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NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.

The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor. It is a single use instrument, supplied sterile and pre-loaded. The NeuGuide device comprises three elements, the anchor-suture unit, an applicator, and a thimble with work channel.

The provided text describes the NeuGuide device, specifically its indications for use, comparison to a predicate device, and performance data. However, it does not include detailed "acceptance criteria" for performance metrics like accuracy, sensitivity, or specificity, nor does it provide a "study that proves the device meets the acceptance criteria" in the context of typical AI/software device studies.

Instead, the document focuses on the mechanical, material, and functional characteristics of the NeuGuide device itself, along with general performance tests to confirm its safety and fundamental functionality compared to a predicate device.

Given this, I will extract and infer information from the provided text to best answer your request, focusing on the available performance data described.

Here's the breakdown of the information that can be extracted or reasonably inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are essentially a "pass" or "fail" for various engineering and biocompatibility tests. No specific numerical thresholds are given in the summary, just the conclusion of "Pass according to predefined acceptance criteria."

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

• Sample Size: Not explicitly stated for most tests. For "Anchor pull-out force in porcine ligament in situ," the sample is "porcine ligament in situ," which implies an ex vivo or in vivo animal model, but the number of samples is not given.
• Data Provenance: The tests are largely laboratory-based performance tests for a medical device (NeuGuide) developed by Pop Medical Solutions Ltd. in Israel. The document does not specify country of origin for test data beyond the company's location. The testing appears to be prospective with respect to the device's design confirmation.

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

This information is not applicable to the studies described. The "ground truth" here is determined by engineering standards (e.g., ASTM, ISO, USP) and the physical properties of the device materials and mechanics, not by expert interpretation of medical images or clinical data.

4. Adjudication Method for the Test Set

Not applicable. The tests are based on objective measurements and compliance with established standards, not expert adjudication of subjective assessments.

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 is a manual surgical instrument, not an AI or imaging diagnostic device that would involve human readers.

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

Not applicable. This device is a manual instrument, not an algorithm or AI system. Its performance is always human-in-the-loop (the surgeon). The studies focus on the intrinsic properties and functionality of the device itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the various tests described is based on established engineering standards, material science specifications, and validated laboratory methodologies. For example:

• Biocompatibility: ISO 10993 standards.
• Corrosion: ASTM F2129, ASTM F1089.
• Suture testing: USP 37-NF32 standards.
• MRI Compatibility: Standards for MR Conditional labeling.
• Sterilization: ETO validation to SAL 10-6.

For functional tests like "Anchor pull-out force," the "ground truth" would be the measured physical force required for pull-out, compared against a predefined engineering specification.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not a machine learning model, 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.

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