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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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A PATIENT EXAMINATION GLOVES 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.

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.

Here's a breakdown of the acceptance criteria and study information for the Rich Mountain Medical Products Ltd. Disposable Vinyl Synthetic Examination Gloves, Powder Free, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:

  • For Physical and Dimensions Testing (ASTM D5250-06): Inspection level S-2, AQL 4.0 (The exact numerical sample size is not explicitly stated but is defined by the AQL and inspection level, which are standard sampling methods).
  • For FDA 1000 ml Watertight Test (ASTM D-5151-06): AQL 2.5, Inspection level I (Again, the exact numerical sample size is not explicitly stated but is defined by these parameters).
  • For Primary Skin Irritation and Skin Sensitization: Not specified beyond "testing was conducted."
  • For Residual Powder Test: Not specified beyond "samplings."

• Data Provenance: The manufacturing company is Rich Mountain Medical Products Ltd., located in China (Jiangsu Province). The testing appears to have been conducted by or for the manufacturer. The data is retrospective relative to the submission date, as it reflects tests performed on manufactured batches of gloves.

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

This type of information is not applicable to this device. This is a Class I medical device (patient examination glove), and the testing involves objective measurement against performance standards (e.g., physical properties, watertight integrity, chemical residue, biocompatibility), not subjective assessments requiring expert consensus on a "ground truth" for diagnostic or interpretative accuracy.

4. Adjudication Method for the Test Set

This information is not applicable. The tests are objective measurements against established standards, not subjective 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices. The device in question is a physical barrier (examination glove), and its effectiveness is measured by its physical properties and barrier integrity, not by human reader performance or AI assistance.

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

No, a standalone algorithm performance study was not done. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by:

• Established ASTM Standards: D5250-06 (Physical and Dimensions), D-5151-06 (Watertight), D6124-06 (Residual Powder).
• Biocompatibility Testing: Results showing "no primary skin irritant or sensitization reactions."
• Regulatory Requirements: FDA's 1000 ml Watertight Test and good manufacturing practices.

These standards and direct measurements form the objective "ground truth" against which the glove's performance is evaluated.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the conventional sense. The "training" for the manufacturing process would be quality control and adherence to manufacturing specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI/ML component, there is no "training set" or "ground truth" for such a set. The manufacturing process's "ground truth" is adherence to quality control parameters and the specifications outlined in the ASTM standards.

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