(139 days)
The Y3 Proximal Femoral Plate System is intended for the temporary internal fixation of fractures and osteotomies of the greater trochanter or of the proximal femur.
It is indicated for the following:
- Re-attachment of the greater trochanter following osteotomy in THA
- Trochanteric and intertrochanteric fractures
- Extended trochanteric osteotomy
- Periprosthetic femoral fractures
- Comminuted fractures
- Mal-unions and non-unions
- Fractures in osteopenic bone
The Y3 Proximal Femoral Plate System is an innovative fixation device intended for the treatment of proximal femoral fractures and osteotomies. The unique Y-shape design divides the proximal portion of the plate into anterior and posterolateral branches, thus intended for stability at the Greater Trochanter level both in rotation and translation while reducing the prominence of the implant. Fixation options include locking and non-locking screws in addition to cerclage cables. The Y3 Proximal Femoral Plate System is manufactured in medical grade Titanium Alloy Ti-6AI-4V ELI as per ASTM F136. The Y3 Proximal Femoral Plate System is available in four lengths: 135, 185, 235 and 285 mm. Left and right versions are offered to accommodate the anatomical shape of the proximal femur.
The provided text describes a 510(k) premarket notification for the Y3 Proximal Femoral Plate System, a medical device for internal fixation of fractures and osteotomies. The FDA determined that the device is substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain information about:
- Acceptance criteria for device performance in a clinical study. The provided document focuses on mechanical equivalence and non-clinical performance data.
- A study proving the device meets specific acceptance criteria.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set.
- How ground truth for the training set was established.
The document explicitly states: "No clinical testing is provided as a basis for substantial equivalence." This means that the FDA's determination of substantial equivalence for this device was based on non-clinical performance data (bench testing, calculations) and a review of scientific literature, rather than data from a clinical trial with specific performance metrics against acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document, nor can I provide information regarding clinical study design elements such as sample sizes, expert involvement, adjudication, or ground truth establishment, as these were not part of the submission described.
The document focuses on demonstrating that the Y3 Proximal Femoral Plate System is substantially equivalent to existing devices based on:
- Intended Use: Similar indications.
- Design: Similar fixation methods (screws, cerclage cables) and materials (Titanium Alloy).
- Mechanical Properties: Bench testing and calculations showing equivalent or superior performance (stiffness, yield strength, bending strength) to the predicate device.
- Literature Review: Analysis of published literature on trochanteric fixation to address identified clinical hazards.
Non-clinical Performance Data Summary (as provided):
| Performance Metric | Y3 Proximal Femoral Plate System | Predicate (NCB Periprosthetic Trochanter System) | Comparison |
|---|---|---|---|
| Stiffness (bending) | 49.5 N/mm | 25.3 N/mm | 1.96 times stiffer |
| Yield point (bending) | 536.6 N | 303.4 N | 1.77 times higher yield |
| Compression bending strength at yield | 34.6 Nm | 21.3 Nm | 1.6 times higher |
| Anterior Migration (cadaveric model) | -0.9 mm ± 1.6 | 9.6 mm ± 9.5 (Lateral locking plate) | Significantly reduced anterior migration compared to the lateral locking plate (referred to in a cited article). |
Study Proving Equivalence (Non-Clinical):
- Verification Calculations: Evaluated resistance and mechanical properties of the Y3 system components in comparison to predicate systems.
- Static and Fatigue Bench Testing: Confirmed the validity of calculations and demonstrated equivalent performance to the predicate NCB system.
- Scientific Literature Search/Clinical Evidence Review: Identified and analyzed published peer-reviewed literature regarding trochanteric fixation, specifically for the two predicate systems, to establish substantial equivalence by addressing clinical hazards from the device Risk Analysis.
- Cadaveric Study (cited from literature): A biomechanical hip extension study on cadaveric models showed the antero-lateral locking plate (referring to a plate with similar design principles to Y3) significantly reduced greater trochanter anterior migration compared to a lateral locking plate.
Regarding the other requested information, the document states:
- Sample size used for the test set and the data provenance: Not applicable as no clinical test set for performance was used. Non-clinical bench testing was performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set requiring expert ground truth was performed.
- Adjudication method for the test set: Not applicable.
- 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 device is a physical implant, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical implant.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the non-clinical testing, "ground truth" would be the measured physical properties and performance metrics established through validated testing procedures. For the literature review, the "ground truth" would be the findings reported in peer-reviewed scientific publications.
- The sample size for the training set: Not applicable as there is no AI component or training set described.
- How the ground truth for the training set was established: Not applicable.
§ 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.