(141 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 provided text describes a medical device, the Compressyn™ Staple, and its 510(k) submission for substantial equivalence to predicate devices. However, the document does not contain explicit acceptance criteria in terms of specific performance metrics or thresholds, nor does it detail a clinical study with human patients, diagnostic performance metrics (e.g., sensitivity, specificity), or comparisons of AI-assisted vs. unassisted human performance.
The submission focuses on technical characteristics and bench testing to demonstrate substantial equivalence against predicate devices.
Here's an analysis based on the provided text, while acknowledging the limitations of the input regarding acceptance criteria and detailed study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to ASTM F564-10 Standard Specification and Test Methods for Metallic Bone Staples | The Compressyn™ Staple conforms to ASTM F564-10. |
| Substantial equivalence in comparative compression force testing to predicate devices | The Compressyn™ Staple was shown to be substantially equivalent to the predicates. |
| Similar physical and technical characteristics to predicate devices | The Compressyn™ Staple has similar physical and technical characteristics to the predicate devices. |
Explanation: The "acceptance criteria" here are implied as the standards and comparative performance metrics used to establish "substantial equivalence," not explicit, quantitative thresholds typical for AI or diagnostic device performance. The device is a physical implant, and its performance is evaluated against engineering standards and direct comparison to existing devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of diagnostic or AI performance evaluation. The "testing" referred to is mechanical and physical verification testing of the staple itself.
- Sample Size for Testing: Not specified, but generally, mechanical testing involves a statistically significant number of samples of the device to ensure consistency and meet specified standards.
- Data Provenance: Not applicable in the context of patient data. The testing is laboratory-based, evaluating the physical properties of the staple.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is not a diagnostic tool that requires human experts to establish "ground truth" from images or patient data. Its "truth" is its mechanical properties validated through engineering tests.
4. Adjudication Method for the Test Set
Not applicable. There's no human interpretation or adjudication described for the mechanical and physical tests performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
Not applicable. The Compressyn™ Staple is a medical implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related performance metrics are relevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established engineering standards, material properties, and mechanical performance characteristics defined by ASTM F564-10 and the performance of the legally marketed predicate devices. The device's performance is measured against these objective, quantifiable physical parameters.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device Acceptance:
The Compressyn™ Staple gained acceptance (510(k) clearance) based on demonstrating substantial equivalence to existing, legally marketed predicate devices. This was achieved through:
- Conformance to Industry Standards: The device was tested and found to conform to ASTM F564-10, a standard specification and test method for metallic bone staples.
- Comparative Performance Testing: Comparative compression force testing was performed, showing the Compressyn™ Staple to be substantially equivalent to the predicate devices in this critical performance aspect.
- Similar Technical Characteristics: The device was shown to have physical and technical characteristics similar to the predicate devices.
The "study" that proves the device meets the (implied) acceptance criteria is the verification testing described under "Performance Data," which confirmed adherence to ASTM F564-10 and substantial equivalence in comparative compression force. This type of submission relies on engineering and in vitro (bench) testing, rather than clinical trials with patient outcomes or diagnostic performance evaluations, because it is a physical implant deemed similar to existing 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.