(152 days)
The Aesculap Implant Systems Targon FN System is intended to be used for splinting, stabilization and fixation of the proximal femur.
The Aescular Implant Systems Targon FN System consists of a single tapered plate and screws (cancellous and bicortical design) in various sizes. The plate in this system accepts 6.5 mm cancellous screws proximally and 4.5 mm bicortical screw distally. The Aesculab Implant Systems Targon FN System is manufactured from Titanium Allov and will be provided sterile.
This document describes a 510(k) premarket notification for the Targon FN System, an internal fracture fixation device. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and a study proving those criteria are met for the Targon FN System itself in a clinical performance context.
Therefore, many of the requested details, such as specific acceptance criteria for a clinical study, reported device performance against those criteria, sample sizes for test sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance, are not present in the provided text.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria for clinical performance or report specific device performance results against such criteria. The "Performance Data" section broadly states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable." It also states, "Biomechanical testing of the subject device was found to be similar in performance to previously cleared proximal femoral fixation systems with similar indications." This implies that the acceptance criteria are based on equivalence to the predicate device's biomechanical performance, but no specific metrics or thresholds are provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for clinical performance | "Biomechanical testing of the subject device was found to be similar in performance to previously cleared proximal femoral fixation systems with similar indications." |
| Likely based on performance equivalent to predicate device (Synthes Titanium Limited Contact Dynamic Hip Screw Plate [TILC-DHS] (K953607)) in biomechanical tests. | No specific quantitative results provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document refers to "biomechanical testing" rather than clinical test sets with patient data. No sample sizes, data provenance, or study design (retrospective/prospective) are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device underwent biomechanical testing for substantial equivalence, not clinical evaluation with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set with expert adjudication is 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
Not applicable. This is not an AI/imaging device. The notification is for an internal fracture fixation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable to the presented information, as the performance data cited is biomechanical testing demonstrating similarity to a predicate device, not clinical ground truth.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is a physical medical device, not an AI or data-driven software product.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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.