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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 5250-06.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Study Information

Here's the detailed breakdown of the study components based on the provided text:

1. 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 specify the exact sample size for any test set or the data provenance (country of origin, retrospective/prospective). It refers to meeting ASTM and CFR standards, which imply specific testing protocols but don't explicitly state the sample size used in this specific submission's testing.

2. 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 provided in the document. The document describes testing against established standards (ASTM, CFR), not expert-derived ground truth in the context of a clinical or image-based study.

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

   • Adjudication methods are not applicable here as it's not a study involving human interpretation or subjective assessments that would require adjudication. The testing is based on objective measurements against established standards.

4. 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

   • A multi-reader, multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device (patient examination gloves). This device does not involve AI or human interpretation in its function.

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

   • A standalone performance study of an algorithm was not performed, nor is it applicable. This device is a physical medical glove, not a software algorithm.

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

   • The "ground truth" for this device's performance is based on established industry standards and regulatory requirements. This includes:
     • ASTM standard D 5250-06 (for dimensions, physical properties, powder amount)
     • ASTM standard D6124-06 (for powder amount)
     • 21 CFR 800.20 (for freedom from pinholes)
     • FDA recognition number 2-87 for AQL (related to pinholes)
     • ANSI / ISO 10993-10:2002 (for biocompatibility - primary skin irritation and dermal sensitization).

7. The sample size for the training set

   • There is no training set mentioned or implied, as this is a physical product and not an AI/machine learning model.

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

The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)" manufactured by Zhang Jia Gang Fengyuan Plastic Products Co.,Ltd. This is a medical device submission, and the "study" described is the testing conducted to demonstrate substantial equivalence to a predicate device and adherence to relevant standards.

Here's a breakdown of the requested 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 specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many rabbits/guinea pigs were used for biocompatibility). The testing is described as meeting ASTM standards and CFR regulations, which inherently include statistically significant sample size requirements for their respective tests.

• Provenance: This is a submission from China (Zhang Jia Gang Fengyuan Plastic Products Co.,Ltd, Jiangsu, China). The data appears to be prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for their device before submitting for FDA clearance.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of human annotation or interpretation. The tests are for physical and biological properties of the gloves, where the ground truth is established by objective measurements against predefined standards (ASTM, CFR, ISO). These tests are typically performed by laboratory technicians or qualified personnel following standard operating procedures, rather than expert clinicians establishing ground truth through consensus.

4. Adjudication Method for the Test Set

Not applicable. The tests are based on objective measurements and compliance with specified standards, not on human interpretation that would require adjudication.

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

No. This type of study (MRMC) is generally relevant for imaging or diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. This submission is for patient examination gloves, which do not involve such interpretation.

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

Not applicable. This is not an algorithmic or AI-based device, so the concept of standalone performance doesn't apply. The device itself (the glove) is being tested for its physical and biological properties.

7. Type of Ground Truth Used

The ground truth used is based on:

• Predefined Standards: ASTM standard D 5250-06, ASTM D6124-06.
• Regulatory Requirements: 21 CFR 800.20, 21 CFR 801, 21 CFR 803, 21 CFR 807, 21 CFR 820.
• International Standards: FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002.

These standards and regulations define the objective criteria and methodologies for determining dimensions, physical properties, freedom from pinholes, powder residue, and biocompatibility.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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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