(86 days)
The Pivot Knotless Suture Anchor is indicated for the reattachment of hip labrum to the acetabulum.
The Pivot Knotless Suture Anchor is a non-degradable suture anchor manufactured from PEEK-OPTIMA® LT1 polymer attached to / pre-assembled to a stainless steel Inserter. Non-degradable ultra-high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture is provided in the sterile package with the Knotless Suture Anchor and Inserter. The Knotless Suture Anchor with Inserter and Suture is provided as a single use sterile device.
This document is a 510(k) premarket notification for a medical device (Knotless Suture Anchor). It does not contain acceptance criteria or a study proving device performance against acceptance criteria in the typical sense of a diagnostic or AI device. This type of submission relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than specific performance metrics against pre-defined acceptance criteria through a clinical trial.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as they pertain to a different type of device evaluation.
However, I can provide the information that is present and relevant to the "substantial equivalence" claim:
1. A table of acceptance criteria and the reported device performance:
Instead of formal acceptance criteria and quantitative performance metrics like sensitivity/specificity for a diagnostic device, the "acceptance criteria" here is the demonstration of "substantial equivalence" to predicate devices based on technological characteristics and performance testing.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Indications for Use: Same as predicate devices. | "The Knotless 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." (This is the same as the predicate devices, though not explicitly stated as such in terms of comparison within the provided text, it's inferred from the substantial equivalence claim). |
| Technological Characteristics: Equivalent to predicate devices in materials and design. | "The Knotless Suture Anchor is made of poly-etheretherketone (PEEK) with an accompanying UHMWPE #1 suture." "The Knotless Suture Anchor is equivalent in materials and design to the Pivot NanoTack Suture Anchor device (K110473) and the Smith & Nephew (S&N) Knotless Instability Suture Anchor (K093428)." |
| Performance Testing: Insertion and fixation properties substantially equivalent. | "Pre-clinical testing includes insertion strength, suture strength, and biocompatibility testing." "The performance testing conducted demonstrates that the insertion and fixation properties of the Knotless Suture Anchor are substantially equivalent to the NanoTack Suture Anchor." |
| Biocompatibility: Materials are biocompatible. | "All components of the Knotless Suture Anchor system are made from biocompatible materials, as is the case for the predicate devices cited." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This document refers to "pre-clinical testing" for insertion strength, suture strength, and biocompatibility, but does not provide details on sample sizes for these tests. There is no "test set" in the context of diagnostic performance evaluation.
- Data Provenance: Not applicable in the context of a retrospective/prospective study for device clinical performance. The pre-clinical testing would have been conducted in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" to be established by experts as this is not a diagnostic device and no clinical efficacy study is detailed in this 510(k) summary. The evaluation focuses on material properties and mechanical performance compared to predicate devices.
4. Adjudication method for the test set:
- Not applicable. See point 3.
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 not an AI device or a diagnostic device where human reader performance would be a factor.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- Mechanical and Biocompatibility Standards / Predicate Device Performance. The "ground truth" for this type of submission is the established safety and effectiveness of the legally marketed predicate devices, and the demonstration that the new device meets similar performance benchmarks (e.g., strength, biocompatibility).
8. The sample size for the training set:
- Not applicable. There is no "training set" for an AI model or a device of this nature.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.