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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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed,

This is a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)". This type of device does not involve AI/ML technology, imaging, or diagnostics, and therefore the requested information regarding AI/ML study design, reader studies, and ground truth establishment is not applicable. The device is a Class I medical device, which typically relies on established performance standards and non-clinical testing for substantial equivalence.

Here's the relevant information from the provided document:

1. Table of Acceptance Criteria and 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 meeting established ASTM standards and CFR regulations for glove performance. These standards prescribe specific test methods and sample sizes. For example:

• Freedom from pinholes (21 CFR 800.20): This regulation specifies an Acceptable Quality Level (AQL) which implicates a statistically derived sample size for testing.
• ASTM D5250-00e4 (Standard Specification for Poly(Vinyl Chloride) Gloves for Medical Application): This standard outlines specific test methods and the number of specimens required for various tests like dimensions, physical properties (tensile strength, elongation), and powder amount. The document does not provide the specific number of gloves tested for this submission, but it implies compliance with the sampling requirements of these standards.
• Biocompatibility tests (ISO10993-10): These tests also have defined sample sizes for animal models (rabbits for skin irritation, guinea pigs for sensitization).

The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective, but it's generated by the manufacturer, SHIJIAZHUANG PROSPEROUS PLASTIC CO.,LTD, based in China, for submission to the FDA in the USA.

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 (gloves), and performance is assessed against standardized physical and chemical tests rather than expert interpretation of data.

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

Not applicable. This is not an AI/ML or diagnostic device that requires expert adjudication for ground truth.

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. MRMC studies are for diagnostic devices, particularly those involving human readers and AI assistance. This is a medical glove.

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

Not applicable. This 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 is based on pre-defined, objective, and standardized measurements as specified by the referenced ASTM standards (e.g., D 5250-00e4, D6124-01) and regulatory requirements (21 CFR 800.20, ISO10993-10). For example:

• Physical properties (tensile strength, elongation) are measured objectively.
• Freedom from pinholes is determined by a water leak test.
• Biocompatibility is determined by standardized animal tests with observable outcomes (absence of irritation or sensitization).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or ground truth establishment for it.

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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 5250-0008.

The provided text describes the acceptance criteria and the study for a medical device, specifically "Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)". The study's purpose is to demonstrate substantial equivalence to a predicate device, which is a common pathway for Class I medical devices in the US.

Here's the breakdown of the requested information:

1. Table of acceptance criteria and the 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 (e.g., dimension, physical properties, pinholes). It refers to the standards (ASTM D 5250-00e4, ASTM D6124-01, 21 CFR 800.20, ISO10993-10) which would contain the prescribed sampling plans. The data provenance is not specified beyond being "submitted, reference, or relied on". Given the context of a 510(k) submission from a Chinese manufacturer, the testing likely occurred at facilities approved to conduct tests according to these international standards, but specific country of origin for the data is not mentioned. The study is a non-clinical evaluation, not a retrospective or prospective clinical study.

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

Not applicable. This is a non-clinical device performance and biocompatibility study, not a study requiring expert clinical judgment to establish ground truth. The "ground truth" is established by adherence to the specified technical standards and regulations.

4. Adjudication method for the test set

Not applicable. As this is a non-clinical performance test, there isn't an "adjudication method" in the sense of reconciling human expert opinions. The results are based on objective measurements and observations according to standardized test protocols.

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 patient examination glove, a Class I medical device. It is not an AI-powered diagnostic or assistive technology, and therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant to its evaluation.

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

Not applicable. As stated above, this is not an AI algorithm.

7. The type of ground truth used

The "ground truth" in this context is defined by the technical specifications and requirements outlined in recognized standards and regulations:

• ASTM standard D 5250-00e4 (for Dimension, Physical Properties, and Powder Residual)
• 21 CFR 800.20 (for Freedom from pinholes - Waterleak Test)
• ASTM D6124-01 (for Powder Residual)
• ISO10993-10 (for Biocompatibility, specifically Primary Skin Irritation and Dermal Sensitization)

These standards specify the acceptable limits and test methods, which serve as the objective ground truth against which the device's performance is measured.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no training set. The evaluation focuses on the physical and chemical properties of the manufactured gloves.

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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