(85 days)
A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.
Powder-Free Vinyl Examination Glove
The provided document, Premarket Notification 510(k) K071022 for a Powder-Free Vinyl Examination Glove, does not contain any information regarding AI/ML device performance or studies involving human readers, training sets, or ground truth as typically associated with AI-powered medical devices.
Instead, this submission is for a medical glove, and the acceptance criteria and supporting studies are based on traditional physical and biocompatibility testing according to established ASTM and ISO standards.
Therefore, many of the requested categories in your prompt are not applicable to this type of medical device submission. I will answer the applicable questions based on the provided text, and explicitly state when a category is not relevant.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 5250-00 | Meets ASTM D 5250-00 (implied, no specific values listed for device) |
| Width (Small) | 85 +/- 5 mm | (Implicitly meets, specific value not reported for device) |
| Width (Medium) | 95 +/- 5 mm | (Implicitly meets, specific value not reported for device) |
| Width (Large) | 105 +/- 5 mm | (Implicitly meets, specific value not reported for device) |
| Width (X-Large) | 115 +/- 5 mm | (Implicitly meets, specific value not reported for device) |
| Length (all sizes) | 250 +/- 10 mm | (Implicitly meets, specific value not reported for device) |
| Thickness (Finger) | 0.05 mm minimum | (Implicitly meets, specific value not reported for device) |
| Thickness (Palm) | 0.1 mm minimum | (Implicitly meets, specific value not reported for device) |
| Physical Properties | Meets ASTM D 5250-00 | Meets ASTM D 5250-00 (implied, no specific values listed for device) |
| Tensile Strength (Before Aging) | 9 MPa minimum | 9 MPa minimum (stated specification) |
| Tensile Strength (After Aging) | 9 MPa minimum | 9 MPa minimum (stated specification) |
| Ultimate Elongation | 300% minimum | 300% minimum (stated specification) |
| Freedom from pinholes | Meets ASTM D 5250-00 and ASTM D 5151-99 | Meets ASTM D 5250-00 and ASTM D 5151-99 (implied) |
| Water Leak Test | AQL 2.5, Level I | AQL 2.5, Level I (stated specification) |
| Powder Free | Meets ASTM D 6124-00 and ASTM D 5250-00 | Meets ASTM D 6124-00 and ASTM D 5250-00 (implied) |
| Biocompatibility | Based on ISO 10993 | |
| Cytotoxicity - Agar Diffusion | (Acceptance criteria implied by standard) | Passed |
| Primary Skin Irritation | (Acceptance criteria implied by standard) | Passed |
| Guinea Pig Sensitization | (Acceptance criteria implied by standard) | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "The performance test data that support a determination of substantial equivalence are described above in Section 7" (which is the section outlining standards and specifications). However, it does not explicitly state the sample sizes used for the physical or biocompatibility testing, nor does it specify the data provenance (country of origin, retrospective/prospective). The testing would typically be prospective, conducted by the manufacturer (Glormed Colombia S.A.).
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 device is a physical product (medical glove). Ground truth in the context of expert review (e.g., for image interpretation) is not relevant here. Performance is measured against physical and chemical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See explanation for #3. Adjudication methods like 2+1 or 3+1 are used for expert disagreement in diagnostic tasks, which is not relevant for glove testing.
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 device is a medical glove, not an AI software. No MRMC study or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by conformance to internationally recognized industry standards such as ASTM D 5250-00, ASTM D 5151-99, ASTM D 6124-00, and ISO 10993. These standards define the acceptable physical properties, non-toxicity, and integrity of medical examination gloves. There is no biological "ground truth" from patients or pathology in the sense of AI diagnostics.
8. The sample size for the training set
Not applicable. This device is a medical glove and does not involve AI/ML requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See explanation for #8.
§ 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.