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The proposed Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are 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™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are sterile devices 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 assembly and delivery catheter. The delivery system of Resolution 360™ Clip and Resolution 360™ ULTRA Clip will allow for the device to rotate at the distal end. The clip delivery system is offered in a 155cm and 235cm working length for Resolution Clip and Resolution 360 Clip but only 235 cm for Resolution 360 ULTRA Clip. 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 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 (only for Resolution 360 Clip and Resolution 360 ULTRA Clip) may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device. The Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are designed to be compatible with endoscopes with working channels equal to or greater than 2.8 mm.

This document is a 510(k) premarket notification for the Resolution™ Clip, Resolution 360™ Clip, and Resolution 360™ ULTRA Clip. It concerns an update to existing devices, specifically regarding MRI safety information in the Instruction for Use and Patient Information. As such, the study described focuses on demonstrating MRI safety, rather than broad clinical performance or a comparative effectiveness study with AI.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes "bench testing" which refers to laboratory-based evaluations. It does not mention a "test set" in the context of patient data.

• Sample size: Not explicitly stated as a number of devices or subjects. For bench testing, typically a representative sample of devices would be used.
• Data provenance: Not applicable in the context of "country of origin of the data, retrospective or prospective," as this was bench testing (laboratory-based evaluations) for physical characteristics related to MRI compatibility of the devices themselves, not patient data.

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

Not applicable. The ground truth for this type of testing (MRI safety) is established by adherence to recognized ASTM standards and the FDA MR Safety Guidance, not by expert consensus on clinical data. The tests are objective measurements of physical properties.

4. Adjudication Method for the Test Set

Not applicable, as this was bench testing against standardized criteria, not clinical data requiring adjudication.

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 submission is for an updated medical device (hemostatic clip) and focuses solely on its MRI safety, not on AI algorithms or human reader performance.

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

Not applicable. This is not an AI-powered device or algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this study was established by recognized international standards (ASTM) and regulatory guidance (FDA MR Safety Guidance) for evaluating medical device safety in a Magnetic Resonance (MR) environment. It's based on objective physical measurements, not clinical outcomes, expert consensus, or pathology.

8. The Sample Size for the Training Set

Not applicable. This is not a study involving machine learning or AI, so there is no "training set."

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

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

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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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