(30 days)
The SLIM Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in:
- pertrochanteric femoral fractures
- subtrochanteric femoral fractures and
- lateral femoral neck fractures.
Internal fixation with the SLIM Gliding Nail System is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is also suitable for medial femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.
We added the following smaller nails to our predicate device (FRIEDL Gliding Nail System, K974409):
-
132071 Slim Gliding Nail, 125°, 220 mm, 17 mm / 11 mm Ø
-
132072 Slim Gliding Nail, 135°, 220 mm, 17 mm / 11 mm Ø
-
132073 Slim Gliding Nail, 125°, 180 mm, 17 mm / 11 mm Ø,
These 3 nails are narrower than the conventional nails, which 19 mm diameter proximally and 12 mm distally.
-
132140 Femoral Neck Blade, 75 mm length
In addition, this 75 mm long femoral neck blade has been added to the existing range from 80 mm to 125 mm.
This document describes a Special 510(k) Device Modification for the SLIM Gliding Nail System. The modification involves the addition of smaller nails and a shorter femoral neck blade to the existing system. The primary study described is a biomechanical fatigue test.
Here's an analysis of the provided information based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biomechanical fatigue strength/stability (for worst-case model and smaller components) | The test results of the smaller components were equal or better to the predicate device (FRIEDL Gliding Nail System, K974409) and other commercially available devices. |
| Sufficient for in vivo loading | The test results were deemed sufficient for in vivo loading. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Biomechanical fatigue tests have been performed on the worst-case model." It does not specify the number of components or repetitions used in these tests.
- Data Provenance: The study is reported by PLUS ORTHOPEDICS to the FDA, suggesting it was conducted by the manufacturer for regulatory submission. The country of origin for the testing itself is not specified, nor is whether the data is retrospective or prospective, though for a biomechanical test, it's typically a prospective laboratory study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a biomechanical engineering study, not a clinical study involving expert interpretation of medical images or patient outcomes. The "ground truth" is established by the physical testing and engineering principles. The FDA reviewer (Celia M. Witten, Ph.D., M.D.) made the final determination of substantial equivalence, but not of the underlying biomechanical 'ground truth'.
4. Adjudication Method for the Test Set
- Not Applicable. As a biomechanical study, there isn't an adjudication method for reconciling different expert opinions on a test set in the way there would be for a diagnostic study. The determination of whether the test results "equal or better" the predicate would be based on quantitative measurements and engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This document describes a biomechanical engineering study of an orthopedic implant, not a diagnostic device or a study involving human readers or cases. Therefore, an MRMC study is not relevant or included.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm. Therefore, the concept of "standalone performance" for an algorithm is not relevant. The biomechanical testing is inherently "standalone" in that it tests the device properties directly.
7. The Type of Ground Truth Used
- The "ground truth" in this context refers to the objective physical properties and performance characteristics of the device under stress, as measured through biomechanical fatigue testing. This is compared against established engineering standards and the performance of predicate devices.
8. The Sample Size for the Training Set
- Not Applicable. This is a biomechanical engineering study, not a machine learning or AI study. There is no "training set" in this context. The study focuses on evaluating the physical properties of the manufactured device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Since there is no training set, this question is not relevant.
§ 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.