(69 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Patient Examination Glove, Nitrile, Powdered, Turquoise
This submission is for a medical device called an "Omni Flex Nitrile Examination Glove, Powdered, Turquoise." The provided documents are a 510(k) clearance letter and an "Indications For Use Statement." These documents do not contain information about acceptance criteria or performance studies as typically required for clinical software or diagnostic devices.
Instead, they address the regulatory clearance of a physical medical device (gloves) based on substantial equivalence to a predicate device already on the market. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not applicable or available in these documents.
Here's an attempt to address the points based only on the provided text, recognizing its limitations for this type of query:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given documents. The 510(k) clearance process for general-purpose medical gloves typically involves demonstrating substantial equivalence to a legally marketed predicate device through performance criteria such as:
- Physical Properties: Tensile strength, elongation at break, force at break (often specified in ASTM D6319 or similar standards).
- Barrier Integrity: Water leak test (AQL, Acceptable Quality Level, often 2.5 or 4.0 for medical gloves).
- Biocompatibility: Tests for skin irritation and sensitization.
- Powder Residue (if powdered).
However, the specific quantitative acceptance criteria and the Omni Flex Nitrile Examination Glove's performance against these criteria are not detailed in the provided regulatory letter or indications for use. The letter simply states that the FDA has determined the device is "substantially equivalent" to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given documents. For a 510(k) submission for gloves, the "test set" would refer to the samples of gloves tested for physical and barrier properties. The letter indicates the manufacturer is OmniGrace (Thailand) LTD., located in Thailand, suggesting the testing data would likely originate from Thailand or a designated testing facility. The nature of these tests is usually prospective, as manufactured batches are tested.
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)
This is not applicable to this type of device and submission. "Ground truth" in the context of diagnostic devices often refers to an expert-validated diagnosis or pathology result. For medical gloves, the "ground truth" is typically defined by adherence to established material standards and performance specifications, not expert consensus on an image or diagnosis. Quality control personnel and material science engineers would be involved in testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this type of device and submission. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images), which is not relevant to testing the physical properties of gloves.
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
This is not applicable to this type of device and submission. MRMC studies are used for evaluating the performance of diagnostic imaging devices or AI algorithms that assist human readers. Medical gloves are barrier devices, not diagnostic or AI-assisted tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this type of device and submission. This refers to the evaluation of AI algorithms, which is not relevant to medical gloves.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the concept of "ground truth" in the diagnostic or AI sense does not apply here. For medical gloves, the "truth" is established by measured physical properties (e.g., tensile strength, barrier integrity) meeting predefined standards (e.g., ASTM standards, AQL limits) and biocompatibility test results.
8. The sample size for the training set
This is not applicable to this type of device and submission. Training sets are used in machine learning.
9. How the ground truth for the training set was established
This is not applicable to this type of device and submission.
§ 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.