(43 days)
The 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 blue nitrile patient examination glove, that meets all the requirements of ASTM standard D6319, except for sterility requirements.
The provided text describes the regulatory filing for a medical device: "UTB Blue Powder Free Nitrile Patient Examination Gloves." The information focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of AI performance, clinical effectiveness, or diagnostic accuracy. Therefore, many of the requested categories related to AI studies, reader performance, and ground truth establishment are not applicable.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimension | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Freedom from Pinholes | ASTM D5151-06 & D6319-10 | Meets |
| Powder Residual | ASTM D6124-06 | Meets; Results generated values below 2mg of residual powder |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10:2010), Dermal Sensitization in the guinea pig (ISO 10993-10:2010) | Gloves are 'non-irritating'; Gloves do not display any potential for sensitization |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test mentioned (e.g., number of gloves tested for pinholes, number of animals for biocompatibility). The data provenance is described by the standards used, which are international (ASTM, ISO). There is no explicit mention of the country of origin of the data or whether the tests were conducted retrospectively or prospectively, except that they generally refer to evaluations of the product itself for regulatory compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" here is compliance with established international standards for patient examination gloves, rather than interpretation of medical images or data by human experts. The tests are laboratory-based.
4. Adjudication method for the test set
Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments. Here, the tests involve objective measurements against predefined 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
Not applicable. The device is a patient examination glove, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device. The tests performed are on the physical and biological properties of the glove.
7. The type of ground truth used
The ground truth used is the standards themselves (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ISO 10993-10:2010). The device performance is compared against the requirements stipulated in these recognized industry and international standards for each characteristic.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of medical device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.