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The NanoTack Suture Anchor is intended for the fixation of soft tissue to bone in the hip, and is indicated for the reattachment of hip labrum to the acetabulum.

The Pivot NanoTack Suture Anchor 1.4mm is a non-degradable suture anchor manufactured from PEEK-OPTIMA® polymer attached to a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture that is pre-assembled to a Flex stainless steel Inserter. The NanoTack Suture Anchor 1.4mm with Flex Inserter is provided as a single use sterile device.

The Pivot Medical NanoTack Suture Anchor 1.4mm with Flex Inserter is a medical device designed for the fixation of soft tissue to bone in the hip, specifically for the reattachment of the hip labrum to the acetabulum. The device is a "Special 510(k)" submission, meaning it is substantially equivalent to a previously cleared device (NanoTack Suture Anchor 1.4mm - K110473) with minor modifications.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "Pre-clinical testing includes insertion strength and anchor strength." However, it does not specify the sample size used for these tests. The data provenance is also not explicitly mentioned, but "pre-clinical testing" typically implies laboratory or cadaveric studies, not human clinical trials, and would likely be conducted in the country of origin of the manufacturer (USA, given the FDA submission). It is a prospective study as it evaluates the device performance for regulatory submission.

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

This information is not provided in the document. The testing described (insertion strength and anchor strength) are biomechanical performance tests, not subjective evaluations requiring expert clinicians to establish ground truth in the same way as, for example, image interpretation. Therefore, "ground truth" would be established by the objective measurements obtained during the mechanical testing.

4. Adjudication Method for the Test Set:

This information is not applicable and is not provided. The performance testing involves objective measurements rather than subjective assessments that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is evaluated. The NanoTack Suture Anchor is a surgical implant, and its evaluation focuses on mechanical performance, not diagnostic accuracy.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not done. The NanoTack Suture Anchor is a physical medical device, not an algorithm. Its performance is assessed through mechanical and material testing.

7. Type of Ground Truth Used:

The ground truth for the performance testing (insertion strength and anchor strength) was established through objective mechanical and material property measurements. For example, force gauges would be used to measure insertion force, and load cells would measure anchor pull-out strength.

8. Sample Size for the Training Set:

This information is not applicable and is not provided. The NanoTack Suture Anchor is not an AI/ML device that requires a training set. Its design and performance are based on engineering principles and materials science.

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

This information is not applicable, as there is no training set for this type of medical device.

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