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The Surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical gowns are single use, disposable medical devices, provided sterile.

The Surgical gowns is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.

The provided text is a 510(k) summary for a medical device, specifically Surgical Gowns. It details the device's characteristics, intended use, and comparative testing against a predicate device to demonstrate substantial equivalence.

However, the request asks for information relevant to the acceptance criteria and the study that proves a device (likely an AI/ML powered device for diagnosis or similar application) meets those criteria. The provided document does not describe an AI/ML powered device, nor does it detail a study involving expert readers or AI assistance. Instead, it focuses on non-clinical performance testing of a physical product (surgical gowns) based on recognized standards.

Therefore, most of the specific points requested (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to the content of this document.

I will attempt to answer the parts that are applicable based on the provided document, interpreting "acceptance criteria" as the performance requirements for the surgical gowns and "study" as the non-clinical performance testing conducted.

Here's an adaptation based on the provided document, acknowledging the limitations:

Acceptance Criteria and Device Performance for Surgical Gowns (K212718)

This document describes the non-clinical performance testing of surgical gowns (K212718) to demonstrate substantial equivalence to a predicate device, rather than a clinical study of an AI/ML device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., expert readers, MRMC studies, ground truth for training) are not applicable.

Below is a table summarizing the acceptance criteria (performance requirements based on standards) and the reported device performance for the surgical gowns.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (e.g., number of gowns) used for each non-clinical performance test. The data provenance is implied to be from the manufacturer's testing of their product. The testing is non-clinical performance testing, not a human study, and therefore terms like "retrospective or prospective" are not directly applicable in the typical sense for clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a physical product (surgical gowns) and its performance is evaluated through standardized laboratory tests, not by human expert assessment of diagnostic outputs.

4. Adjudication Method for the Test Set:
Not applicable. Performance is determined by objective measurements according to recognized standards (e.g., AATCC 42, AATCC 127, ASTM D5034, ASTM D5733, 16 CFR Part 1610, AAMI PB70, ISO 10993).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
Not applicable. This is not an AI-assisted diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical product, not an algorithm. The reported performance relates to the gown's material properties and barrier protection.

7. The Type of Ground Truth Used:
The "ground truth" for the surgical gowns' performance is established by the results of standardized laboratory testing (e.g., measurements of impact penetration, hydrostatic resistance, tensile strength, tear resistance, flame spread, and biocompatibility assays). These tests provide objective values that are compared against predefined criteria from recognized industry standards (e.g., AAMI PB70, ASTM, AATCC, ISO standards).

8. The Sample Size for the Training Set:
Not applicable. This is a manufactured product, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set is involved for this type of device.

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Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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 Mask is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Polypropylene+Galvanized-iron dual core. The Surgical Mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

The provided document, a 510(k) summary for a Surgical Mask (K212344), outlines the non-clinical tests conducted to demonstrate the device's substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "Lot 1," "Lot 2," and "Lot 3" for several tests (BFE, Differential Pressure, PFE, Synthetic Blood Penetration, Tensile Strength, Product Dimensions). This implies that a sample of masks from at least three different manufacturing lots was used for testing. However, the precise number of individual masks from each lot for each specific test is not explicitly stated, except for the "Resistance to penetration by synthetic blood" test, which used 32 test articles per lot.

The data provenance is from non-clinical testing performed on the device itself, rather than human subject data. The testing was conducted to conform to international standards such as ASTM, EN, and ISO, and potentially US regulations (16 CFR Part 1610(a)). There is no information about the country of origin of the data beyond the manufacturer being in China. The data is prospective in the sense that it was generated specifically for this 510(k) submission.

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

These are non-clinical hardware performance tests. No human experts or ground truth establishment by experts were involved in the traditional sense of clinical studies. The "ground truth" for these tests is defined by the objective, quantitative criteria established in the referenced international standards (ASTM, EN, ISO). The results are based on laboratory measurements and observations performed by accredited testing facilities.

4. Adjudication Method for the Test Set:

Not applicable. As these are non-clinical performance tests, there is no need for an adjudication method by human experts. The results are directly compared to the established numerical acceptance criteria.

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

No. The document explicitly states: "No clinical study implemented for the Surgical Mask." Therefore, no MRMC study was conducted, and no effect size for human readers with or without AI assistance is reported.

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

Not applicable. This device is a physical product (a surgical mask), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is based on defined performance standards and specifications from recognized organizations (e.g., ASTM, EN, ISO) and regulatory bodies (e.g., 16 CFR). For example, for Bacterial Filtration Efficiency, the ground truth is "≥98% filtration." For Biocompatibility, it's defined by specific cellular viability percentages or irritation indices.

8. Sample Size for the Training Set:

Not applicable. As this is a physical medical device and not an AI/ML algorithm requiring training data, there is no "training set."

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

Not applicable. There is no training set for this device.

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