(90 days)
The Arthrex Fingershield finger guards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.
The Arthrex Fingershield Finger Guards are woven polyester with a marker thread of radio opaque Micropake®. These are offered in a one size fits all cylinder shape. They are offered sterile.
The provided 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/ML devices or diagnostic tools.
The Arthrex Fingershield is a Class I medical device (Finger Cot) and the submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing performance against quantitative metrics through a clinical study with acceptance criteria.
Therefore, the requested information elements (1-9) which are relevant to clinical performance studies, ground truth establishment, and AI/ML evaluation, are largely not applicable to this 510(k) submission.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The submission does not specify quantitative acceptance criteria. The basis for clearance is substantial equivalence to predicates (Percuguard by Digit-Pro, K992539, and Latex Finger Cot by Tucker & Associates, K980827). The general criteria for substantial equivalence are having the same intended use and technical characteristics, or the same intended use and different technological characteristics but demonstrably as safe and effective.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or clinical study data is reported for performance evaluation as part of this 510(k) summary. The submission relies on the characterization of material properties and intended use.
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. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring adjudication is described.
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 finger cot, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth in the context of clinical performance evaluation is described. The "ground truth" for this type of submission is typically based on the established safety and effectiveness of the predicate devices and the material properties of the new device.
8. The sample size for the training set
- Not Applicable. No training set is described as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. No training set or associated ground truth establishment is described.
In summary, the 510(k) for the Arthrex Fingershield focuses on demonstrating substantial equivalence based on the device's physical characteristics (woven polyester with radio-opaque marker, sterile, one-size-fits-all cylinder shape) and its intended use (protection over surgical gloves while tensioning suture or tying knots). This type of device's clearance process relies on material characterization and comparison to legally marketed predicate devices, rather than a clinical performance study with defined acceptance criteria and ground truth as would be required for a diagnostic or AI-enabled 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.