(168 days)
The Threaded PEEK K-Wire is intended for use with suture in metatarsal ligament and tendon repairs.
Threaded K-Wire is manufactured from PEEK and is 1.6 mm in diameter over its entire length. Both ends of the K-Wire are threaded, providing for two implants per device. The diameter of the pin allows it to function well with standard K-Wire drivers and the device is meant to be trimmed to length once in place.
The provided text addresses the FDA 510(k) submission for the "Threaded PEEK K-Wire," which is a medical device, not a diagnostic AI/ML device. Therefore, the questions related to AI/ML device performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this document.
The document discusses the testing and criteria used to demonstrate substantial equivalence to a predicate device, which is a common pathway for medical device clearance.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The document lists the types of nonclinical testing performed to establish substantial equivalence and demonstrate the device performs as intended. It states that "The Threaded PEEK K-Wire met all specified criteria performing as intended." However, specific quantitative acceptance criteria values and corresponding reported performance values are not detailed in the provided text.
The tests performed were:
- Simulated use Testing
- Ultimate Strength Testing
- Initial Stiffness Testing
- Suture Strength Testing
- Cyclic Testing
The conclusion explicitly states: "The results of this testing demonstrate that the Threaded PEEK K-Wire performs as intended and demonstrate that the Threaded PEEK K-Wire is substantially equivalent to its predicates."
2. Sample sizes used for the test set and the data provenance:
- Sample Size: The document mentions "All testing was performed on test units representative of finished devices." However, it does not specify the sample size (number of units) used for each test.
- Data Provenance: The testing is described as "Nonclinical Testing," which means it was performed in a lab setting, not using human patient data. Therefore, questions of country of origin or retrospective/prospective clinical data are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as the document describes nonclinical mechanical testing, not a diagnostic study requiring expert ground truth establishment.
4. Adjudication method for the test set:
This question is not applicable as there is no human interpretation or ground truth adjudication involved in the mechanical tests described.
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:
This question is not applicable as this is a medical implant device, not an AI/ML diagnostic system. No MRMC study was conducted or is relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as this is a medical implant device, not an AI/ML diagnostic system.
7. The type of ground truth used:
The "ground truth" for the mechanical tests would be the established engineering and material science standards and performance specifications for bone fixation devices and PEEK material. The testing aims to meet these predefined performance benchmarks. "Pathology" or "outcomes data" are not applicable to this type of testing.
8. The sample size for the training set:
This question is not applicable as this is a medical implant device undergoing nonclinical testing, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
This question is not applicable for the same reason as above.
§ 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.