(91 days)
The Biomet Hip Fracture Plating Systems are 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. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies.
The TSP Hip Fracture Plating System consists of a series of side specific fracture plates designed to treat femoral neck, intertrochanteric and subtrochanteric fractures.
The TSP Hip Fracture Plating System incorporates fracture plates with multiple cortical screw hole configurations, three 7.5mm telescoping lag screws in lengths from 70mm to 130mm that are inserted into the femoral head and lock into the fracture plate, and 4.5mm cortical screws in lengths ranging from 14mm to 95mm with either locking or non-locking head designs. The plates, lag screws and cortical screws are all made of Ti-6A1-4V titanium alloy with a TiMax® Type II anodized finish.
Limited collapse sleeves are also available in 5mm, 10mm, 15mm and 20mm lengths to limit the amount of distraction of the telescoping lag screws.
The provided document is a 510(k) summary for the TSP Hip Fracture Plating System, which is a medical device for fixing bone fractures. This type of regulatory submission generally focuses on demonstrating substantial equivalence to a predicate device through non-clinical (e.g., benchtop) testing, rather than detailed clinical trials with acceptance criteria and statistical analysis of performance metrics typically seen for AI/ML devices.
Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are highly relevant for AI/ML device evaluations, are not applicable or available in this document.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance
This document does not specify quantitative acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity for a diagnostic or prognostic device. Instead, it concludes that the device performs "as well as the predicate hip screw systems" based on non-clinical tests.
Table of Acceptance Criteria and Reported Device Performance (Not Applicable in the traditional sense for this device):
| Acceptance Criteria Category | Specific Metric | Threshold | Reported Performance |
|---|---|---|---|
| Non-Clinical Performance | Static Fatigue | Not explicitly stated (implied: comparable to predicate) | Performed as well as predicate hip screw systems |
| Cyclic Fatigue | Not explicitly stated (implied: comparable to predicate) | Performed as well as predicate hip screw systems | |
| Lag Screw Torsional Properties | Not explicitly stated (implied: comparable to predicate) | Tested | |
| Lag Screw Insertion/Removal Torques | Not explicitly stated (implied: comparable to predicate) | Tested | |
| Lag Screw Pullout Strength | Not explicitly stated (implied: comparable to predicate) | Tested | |
| Cortical Screw Torsional Properties | Not explicitly stated (implied: comparable to predicate) | Tested | |
| Cortical Screw Insertion/Removal Torques | Not explicitly stated (implied: comparable to predicate) | Tested | |
| Cortical Screw Pullout Strength | Not explicitly stated (implied: comparable to predicate) | Tested |
Study Details
- 1. Sample size used for the test set and the data provenance:
- Not Applicable. No clinical test set data from human subjects is mentioned. The testing focused on the physical device components.
- 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical data was used, no expert ground truth establishment for a test set was conducted.
- 3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set.
- 4. 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-enabled device; therefore, no MRMC study, human readers, or AI assistance is relevant.
- 5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical orthopedic implant system, not an algorithm, so standalone performance is not relevant in this context.
- 6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For non-clinical testing, "ground truth" would refer to engineering specifications, material properties, and established test standards for mechanical devices. The document implies comparison to industry standards and predicate device performance.
- 7. The sample size for the training set:
- Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
- 8. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this type of device.
Conclusion from the Document
The 510(k) submission for the TSP Hip Fracture Plating System states that:
"Non-Clinical Testing: Testing of the TSP Hip Fracture Plating System included static and cyclic fatigue tests. Additionally, the lag screws and cortical screws were tested for torsional properties, insertion and removal torques and pullout strength. Testing indicated that the system would perform as well as the predicate hip screw systems."
"Clinical Testing: Clinical testing was not determined to be necessary to demonstrate substantial equivalence of the TSP Hip Fracture Plating System to the predicate hip fracture plating systems."
This clearly indicates that the substantial equivalence was demonstrated solely through benchtop, non-clinical testing, comparing the device's mechanical properties to those of existing, legally marketed predicate devices. The "acceptance criteria" were implicitly met by demonstrating comparable performance in these non-clinical tests to the predicate devices.
§ 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.