(189 days)
The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Elbow, Hand and Wrist - Biceps tendon reattachment - Ulnar or lateral collateral ligament reconstruction . - ◆ Scapholunate ligament reconstruction - . Lateral epicondylitis repair
The Micro/Mini N-PK(H) Bone Anchor consists of an adjustable loop of non-absorbable suture (Sizes 2, 0 and 2- 0) with one (1) or two (2) attached anchors. The bone anchor is a two part system, one part nickel-titanium (nitinol) and the second part polyetheretherketone (PEEK). The PEEK part resides within the nitinol sleeve and retains the suture. The nitinol part expands upon delivery providing resistance to pullout. The construct is provided sterile and preloaded on a disposable delivery instrument.
This 510(k) summary describes the Micro/Mini N-PK(H) Bone Anchor, a device intended for the reattachment of soft tissue to bone. The study focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Functional and Safety Testing | |
| Biocompatibility | Conducted in accordance with ISO 10993-1 standards. |
| Corrosion testing | Conducted in accordance with ASTM F2129. |
| Tensile testing | Performed to verify compliance with USP suture requirements. |
| Fixation/Static disassembly strength | Comparison testing performed. |
| Cyclic fatigue performance | Comparison testing performed. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (biocompatibility, corrosion, tensile, fixation/static disassembly, cyclic fatigue). The data provenance is not specified either (e.g., country of origin, retrospective or prospective). These tests are typically performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study involves laboratory-based functional and safety testing of a medical device, not a diagnostic or prognostic assessment requiring expert interpretation of results. Therefore, there is no "ground truth" in the clinical sense established by experts.
4. Adjudication method for the test set
Not applicable, as this is laboratory testing.
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 a 510(k) submission for a bone anchor, not an AI-based diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For the functional and safety testing, the "ground truth" is defined by the established industry standards and requirements against which the device's performance is measured:
- Biocompatibility: ISO 10993-1 standards.
- Corrosion: ASTM F2129 standards.
- Tensile testing: USP suture requirements.
- Fixation/Static disassembly strength and Cyclic fatigue performance: Comparison testing to predicate devices, implying that the performance of the predicate devices serves as the benchmark or "ground truth" for acceptable performance.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of medical device testing. The device's design and materials are tested against established performance standards and predicate device performance.
9. How the ground truth for the training set was established
Not applicable, as there is no training set involved. The ground truth for the device's performance is established by recognized international and industry standards (ISO, ASTM, USP) and the performance characteristics of legally marketed predicate devices.
§ 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.