Search Results

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.

Ask a specific question about this device

The intended use of PERCUGUARD ™ is to prevent accidental needle stick and/or sharps injuries to healthcare workers on the fingers and thumbs exposed lo injuries.

It is a protective finger guard accessory to the examination glove. It is used on the finger and/or the thumb of the non-dominant hand usually used to retract, stabilize. or isolate in preparation for an injection procedure. Il may be inverted and used to prevent accidental needle sticks while suluring. It can be used on the dominant hand (device inverted) when isolating, retracting, stabilizing, or palpating tissue where sharp bone or wires are present in order to protect the palm side of the fingers or thumbs

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets them. The document is a 510(k) clearance letter from the FDA for a device named "Percuguard™," indicating that it has been found substantially equivalent to a predicate device.

The letter discusses:

• The review of the 510(k) notification.
• The determination of substantial equivalence.
• Regulatory classifications and general controls.
• Contact information for various FDA offices.
• The product's intended use.

However, there is no mention of specific acceptance criteria, performance data, study design, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

Ask a specific question about this device

A finger cot is a disposable device intended for medical purposes that is worn on the examiner's finger to prevent contamination between patient and examiner.

Latex Finger Cot, Powder-Free, with Protein Labeling

This 510(k) submission (K980827) describes a Latex Finger Cot, Powder-Free, with Protein Content Labeling Claim (50 Micrograms or Less). This device is a Class I medical device (Product Code: LZB) and is substantially equivalent to predicate devices already on the market.

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not include specific quantitative acceptance criteria or detailed device performance results beyond the protein labeling claim. The submission focuses on substantial equivalence to existing devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary and FDA letter do not describe a specific clinical or performance study with a test set. The submission relies on demonstrating substantial equivalence to predicate devices already on the market. Therefore, information on sample size and data provenance for a test set is not applicable here as no such study is detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As no specific study with a test set is detailed in the provided documents, there is no mention of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

As no specific study with a test set is detailed, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is described in the provided documents. The submission focuses on substantial equivalence of the device itself, not on its impact on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a physical medical device (latex finger cot), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.

7. The Type of Ground Truth Used

Given that this is a physical device and the submission focuses on substantial equivalence based on its physical characteristics and intended use, the "ground truth" would primarily refer to objective measurements of the device's properties (e.g., latex protein content, physical integrity, barrier properties) and comparison to established standards for similar devices. However, the provided documents do not detail these specific measurements or the type of ground truth used beyond the protein claim.

8. The Sample Size for the Training Set

No training set is mentioned or applicable as this is a physical medical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device