(124 days)
The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
· Opening wedge osteotomies of Hallux Valgus
· Evans lengthening osteotomies
· Metatarsal/cuneiform arthrodesis
The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot. The implant is available in a range of sizes and footprints to suit the individual anatomical conditions of the patient. Additionally, the wedge is fabricated and manufactured with two different materials: 1) Polyetheretherketone (PEEK) with tantalum markers and titanium pins (Ti 6Al-4V ELI). 2) Titanium (Ti 6Al-4V ELI).
The implant is hollow to permit packing with autogenous bone graft to help fusion. A C-Shape footprint of the device is also offered for use in procedures where bone graft is not required. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the wedge to provide internal fixation. Devices are offered with either midline or offset screw pockets.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the TARSA-LINK Stand-Alone Wedge Fixation System components with components from any other system or manufacturer. The TARSA-LINK Stand-Alone Wedge Fixation System components should never be reused under any circumstances.
This document is a 510(k) Premarket Notification from the FDA regarding the "TARSA-LINK Stand-Alone Wedge Fixation System." It's for a medical device that provides internal bone fixation. Therefore, the "acceptance criteria" and "study" refer to engineering and benchtop tests to demonstrate substantial equivalence to predicate devices, not clinical studies with human participants or AI performance metrics.
Here's the breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: The device must demonstrate mechanical integrity and function comparable to predicate devices for internal bone fixation. | Finite Element Analysis (FEA) and benchtop testing were presented. |
| Material Compatibility: Materials used must be implantable grade and meet established standards. | Polyetheretherketone (PEEK) per ASTM F2026 or Titanium (Ti 6Al-4V ELI) per ASTM F136. Tantalum markers per ASTM F560. Titanium screws per ASTM F136. |
| Design and Function: The design and function of the device must be substantially equivalent to predicate devices. | The TARSA-LINK system is described as substantially equivalent to the predicate systems in terms of design, materials, and indications for use. It is available in various sizes and footprints, with both hollow and C-shape options, and allows for screw placement. |
| Indications for Use: The device must be suitable for its stated indications: internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot (e.g., Opening wedge osteotomies of Hallux Valgus, Evans lengthening osteotomies, Metatarsal/cuneiform arthrodesis). | The device's intended use matches the stated indications and is compared to predicate devices which also have these indications for use. |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a test set in the context of clinical data for AI or human reader performance. Instead, it refers to benchtop testing and Finite Element Analysis (FEA) for a physical medical device. Therefore:
- Sample Size: Not specified in terms of number of "samples" in a clinical or AI dataset. For benchtop testing, typically a certain number of devices would be tested, but the exact quantity is not detailed here. For FEA, it's a computational simulation.
- Data Provenance: Not applicable in the context of country of origin or retrospective/prospective data as this is a physical device and engineering tests. The data comes from internal testing and analysis performed by the manufacturer, Life Spine.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of submission. "Ground truth" in this context would refer to the expected mechanical performance, material properties, and design specifications, which are established through engineering standards and internal design verification, not through expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers (e.g., radiologists) when establishing ground truth for diagnostic studies. The evaluation for this device involves engineering tests, not human interpretation of data requiring adjudication.
5. 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
This is not applicable. This document is for a physical medical implant, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for evaluating this device's performance is based on:
- Engineering Standards: Adherence to material specifications (e.g., ASTM F2026, F136, F560) and mechanical performance criteria derived from established biomechanical principles for bone fixation.
- Comparison to Predicate Devices: The reference point for "truth" is the known performance and safety profile of the legally marketed predicate devices. The new device must demonstrate "substantial equivalence" in design, materials, and performance.
8. The sample size for the training set
This is not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
This is not applicable. As there is no training set, there is no ground truth established for it.
§ 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.