FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Resolution™ Hemostasis Clipping Device is a sterile, single-use, endoscopic clipping device consisting of two main components; the delivery system, and the clip. The delivery system is made up of a handle and delivery catheter. The delivery system is constructed using thermoplastic elastomers, stainless steel, polyethylone, and polyester materials. The Resolution™ Hemostasis Clipping Device delivery system is offered in 155cm and 235cm working lengths. The clip consists of a stainless steel capsule, and clip anns, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The Resolution clip jaws are engineered such that they can be opened and closed up to five times, aiding in repositioning of the clip at the lesion site. Opening and closing capability may be limited by clinical circumstances and patient anatomy, among other factors.

AI/ML Overview

The provided text describes the Resolution™ Hemostasis Clipping Device and its indications for use, but it does not contain specific acceptance criteria or details of a study that proves the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.

Instead, the document focuses on regulatory approval (510(k) submission) for a medical device and mentions non-clinical bench testing to support an MR Conditional labeling claim.

Therefore, I cannot provide the requested information based on the input document.

However, I can extract what limited information is available and explain why other requested details are not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific study. The "performance data" section only mentions "Non-clinical bench testing was conducted to support the MR Conditional labeling claim."
Reported Device Performance: Not provided beyond the statement that bench testing was done to support MR Conditional labeling. No specific metrics (e.g., sensitivity, specificity, accuracy, or other performance measures typically associated with AI/diagnostic devices) are given.

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/Not provided. The document refers to "non-clinical bench testing," which implies physical device testing rather than testing on patient data. There is no mention of a "test set" in the context of patient data, data provenance, or study design (retrospective/prospective).

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/Not provided. This information pertains to studies involving human interpretation of data for ground truth, which is not described in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. This is relevant for expert-adjudicated ground truth in studies, which is not mentioned here.

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. An MRMC study was not done. The device is an endoscopic clipping device, not an AI or diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided for a clinical "ground truth." For the "MR Conditional" claim, the "ground truth" would be established by specific MR safety testing standards and measurements of magnetic field interactions (e.g., heating, artifact, force, torque). The document does not detail these specific measurements or the standards used.

8. The sample size for the training set

Not applicable/Not provided. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. This device is not an AI algorithm that requires a training set.

Summary of what is present:

Device Name: Resolution™ Hemostasis Clipping Device
Indications for Use: Endoscopic marking, hemostasis for various defects/bleeding, anchoring feeding tubes, supplemental closure for luminal perforations.
Purpose of 510(k): To request a labeling claim that the proposed Resolution™ Hemostasis Clips are Magnetic Resonance (MR) Conditional for both 1.5 and 3.0 Tesla MRI devices.
Performance Data Mentioned: "Non-clinical bench testing was conducted to support the MR Conditional labeling claim." (No details provided on the criteria or specific results of this testing).

Summary

Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.