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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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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. 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) summary for Disposable Synthetic Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing against established standards. There is no information in this document about a study conducted to "prove the device meets acceptance criteria" in the way one might describe a clinical trial for a diagnostic algorithm or a comparative effectiveness study. This document is a regulatory submission for a Class I medical device (examination gloves), which have different evaluation requirements than, for example, AI-powered diagnostic software.

Therefore, many of the specific questions about "acceptance criteria," "device performance," "sample size for test set," "ground truth," "MRMC," and "standalone performance" are not applicable in the context of this document. This document details how the device meets regulatory and standard requirements, not how it performs in a diagnostic or clinical efficacy study.

However, I can extract the relevant information regarding the performance characteristics and safety evaluations presented in the document, framed as how the device demonstrates substantial equivalence and meets referenced standards.

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

For examination gloves, "acceptance criteria" are typically defined by recognized consensus standards which specify physical properties, freedom from holes, and biocompatibility. The "reported device performance" refers to the results of tests conducted to ensure the device meets these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes for each non-clinical test (e.g., how many gloves were tested for tensile strength or holes). It references compliance with standards like ASTM D5151, which would imply specific sampling plans are followed within those standards. The data provenance is implied to be from the manufacturer, Shandong Shengshixincheng Medical Science & Technology Co., Ltd. (China), which conducted the tests to verify design specifications. The nature of these tests is prospective for the submission, meaning they were performed specifically to support the 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. For medical gloves, "ground truth" is established by adherence to physical, chemical, and biological performance standards (e.g., tensile strength, barrier integrity, biocompatibility), not by expert consensus on clinical images or diagnoses. The testing is objective and quantitative, performed in a lab setting.

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

This is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/imaging studies where interpretations can vary. Non-clinical tests for gloves involve standardized laboratory procedures with measurable outcomes.

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 is not applicable. MRMC studies and AI assistance are relevant for diagnostic or interpretive devices; this document concerns examination gloves.

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

This is not applicable. This device is a physical product (gloves), not a software algorithm.

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

The "ground truth" in this context is defined by the objective performance criteria specified in international consensus standards (ASTM D5250, ASTM D5151, ASTM D6124) and biocompatibility standards (ISO 10993-10, ISO 10993-5). Successful compliance with these measured physical/chemical/biological properties constitutes the "ground truth" for showing the device is safe and effective as examination gloves.

8. The sample size for the training set

This is not applicable. There is no "training set" for a physical device like examination gloves in the way it applies to machine learning algorithms.

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

This is not applicable. There is no "training set" for this type of device.

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