(101 days)
These examination gloves are to be worn by healthcare workers or similar personnel duringwork to prevent cross contamination between the user and the patient.
SENSIFLEX meet the requirement for examination gloves described by the American Standard for Testing and Material ASTM D3578, white in color and non-powdered. Sizes available is from XS -- XL
The provided text describes the 510(k) summary for the TERANG NUSA Sdn Bhd SENSIFLEX Powderfree Latex Examination Glove. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on algorithm performance.
Therefore, many of the requested sections regarding algorithm performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable.
Here's an attempt to answer the applicable sections based only on the provided text, and indicating where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the SENSIFLEX Powderfree Latex Examination Glove are based on meeting the requirements of specific ASTM standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D3578 | Product meets requirements |
| ASTM D512 | Product meets requirements |
| Primary Skin irritation test ASTM F 719-81 | Indicates no irritation |
| Dermal sensitization Test ASTM F 720-81 (86) | Indicates no sensitization |
| Starch-free status (Iodine test) | Final product is iodine tested for starch free status. (Implies meeting requirement) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The tests are general performance tests, not clinical studies with a defined patient test set.
- Data Provenance: Not specified in the provided text. The manufacturing company is in Malaysia, but the testing location/origin is not stated. The tests are non-clinical, laboratory-based tests.
- Retrospective/Prospective: Not applicable as these are non-clinical product performance tests, not patient studies.
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. Ground truth and expert consensus are not relevant for these types of device performance tests (e.g., tensile strength, sensitivity to irritation). The "ground truth" is defined by the passing criteria of the ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies, particularly with human readers or AI. These are product performance tests.
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 an examination glove, not an AI diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an examination glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests is the quantitative and qualitative criteria defined by the specified ASTM (American Standard for Testing and Material) standards for examination gloves and biocompatibility tests. For example, for physical properties like tensile strength, the standard specifies acceptable ranges. For skin irritation/sensitization, the "ground truth" is the observation of no irritation/sensitization.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" and therefore no ground truth established for one.
§ 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.