(65 days)
The Linkt™ Compression Staple System is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
The Linkt Compression Staple System consists of individually packaged, sterile, bone staple implants and a separate single use, sterile instrument set. The implants are manufactured from a nickel titanium alloy (Nitinol) which meets the requirements of ASTM F2063. The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The staples are available in sizes ranging from 9mm x 9mm to 20mm x 20mm to allow the surgeon to select the appropriate device for the patient's anatomy.
The single use instruments are intended to prepare the site and deploy the staple. The instrument kit includes a drill, drill guide, locating pins and an insertion tool.
This FDA 510(k) clearance letter is for a physical medical device, the Linkt Compression Staple System, not a software or AI-based diagnostic device. Therefore, many of the typical acceptance criteria and study details relevant to AI/software (like sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable.
The clearance is based on non-clinical performance testing to demonstrate substantial equivalence to previously cleared predicate devices.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Performance Area) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Pull-out Strength | Demonstrated substantial equivalence to predicates via ASTM F564 testing. |
| Static 4-Point Bend | Demonstrated substantial equivalence to predicates via ASTM F564 testing. |
| Dynamic 4-Point Bend | Demonstrated substantial equivalence to predicates via ASTM F564 testing. |
| Corrosion Susceptibility | Demonstrated substantial equivalence to predicates via ASTM F2129 testing. |
| Radio-Frequency Induced Heating | Demonstrated substantial equivalence to predicates via ASTM F2182 testing. |
| Material (Nitinol) | Meets requirements of ASTM F2063. |
| Design and Indications for Use | Similar to predicates. |
| Principles of Operation | Same as predicates for bone fixation. |
| Sterilization Method | Gamma irradiation (same as primary predicate). |
2. Sample size used for the test set and the data provenance:
This information is not provided as the evaluation was based on non-clinical, benchtop testing, not a dataset of patient cases.
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 as there was no test set requiring expert ground truth for diagnosis/interpretation. The device's performance was evaluated through standardized mechanical and material testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there was no test set 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:
Not applicable. This device is a surgical staple, not a diagnostic AI tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device's performance is established by its ability to meet specific engineering and material standards through validated testing methods (ASTM standards) and demonstrate mechanical properties equivalent to legally marketed predicate devices.
8. The sample size for the training set:
Not applicable. There is no "training set" for this physical device.
9. How the ground truth for the training set was established:
Not applicable.
Study/Evidence that Proves the Device Meets Acceptance Criteria:
The device claims to meet its acceptance criteria through non-clinical performance testing that demonstrates substantial equivalence to legally marketed predicate devices. The studies conducted were:
- Pull out Strength Testing according to ASTM F564.
- Static 4 Point Bend Testing according to ASTM F564.
- Dynamic 4 Point Bend Testing according to ASTM F564.
- Corrosion Susceptibility Testing according to ASTM F2129.
- Radio-Frequency Induced Heating according to ASTM F2182.
These tests are standard methods for evaluating the mechanical and material properties of bone fixation devices. The conclusion reached by Trax Surgical and accepted by the FDA is that based on the results of these tests, the Linkt Compression Staple System is substantially equivalent to the predicate devices and does not raise new questions of safety or effectiveness.
Key takeaway for this specific device: The FDA clearance is based on the device conforming to established engineering standards and demonstrating equivalent physical performance to existing devices, rather than clinical efficacy or diagnostic accuracy, which would involve different types of studies.
§ 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.