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The Resolution™ 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™ 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 assembly and delivery catheter. The clip delivery system is offered in a 155cm and 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 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 and closing may be limited by clinical circumstances and patient anatomy, among other factors. The Resolution™ Clip is designed to be compatible with endoscopes with working channels equal to or greater than 2.8 mm. There are no associated accessories included with this device.

The provided text is a 510(k) summary for a medical device (Resolution Clip) and does not describe acceptance criteria or a study proving the device meets acceptance criteria for an AI/ML-driven medical device.

The document discusses a physical medical device, specifically a hemostatic clip for the GI tract. The 510(k) submission is for a modification to an existing device (removal of an outer sheath component). The "performance data" mentioned refers to non-clinical bench testing to confirm that the modified physical device still meets performance requirements (e.g., proper device removal from endoscope, passability within endoscope, absence of endoscope damage).

Therefore, I cannot extract the requested information about acceptance criteria or a study proving an **AI/ML-**driven device meets acceptance criteria from the provided text. The questions regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for training sets are not applicable to this type of device modification submission.

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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 Clip is indicated for placement in the Gastrointestinal tract for:

1. Endoscopic Marking
2. Hemostasis for:
   • Mucosal/sub-mucosal defects

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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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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The Resolution™ Hemostasis Clipping Device is indicated for endoscopic clip placement within the gastrointestinal 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, 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.

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).

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