(189 days)
The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle - . Hallux valgus repairs - Medial or lateral instability repairs/reconstructions . - Achilles tendon repairs/reconstructions - . Midfoot reconstructions - Metatarsa} ligament/tendon repairs/reconstructions . - . Bunionectomy
The Micro/Mini N-PK(F) 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.
The provided text describes a medical device, the Micro/Mini N-PK(F) Bone Anchor, and its substantial equivalence to predicate devices, but it DOES NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML device performance.
The document is a 510(k) summary for a physical medical device (a bone anchor) and focuses on demonstrating substantial equivalence through materials, technological characteristics, and performance testing typically associated with mechanical medical devices (biocompatibility, corrosion, tensile, fixation strength, cyclic fatigue).
Therefore, I cannot extract the requested information using the provided text. The questions you've asked are relevant to the evaluation of AI/ML-driven medical devices, which this document does not cover.
To elaborate on why the requested information cannot be found:
- A table of acceptance criteria and the reported device performance: The document mentions "Functional and Safety Biocompatibility testing," "Corrosion testing," "Tensile testing," and "fixation/static disassembly strength and cyclic fatigue performance." However, it does not provide specific acceptance criteria (e.g., minimum tensile strength value, maximum corrosion rate) or the quantitative results of these tests in a table. It only states that these tests were "conducted" or "performed to verify compliance" or "support safety and effectiveness."
- Sample size used for the test set and the data provenance: Not applicable, as this is not an AI/ML device study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. For a mechanical device, "ground truth" would be the measured physical properties or performance under stressed conditions.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
This document describes a traditional medical device submission, not one for an AI/ML-enabled product.
§ 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.