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The Resolution 360 Clip is indicated for placement in the Gastrointestinal tract for:

1. Endoscopic Marking
2. Hemostasis for:
   • Mucosal/sub-mucosal defects < 3 cm
   • Bleeding ulcers
   • Arteries < 2 mm
   • Polyps < 1.5 cm in diameter
   • Diverticula in the colon
   • Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection
3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus
4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively

The Resolution 360™ Clip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel, and polyester materials. The delivery system will allow for the device to rotate at the distal end. The Resolution 360™ Clip delivery system is offered in 155cm and 235cm working lengths. The clip consists of a stainless steel capsule, and clip arms, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The Resolution™ 360 Clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device.

The provided text is a 510(k) summary for the Resolution 360 Clip, a medical device. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria, study designs with sample sizes, expert qualifications, or adjudication methods for evaluating device performance against numerical thresholds.

The "Performance Data" section mentions that "bench tests were performed" and that "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent." This is a qualitative statement about equivalence based on bench testing, not a detailed report of quantitative acceptance criteria and results.

Therefore, I cannot fulfill all parts of your request with the provided input. I will extract what information is present and explicitly state what is missing.

Here's an analysis of the provided text in relation to your request:

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

This information is not provided in the document. The document states that "bench tests were performed on the Resolution™ 360 Clip" and lists the types of tests (e.g., Clip Assembly Repeated Open/Close, Retention Force, Torque, Rotation, etc.). It then concludes, "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent." However, it does not provide specific acceptance criteria (e.g., "Clip must withstand X cycles" or "Retention Force must be Y N") nor specific numerical performance results for these criteria.

2. Sample sized 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. The document mentions "bench tests" but does not specify sample sizes for these tests, nor the data provenance (e.g., country, 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)

This information is not applicable/provided. The performance data discussed are bench tests of mechanical and material properties, not clinical studies requiring expert ground truth assessment.

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

This information is not applicable/provided. Adjudication methods are relevant for clinical studies or evaluations where human judgment on image interpretation or clinical outcomes is involved. The "Performance Data" describes bench testing.

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 information is not applicable/provided. The device is a "hemostatic metal clip" used for endoscopic procedures, not an AI-based diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant.

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

This information is not applicable/provided. This question applies to AI algorithms. The Resolution 360 Clip is a mechanical medical device, not an algorithm.

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

This information is not applicable. For the bench tests described, the "ground truth" would be the engineering specifications and established test methods, not clinical ground truths like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable/provided. "Training set" is relevant for machine learning/AI models. The device is a physical medical device.

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

This information is not applicable/provided. As above, this question applies to AI models.

Summary of what is available in the document:

• Device Name: Resolution 360 Clip
• Intended Use: Placement in the Gastrointestinal tract for endoscopic marking, hemostasis, anchoring, and as a supplemental closure method for luminal perforations.
• Performance Testing Mentioned: Bench tests were performed covering aspects like: Clip Assembly Repeated Open/Close; Retention Force; Clip Approach; Torque; Rotation; Clip Opening and Close Force; Clip Deployment; Force; Scope Compatibility/Usability; Working Length; Endoscope Damage; Biopsy Valve Compatibility; Coil to Handle tensile; and Push/Pull wire to Handle Spool Slider tensile.
• Conclusion of Performance Testing: "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent."
• Predicate Device: Resolution™ Hemostasis Clipping Device (K142973)
• Technological Characteristics Comparison: The proposed device has identical intended use and methodology as the predicate but allows for 360° rotation of clip jaws via a control knob. Materials are identical to the predicate device.
• Regulatory Compliance: Meets requirements of ISO 10993, ISO 11135-1, and ISO 10993-7 for biological evaluation and sterilization.

The 510(k) summary provides a high-level overview for substantial equivalence determination but does not include the detailed technical report with specific acceptance criteria and performance data that would typically be found in the full submission.

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