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Powdered vinyl patient examination glove 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.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

Here's an analysis of the provided text regarding acceptance criteria and study information for the "Powdered Vinyl Patient Examination Gloves, White (Non-colored)":

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). However, the tests are conducted in accordance with referenced standards (ASTM D 5250-00c4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10). These standards typically specify sample sizes or methodologies for such testing.

The data provenance is not specified beyond "Hebei Manful Import & Export Co., Ltd." as the submitter, located in China. The studies are non-clinical (laboratory testing) and are retrospective in the sense that they were completed before the 510(k) submission.

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

This information is not provided. For non-clinical, objective performance tests like those conducted for examination gloves (dimensional, physical properties, pinholes, powder amount), the "ground truth" is typically established by laboratory measurements against defined standards, rather than expert consensus on subjective findings. For biocompatibility, the ground truth is established by the observed biological response in animal models, interpreted by qualified toxicologists or study directors, though their number and specific qualifications are not detailed here.

4. Adjudication Method for the Test Set

Not applicable for these types of non-clinical performance and biocompatibility studies. The results are typically objective measurements or observations against predefined pass/fail criteria according to the referenced standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. Examination gloves are medical devices with objective performance criteria.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently against the specified standards without human interaction influencing the device's function or interpretation of its output. The device itself (the glove) is not an algorithm, so "algorithm only" is not directly applicable. However, its physical characteristics and biological safety were tested in an isolated manner.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Defined Standards: For dimensions, physical properties, powder amount, and freedom from pinholes, the "ground truth" is adherence to the specified ASTM and CFR standards with their quantitative limits.
• Laboratory Observations/Measurements: For biocompatibility, the ground truth is established through observed biological responses in animal models (e.g., presence or absence of irritation or sensitization), as interpreted by testing personnel/toxicologists following the ISO standard.

8. Sample Size for the Training Set

Not applicable. This device is an examination glove, not an AI/ML algorithm or a device that requires a "training set" in the context of machine learning. The studies described are performance and safety tests, not algorithm training.

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

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

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Powder free vinyl patient examination glove 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.

powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

This is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," a Class I medical device. The information provided is standard for this type of device and does not involve complex AI algorithms or detailed clinical studies in the way you might expect for an AI-powered diagnostic tool. Therefore, many of your requested items, such as expert adjudication, MRMC studies, and detailed training set information, are not applicable in this context.

Here's an analysis based on the provided document:

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

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

The document indicates that the device meets the specified ASTM standards and FDA regulations, which involve testing batches of gloves to ensure compliance. However, it does not specify explicit sample sizes for the "test set" in the context of a software or AI device. The testing related to manufacturing quality (pinholes, dimensions, physical properties, powder residual) is typically done on a statistically representative sample from each production lot, as per the respective standards (e.g., AQL levels for pinholes).

• Sample Size: Not explicitly stated for each test, but implied to be statistically significant samples as required by the referenced ASTM standards and 21 CFR 800.20 for manufacturing quality control.
• Data Provenance: The tests are conducted by the manufacturer, HEBEI MANFUL IMPORT & EXPORT CO., LTD, presumably in their facilities in P.R. CHINA, to demonstrate compliance with US standards (ASTM, FDA). This is a prospective evaluation of manufactured product batches.

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

This type of examination glove does not involve expert interpretation or ground truth establishment in the way AI diagnostics do. The "ground truth" for these tests are objective measurements against established physical and chemical standards.

• Number of Experts: Not applicable. The "ground truth" is defined by the objective measurement criteria of the ASTM and FDA standards.
• Qualifications of Experts: Not applicable in the context of human interpretation. Quality control technicians, chemists, and engineers with expertise in materials testing perform the measurements.

4- Adjudication method for the test set

Not applicable. Testing involves objective measurements (e.g., tensile strength, elongation, physical dimensions, water leak test for pinholes, chemical analysis for powder residue, and biological assays for biocompatibility). There is no subjective interpretation 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

Not applicable. This is a physical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical device.

7- The type of ground truth used

The ground truth used for demonstrating compliance is based on:

• Objective Measurement Data: Physical dimensions, tensile strength, elongation, freedom from pinholes (water leak test AQL), and powder residual measured against an absolute standard.
• Biological Assay Results: Results from standardized in vivo tests for primary skin irritation and dermal sensitization, which are objective pass/fail criteria.

8- The sample size for the training set

Not applicable. There is no software or AI algorithm in this device that requires a training set.

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

Not applicable. There is no software or AI algorithm in this device that requires a training set.

In summary: The provided document describes a medical device that undergoes quality control testing to meet established industry and regulatory standards. It is not an AI-powered device, so many of the questions asked in the prompt, which are typically relevant for AI/ML device evaluations, do not apply here. The "study" proving the device meets acceptance criteria refers to manufacturing quality control and biocompatibility testing against defined industry standards (ASTM) and FDA regulations.

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