(91 days)
The Javelin Tailor's Bunion Fixation System is indication and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the foot (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent (13-21 years of age) patients.
The Javelin Tailor's Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal. The plate has 4 screw-receiving holes and is designed to allow for intramedullary insertion and fixation at the proximal end. The associated 2.0mm to 3.0mm diameter titanium screws, locking and non-locking, are designed in lengths of 6 to 16mm. The system is provided non-sterile.
This FDA 510(k) K202657 document does not describe the acceptance criteria, study details, or performance of a device in the context of an AI/ML or diagnostic imaging device that would typically involve a test set, ground truth, expert readers, or MRMC studies.
Instead, the document details the substantial equivalence of the "Javelin Tailor's Bunion Fixation System," which is a metallic bone fixation appliance used in orthopedic surgery. The "acceptance criteria" here refer to performance standards for the mechanical properties of a physical implant, not diagnostic accuracy.
Therefore, most of the requested information (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) is not applicable or present in this document.
Here's an attempt to answer the relevant parts based on the provided text, while clearly stating what information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Testing) | Reported Device Performance |
|---|---|
| Static Bending (per ASTM F382) | Pass (Substantially equivalent to predicates) |
| Dynamic Bending (per ASTM F382) | Pass (Substantially equivalent to predicates) |
| Axial Pull-out (per ASTM F543) | Pass (Substantially equivalent to predicates) |
| Screw Mechanical Strength (Engineering Analysis) | Pass (Substantially equivalent to predicates) |
| Overall Conclusion | Does not raise new issues of safety or efficacy compared to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document describes non-clinical mechanical testing of a physical implant, not a diagnostic device with a "test set" of patient data. The "samples" would refer to the physical devices tested (e.g., number of plates/screws), but the exact quantities are not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of a diagnostic test (like AI/ML), is not relevant here. The "ground truth" for a bone fixation system's performance is determined by established engineering standards and material properties, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set:
- Not Applicable. As no "test set" of patient data or expert review is involved, no adjudication method is described or necessary.
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 non-clinical evaluation of an orthopedic implant. MRMC studies are used for diagnostic accuracy assessments, typically involving medical imaging and human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical bone fixation system; there is no algorithm involved in its direct function.
7. The type of ground truth used:
- Engineering Standards and Material Properties: The "ground truth" for the device's performance is based on its compliance with established ASTM (American Society for Testing and Materials) standards for metallic bone fixation appliances and general engineering principles for mechanical strength.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
Summary of the Study (Non-Clinical Testing):
The "study" conducted for the Javelin Tailor's Bunion Fixation System was a series of non-clinical mechanical tests to evaluate its physical properties and compare them to legally marketed predicate devices. The tests performed were:
- Static Bending (per ASTM F382): Assesses the device's ability to withstand a constant load without permanent deformation.
- Dynamic Bending (per ASTM F382): Evaluates the device's resistance to fatigue under repetitive loading conditions that mimic physiological stresses.
- Axial Pull-out (per ASTM F543): Measures the force required to pull a screw out from a test material, indicating its fixation strength.
- Engineering analysis to evaluate screw mechanical strength: A broader analytical assessment of the screws' structural integrity.
The purpose of these tests was to demonstrate substantial equivalence to existing predicate devices by showing similar performance characteristics. The conclusion was that the device "does not raise new issues of safety or efficacy" compared to the predicates based on these mechanical test results. No human or clinical studies are mentioned for this 510(k) submission summary.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.