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The Resolution 360 ULTRA Clip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of:

1. Endoscopic marking

2. Hemostasis for:

-Mucosal/sub-mucosal defects

The Resolution 360TM ULTRA 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™ ULTRA Clip delivery system is offered in a 235cm working length.

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 ULTRA 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 clip jaws will be available with a 17mm clip opening.

This document is a 510(k) summary for the Boston Scientific Resolution 360™ ULTRA Clip. It does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, I cannot provide information on acceptance criteria, reader improvement with AI assistance, or standalone algorithm performance for such a device.

However, I can extract information regarding the device acceptance criteria and the bench tests conducted to demonstrate the Resolution 360™ ULTRA Clip meets these criteria.

Here's the information based on the provided text, focusing on the device's physical and functional performance:

Accepted Criteria and Reported Device Performance

The document states that the proposed device was evaluated against predefined acceptance criteria, and the performance met these requirements. While the specific numerical acceptance criteria are not detailed in this summary, the document lists the bench tests performed to demonstrate compliance.

Study Details (Focusing on Device Performance, not AI)

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided summary.
• Data Provenance: The tests are "bench tests," meaning they were conducted in a laboratory setting. The country of origin of the data is not specified, but the applicant is Boston Scientific Corporation, located in Marlborough, MA. The study is prospective in the sense that the tests were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable as these are bench tests for a mechanical clip, not a diagnostic device requiring expert interpretation for ground truth. Performance is measured objectively.

4. Adjudication method for the test set:

• Not applicable for bench testing of a mechanical device. Performance is determined by direct measurement against specifications.

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, this was not done. This submission is for a medical device (hemostatic clip), not an AI-powered diagnostic tool.

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

• No, this was not done. This submission is for a medical device (hemostatic clip), not an algorithm.

7. The type of ground truth used:

• The "ground truth" for these bench tests would be the pre-defined engineering specifications and performance targets for the device's mechanical and functional characteristics.

8. The sample size for the training set:

• Not applicable. This is not an AI/Machine Learning study, so there is no "training set."

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

• Not applicable. There is no training set. The "ground truth" for the device's general design and functional requirements would be established through engineering design principles, industry standards (like ISO 10993, ISO 11135-1, ISO 10993-7), and regulatory guidance (like the FDA Guidance for Establishing Safety and Compatibility of Passive Implants in the MR Environment).

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The Resolution Hemostasis Clipping Device is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

1. Endoscopic marking
2. Hemostasis for:
   · Mucosal/sub-mucosal defects

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, polyethylene, 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 arms, 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. There are no associated accessories included with this device.

This document describes the Acceptance Criteria and the studies that prove the Resolution™ Hemostasis Clipping Device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Study by Vanbiervliet G, Filippi J, Karimdjee BS, et al. (2012):

  • Sample Size: The document does not explicitly state the total number of patients or stents included. It references a "pilot comparative study," suggesting a smaller sample size typical of pilot studies. The percentages of migration (13% vs. 57%) are given, implying a comparison between two groups (clipped vs. non-clipped SEMSs).
  • Data Provenance: Prospective study. The country of origin is not specified in the provided text.

• Study by Liaquat, H, Rohn E, Rex DK (2013):

  • Sample Size:
    • Clipped lesions: 277 large sessile or flat colorectal lesions were prophylactically clipped.
    • Control lesions: 247 control lesions (non-clipped).
  • Data Provenance: Experience from the specified authors, implying a retrospective analysis of clinical records. The country of origin is not specified in the provided text.

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

• The provided text does not contain information about the number or qualifications of experts used to establish ground truth for the test sets. The studies referenced are clinical studies reporting outcomes (stent migration, delayed bleeding) rather than evaluations of device performance against expert-derived ground truth.

4. Adjudication Method for the Test Set

• The provided text does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test sets. The clinical studies likely rely on objective clinical observations and outcomes as reported by treating physicians.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described in the provided text. The studies are clinical outcome studies comparing device use to non-use, not studies evaluating human readers' diagnostic performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone (i.e., algorithm only without human-in-the-loop performance) study was not conducted or described. The Resolution™ Hemostasis Clipping Device is a physical medical device, not an AI algorithm. Its performance is directly tied to its use by a clinician.

7. Type of Ground Truth Used

• Clinical Outcomes/Events:
  • For the Vanbiervliet G et al. study: The ground truth was the objective occurrence of stent migration.
  • For the Liaquat, H et al. study: The ground truth was the objective occurrence of delayed post-polypectomy hemorrhage.

8. Sample Size for the Training Set

• The provided text does not mention any training set. Since this is a physical medical device and not an AI algorithm, the concept of a "training set" for an algorithm is not applicable here. The device itself was developed and validated through engineering design and possibly pre-clinical testing, but not typically through "training" on a specific dataset like an AI model.

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

• This question is not applicable as there is no "training set" described for this physical device.

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