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Disposable Surgical Gown is 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 4 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. It is single use, disposable medical devices, provided sterile.

The subject devices 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 materials.

In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

The proposed device is single use, disposable medical devices and provided sterile.

The main materials of device are SMS nonwoven +TPU membrane, PP and Polyester fiber, and the main manufacturing technique are Ultrasonic welding and Sewing.

The provided text is a 510(k) Summary for a medical device (Disposable Surgical Gown) and does not describe an AI/ML-driven device or study. Therefore, most of the requested information regarding acceptance criteria, training/test sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is not applicable.

Instead, the document details the device's physical properties, material composition, and performance against established industry standards for surgical gowns. The "study" mentioned is a series of non-clinical tests to verify the device meets design specifications and relevant standards.

Here's a breakdown of the relevant information from the document, tailored to the non-AI/ML context:

Device Description: Disposable Surgical Gown

Purpose of the "Study" (Non-Clinical Testing): To verify that the proposed device (Disposable Surgical Gown) meets all design specifications and complies with relevant standards for surgical gowns, demonstrating its safety and effectiveness compared to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table of non-clinical tests conducted, their purpose, acceptance criteria, and results.

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Sterilization Wraps is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
• Pre-vacuum steam at 270°F/132°C for 4 minutes

Types of medical devices to be sterilized in the pre-vacuum cycle:
General purpose reusable metal and nonmetal devices(No lumen) including devices with stainless steel diffusionrestricted spaces such as forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.

The size of the Devices to be sterilization Wraps pack and form a closed space. Validated for dry time is 30 minutes for Sterilization Wraps.

Color of wrap: Blue Size of wrap: 48 in x 48 in

The maximum validated weight of load for Sterilization Wraps is 12kg.

The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.

Sterilization Wraps is a 63gsm, latex-free, 3-layer (SMS) non-woven sterile wrap, manufactured with spun-bonded / meltblown polypropylenem. Sterilization Wraps provides a strong barrier which protects against cuts, tears with particularly heavy orthopedic sets. Sterilization Wraps is designed to be implemented as an outer sterilization wrap which can be used in combination with Clinipak choice. Sterilization Wraps is made of polypropylene and blue pigment by non-woven process.

The provided document describes the acceptance criteria and the results of the study for the Sterilization Wraps device (K220133). This is a non-clinical study focused on the physical and biological characteristics of the wrap, rather than a clinical study involving human or AI performance.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by meeting the requirements of recognized industry standards. The study demonstrates that the proposed device complies with these standards.

Additional Information

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

• The document does not explicitly state numerical sample sizes for each test. Instead, it refers to "test samples" or "subject wrap."
• Data Provenance: Not specified, but generally, these types of non-clinical tests are performed in a laboratory setting. There is no information regarding country of origin for the test data, nor if it's retrospective or prospective.

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

• This is a non-clinical study involving material and biological performance testing (e.g., sterilization effectiveness, physical properties, biocompatibility). It does not involve "experts" establishing a ground truth in the way a clinical diagnostic study would (e.g., radiologists interpreting images). The "ground truth" is established by the technical specifications and performance requirements outlined in the referenced international standards.

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

• Not applicable. This is a non-clinical performance study against predetermined technical standards, not a diagnostic accuracy study requiring adjudication of interpretations.

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 is not a study involving human readers, AI assistance, or diagnostic effectiveness.

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

• Not applicable. This device is a physical sterilization wrap, not an algorithm.

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

• The ground truth is based on the requirements and methodologies defined by internationally recognized standards (e.g., ISO, ASTM, AAMI, AATCC, USP) for sterilization wraps and medical device packaging. Compliance with these standards serves as the "ground truth" for acceptable performance.

8. The sample size for the training set:

• Not applicable. This is a physical product, not an AI/machine learning model that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

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The Nitrile Examination Gloves (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device, Nitrile Examination Gloves (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.

The proposed device is provided non-sterile. The proposed device is made of Nitrile.

The provided text describes the acceptance criteria and the study results for "Nitrile Examination Gloves (Powder free, Blue)". This is a physical medical device, not a software-driven AI device. Therefore, the specific questions regarding AI-related performance metrics (like sample size for test set/training set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance) are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided tables.

Acceptance Criteria and Reported Device Performance

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The Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Masks 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 Model YH-EZ-004(White Color, Blue Color) is Level 2 barrier as ASTM F2100 requirements.

The proposed device(s) includes 1 model, which is YH-EZ-004. This model has two colors, Blue color and White color. This model is Flat Pleated type mask, utilizing Ear Loops' way for wearing, and it has Nose Piece design for fitting the facemask around the nose.

All two colors of the model YH-EZ-004 of proposed device(s) share same materials and structure, they all are manufactured with three layers, the inner and outer layers are made of spunbonded non-woven fabric, and the middle layer is made of melt-blown non-woven fabric.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene.

The proposed device(s) is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with terylene and spandex.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

Based on the provided text, the device in question is a Surgical Mask, and the submission is a 510(k) premarket notification. This type of submission typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical studies for novel AI/ML-driven diagnostics.

Therefore, the requested information regarding AI/ML-specific acceptance criteria, test sets, expert ground truth, MRMC studies, and standalone algorithm performance is not applicable to this document. This document describes the testing for physical and biological properties of the surgical masks to show they perform as well as a predicate device.

Here's the information that is applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the surgical masks are based on ASTM F2100 Level 2 requirements and other relevant standards.

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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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