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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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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 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 stainless steel Inserter. The NanoTack Suture Anchor with Inserter is provided as a single-use sterile device.

Based on the provided text, the device in question is the NanoTack Suture Anchor 1.4mm, a non-degradable suture anchor intended for the fixation of soft tissue to bone in the hip, specifically for the reattachment of the hip labrum to the acetabulum.

However, the provided document does not contain the details necessary to answer all parts of your request. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study report with specific acceptance criteria, performance metrics, or ground truth establishment.

Here's an attempt to answer as much as possible based on the given text, with explicit notes for missing information:

1. A table of acceptance criteria and the reported device performance

Missing Information: Specific quantifiable acceptance criteria (e.g., minimum pull-out strength, insertion torque, etc.) and the detailed numerical results from the performance testing are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing Information: The document does not specify the sample size for any test set (e.g., how many anchors were tested, how many times). It also doesn't mention the data provenance (country of origin, 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 is not applicable to this type of device and study. The "ground truth" concept usually applies to diagnostic or prognostic devices where a true clinical state needs to be determined by human experts. For a mechanical device like a suture anchor, "ground truth" would relate to its physical properties and mechanical performance, which are measured using engineering tests, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for the reasons stated above (mechanical device, not diagnostic).

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 device is a surgical implant, not an AI-assisted diagnostic tool or a device that involves human "readers" interpreting images. Therefore, an MRMC study and AI improvement effect size are not relevant.

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

Not applicable. This device is a physical surgical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

As explained, "ground truth" in the diagnostic sense is not directly applicable. For performance testing of a mechanical device like this, the "ground truth" would be established by standardized engineering and mechanical test methods to measure properties like pull-out strength, ultimate tensile strength, fatigue life, etc., comparing them against the known performance of the predicate devices. The document states "performance testing conducted demonstrates that the insertion and fixation properties... are substantially equivalent." This implies that standard mechanical tests were performed.

8. The sample size for the training set

There is no mention of a training set. This is a physical medical device, not a machine learning model, so the concept of a "training set" is not applicable in this context.

9. How the ground truth for the training set was established

Not applicable as there is no training set mentioned or relevant for this device.

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