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Disposable Vinyl Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The subject device is a patient examination glove made of Poly (vinyl chloride) compound. It is Non-Sterile, Powder free and is clear in colour. The device is ambidextrous and can be worn on either the left or right hand. (Per 21 CFR 880.6250, class I). The device provides four specifications: S, M, L and XL. The device meets all the specifications in ASTM D5250-19, Standard specification for Vinyl Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-10, ISO 10993-23, ISO 10993-5

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Disposable Vinyl Examination Gloves":

This document is a 510(k) summary for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device. As such, it describes performance testing rather than a study proving the device meets acceptance criteria in the context of clinical AI performance. The device in question is a physical product (gloves), not an AI/software device.

Therefore, many of the requested points, especially those related to AI device performance, sample sizes for test/training sets, ground truth, experts, and MRMC studies, are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided tables for the physical aspects of the gloves.

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance

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The Disposable Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free non-colored vinyl examination glove. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

The provided text describes the acceptance criteria and the study that proves a "Disposable Vinyl Examination Glove" meets these criteria. It is important to note that this is a Class I medical device (non-AI/ML).

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

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The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, 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 subject device is powder free vinyl examination glove. The subject device's color is pink, black and blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for Disposable Vinyl Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device based on bench testing (non-clinical testing) rather than clinical studies involving human patients or complex AI algorithms.

Therefore, many of the requested points related to AI, MRMC studies, expert ground truth adjudication, and clinical trial specifics are not applicable to this submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

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The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination gloves. The subject device's color is yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

This document describes the regulatory approval for "Disposable, vinyl examination gloves, Yellow" and focuses on non-clinical testing for equivalence. Therefore, it does not contain the information requested for a study proving device performance against acceptance criteria in the context of an AI/medical imaging device.

The provided text pertains to a Class I medical device (disposable vinyl examination gloves) and its 510(k) submission for substantial equivalence to a predicate device. The information requested (acceptance criteria and study details for an AI-powered device or diagnostic tool) is not applicable to this submission.

However, I can extract the acceptance criteria and reported device performance from the "Summary of Non-clinical Testing" section (Table 2) in the document, which are related to the physical and biocompatibility properties of the gloves.

Here's a breakdown of the available information based on your request, with the understanding that it will not completely align with the format for AI/diagnostic studies:

1. Table of Acceptance Criteria and the Reported Device Performance

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The Disposable Vinyl Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Disposable Vinyl Examination Gloves

The provided document is an FDA 510(k) clearance letter for "Disposable Vinyl Examination Gloves." This document does not contain any information regarding acceptance criteria or a study that proves a device meets such criteria, as it pertains to medical gloves, not a diagnostic or AI-powered device.

The questions in the prompt are typical for evaluating a new diagnostic or AI-driven medical device submission, which would involve performance metrics like sensitivity, specificity, accuracy, and detailed study methodologies. This document is a regulatory clearance for a Class I medical device (non-powdered patient examination glove) which typically relies on established performance standards for physical properties rather than clinical performance studies described by the questions.

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The Disposable Vinyl Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject devices have two color: blue and clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided text is a 510(k) Premarket Notification for Disposable Vinyl Examination Gloves. This document is for a Class I medical device, which falls under general controls and typically does not require extensive clinical studies or complex performance criteria like those for AI-powered diagnostic tools. Therefore, the information needed to answer the prompt's specific questions regarding acceptance criteria, study methodologies for AI/software, ground truth establishment, expert adjudication, or MRMC studies for this type of device is not present in the document.

The document mainly focuses on demonstrating substantial equivalence to a predicate device (K163168) through:

• Identical Intended Use: Both devices are disposable gloves for preventing contamination between patient and examiner.
• Similar Technological Characteristics: Material (vinyl), design (ambidextrous, powder-free), and basic physical properties.
• Compliance with Recognized Standards: ASTM D5250 (physical dimensions, performance), ASTM D5151 (freedom from holes), ASTM D6124 (powder content), and ISO 10993 (biocompatibility).

Based on the provided document, here's an attempt to address your questions, highlighting what information is available and what is not applicable or not provided for this type of device:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria in a pass/fail table format, nor does it typically report specific "performance" metrics in the way an AI algorithm would (e.g., sensitivity, specificity). Instead, it shows comparative data with the predicate device against established standards.

Here's an extraction of relevant "performance" data and standards from the "Technological Characteristic Comparison Table" (Table3) and "Device Dimensions Comparison" (Table2), indicating compliance with ASTM standards which serve as de facto acceptance criteria for these physical properties:

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

The document refers to "non-clinical tests" such as those for physical properties, freedom from holes, powder content, and biocompatibility, which are conducted on samples of the manufactured gloves.

• Sample Size: The exact sample sizes for each specific test (e.g., number of gloves tested for tensile strength, number of gloves tested for holes, number of specimens for biocompatibility) are not explicitly stated in this summary document. These details would typically be found in the full test reports referenced by the standards (e.g., ASTM D5151 specifies sampling plans for AQL).
• Data Provenance: The tests were performed by the manufacturer (Shandong Shengshixincheng Medical Science & Technology Co., Ltd. is the submitter) and/or their designated testing labs. The country of origin for the data is implicitly China, where the manufacturer is located. The tests are prospective in the sense that they are performed on samples of the manufactured device to verify its properties.

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

This question is not applicable to this type of device. "Ground truth" established by experts (like radiologists for imaging) is relevant for diagnostic devices that interpret complex data or images. For examination gloves, the "ground truth" is defined by the physical and chemical properties measured against established engineering and biocompatibility standards (e.g., a glove either passes or fails a hole test, or its tensile strength meets the specified MPa). No human experts are needed to adjudicate these objective measurements.

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

This question is not applicable. Adjudication methods are specific to scenarios where human interpretation or consensus is required (e.g., in medical image reading trials). The tests for examination gloves involve objective measurements, not subjective human assessments requiring adjudication.

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

This question is not applicable. MRMC studies are used for evaluating the performance of diagnostic imaging devices, particularly those involving AI assistance, and comparing human reader performance with and without AI. This device is an examination glove, not a diagnostic imaging device or an AI product.

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

This question is not applicable. This device is a physical product (a glove), not an algorithm or software requiring standalone performance evaluation.

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

The "ground truth" for this device is based on objective engineering standards, physical measurements, and chemical/biological test results. For example:

• Physical dimensions: Measured against specified ranges (e.g., length, width, thickness).
• Tensile Strength & Elongation: Measured in MPa and % elongation against minimum thresholds.
• Freedom from Holes: Determined by an objective test method (ASTM D5151) with an Acceptable Quality Limit (AQL).
• Powder Content: Measured against a maximum threshold (ASTM D6124).
• Biocompatibility: Determined by standardized in-vitro and in-vivo tests (ISO 10993-5, -10) for irritation, sensitization, and cytotoxicity.

These are not based on expert consensus, pathology, or outcomes data in the medical sense, but rather on compliance with established consensus standards for medical devices.

8. The sample size for the training set

This question is not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI models.

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

This question is not applicable, as there is no "training set" for this type of device.

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The Disposable Vinyl Examination Gloves are intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided text describes the acceptance criteria and a study for Disposable Vinyl Examination Gloves. It is a 510(k) summary for a medical device seeking substantial equivalence to a legally marketed predicate device.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR POWDER FREE WITH VITAMIN E

This document is a 510(k) clearance letter from the FDA for disposable vinyl examination gloves. It does not contain information on acceptance criteria or a study proving the device meets those criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. Therefore, I cannot extract the requested information from the provided text.

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