(172 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 is a fully integrated system that consists of a stainless steel staple preloaded on a handheld ABS and polycarbonate mechanical delivery device. The staple is offered in 14 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 disposable tray with a drill bit, drill guide, placement pins and staple sizing guide.
This document describes a 510(k) premarket notification for the "Compressyn™ Staple" device. It is a medical device for bone fixation. Here's an analysis of the provided text in relation to acceptance criteria and study information:
Analysis of Acceptance Criteria and Study Information for Compressyn™ Staple
The provided text is a 510(k) summary for a medical device (Compressyn™ Staple). In the context of a 510(k), "acceptance criteria" for showing substantial equivalence are primarily met by demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, and that any differences do not raise new questions of safety or effectiveness. The "study" in this context refers to the testing performed to support this claim of similarity.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The device's intended use should be substantially similar to that of the predicate device(s). | "The Compressyn Staple is identical to the predicate and therefore has the same physical and technical characteristics." |
Indications for Use (same as stated on page 2):
- hand and foot bone fragment and osteotomy fixation and joint arthrodesis
- fixation of proximal tibial metaphysis osteotomy
- adjunctive fixation of small bone fragments (in various long, upper, and flat bones). |
| Technological Characteristics Equivalence: The device's design, materials, and other physical/technical attributes should be substantially similar to the predicate device(s). | "The Compressyn Staple is identical to the predicate and therefore has the same physical and technical characteristics."
Specifics: "stainless steel staple preloaded on a handheld ABS and polycarbonate mechanical delivery device." Offered in 14 sizes with barbs. |
| Performance Equivalence: The device should perform in a manner substantially similar to the predicate device, especially regarding critical functions (e.g., compression, delivery). | "The Compressyn Staple was tested for staple delivery and compressive force and was shown to be equivalent to the predicate."
"Testing to ASTM F564-10 was also performed for the Compressyn Staple, Preloaded Sterile System." |
| Safety and Effectiveness (implied): Any differences in technological characteristics should not raise new questions of safety or effectiveness. | Not explicitly stated as a separate criterion, but the overall conclusion of "substantial equivalence" implies this was met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "The Compressyn Staple was tested for staple delivery and compressive force" and "Testing to ASTM F564-10 was also performed." However, the exact number of staples or test specimens used for these tests is not specified in the provided text.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). While it's implied the testing was conducted by Dallen Medical, Inc. (USA-based), the location of the testing facility or origin of specific data points is not detailed. The nature of the tests (mechanical performance) suggests laboratory testing rather than clinical data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the context of this 510(k) submission. Mechanical testing (like staple delivery, compressive force, and ASTM F564-10) relies on objective measurements and predefined test standards, not expert clinical assessment or ground truth establishment in the way it would be for diagnostic AI.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As the testing involves mechanical performance, there is no expert adjudication process in the traditional sense. The results are compared against a predicate device or engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
- Effect Size of Human Reader Improvement: Not applicable, as this device is a surgical staple, not a diagnostic imaging AI algorithm that assists human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, this is not an AI algorithm, so a standalone study of this nature was not performed. The device itself is a physical medical device (staple system), and its performance is evaluated through mechanical testing.
7. Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is established through:
- Objective Mechanical Measurements: Such as force measurements for staple delivery and compression.
- Adherence to Industry Standards: Specifically, "Testing to ASTM F564-10" refers to a standard test method for metallic bone staples. The ground truth is effectively defined by the requirements and test methodologies outlined in this standard.
- Predicate Device Performance: The performance of the predicate device serves as the benchmark for substantial equivalence.
8. Sample Size for the Training Set
This information is not applicable and not provided. This device is a physical medical instrument, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no "training set" for this device.
§ 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.