(30 days)
InstaFix™ Shape Memory Fixation System is intended for use in:
Fixation of Osteotomies of the Hand, Foot and Tibia
Arthrodesis of the Joints of the Hand and Foot
Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament
InstaFix™ Shape Memory Fixation System is also indicated for adjunctive fixation of Small Bone Fragments of:
The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula
The Lower Extremity, such as the Tibia, Fibula and the Femur
The Upper Torso, such as the Sternum and the Ribs
InstaFix™ Shape Memory Fixation System is a set of dynamic compression implants made from shape memory metal nickel-titanium alloy called NiTinol. The staples are available in sizes 8mm to 30mm. The NiTinol construction causes the legs of the implant to deflect, thereby creating a compressive force across the site of fixation. InstaFix™ Shape Memory Fixation implants are advantageous to screws and plates in that they require less disruption of the surrounding bone for implantation and provide 'low-profile' fixation. The most important factor related to the use of NiTinol is its ability to maintain a compressive force across the site of fixation during the healing process. Each staple is packaged sterile along with the corresponding drill guide and implant holder. The one time use Accessory Kit and the Sizer Kit are packaged sterile to assist in the procedure. The Accessory Kit contains one drill and two locating pins. The Sizer Kit contains samples of the available staple sizes.
Here's a breakdown of the acceptance criteria and the study information for the InstaFix™ Shape Memory Fixation System, based on the provided document:
This document is a 510(k) summary for a medical device. For such submissions, the primary "study" proving acceptance criteria is a demonstration of substantial equivalence to a previously cleared predicate device. This typically involves non-clinical testing to show that the new device performs at least as well as the predicate device in relevant performance areas. There isn't usually a clinical study with human patients and outcomes data for this type of submission.
Therefore, many of the requested categories related to clinical studies, human readers, and training data will not be applicable or will have limited information.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are implicitly that the device performs functionally equivalent or better than the predicate device in key mechanical and material characteristics. The reported device performance is presented as successful completion of these non-clinical tests, demonstrating equivalence. Specific quantitative acceptance targets are not explicitly stated in a table within this summary, but rather are inherent in demonstrating performance comparable to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Staple Fatigue Life: Demonstrate sufficient durability under cyclic loading. | Testing performed; conclusions state the proposed device "performs as well as the predicate device." |
| Pull-out Fixation Strength: Demonstrate adequate fixation strength in bone. | Testing performed; conclusions state the proposed device "performs as well as the predicate device." |
| Elastic Static Bending: Demonstrate appropriate mechanical properties under bending. | Testing performed; conclusions state the proposed device "performs as well as the predicate device." |
| Sterilization Validation: Ensure device can be reliably sterilized. | Testing performed; the method (gamma radiation) is the same as the predicate and successfully validated. |
| Packaging Validation: Ensure package integrity and sterility maintenance. | Testing performed; successfully validated. |
| Sealing and Aging Study: Verify long-term package integrity and device stability. | Testing performed; successfully validated. |
| Biocompatibility: Demonstrate materials are safe for human contact. | "All patient contact components are made from biocompatible materials. This indicates that the components are safe for their intended use." (This implies testing was done to confirm biocompatibility, although details are not provided in this summary.) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each non-clinical test (e.g., how many staples were tested for fatigue life). However, this refers to numbers of physical devices tested, not human subjects or patient data.
- Data Provenance: Not applicable in the context of clinical data. The tests are benchtop, non-clinical studies performed on the physical device itself. The data is generated from laboratory testing of the InstaFix™ devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical device performance study. "Ground truth" in this context refers to established engineering standards or the performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical device performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic devices or devices where human interpretation plays a significant role. The InstaFix™ system is a surgical fixation device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve algorithms or human-in-the-loop performance in the sense of AI. Its "performance" is based on its mechanical and material properties.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established through bench-top engineering tests designed to evaluate the mechanical and material performance of the device against a known predicate device's performance standards/characteristics and relevant industry standards for orthopedic implants.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in this non-clinical submission, as it does not involve machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set.
§ 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.