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HONGYU Disposable Surgical Drapes are devices made of synthetic material intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only.

This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

Models C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Neck Drape, Simple Drape, Simple Drape, Extremity Drape, Universal Drape, Head Drape, Craniotomy Drape, Buttock Drape, ENT Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape.

HONGYU Disposable Surgical Drapes are devices made of synthetic material intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only.

This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

HONGYU Disposable Surgery Drapes offer a variety of surgery drapes (23 types), including C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Neck Drape, Fenestrated Drape, Simple Drape, Extremity Drape, Universal Drape, Head Drape, Craniotomy Drape, Buttock Drape, Dental Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape.

The HONGYU Disposable Surgery Drapes have a basic drape. Additionally, each of the drapes has different drape components according to the intended clinical surgery sites, such as the reinforcement, fenestration, single-coating/ double-coating medical tape. PE film and Velcro-style line holders/ tube holders.

The provided text describes the regulatory clearance of a medical device (HONGYU Disposable Surgical Drapes) and includes a summary of non-clinical testing to demonstrate substantial equivalence to a predicate device. However, it does not contain information about a clinical study involving human subjects or AI performance. Therefore, I cannot fully answer all aspects of your request, particularly those pertaining to AI assistance, human reader performance, training set, or ground truth derived from pathology/outcomes data.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-AI, non-diagnostic product, and its performance is evaluated against material properties and sterile barrier standards. The acceptance criteria are typically the standards themselves, and the reported performance is conformity to these standards.

2. Sample size used for the test set and the data provenance

The document describes non-clinical tests on the device materials and packaging, not human studies. Therefore, there isn't a "test set" in the context of patient data. The samples would be batches of the surgical drape and its component materials. The document does not specify the number of samples tested for each non-clinical test. The provenance of the data is from Weihai Hongyu Nonwoven Fabric Products Co., Ltd in China, performing tests to demonstrate conformity to international and US standards. These tests are inherently retrospective in the sense that they are performed on manufactured products.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a non-clinical device that relies on standardized material testing. "Ground truth" in this context refers to the defined parameters of the standards themselves (e.g., a material either passes a certain barrier test or it doesn't). No human experts are involved in establishing "ground truth" for each individual test sample; rather, the tests are performed by technicians/engineers following established protocols.

4. Adjudication method for the test set

Not applicable. As described above, there is no need for adjudication as these are objective material property tests against defined standards.

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

Not applicable. This device is a surgical drape, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used

The "ground truth" for the performance of this device is established by international and national consensus standards for material properties, barrier performance, biocompatibility, and sterilization. For example, the "ground truth" for liquid barrier performance is a specified level (like Level 4) defined within the AAMI PB70 standard. "Pathology" or "outcomes data" are not relevant for the substantial equivalence demonstration of this type of device.

8. The sample size for the training set

Not applicable. This is a non-AI product, so there is no "training set."

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

Not applicable. There is no training set.

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Disposable Surgical Gowns, which are blue colored and EO sterilized, are indicated 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 could achieve Level 3 Barrier Performance as per AAMI PB70:2003. It is for single use only.

Disposable 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 transfer of microorganisms, body fluids, and particulate material. Disposable Surgical Gowns are manufactured from three layers nonwoven fabric that is comprised of Spunbond (SMS) materials. Disposable Surgical Gowns are reinforced with an additional layer of SPP (Syndiotactic Polyprogylene) laminating film in the sleeve and body areas for higher barrier protection. The proposed Disposable Surgical Gowns include four sizes, which are presented in Table V-1 General Description.

The provided text describes a 510(k) summary for disposable surgical gowns, focusing on their physical and biological properties. It does not contain any information about an AI-powered device, a test set, expert readers, or ground truth establishment in the context of medical imaging or diagnostic algorithms.

Therefore, I cannot fulfill your request to describe acceptance criteria and study proving device meets acceptance criteria for an AI device based on the provided text.

The document discusses:

• Device: Disposable Surgical Gowns
• Intended Use: Protection during surgical procedures.
• Acceptance Criteria (for this product): Primarily physical barrier performance (e.g., Level 3 per AAMI PB70), tear strength, fire protection, and biocompatibility, along with manufacturing standards. These are verified through bench tests against established standards (e.g., ASTM, AAMI, ISO).
• Study Proving Acceptance: "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards..."

The text provided does not contain the information requested for an AI-powered device, such as:

1. A table of acceptance criteria and reported device performance (for an AI).
2. Sample size for a test set or data provenance for an AI.
3. Number of experts or their qualifications for ground truth establishment for an AI.
4. Adjudication method for a test set for an AI.
5. MRMC comparative effectiveness study or effect size for AI assistance.
6. Standalone performance of an algorithm.
7. Type of ground truth (expert consensus, pathology, outcomes data) for an AI.
8. Sample size for a training set for an AI.
9. How ground truth for the training set was established for an AI.

The information is related to the regulatory approval process for a physical medical device (surgical gowns), not an AI/software as a medical device.

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