(27 days)
The One-Piece PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
The One-Piece PEEK Fusion Implant is manufactured from polyetheretherketone (PEEK). It is threaded on one end and ridged on the other to engage either side of an osteotomy or reconstruction site. The One-Piece PEEK Fusion Implant is threaded into the proximal phalanx and then it is press fit into the middle phalanx, allowing for reduction and fixation of the bone fragments.
This report describes the acceptance criteria and the study proving the device meets those criteria, based on the provided 510(k) summary for the One-Piece PEEK Fusion Implant.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength | Pre-determined acceptance criteria | Met the pre-determined acceptance criteria |
| Bending Strength | Pre-determined acceptance criteria | Met the pre-determined acceptance criteria |
| Torsional Strength | Pre-determined acceptance criteria | Met the pre-determined acceptance criteria |
| Fatigue Testing | Pre-determined acceptance criteria | Met the pre-determined acceptance criteria |
| Post-Fatigue Tensile Strength | Pre-determined acceptance criteria | Met the pre-determined acceptance criteria |
Note: The specific numerical values for the acceptance criteria and corresponding device performance are not provided in the 510(k) summary. It only states that the device "met the pre-determined acceptance criteria." The summary also mentions that these are "the same tests performed on the predicate device to establish its substantial equivalence in submission K133515."
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing described is nonclinical (mechanical/material properties), not clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The described testing is nonclinical mechanical testing, not a study requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was nonclinical 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
No MRMC comparative effectiveness study was mentioned. This device is an implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the nonclinical testing, the "ground truth" would be the engineering or materials science standards and specifications defining acceptable performance for each test (Tensile Strength, Bending Strength, etc.).
8. The sample size for the training set
Not applicable. This device is an implant, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set 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.