(90 days)
The DYNAMIC COMPRESSION SMA Staple System is indicated for use in: (1) Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, (2) Fixation of proximal tibial metaphysis osteotomy, and (3) Fixation of soft tissue to bone such as in anterior cruciate ligament reconstruction.
The DYNAMIC COMPRESSION SMA Staple is fabricated from Nitinol Shape Memory Alloy. This bone fixation device consists of both two and four prong staples and is intended to achieve compression in fixation of bones in the hand, foot, tibia and ankle. Nitinol can change its configuration (shape) based on temperature. At room temperature, the material is pliant and the staple prongs can be straightened. This allows for easy insertion into the bone. After the staple has reached body temperature, the staple prongs deflect inward to their original shape. This inward deflection causes staple retention and compression across the osteotomy or arthrodesis site. This inward bending creates a claw effect, and helps prevent the staple from backing out of the bone.
The provided text is a 510(k) summary for the DYNAMIC COMPRESSION Shape Memory Alloy (SMA) Staple System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than a study with acceptance criteria for a new device's performance.
Therefore, the specific information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment cannot be found in this document because the 510(k) pathway for this device relies on equivalence, not a direct performance study with defined criteria against a new benchmark.
Specifically:
- A table of acceptance criteria and the reported device performance: Not applicable. The document assesses substantial equivalence, not performance against specific criteria.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set or specific performance data from a study is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No test set or ground truth establishment process is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process is described.
- 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 an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical staple, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established in the context of a performance study.
- The sample size for the training set: Not applicable. No training set is mentioned as this is not a machine learning device.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment process is described.
Summary from the provided text:
- Mechanism of Equivalence: The submission primarily relies on demonstrating substantial equivalence to other previously cleared shape memory alloy staples.
- Device Description: The DYNAMIC COMPRESSION SMA Staple is made from Nitinol, which changes shape with temperature (pliant at room temperature for insertion, deflects inward at body temperature for compression).
- Indications for Use: Hand and foot bone fragment and osteotomy fixation, joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and fixation of soft tissue to bone (e.g., ACL reconstruction).
Since this 510(k) is based on substantial equivalence, it does not describe a study involving detailed acceptance criteria and performance metrics for the device itself, but rather references its similarity to already approved 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.