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The Elective Vascular Intervention (EVI) Sutured-Clip™ and Sutured-Clip Applier™ are intended for endoscopic and non-endoscopic use in the creation of everting anastomoses in blood vessels, grafts and other tubular structures.

The Elective Vascular Intervention (EVI) Sutured-Clip™ and Clip Applier is a single fire applier that applies EVI Sutured-Clips™ for vascular anastomsis and tissue approximation applications. The Sutured-Clip consists of a vascular clip with a needle swaged or connected to one end. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.

The provided document, K971588, is a 510(k) premarket notification for the EVI Sutured-Clip™ and Sutured-Clip™ Applier. This device is a Class I (Exempt) Clip Applier and Class II Implantable Clips, intended for use in endoscopic and non-endoscopic creation and repair of arteriovenous fistulae, creation of everting anastomoses in blood vessels, grafts, and other tubular structures, and approximation of other soft tissue structures.

Due to the nature of this submission being a 510(k) for a medical device (an implantable clip and applier), the acceptance criteria and study detailed differ significantly from what would be expected for a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The "acceptance criteria" here refer to demonstrating substantial equivalence to predicate devices through design analysis and in vitro testing, rather than performance metrics like sensitivity, specificity, or AUC, which are common for diagnostic algorithms.

Here's an analysis of the provided information, framed to address your specific points where applicable, and noting where the information is not relevant to a traditional AI/SaMD assessment:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" revolve around established safety and effectiveness of predicate devices, and the "reported device performance" demonstrates equivalence through mechanical testing.

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

This information is not provided in the 510(k) summary for the in vitro testing. The summary states "In Vitro Test Data" and refers to "design analysis and in vitro data," but does not explicitly detail the number of clips, appliers, or specific test configurations used. Data provenance generally refers to the source of patient data. Since this is an in vitro study, there are no patient data, and thus no country of origin or retrospective/prospective classification in the typical sense for clinical studies.

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

This applies to studies assessing diagnostic accuracy or subjective interpretation. For this pre-market notification of a mechanical device, there is no ground truth established by experts in the context of interpreting images or clinical outcomes. The "ground truth" for mechanical performance is defined by engineering specifications and predicate device performance.

4. Adjudication Method for the Test Set

This is typically relevant for studies involving human interpretation or subjective assessments where discrepancies need resolution. For an in vitro mechanical test, no adjudication method between human interpreters is mentioned or applicable.

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

A MRMC study evaluates human reader performance with and without AI assistance, common for AI-powered diagnostic tools. This is a mechanical surgical device, not an AI or diagnostic tool. Therefore, no MRMC comparative effectiveness study was done, and this question is not applicable to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is applicable to algorithms. The EVI Sutured-Clip™ and Applier is a physical medical device, not an algorithm. Therefore, no standalone performance study of an algorithm was conducted or is applicable.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the in vitro testing was based on engineering specifications, internal specification requirements, external standard requirements, and predicate performance expectations. This is not pathology, outcomes data, or expert consensus in the clinical sense, but rather defined mechanical and functional parameters.

8. The Sample Size for the Training Set

This refers to the data used to train an AI model. Since this is a mechanical device with no AI component, there is no training set, and therefore, no training set sample size.

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

As there is no training set for an AI model, this question is not applicable. The "ground truth" for the device's design and manufacturing would be established through engineering design principles, material science, and quality control processes.

In Summary for K971588:

The provided document describes a 510(k) application for a physical medical device. The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to existing predicate devices through in-vitro mechanical testing and design analysis, rather than clinical efficacy through human studies or performance metrics typical of AI or diagnostic software. Many of the questions posed are specifically designed for evaluating AI/SaMD and are therefore not applicable to this type of device submission.

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