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The Surgical Face 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Surgical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.

The body of the face mask is composed of 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 two elastic ear loops are welded to the face mask, can held the face mask in place over the users' mouth and nose. The elastic ear loops are made of Spandex and polyester, is not made with natural rubber latex.

The nose piece is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PP-Ferrum wire.

The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

The document is a 510(k) premarket notification for a Surgical Face Mask. It primarily focuses on the device's substantial equivalence to a predicate device, supported by non-clinical performance testing and biocompatibility assessments. It explicitly states that no clinical studies were performed. As such, the information provided does not pertain to the "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/human-in-the-loop diagnostic device as implied by the detailed questions.

Therefore, many of the requested details, such as those related to AI performance, human reader improvement, ground truth establishment for training and test sets, expert consensus, and multi-reader multi-case studies, are not applicable to this document.

However, I can extract the acceptance criteria and the device performance for the non-clinical tests conducted for this surgical face mask.

Here's the information based on the provided document, addressing the extractable points and noting the non-applicability of others:

Device: Surgical Face Mask (Kingstar Medical (Xianning) Co., Ltd.)
Predicate Device: K210433 Surgical Face Mask (Wuhan Dymex Healthcare Co., Ltd.)

1. Table of Acceptance Criteria and Reported Device Performance (for Non-Clinical Tests)

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

• Sample Size for Test Set:
  • Fluid Resistance: "32 out of 32 pass" indicates at least 32 samples were tested across 3 lots.
  • For other functional tests (PFE, BFE, Differential Pressure, Flammability) and biocompatibility tests (Cytotoxicity, Irritation, Sensitization), the specific number of masks or test replicates is not explicitly stated, beyond the qualitative "Pass" or "minimum/maximum" values. However, the tests are done according to recognized standards (ASTM, EN, ISO) which would prescribe sample sizes.
• Data Provenance: The tests were non-clinical, conducted to verify compliance with standards. The origin of the raw materials is China (Xianning City, Hubei Province), and the testing facilities are not explicitly named or their location revealed. It is a pre-market notification, implying this data was generated specifically for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This document describes the performance of a physical medical device (surgical face mask) through non-clinical laboratory testing, not a diagnostic AI device requiring expert-established ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication of results is mentioned for these physical performance tests. The tests are conducted according to standardized laboratory procedures yielding objective measurements.

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

• Not Applicable. No clinical studies, especially MRMC studies comparing human readers with and without AI assistance, were performed. The submission explicitly states: "No clinical study is included in this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Not Applicable. This is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

• Not Applicable. The "ground truth" for this device's performance is established by objective measurements against recognized industry standards (e.g., ASTM F2100 Level 3 requirements for fluid resistance, filtration efficiency, etc.) and biocompatibility standards (e.g., ISO 10993 series).

8. Sample Size for the Training Set

• Not Applicable. This device did not involve machine learning or AI, hence no training set.

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

• Not Applicable. No training set was used.

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