(96 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Properties Demonstrating Substantial Equivalence to Predicate Devices: This is implied as the primary acceptance criterion for 510(k) clearance, rather than specific numerical criteria. The NanoTack Suture Anchor must perform equivalently to its predicates in terms of insertion and fixation properties. | "The performance testing conducted demonstrates that the insertion and fixation properties of the NanoTack Suture Anchor are substantially equivalent to the Smith and Nephew BioRaptor 2.3PK and the Biomet Sleeve with ZipLoop anchors." (Page 1 of 2, "Summary of Performance Testing") |
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.