(170 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.
Sterile, powder free, examination gloves made of nitrile. The gloves are provided in sizes small, medium, and large. Sterile gloves are provided in dispenser boxes.
This looks像 a request for structured information extracted from the provided text about the K122727 device. Unfortunately, the provided text describes a Disposable Nitrile Examination Glove and not an AI/ML medical device.
Therefore, many of the requested fields, such as "Sample size used for the test set," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Training set sample size," and "Ground truth for the training set," are not applicable to this type of device. These fields are specifically relevant to studies involving diagnostic or AI-powered devices that produce results requiring interpretation or comparison to a ground truth established by experts.
However, I can still extract the acceptance criteria and performance for the physical device characteristics from the provided text.
Here's the information that is applicable and can be extracted:
Acceptance Criteria and Device Performance (for a Nitrile Examination Glove)
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM Standard D6319-10 | Meets |
| Physical Properties | ASTM Standard D6319-10 | Meets |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151-06 | Meets |
| Powder Residual | ASTM Standard D6124-06 | Meets (values below 2mg of residual powder) |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10:2010) | Gloves are non-irritating |
| Biocompatibility | Dermal Sensitization in the guinea pig (ISO 10993-10:2010) | Gloves do not display any potential for sensitization |
Regarding the other requested points, they are not applicable to this medical device type:
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical glove's performance testing described here. Performance is measured against physical standards, not, for example, diagnostic data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties is established by the ASTM and ISO standards themselves, not by expert consensus on specific cases.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against objective 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. This is a physical glove, not an AI diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical glove.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For physical properties, the "ground truth" is defined by the objective metrics and thresholds within the cited ASTM and ISO standards. For biocompatibility, it's the observed biological reactions in animal models as per ISO 10993-10:2010.
- 8. The sample size for the training set: Not applicable. There is no "training set" for a physical glove.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.