(108 days)
The Compressyn™ Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis, scapula and sternum.
The Compressyn™ Staple consists of a stainless steel staple held on a carriage delivered by a pneumatic delivery device. The staple is offered in several sizes with barbs to prevent back out. It is a compression staple fixation device that is placed into two tissue segments using pre-drilled holes to provide stabilized fixation. The Compressyn Staple is provided sterile in a kit with accessories.
This 510(k) submission for the Compressyn™ Staple does not include a study that proves the device meets specific acceptance criteria in terms of performance metrics.
Instead, the submission relies on demonstrating substantial equivalence to an existing legally marketed device. The core argument is based on the Technical Characteristics and Performance Data section, which states: "The Compressyn™ Staple is identical to the predicate and therefore has the same physical and technical characteristics."
This means that the device's acceptance is based on the assumption that if it is identical to a predicate device, it inherently meets the acceptance criteria previously established for that predicate.
Therefore, the requested information cannot be fully provided as a performance study with specific acceptance criteria and results is not present in the provided document.
Here's a breakdown of what can be gleaned:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties (e.g., strength, stiffness, fatigue resistance) | "Identical to the predicate" in physical and technical characteristics, implying it meets the same performance as the predicate. |
| Biocompatibility | "Identical to the predicate," implying the same biocompatibility as the predicate. |
| Sterility | "Provided sterile in a kit with accessories." (This is a statement of provision, not a performance test outcome in this context) |
| Fixation capabilities for specified indications (hand/foot bone, tibial metaphysis, small bone fragments) | "Identical to the predicate," implying it offers comparable fixation capabilities as the predicate. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable, as no new performance test data is presented. The substantial equivalence relies on the established performance of the predicate device.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no new performance study with a test set requiring expert ground truth was conducted for this submission.
4. Adjudication method for the test set:
- Not applicable.
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 is a medical device (staple) for fixation, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Not applicable, as substantial equivalence relies on the existing performance data of the predicate device.
8. The sample size for the training set:
- Not applicable, as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.