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Disposable Surgical Gown (Level 3, MF2103 Series)/ Disposable Surgical Gown (Level 3, MF2104 Series)/ Disposable Surgical Gown (Level 4, MF2105 Series) is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is single use, disposable and supplied sterile.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, MF2103 Series and MF2104 Series met the requirements for Level 3 classification, MF2105 Series met the requirements of Level 4 classification.

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This document is a 510(k) premarket notification from the FDA, specifically concerning the substantial equivalence determination for Disposable Surgical Gowns. It clarifies that the device is found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about an AI/ML-based medical device, its acceptance criteria, or the study that proves it meets those criteria. The device in question is a physical product (surgical gowns), and the assessment is based on physical barrier performance standards (ANSI/AAMI PB70:2012), not on AI/ML algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including details like:

1. A table of acceptance criteria and the reported device performance: Not applicable as the "performance" here refers to physical barrier properties, not algorithmic output.
2. Sample sizes used for the test set and the data provenance: Not applicable. Testing for surgical gowns involves physical property tests (e.g., liquid barrier, particulate material transfer), not data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical product like a surgical gown is established by standardized physical testing methods, not expert consensus on data.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is relevant for AI-assisted image interpretation, not physical products.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the context of AI/ML. The "ground truth" for the gowns is their adherence to ANSI/AAMI PB70:2012 standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on the regulatory clearance for a medical device (surgical gowns) based on their physical barrier performance against industry standards, not on an AI/ML algorithm's diagnostic or analytical performance.

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The StringKing Disposable Surgical Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The StringKing Surgical Gowns meet Level 3 and Level 4 requirements of ANSI/AAMI PB 70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

The Disposable Surgical Gown consists of a multi-layer nonwoven spunbond-meltblownspunbond (SMS) polyolefin & Film Lamination in the critical zones and a single layer of lighter, more breathable nonwoven SMS polvolefin in the non-critical zones. The StringKing Disposable Surgical Gown is designed for easy donning and doffing with hook and loop neck tabs, belt ties, removable transfer accessory, and polyester wrist cuffs. The StringKing Disposable Surgical Gown is one gown design that meets both Level 4 requirements of AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The gown will be marketed as a L3 gown as well as a L4 gown. The StringKing Disposable Surgical Gowns are single use, disposable medical devices that will be provided sterile.

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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