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Disposable Surgical Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.

The Disposable Surgical Mask is Flat Pleated style mask, utilizing ear loops way for wearing, and they all has nose piece design for fitting the Disposable Surgical Mask around the nose. The Disposable Surgical Mask are manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8) and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the Disposable Surgical Mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Disposable Surgical Mask is in the middle layer of Disposable Surgical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of malleable aluminum wire. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Surgical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm. The Disposable Surgical bag packaging material is Polypropylene and box packaging are carton.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Disposable Surgical Mask (Model: Flat-type) (K202126):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document explicitly states "32/32 Passed" for all performance tests (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Resistance to Synthetic Blood, and Flammability). This indicates a sample size of 32 units for each of these performance tests.

For biocompatibility tests (Cytotoxicity, Sensitization, Irritation), no specific number of samples is provided beyond the statement "Under the conditions of the study," which is typical for such assessments and does not usually involve a large numerical sample count for establishing non-toxicity/irritation/sensitization.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. However, given that these are laboratory performance tests conducted by the manufacturer for regulatory submission, they are almost certainly prospective tests performed on newly manufactured devices.

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

This information is not applicable and therefore not provided in the document. The "ground truth" for device performance in this context is established through objective, standardized laboratory tests (e.g., ASTM F2101-14 for BFE, ASTM F2299-03 for PFE, ASTM F1862/F1862M-17 for fluid resistance). These tests have defined methodologies and pass/fail criteria, and their results are quantitative or qualitative based on the test method itself, not on expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation (e.g., image analysis by radiologists) where disagreements between evaluators need to be resolved to establish ground truth. For standardized laboratory performance tests, the results are objectively measured according to the test method and do not require expert adjudication.

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

This information is not applicable and therefore not provided in the document. An MRMC study is relevant for diagnostic devices where human readers interpret data, and the study assesses the impact of an AI alongside human readers. This submission is for a physical medical device (surgical mask) and involves laboratory performance testing, not diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable and therefore not provided in the document. This device is a physical product (surgical mask), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. Type of Ground Truth Used

For the performance and biocompatibility tests, the "ground truth" is established by objective measurements and results from standardized laboratory test methods (e.g., ASTM F2100-19, ASTM F2101-14, EN 14683: 2019, ASTM F2299-03, ASTM F1862/F1862M-17, 16 CFR Part 1610 for performance testing; ISO 10993-5:2009, ISO 10993-10:2010 for biocompatibility). These methods have predefined criteria for what constitutes a "Pass" or "Fail."

8. Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. The product is a physical medical device (surgical mask) and does not involve AI or machine learning algorithms that require training sets.

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

This information is not applicable and therefore not provided in the document, as there is no training set for this type of device.

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