(266 days)
Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or linger to prevent comamination between patient and examiner.
Powder Free Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves":
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Characteristic | Acceptance Criteria (Predicate or ASTM Standard) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|
| Dimensions: | |||
| -- Length | Meets ASTM D5250-06 (Reapproved 2011) ≥230mm min. | 230mm min. for all sizes | Substantially equivalent |
| -- Width (Small) | Meets ASTM D5250-06 (Reapproved 2011) 80-90 mm | 80-85 mm | Substantially equivalent |
| -- Width (Medium) | Meets ASTM D5250-06 (Reapproved 2011) 90-100 mm | 95-97 mm | Substantially equivalent |
| -- Width (Large) | Meets ASTM D5250-06 (Reapproved 2011) 100-110 mm | 102-108 mm | Substantially equivalent |
| -- Width (X large) | Meets ASTM D5250-06 (Reapproved 2011) 110-120 mm | 114-118 mm | Substantially equivalent |
| Thickness: | |||
| -- Finger | 0.05mm min. | 0.05mm min. | Substantially equivalent |
| -- Palm | 0.08mm min. | 0.08mm min. | Substantially equivalent |
| Physical Properties: | Meets ASTM D5250-06 (Reapproved 2011) | ||
| -- Elongation (Before/After aging) | ≥300% | ≥300% | Substantially equivalent |
| -- Tensile Strength (Before/After aging) | ≥14MPa | ≥14MPa | Substantially equivalent |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06, ASTM D5151-06; Inspection Level I, AQL 2.5 | Meets ASTM D5151-06 (Reapproved 2011) (Holes Inspection Level I, AQI 2.5 mentioned in general for predicate, implied for subject) | Substantially equivalent |
| Residual Powder | Meets ASTM D 6124-06 (Reapproved 2011) | Results generated values below 2mg of residual powder | Substantially equivalent |
| Biocompatibility | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 | The test article was a non-irritant or non-sensitizer. (SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10) | Substantially equivalent |
Note: The document explicitly states that the "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011)" and other relevant standards. The table re-iterates specific performance metrics where provided.
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes used for the testing of the subject's device for each of the listed criteria (e.g., how many gloves were tested for length, width, tensile strength, pinholes, etc.).
- The data provenance is not specified (e.g., country of origin of data). Given the manufacturer is from China, it's likely the testing was conducted there or by a lab associated with the manufacturer.
- The data is retrospective, as it refers to tests conducted on manufactured products to demonstrate compliance with existing standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this type of device and study. The "ground truth" for patient examination gloves is established by adherence to engineering and material performance standards (e.g., ASTM, ISO), not by expert consensus on interpretations of medical images or conditions. The standards themselves define the acceptable performance parameters.
4. Adjudication method for the test set:
- This information is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies) to resolve disagreements among experts. Here, the assessment is based on 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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive devices, often involving AI, where human readers interact with the device's output. The device in question is a patient examination glove, which does not involve human readers in the context of interpretation or diagnosis that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study in the context of an "algorithm only" or "AI without human-in-the-loop" was not done. This device is not an algorithm or AI system. Its performance is assessed through physical and chemical testing against established standards.
7. The type of ground truth used:
- The ground truth used is based on established industry standards and regulatory requirements. Specifically:
- ASTM Standard D 5250-06 (Reaffirmation 2011): Standard Specification for Poly(Vinyl Chloride) Patient Examination Gloves. This defines physical characteristics like dimensions, tensile strength, elongation, and freedom from holes.
- ASTM D 5151-06 (Reaffirmation 2011): Standard Test Method for Detection of Holes in Medical Gloves. This specifies the water leak test for pinholes.
- ASTM D 6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves.
- 21 CFR 800.20: FDA regulation concerning medical gloves.
- ISO 10993-10: 2002/Amd. 1:2006(E): Biocompatibility testing for irritation and sensitization.
8. The sample size for the training set:
- This information is not applicable. There is no "training set" in the context of a medical device like a patient examination glove. Training sets are used in machine learning or AI algorithm development. The gloves are manufactured and then tested to ensure they meet specifications.
9. How the ground truth for the training set was established:
- This information is not applicable as there is no training set for this type of 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.