(312 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterile, Low Dermatitis Potential Labeling Claim, meets all of the requirements of ASTM D 6319-10.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pin-holes | ASTM D 5151-06 | |
| ASTM D 6319-10 | Meets | |
| Powder Free Residue | ASTM D 6124-06 | |
| ASTM D 6319-10 | Meets | |
| Biocompatibility (Dermal Sensitization) | Dermal Sensitization (as per ISO 10993-10:2010) | Not a contact skin sensitizer |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation Test (as per 16 CFR Part 1500.41) | Not a primary skin irritant |
| Low Dermatitis Potential | Modified Draize-95 Test | No clinical evidence presence of residual chemical additives that may induce Type IV allergy in human subjects. (This is the result of the study described below) |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: 200 non-sensitized adult human subjects.
- Data Provenance: The document states the study subjects "reasonably reflect the general user population in the US," implying the study was conducted with a US-representative population, making it prospective in nature for the purpose of this assessment.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth in the Modified Draize-95 Test. It only mentions that the study was "conducted" and "gave all negative results," indicating a clinical assessment.
-
Adjudication method for the test set:
- The document does not explicitly state an adjudication method (like 2+1 or 3+1). The "Modified Draize-95 Test" involves clinical observation and assessment.
-
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:
- No, an MRMC comparative effectiveness study was not done. This device is a patient examination glove, and the studies performed are related to its physical and biological properties in humans, not diagnostic reading by human experts with or without AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance of the device itself was evaluated in a standalone manner against established standards and through clinical testing. The Modified Draize-95 Test assessed the glove's potential to cause irritation or sensitization directly, without human "reading" of an output or an AI algorithm.
-
The type of ground truth used:
- For the "Low Dermatitis Potential" claim, the ground truth was clinical outcomes data from human subjects (i.e., observation of skin reactions like irritation or sensitization).
- For other characteristics (Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Biocompatibility), the ground truth was based on adherence to quantitative and qualitative standards defined by ASTM and ISO.
-
The sample size for the training set:
- This is not applicable as the studies described are for verification and validation of a physical medical device (examination gloves), not for training an AI model.
-
How the ground truth for the training set was established:
- Not applicable, as there is no AI model or training set mentioned for this 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.