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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner

This device is a powder free vinyl examination glove.

The provided text describes a 510(k) summary for the SensiTex Examination Glove, focusing on its substantial equivalence to a predicate device. This is primarily a regulatory submission rather than a study report proving device performance against acceptance criteria in the typical sense of a clinical or analytical performance study for an AI/ML medical device.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information (which are common in AI/ML performance studies) are not applicable or
available in this document.

However, I can extract the acceptance criteria and performance data as presented for the product compared to its predicate device.

1. Table of acceptance criteria and the reported device performance

The document compares the Oak Vinyl Exam Glove (SensiTex) to the Maxxim Vinyl Exam Glove based on several tests. The "acceptance criteria" here are essentially the performance of the predicate device, as the goal is to show substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not specified. This document only provides aggregated results ("Pass", "10.1", etc.) and does not detail the number of gloves tested for each metric.
• Data provenance: Not specified.

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 is a physical device performance test, not an AI/ML diagnostic or prognostic study requiring expert ground truth establishment.

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

• Not applicable.

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/ML device.

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

• Not applicable. This is not an AI/ML device. The performance data presented are for the standalone vinyl glove against the predicate glove.

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

• Not applicable in the context of expert consensus or clinical outcomes. The "ground truth" or reference standards are the specified ASTM test methods (e.g., ASTM D5151-92 for water leak, ASTM 5250-92 for general glove standards) and the measured performance of the predicate device.

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.

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A 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.

This device is a powder free vinyl examination glove.

The provided text describes a 510(k) summary for the OAKTEX Examination Glove, a powder-free vinyl examination glove. The study presented is a substantial equivalence comparison with a predicate device, the Maxxim powder-free vinyl examination glove.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device. The "Pass" for the Water Leak Test indicates meeting a specific standard, while other metrics are directly compared.

*Except for (width) dimensional requirements.

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

The document does not explicitly state the sample size used for each test (e.g., number of gloves tested for water leak, tensile, etc.) nor the data provenance specifications like country of origin. The study appears to be a direct comparison of physical properties and performance against a predicate device, likely conducted as part of the manufacturing quality control and regulatory submission process. There is no indication of retrospective or prospective data in the typical sense of clinical studies.

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

This type of information (experts for ground truth) is not applicable to this study. The study involves laboratory-based physical and performance testing of a medical device (gloves) against established ASTM standards and a predicate device's specifications. The results are objective measurements rather than interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements, not subjective interpretations requiring adjudication.

5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study

No. This is not an MRMC study. It is a comparison of physical and performance characteristics of a medical glove.

6. Standalone Performance Study

Yes, in a sense. The "OAK Vinyl Exam Glove 96-X61 Series" performance data represents the standalone performance of the device on various metrics. This data is then directly compared to the predicate device.

7. Type of Ground Truth Used

The "ground truth" for this study is based on established ASTM standards (e.g., ASTM D5151-92 for water leak, and ASTM 5250-92) and the specified characteristics of a legally marketed predicate device (Maxxim powder-free vinyl examination glove).

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set." The study involves direct physical and performance testing.

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

As there is no training set, this question is not applicable.

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Their intended use is to prevent an interchange of body fluids via the hands of the wearer and the person (patient) being examined. Specifically, they are designed to prevent blood or other body fluids from the hands of the wearer from being transferred to the examinee. Also they are designed to prevent body fluids from the examinee from being transferred to the wearer via the wearer's hands.

Oak Carolina examination gloves are made from poly vinyl chloride (vinyl). They are to be marketed under the trade name Sensi-tex.

The provided text describes a medical device, specifically Oak Carolina Examination Gloves, and outlines its specifications and some testing results. However, it does not describe an AI/ML powered device or a study involving such a device, and therefore the specific questions you've asked about acceptance criteria and a study proving an AI device meets them are largely not applicable.

The document focuses on the physical properties and basic performance of examination gloves as per FDA requirements in 1996 for a 510(k) submission.

Here's an attempt to answer your questions based on the provided text, flagging where the information is not present or not applicable to an AI device:

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

Regarding AI-specific acceptance criteria (Sensitivity, Specificity, AUC, etc.): Not applicable. This document is for a medical glove, not an AI device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document mentions physical requirements tested "before and after accelerated aging" and "when tested in accordance with ASTM D5151-92" and "Biocompatibility studies." However, specific sample sizes for these tests are not provided.
• Data Provenance: The document is dated April 26, 1996, and relates to a submission to the FDA in the USA. The manufacturer is "Oak Carolina Inc. 100 Roe Road Travelers Rest, S.C. 29690" in the USA. The data would therefore be assumed to be from tests performed in the USA by the manufacturer. It is a report on testing, so it can be considered a retrospective summary of completed tests.

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

• Not applicable. This pertains to a physical product's performance against pre-defined engineering and safety standards, not an AI model's diagnostic accuracy where expert ground truth is typically used. The "ground truth" here is the pass/fail result of physical and chemical tests against established standards (e.g., ASTM standards).

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

• Not applicable. This concept typically applies to discrepancies in expert annotations for AI model ground truth. The tests described are objective measurements (e.g., width, length, tensile strength, water leak) against a standard, not subjective interpretations 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 document describes a physical medical device (examination gloves), not an AI algorithm designed to assist human readers.

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

• Not applicable. This document describes a physical medical device (examination gloves), not an AI algorithm.

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

• The "ground truth" for the glove's performance is based on objective measurements against established industry standards (e.g., ASTM D5250, ASTM D5151-92) and biocompatibility testing. This is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device (examination gloves), not an AI algorithm that undergoes training.

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

• Not applicable. This document describes a physical medical device (examination gloves), not an AI algorithm.

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