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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.

Additional Performance Claim: The device also 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. This is a key difference and perceived improvement over the predicate device, which met Level 3.

2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test, nor does it detail the provenance of the materials tested (e.g., country of origin). However, it implies standardized testing conducted to meet regulatory and industry standards. The tests are "non-clinical" and laboratory-based, focused on material properties of the manufactured gown samples.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable as this is not an AI/ML-driven study requiring expert interpretation of data/images. The "ground truth" is established by the specified industry standards and test methodologies (e.g., ASTM, AAMI, ISO, AATCC, 16 CFR).

4. Adjudication Method for the Test Set:
Not applicable. Performance is determined by standardized physical and chemical tests against defined numerical criteria, not by human adjudication of qualitative data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI/ML diagnostic or assistive device. The comparison is between the proposed device's physical properties and the requirements of recognized standards, as well as a direct comparison of specifications with a predicate device.

6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:
The "ground truth" for the performance evaluation is based on established industry standards and test methodologies (e.g., ANSI/AAMI PB70:2012 for liquid barrier performance, ASTM F2407-06 for specifications of surgical gowns, ISO 10993 for biocompatibility). The device must demonstrate that its physical and chemical properties meet or exceed the requirements set forth in these standards.

8. Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" for this type of device and non-clinical testing. The manufacturing process and material selection are validated against the final product specifications.

9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set. The "ground truth" for establishing the device's design and performance goals is rooted in existing regulatory requirements and recognized consensus standards for surgical apparel.

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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

Study Information (where applicable based on the provided document):

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

   • Freedom from Holes (ASTM D5151): 200 samples were inspected.
   • Biocompatibility (ISO 10993-10 for sensitization): Guinea pig was used for sensitization test. The document does not specify the exact number of guinea pigs.
   • Data Provenance: The document does not explicitly state the country of origin where the tests were performed or if they were retrospective or prospective studies. The company is based in China.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical and chemical bench tests, not involving expert interpretation of data for ground truth.

3. Adjudication method for the test set: Not applicable.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical device, not an AI or imaging device involving human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical device.

6. The type of ground truth used: For physical and chemical tests, the "ground truth" is defined by the technical specifications outlined in the referenced ASTM and ISO standards (e.g., specific tensile strength values, elongation percentages, powder residue limits for ASTM standards, and bio-response criteria for ISO biocompatibility standards).

7. The sample size for the training set: Not applicable, as this is a physical device.

8. How the ground truth for the training set was established: Not applicable.

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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.

The study proves the device meets the acceptance criteria as indicated by the "Results" columns. All reported values fall within or exceed the specified acceptance criteria.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of masks tested for fluid resistance). The studies are non-clinical bench tests performed on the physical masks themselves (e.g., measuring filtration efficiency, pressure drop, flammability, and conducting biocompatibility tests).
The provenance of the data is from non-clinical bench testing performed on the devices manufactured by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. in China. The tests are reported as "Nonclinical Test Conclusion," implying they were conducted in a laboratory setting to verify the device's design specifications. The studies are prospective in the sense that the tests were conducted specifically for this submission to demonstrate compliance with standards.

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

This concept is not applicable to a submission for surgical masks based on physical and biological performance testing. "Ground truth" in this context refers to the results of standardized laboratory tests performed by qualified personnel using specified methodologies. There is no mention of expert consensus or human interpretation being part of establishing "ground truth" for these performance metrics.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of results/labels. The tests are laboratory-based measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-driven diagnostic aids where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device (surgical masks).

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

Not applicable. This device is not an algorithm or software. Its performance is evaluated through physical and biological testing.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance characteristics (e.g., filtration efficiency, fluid resistance) is established by standardized laboratory test methods (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610) and biocompatibility testing (ISO 10993). These are objective, quantitative measurements against predefined criteria.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI/ML algorithm 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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