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The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical mask 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, provided non-sterile.

The surgical mask is a three-layer flat-pleated mask made of nonwoven polypropylene materials. The inner layer (white color) and the outer layer (blue color) are made of spunbonded polypropylene to provide comfort and breathability; the middle filtration layer is made of melt-blown polypropylene. The three layers are bonded together sonically along the four edges with the inner layer slightly folded over the outer layer along the long edges.

The mask is fitted to cover the wearer's nose and mouth with ear-loops. The ear-loops are made of knitted polyester/ elastane. They are welded to the mask. The materials do not contain natural rubber latex.

A malleable polyethylene laminated aluminum nosepiece is placed between the layers along the top edge of the mask for extra comfort and fit around the wearer's nose.

The surgical mask is intended to be a single-use disposable device, provided non-sterile.

The provided text is a 510(k) Summary for a Surgical Mask, specifically K210524 from Changzhou Holymed Products Co., Ltd. It details the device, its intended use, comparison to a predicate device, and performance testing to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the performance testing is summarized in Table 2: Non-Clinical Performance Testing Table on page 6.

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HM Surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of micro-organisms, body fluids, and particulate matter.

HM Surgical Gowns are disposable, single use, sterile or nonsterile surgical gowns manufactured from nonwoven Spunbond-Meltblown-Spunbond (SMS) polypropylene fabrics.

Non-sterile HM surgical gowns are to be sold to repackager/relabeler establishments for EtO sterilization according to ISO 11135-1 and Sterile surgical gowns are to be sold directly to users after EtO sterlization validation to ISO 11135-1.

HM Surgical Gowns are disposable, single use, sterile or nonsterile surgical gowns manufactured from nonwoven Spunbond-Meltblown-Spunbond (SMS) polypropylene fabrics. Gowns are provided in three families: Gown Family A (Non Reinforced), Gown Family B (Fabric Reinforced), and Gown Family C (Poly Reinforced). They are available in sizes M, L, XL, and XXL (with an additional XL, X-Long size in Family C) and are blue in color.

This document is a 510(k) premarket notification response for a medical device, specifically HM Surgical Gowns. It primarily focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device.

Crucially, this document does not contain information about specific acceptance criteria or an analytical study proving the device meets those criteria, as one would typically find for an AI/ML medical device.

The content details the regulatory classification, general controls, and provides an "Indications for Use" statement, along with a list of the different gown families, product codes, sterilization status, and sizes.

Therefore, I cannot extract the requested information like a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth methods, or MRMC study results because this document describes a physical medical device (surgical gowns), not a software algorithm or AI/ML product. The FDA 510(k) clearance process for devices like surgical gowns typically relies on compliance with recognized standards (e.g., fluid resistance, tensile strength, barrier effectiveness) rather than AI-specific performance metrics.

To provide the information you requested, I would need a document describing the validation of an AI/ML-based medical device.

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HM surgical drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
HM surgical drapes are disposable, single use, sterile or nonsterile.
Non-sterile HM surgical drapes are to be sold to repackager/relabeler establishments for EtO sterilization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
HM Surgical Equipment Covers are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
HM surgical equipment covers are disposable, single use, sterile or nonsterile.
Non-sterile HM surgical equipment covers are to be sold to repackager/relabeler establishments for E!O sterflization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.

Not Found

This document is a 510(k) premarket notification for "HM Surgical Drapes" and "HM Surgical Equipment Covers." It primarily concerns the regulatory approval of these devices and does not contain information about acceptance criteria for performance, nor a study proving the device meets said criteria, in the context of an AI/ML device.

The document lists:

• Trade/Device Name: HM Surgical Drapes, HM Surgical Equipment Covers
• Regulation Number: 21 CFR 878.4370
• Regulation Name: Surgical Drape and Drape Accessories
• Regulatory Class: II
• Product Code: KKX
• Indications for Use: HM surgical drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. HM surgical equipment covers are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
• Sterilization: Products are either sterile or non-sterile. Non-sterile products are to be sterilized by repackager/relabeler establishments using EtO sterilization according to ISO 11135-1. Sterile products are sold directly to users after EtO sterilization validation to ISO 11135-1.
• Materials: Various drapes and covers are made from SMS (Spunbond-Meltblown-Spunbond) base panel, SM (Spunbond-Meltblown) pad, polyethylene film, polyethylene pouch, or polyethylene bags, sometimes with SM reinforcement.

The document does not include any of the following information relevant to the performance acceptance criteria or a study proving device performance:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI assistance.
6. Information on a standalone AI algorithm performance study.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This document is solely a regulatory letter of substantial equivalence for a physical medical device (surgical drapes and equipment covers), not an AI/ML powered device, and thus the requested information concerning AI/ML device performance is not applicable or present in this context.

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