinical bench testing against established standards, the results are typically objectively measured and compared to the standard's limits. No adjudication method in the context of expert review for clinical outcomes is mentioned.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC study is relevant for evaluating the performance of diagnostic tools that involve human interpretation (e.g., radiologists reading images). This 510(k) pertains to a physical device (surgical respirator), for which such a study is not applicable.

5. Standalone Performance (Algorithm Only)

Not applicable. This is a physical N95 surgical respirator, not an AI algorithm. Its performance is inherent in the device itself, without a "human-in-the-loop" or standalone algorithm component.

6. Type of Ground Truth Used

For non-clinical tests, the "ground truth" is defined by the objective standards and test methods (e.g., NIOSH 84.188 for exhalation resistance, 16 CFR 1610 for flammability). The device's physical properties and performance characteristics are measured against the specified limits within these standards.

7. Sample Size for the Training Set

Not applicable. There is no training set in the context of machine learning or AI models, as this is a physical device submission.

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

Not applicable, as there is no training set. The "ground truth" for the device's acceptable performance is established by the regulatory standards mentioned above.

Summary Takeaway:

The provided document is a 510(k) summary demonstrating substantial equivalence of a new surgical respirator to existing predicate devices. The "study" in this context refers to a series of non-clinical bench tests performed according to recognized national and international standards (NIOSH, CFR, ISO) to prove the new device meets the same performance characteristics as its predicates. It explicitly states that "no clinical tests were performed." Therefore, many of the typical questions for AI/diagnostic device studies (like sample size for test/training sets, expert ground truth, MRMC studies) are not applicable here.

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