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510(k) Data Aggregation
(88 days)
COMFIT ORTHOPEDIC
The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
Class I natural rubber latex surgeon glove, 79 KGO, powdered with absorbable dusting powder, hypoallergenic, that meets all of the requirements of ASTM standard D3577-91.
COMFIT ORTHOPAEDIC brown surgical gloves are 0.30 mm (minimum) thick single wall at finger and palm areas to reduce damage from contacting bone, screws, wires or instruments.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | ASTM D 3577-91 (Acceptance Criteria) | COMFIT ORTHOPAEDIC Brown Beaded Surgeon's Gloves (Reported Performance) |
|---|---|---|
| Watertight (1000 ml) | S-4, AQL 1.5 | Pass based on AQL of 1.0 |
| Length (mm) | ||
| Size 5.5 | min 245 | 260 |
| Size 6.0 | min 265 | 265 |
| Size 6.5 | min 265 | 265 |
| Size 7.0 | min 265 | 270 |
| Size 7.5 | min 265 | 293 |
| Size 8.0 | min 265 | 293 |
| Size 8.5 | min 265 | 293 |
| Size 9.0 | min 265 | 293 |
| Palm width (mm) | ||
| Size 5.5 | $70 \pm 6$ | 72 |
| Size 6.0 | $76 \pm 6$ | 77 |
| Size 6.5 | $83 \pm 6$ | 83 |
| Size 7.0 | $89 \pm 6$ | 89 |
| Size 7.5 | $95 \pm 6$ | 94 |
| Size 8.0 | $102 \pm 6$ | 102 |
| Size 8.5 | $108 \pm 6$ | 108 |
| Size 9.0 | $114 \pm 6$ | 114 |
| Thickness (mm) | ||
| Finger | min 0.10 | 0.36 |
| Palm | min 0.10 | 0.31 |
| Physical Properties (Before Ageing): | ||
| Tensile Strength (MPa) | min 24 | 29.29 |
| Ultimate Elongation (%) | min 750 | 890 |
| Physical Properties (After Ageing): | ||
| Tensile Strength (MPa) | min 18 | 28.38 |
| Ultimate Elongation (%) | min 560 | 852 |
2. Sample size used for the test set and the data provenance:
- Non-Clinical Performance Data (Physical/Mechanical Tests): The document doesn't explicitly state the sample size for each specific test (e.g., how many gloves were tested for length or tensile strength). However, it refers to passing based on an AQL (Acceptable Quality Level) of 1.0 for the watertight test, which implies a sampling plan was followed. The data provenance is not explicitly stated as country of origin, but the manufacturer is based in Selangor, Malaysia. The data is retrospective, as it's a summary of performance.
- Clinical Performance Data (Hypoallergenic Claim): The test set for the "hypoallergenic" claim used 200 Human Subjects in a Modified Draize test. The provenance or specific location of these human subjects is not mentioned. This data is also retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Non-Clinical Performance Data: Not applicable. The ground truth for these tests (e.g., length, tensile strength) is objectively measured against specified ASTM standards, not established by human experts.
- Clinical Performance Data (Hypoallergenic Claim): The document does not specify the number or qualifications of experts involved in establishing the ground truth for the Modified Draize test. The "Modified Draize test" itself is a standardized method for assessing skin irritation and sensitization, and its interpretation would typically be done by qualified personnel (e.g., dermatologists, toxicologists), but their role in this specific submission is not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Non-Clinical Performance Data: Not applicable for objective measurements against a standard.
- Clinical Performance Data (Hypoallergenic Claim): The document does not describe any specific adjudication method for the Modified Draize test results beyond conducting the test itself.
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 device is a surgical glove, not an imaging or diagnostic AI-assisted device, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (surgical glove), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Non-Clinical Performance Data: The ground truth is established by objective measurements against predefined scientific and engineering standards (ASTM D 3577-91).
- Clinical Performance Data (Hypoallergenic Claim): The ground truth for the "hypoallergenic" claim is established through the outcomes data of a Modified Draize test on human subjects, demonstrating no potential for dermal irritation or sensitization.
8. The sample size for the training set:
- Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of validating its physical properties or hypoallergenic claim.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for this type of device, no ground truth needed to be established for it.
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