(90 days)
The Osteotomy Truss System (OTS) is intended to be used for internal bone fractures or osteotomies in the foot, such as:
- · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
- · Opening wedge of Medial Cuneiform or Cotton osteotomies
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- · Metatarsal/Cuneiform osteotomies
- · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus)
- · Hindfoot osteotomies
The device is intended for use with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.
The Osteotomy Truss System (OTS) consists of three implant designs in a variety of footprints and opening wedge height options to accommodate the patient's anatomy. It is intended to be used with supplemental fixations.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.
This 510(k) premarket notification describes a design update to an existing device, the Osteotomy Truss System (OTS). The submission focuses on demonstrating substantial equivalence to the predicate devices through non-clinical performance testing. Therefore, it does not involve clinical studies or in-depth performance metrics typically associated with AI/ML devices.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Summary) |
|---|---|
| Static axial compression (ASTM F2077) | Sufficient for intended use |
| Dynamic axial compression fatigue (ASTM F2077) | Sufficient for intended use |
| Expulsion testing (ASTM F-04.25.02.02) | Sufficient for intended use |
| MR image artifact (ASTM F2119) | Sufficient for intended use |
| MR induced heating (ASTM F2182) | Sufficient for intended use |
| MR induced torque (ASTM F2213) | Sufficient for intended use |
| MR induced displacement force (ASTM F2052) | Sufficient for intended use |
| Finite element analysis | Does not introduce a new worst-case compared to previously cleared devices for mechanical properties. |
2. Sample Size Used for the Test Set and Data Provenance
This submission relies on non-clinical performance testing (in vitro/bench testing and computational modeling). The document does not specify a "test set" in the context of patient data or clinical imaging. The tests were performed on the device itself and its components. Therefore, information regarding human data provenance (country of origin, retrospective/prospective) is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for the non-clinical performance testing is established by the specifications defined in the referenced ASTM standards and engineering principles for finite element analysis.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation of data where adjudication would be necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is a submission for a medical device (implant) and not an AI/ML-driven diagnostic or assistive tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study in the context of an algorithm or AI was not conducted. The device itself is the subject of the testing.
7. Type of Ground Truth Used
The ground truth used for this submission is based on:
- Established engineering standards: ASTM standards for mechanical testing and MR compatibility.
- Computational modeling results: Finite element analysis, which provides simulated performance data.
- Predicate device characteristics: The substantially equivalent performance to previously cleared predicate devices serves as the benchmark.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device or a study involving machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set involved.
§ 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.