(51 days)
The THP™ Hip Fracture Plating System is indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures.
THP Hip Fracture Plating System is a set of metal plates and associated screws designed to affix to the lateral aspect of the proximal femur and provide fracture stabilization for femoral neck fractures and intertrochanteric fractures. The THP 5.0mm Cortical Screws are both locking and non-locking. The locking screws contain external threads that can be used to lock the threaded holes on the plate body, while the non-locking screws do not include the external threads to complete this task.
The provided document is a 510(k) premarket notification for the "THP™ Hip Fracture Plating System" by Biomet, Inc. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily addressing design modifications (specifically related to 5.0mm cortical screws and plate modifications) and confirming that these changes do not adversely affect the device's safety and effectiveness.
Crucially, this document does not describe a study involving an AI/Machine Learning device or a diagnostic device that would require the typical performance metrics of sensitivity, specificity, or reader studies. Instead, it describes mechanical and biocompatibility testing of a physical implantable medical device.
Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this submission.
Here's how to address the request based on the provided document:
Acceptance Criteria and Study for the "THP™ Hip Fracture Plating System"
This 510(k) submission for the THP™ Hip Fracture Plating System focuses on demonstrating substantial equivalence to predicate devices, particularly in light of design modifications to address a head breakage issue in previously cleared screws and enhancements to the plates. The "acceptance criteria" in this context are primarily related to the mechanical performance and biocompatibility of the revised components being equivalent or superior to the predicate devices, ensuring no new safety or effectiveness concerns are introduced.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criterion | Acceptance Criteria (Defined by substantially equivalent performance) | Reported Device Performance |
|---|---|---|
| Mechanical Performance: | ||
| Shaft Screws (FX00080-09) - Max Failure Torque (for 5.0mm cortical screws) | To demonstrate that the mechanical strength of the proposed 5.0mm cortical screws is statistically equivalent to or superior to the predicate 4.5mm cortical screws (from K140018) and CHS screws (from K813554), specifically addressing the head breakage issue. | Improved Strength: The 5.0mm cortical screws were found to be 106.6% stronger than the equivalent 4.5mm TSP (predicate K140018) in max failure torque, and had an increase of 21.1% in max failure torque when compared to the equivalent CHS screws (predicate K813554). This not only eliminated the head breakage issue but also demonstrated superior strength. Conclusion: "This study demonstrated that the mechanical strength of the proposed device is statistically equivalent to that of the predicate devices." (Note: "equivalent" here implies at least as good, with demonstrated superiority in key metrics.) |
| Hip FX Plate Construct Fatigue Testing (FX00080-10) | To demonstrate that the proposed device (plate construct) can withstand a cyclic moment load equal to or greater than the predicate device. | "This study demonstrated that the proposed device can withstand a cyclic moment load equal to or greater than the predicate device." |
| Hip Fx vs. CHS Plate Construct Fatigue Test (FX00080-05) | To demonstrate that the proposed device (plate construct) can withstand a fatigue load, of the 2 Screw and 3 Screw constructs in a simulated bone with an intertrochanteric fracture, equal to or greater than the predicate device. | "This study demonstrated that the proposed device can withstand a fatigue load, of the 2 Screw and 3 Screw constructs in a simulated bone with an intertrochanteric fracture, equal to or greater than the predicate device." |
| Biocompatibility: | To ensure that the minor changes in geometry do not affect the biological safety of the plates, screws, and instruments. Based on prior testing of similar materials. | "The minor changes in geometry do not affect the biological safety of the plates, screws, and instruments in this submission. The original Biocompatibility testing was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed." |
| Sterilization (Shelf Life): | To verify the minimum sterilization dose. | "The minimum sterilization dose was verified using method VDmax 25 per ISO 11137-2:2013, 'Sterilization of health care products – Radiation Part 2: Establishing Radiation Dose'." |
| Bacterial Endotoxin Test (BET): | To establish product non-pyrogenicity. | "Testing has been performed to establish product non-pyrogenicity." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (e.g., number of screws or plates) used for each mechanical test. This level of detail is typically found in the full test reports, which are part of the detailed submission but not typically summarized in the 510(k) summary. However, the studies were sufficient for the FDA to draw conclusions of substantial equivalence.
- Data Provenance: The data is non-clinical performance data generated through mechanical and chemical testing of the device components (screws and plates). The location of the testing is not specified, but it would have been conducted under controlled laboratory conditions, likely by or for the manufacturer (Biomet, Inc., Warsaw, Indiana, USA). This is retrospective testing in the sense that it evaluates manufactured device components against predefined standards or predicate device performance. It is not human clinical data or patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is not a diagnostic device or an AI/ML device requiring human expert annotation or ground truth derived from clinical interpretation. The "ground truth" for these mechanical tests is established by published ISO standards (e.g., ISO 11137-2:2013 for sterilization, ISO 10993-1 for biocompatibility) and direct physical measurements/testing against specified engineering parameters or predicate device performance.
4. Adjudication Method for the Test Set:
- Not Applicable. No human adjudication method is relevant for these non-clinical, objective mechanical and chemical tests. The results are quantitative measurements interpreted against pre-defined performance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This submission is for a physical implantable orthopedic device, not a diagnostic imaging device or an AI component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or an AI device. The "performance" discussed is the physical, mechanical, and biological performance of an implantable metallic device.
7. The Type of Ground Truth Used:
- Engineering Specifications / Predicate Device Performance / ISO Standards. The "ground truth" for the mechanical tests is the measured performance of the predicate devices or established engineering specifications for strength and fatigue resistance. For biocompatibility and sterilization, the ground truth is adherence to international standards (ISO 10993-1, ISO 11137-2:2013) and cGMP (21 CFR 58 for GLP). It is not expert consensus, pathology, or outcomes data in the sense of clinical studies.
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of an AI/ML algorithm here. The device itself is the product under evaluation, and its properties are tested directly.
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.
In summary, the provided FDA 510(k) document is for a traditional physical medical device (an orthopedic implant) and primarily demonstrates substantial equivalence through non-clinical mechanical and biocompatibility testing. The questions posed in the prompt are largely designed for AI/Machine Learning diagnostic devices and therefore do not directly apply to this specific submission.
§ 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.