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Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

This section describes acceptance criteria and the study proving the device meets said criteria.

The device under consideration is "Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color."

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 sample sizes used for each specific test (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility). The tests are based on established ASTM standards and FDA regulations, which typically specify sampling plans. The provenance of the data is not described beyond stating that the device "meets" the requirements of these standards. It is implied that these are non-clinical studies conducted by the manufacturer for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
   Not applicable. This device is a physical product (gloves) and not an AI or diagnostic device that requires expert adjudication of results to establish ground truth in the same way. The "ground truth" is established by adherence to physical and chemical standards and biological safety tests.

4. Adjudication Method for the Test Set:
   Not applicable. As noted above, this product does not involve adjudication of results by multiple experts. Compliance is determined by objective measurement against specified standards and laboratory testing protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   Not applicable. This is not a diagnostic device or an AI-assisted system that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
   Not applicable. This is a physical product, not an algorithm.

7. Type of Ground Truth Used:
   The "ground truth" for this device is based on established industry standards and regulatory requirements, including:

   • ASTM standard D 5250-06 e1 (for dimensions and physical properties).
   • 21 CFR 800.20 (for freedom from pinholes, specifically waterleak test on pinhole AQL).
   • ASTM D6124-06 (for powder residual).
   • AAMI / ANSI / ISO 10993-10 (for biocompatibility, specifically primary skin irritation and dermal sensitization).
     These are objective, measurable criteria with defined pass/fail thresholds.

8. Sample Size for the Training Set:
   Not applicable. This device is a physical product and does not involve machine learning or AI models, therefore, there is no "training set" in the context of data used for algorithm development.

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 Gloves, Light Yellow Color 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, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Light Yellow Color." This is a Class I medical device, and the study described is a non-clinical assessment against established standards, not a study of an AI-powered device. Therefore, many of the requested fields related to AI, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "training set," and "adjudication method," are not applicable.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" sample size in the context of a typical AI/software study. Instead, it refers to compliance with established standards (ASTM, CFR, ISO) which define their own sampling methods for quality control testing of physical products. The data provenance is implied to be from the manufacturer's own testing procedures to demonstrate compliance with these standards. There is no mention of country of origin of data (beyond the manufacturer's location in China) or whether it was retrospective or prospective in the sense of a medical study.

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

Not applicable. The "ground truth" for this device is compliance with established physical and biological standards, determined through laboratory testing, not expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of results 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 not an AI device.

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

Not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The ground truth used is defined by established regulatory and industry standards for patient examination gloves, including:

• ASTM standard D 5250-06 e1 (for dimensions and physical properties)
• 21 CFR 800.20 (for freedom from pinholes)
• ASTM D6124-06 (for powder residual)
• AAMI / ANSI / ISO 10993-10 (for biocompatibility - primary skin irritation and dermal sensitization)

8. The Sample Size for the Training Set

Not applicable. This is a physical product and not an AI/machine learning device that requires a training set.

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

Not applicable. As above, there is no training set for this type of device.

Ask a specific question about this device

Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile 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, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes the acceptance criteria and performance of Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, as submitted in a 510(k) summary (K093570) to the FDA. The study presented a non-clinical evaluation to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

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 sample size used for the test set for each characteristic. However, it indicates that the tests were performed according to specified ASTM and CFR standards, which would inherently include appropriate sample size requirements for those tests. The data provenance is not specified beyond the tests being conducted for the Jiangsu Jaysun Glove Co.,Ltd., located in China. The study is a non-clinical evaluation.

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

This section is not applicable as the device is a medical glove, and the evaluation involves objective performance testing against established physical and chemical standards, not expert interpretation of outputs like in imaging or diagnostic AI.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. The evaluation relies on objective measurements against predefined standards, not subjective assessment requiring adjudication.

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

This section is not applicable. The device is a medical glove, not an AI system. Therefore, an MRMC study and the concept of human readers improving with or without AI assistance are irrelevant.

6. Standalone (Algorithm Only) Performance Study

This section is not applicable. The device is a medical glove. The evaluation focuses on the physical and biological properties of the glove itself, not on an algorithm's performance.

7. Type of Ground Truth Used

The ground truth used for the device's performance evaluation is based on established industry and regulatory standards. These include:

• ASTM standard D 5250-06e1 (for dimensions and physical properties)
• 21 CFR 800.20 (for freedom from pinholes, commonly referred to as the "waterleak test" for AQL)
• ASTM standard D 6124-06 (for powder residual)
• AAMI / ANSI / ISO 10993-10 (for biocompatibility, specifically primary skin irritation and dermal sensitization)

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

8. Sample Size for the Training Set

This information is not applicable. The device is a medical glove, and its evaluation does not involve a "training set" in the context of machine learning or AI.

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

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

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