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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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

This is a summary of the acceptance criteria and study information for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test in the "test set". However, the tests are conducted in accordance with the cited ASTM and CFR standards, which would specify appropriate sample sizes.

Data Provenance: The data provenance is not explicitly stated in terms of country of origin but is based on non-clinical laboratory testing (e.g., in vitro, animal studies for biocompatibility) and adherence to international and national standards (ASTM, CFR). The testing is retrospective in the sense that completed tests are submitted, but the source of the materials tested would be the manufacturer's products.

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

This device does not involve a scenario where human experts establish ground truth for a test set in the way a diagnostic imaging device would. The "ground truth" here is defined by the objective pass/fail criteria of the specified ASTM and CFR standards for physical properties and biocompatibility. The "experts" would be the accredited laboratories and personnel conducting these standardized tests. Their qualifications would involve expertise in materials testing, chemistry, and toxicology, following good laboratory practices (GLP) to ensure the validity and reliability of the results against the defined standards.

4. Adjudication method for the test set

Not applicable. The tests are based on objective measurements and predefined pass/fail criteria from recognized standards. There isn't a need for expert adjudication in the context of image interpretation or subjective assessments.

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 device is a physical medical device (examination glove), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical medical device.

7. The type of ground truth used

The ground truth used for this device's performance evaluation is based on objective standards and regulatory requirements. Specifically:

• ASTM standards (D 5250-06, D6124-01) for dimensions, physical properties, and powder residual.
• 21 CFR 800.20 for freedom from pinholes (waterleak test).
• ISO 10993-10 (referenced for biocompatibility testing, specifically primary skin irritation and dermal sensitization).

These standards define the acceptable range or threshold for each characteristic.

8. The sample size for the training set

Not applicable. This device is a physical medical device. The concepts of "training set" and "ground truth for training set" are relevant to machine learning or AI models, not to the premarket notification of a patient examination glove. The manufacturer's production process would involve quality control and specification adherence, but not a "training set" in the computational sense.

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

Not applicable (as explained in point 8).

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A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.

Powder-Free Vinyl Examination Glove

The provided document, Premarket Notification 510(k) K071022 for a Powder-Free Vinyl Examination Glove, does not contain any information regarding AI/ML device performance or studies involving human readers, training sets, or ground truth as typically associated with AI-powered medical devices.

Instead, this submission is for a medical glove, and the acceptance criteria and supporting studies are based on traditional physical and biocompatibility testing according to established ASTM and ISO standards.

Therefore, many of the requested categories in your prompt are not applicable to this type of medical device submission. I will answer the applicable questions based on the provided text, and explicitly state when a category is not relevant.

Acceptance Criteria and Device Performance

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

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 refers to "The performance test data that support a determination of substantial equivalence are described above in Section 7" (which is the section outlining standards and specifications). However, it does not explicitly state the sample sizes used for the physical or biocompatibility testing, nor does it specify the data provenance (country of origin, retrospective/prospective). The testing would typically be prospective, conducted by the manufacturer (Glormed Colombia S.A.).

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)

Not applicable. This device is a physical product (medical glove). Ground truth in the context of expert review (e.g., for image interpretation) is not relevant here. Performance is measured against physical and chemical standards.

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

Not applicable. See explanation for #3. Adjudication methods like 2+1 or 3+1 are used for expert disagreement in diagnostic tasks, which is not relevant for glove testing.

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 device is a medical glove, not an AI software. No MRMC study or AI assistance is involved.

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

Not applicable. This device is a medical glove, not an algorithm.

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

The "ground truth" for this device's performance is established by conformance to internationally recognized industry standards such as ASTM D 5250-00, ASTM D 5151-99, ASTM D 6124-00, and ISO 10993. These standards define the acceptable physical properties, non-toxicity, and integrity of medical examination gloves. There is no biological "ground truth" from patients or pathology in the sense of AI diagnostics.

8. The sample size for the training set

Not applicable. This device is a medical glove and does not involve AI/ML requiring a training set.

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

Not applicable. See explanation for #8.

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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Vinyl Examination Gloves

The provided documents are a letter from the FDA regarding a 510(k) premarket notification for "Powder Free Vinyl Examination Gloves" and an "INDICATION FOR USE" statement for the same device. These documents do not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications necessary to answer the prompt.

The letter is a notification of substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market their product. It does not include a technical evaluation or performance study report.

Therefore, I cannot provide a detailed response to the prompt's requirements based on the given information.

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