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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, yellow) that meets all of the requirements of ASTM standard D 5250-00-3.

The provided document describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Colored (White, Yellow)". This is a Class I medical device, and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device. The information details the acceptance criteria and the methods used to prove the device meets these criteria.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Meets" or "Passes" for most criteria, indicating successful adherence to the specified standards or thresholds. For powder amount, a specific value (<10mg/dm2) is given.

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

The document does not specify a distinct "test set" in the context of an AI/algorithm-driven device. Instead, the device is a physical product (gloves) and its performance is evaluated against established physical and chemical standards. Therefore, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) for data in the typical sense of AI/machine learning studies is not directly applicable here.

For the physical and chemical property tests, it's highly probable that samples from manufacturing batches were used. However, the exact sample sizes for each test (e.g., how many gloves were tested for pinholes, how many for dimensions, how many animals for biocompatibility) are not provided in this summary.

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

This question is not applicable to this device and study. The "ground truth" for the performance of these gloves is established by objective, standardized tests and measurements against published ASTM and CFR standards, not by expert consensus on clinical findings or images.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations. The performance of these gloves is determined through objective laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI systems where the performance of human readers with and without AI assistance is compared. This device is a patient examination glove, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No, a standalone performance study was not done. This concept applies to AI algorithms and is not relevant for a physical medical device like examination gloves.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective, predefined standards and test methods. Specifically:

• ASTM standard D 5250-00e4: For dimensions, physical properties, and powder amount. This standard outlines measurable specifications and test procedures.
• 21 CFR 800.20: For freedom from pinholes. This regulation defines the acceptable quality level (AQL) for pinholes and the test method (water leak test).
• ISO10993-10: For biocompatibility (primary skin irritation and dermal sensitization). This standard specifies the in-vivo biological evaluation tests to assess potential adverse reactions.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" for this device, as it is a physical product, not an AI model requiring data for training.

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

This question is not applicable, as there is no training set.

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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, yellow) that meets all of the requirements of ASTM standard D 5250-00t4.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Colored (White, Yellow)":

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 does not explicitly state the sample sizes used for testing each characteristic (Dimension, Physical Properties, Freedom from Pinhole, Powder Residual, Biocompatibility).

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. The studies were conducted to meet "ASTM standard D 5250-00-4, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10," which are international and US standards. The testing itself would typically be prospective for these types of device characteristics.

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 information is not applicable to this type of device and study. The testing for examination gloves involves physical and chemical property measurements against established international and regulatory standards, not expert interpretation of qualitative data.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation or subjective assessments, often in medical imaging or clinical trials, to resolve discrepancies. The tests for these gloves are objective measurements against defined standards.

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 information is not applicable. MRMC studies are relevant for AI-assisted diagnostic devices or imaging systems. This document describes a medical device (examination gloves) that does not involve human "readers" or Artificial Intelligence.

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

This information is not applicable. This device is a physical product (examination gloves), not an algorithm or AI system.

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

The "ground truth" for the performance characteristics of these gloves is defined by the specified ASTM and CFR standards. These standards provide objective measurement methodologies and acceptance limits for physical dimensions, tensile strength, elongation, freedom from pinholes, and powder residue. For biocompatibility, the ground truth is established by the results of animal testing (rabbits and guinea pigs) against established toxicological assessment criteria compliant with ISO10993-10.

8. The sample size for the training set

This information is not applicable. There is no "training set" for this type of medical device testing. Training sets are used in machine learning and AI development.

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

This information is not applicable for the same reason as point 8.

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This 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 (21CFR 880.6250).

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-004.

The provided text is a 510(k) Premarket Notification Summary for Powdered Vinyl Patient Examination Gloves, White (Non-colored). This type of document is about demonstrating substantial equivalence to a predicate device, not necessarily proving novel clinical effectiveness or advanced AI performance. As such, the requested information regarding AI device acceptance criteria, expert adjudication, MRMC studies, and standalone algorithm performance, as well as specific details about training and test sets common for AI/ML device submissions, are not applicable to this traditional medical device submission.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical tests conducted to ensure the gloves meet established standards for similar devices.

Here's the relevant information 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 specifies that the device meets requirements per ASTM D5250-00e4, ASTM D6124-01, 21 CFR 800.20, and ISO10993-10. These are established standards for patient examination gloves and biocompatibility. The sample size for these tests is generally defined within the respective ASTM and ISO standards for statistical validity. However, the exact sample sizes used for the testing of this specific device are not explicitly stated in the provided summary.

The provenance of this data would be from laboratory testing conducted by the manufacturer or accredited testing facilities to comply with these standards. The information does not specify country of origin for the data (beyond the manufacturer being in China) or whether it was retrospective or prospective, as these terms are not typically applicable to this type of device testing.

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. The "ground truth" for this device is established by objective physical and chemical testing against recognized industry standards (ASTM, ISO, and CFR regulations), not by expert human interpretation or consensus.

4. Adjudication method for the test set

This question is not applicable. As the evaluation is based on objective physical and chemical tests against predefined standards, there is no need for expert 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. This submission is for traditional patient examination gloves, not an AI-powered device.

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

This question is not applicable. This submission is for traditional patient examination gloves, not an AI-powered device.

7. The type of ground truth used

The ground truth used is based on pre-established objective standards and specifications from ASTM International (e.g., D5250-00e4 for physical properties and dimensions), the Code of Federal Regulations (e.g., 21 CFR 800.20 for freedom from pinholes), and ISO (e.g., ISO10993-10 for biocompatibility).

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of this traditional medical device submission, as it does not involve machine learning or AI.

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

This question is not applicable. There is no "training set" in the context of this traditional medical device submission.

Ask a specific question about this device

Ask a specific question about this device