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The NCompass Nitinol Stone Extractor is a single-use, sterile, disposable device. The extractor is a stone retrieval device consisting of nitinol basket with a 1.5 cm wide diameter when fully expanded and a 2.4 Fr shaft diameter sheath. The device is packaged with a Touhy-Borst adapter accessory.

AI/ML Overview

The NCompass Nitinol Stone Extractors are intended for extraction of stones or debris during biliary surgical procedures.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Specific Test	Acceptance Criteria	Reported Device Performance
Biocompatibility	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity	Materials are biocompatible (per ISO 10993-1)	All materials found to be biocompatible.
Mechanical Properties	Dimensional and Compatibility Evaluation	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Radiopacity Evaluation	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Performance	Multiple Stone Retrieval Testing	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Tensile Test: Basket Formation	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Tensile Test: Basket Coil	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Tensile Test: Basket Sheath	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Tensile Test: Basket Sheath to Handle Connection	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Tensile Test: Basket Assembly to Shaft Connection	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Tensile Test: Cannula to Basket Coil Connection	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.

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

The document does not explicitly state the sample sizes used for each of the listed tests. The provenance of the data (country of origin, retrospective/prospective) is also not specified. These are typically details found in the full test reports, not a 510(k) summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The tests performed are primarily engineering and material science tests, not clinical studies requiring expert ground truth establishment in the traditional sense (e.g., for diagnostic accuracy).

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The tests described are objective engineering and performance tests, not those that typically require adjudication by multiple experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through non-clinical performance and material testing.

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

Not applicable. The device is a medical instrument (stone extractor), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

For the tests described (biocompatibility, dimensional, radiopacity, mechanical, multiple stone retrieval), the "ground truth" would be established by:

Established standards and specifications: For biocompatibility, ISO 10993-1 is explicitly mentioned. For dimensional, tensile, and radiopacity tests, there would be internal design specifications and recognized test methods.
Physical measurements and objective observations: Test results are compared against predefined numerical or qualitative criteria.

8. The Sample Size for the Training Set:

Not applicable. The device is a medical instrument, not an AI or machine learning model that requires a training set.

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

Not applicable. As above, there is no training set for this type of device.

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