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The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield 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 potential exposure to blood and body fluids. The face masks are single use, disposable device, provided non-sterile.

The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are composed of four layers and are flat-pleated and offers both ear loops and tie strings types. The mask materials consist of outer layer (Polypropylene Spunbond), insertion layer (Polypropylene Spunbond) and inner layer (Polypropylene Spunbond), and middle layer filter (polypropylene melt-blown). Each mask contains ear loops or tie strings to secure the mask over the user's mouth and face with nose piece to firmly fit over the nose. The mask may also contain a face shield made from a polyethylene terephthalate film, with an anti-glare strip. The face shield is adhered to the top edge of the mask to cover the upper part of the face to prevent potential exposure to blood and body fluids. The mask(s) are single use, disposable device(s), provided non-sterile.

The provided text describes a 510(k) premarket notification for a surgical mask, not an AI/ML medical device. Therefore, most of the requested information regarding AI/ML device performance, such as sample sizes for test and training sets, data provenance, expert adjudication, MRMC studies, and standalone performance, is not applicable.

However, I can extract the acceptance criteria and reported performance for the surgical mask based on the provided tables and text.

Acceptance Criteria and Device Performance for Unico High Performance Surgical Mask

Since this is a submission for a surgical mask and not an AI/ML medical device, the following points are not applicable (N/A):

2. Sample size used for the test set and the data provenance: N/A (Not an AI/ML device)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/ML device)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (Not an AI/ML device)
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: N/A (Not an AI/ML device)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (Not an AI/ML device)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (Not an AI/ML device)
8. The sample size for the training set: N/A (Not an AI/ML device)
9. How the ground truth for the training set was established: N/A (Not an AI/ML device)

The study proving the device meets the acceptance criteria consists of a series of performance and biocompatibility tests conducted on the Unico High Performance Surgical Mask based on relevant ASTM, ISO, EN, and CFR standards. These tests demonstrate the mask's barrier properties (PFE, BFE, Fluid Resistance), breathability (Differential Pressure), flammability, and biocompatibility (Cytotoxicity, Sensitization, Irritation). The results, as shown in the table above, meet or exceed the specified acceptance criteria for an ASTM Level 3 surgical mask.

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The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

The subject device offers the two material models which are Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE). The two models use different base materials but use the same PE film layer in addition to the fabric. They have slightly different design elements in neck, body, and belt straps.

The Unico Global Level 3 Surgical Gowns (Film-reinforced SMS and PP+PE) have been tested according to AATCC Test Method 127:2017, ANSI/AAMI PB70:2012, and ISO 811, and meet the AAMI Level 3 barrier level protection for a surgical gown.

The Unico Global Level 3 Surgical Gowns are single use that will be provided in both sterile and non-sterile packaging configurations and offer a variety of sizes ranging from medium to XX-large.

The provided document is a 510(k) summary for a medical device: Unico Global Level 3 Surgical Gown. It is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. This document does NOT contain information about an AI/ML powered device, nor does it contain a comparative effectiveness study with human readers (MRMC study) or a standalone algorithm performance study.

Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device cannot be extracted from this document. The document describes the performance testing of a physical product (surgical gowns) against established standards for physical properties and safety.

However, I can extract the acceptance criteria and performance for the surgical gown itself as presented in the document.

Detailed Breakdown based on the provided document:

The product in question is a physical medical device (surgical gown), not an AI/ML powered device. As such, the study design and acceptance criteria relate to the physical properties, safety, and performance of the gown, not to AI model performance, human reader improvement, or ground truth establishment in the context of AI/ML.

Here's an attempt to answer your questions based on the available information in the provided document, acknowledging the mismatch with a typical AI/ML device request:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact sample sizes (number of gowns) used for each test. It states "The following tests were performed on the subject device and the test results support that the subject device met the requirement for each test."
• Data Provenance: The document does not specify the country of origin of the test data. It indicates the manufacturer is "Unico Global VN Co., Ltd." in the "Republic of Korea" (though the contact person is in Irvine, California). The testing is non-clinical, likely conducted in a lab setting, not on patient data. The tests are prospective in the sense that they are conducted specifically for this submission.

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 as this is not an AI/ML device requiring expert-established ground truth from clinical images or data. The "ground truth" for this device's performance is objective measurements against established engineering and safety standards (e.g., amount of water penetration, sterilant residue concentration).

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

• Not applicable for a physical device performance test. The results are typically numerical measurements or pass/fail determinations based on predefined criteria, not expert adjudication of qualitative findings.

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

• No, an MRMC study was not done. This is not an AI/ML device where human readers interact with AI. The regulatory submission focuses on demonstrating substantial equivalence of the surgical gown's physical properties and safety to a predicate device.

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

• No, a standalone algorithm performance study was not done. This is not an AI/ML device. The tests performed are for the physical product's performance independently.

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

• The "ground truth" for this device is based on objective measurements against internationally recognized performance standards (e.g., AATCC Test Method 42, AATCC Test Method 127, ISO 11135-1, ASTM D5587, ISO 10993-11, etc.). It's based on the physical and chemical properties of the material, not clinical outcomes or expert consensus on observations.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device with a training set.

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

• Not applicable. This is not an AI/ML device.

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