(69 days)
The CALCANEA™ -PLATE is indicated for use in fixation of fractures or osteotomies of the calcaneus.
The CALCANEA 100 PLATE is a Titanium low profile anatomical plate dedicated for fixation of calcaneal fractures. The CALCANEATM PLATE enables a reconstruction of height and width of the calcaneus and a possible remodeling to the lateral calcaneus. Its anatomical design provides optimal bone coverage while its low profile provides a minimal irritation of soft tissues. The CALCANEA 110 PLATE is available in three different sizes (1-2-3) for optimal anatomical fit. Numerous holes enable a versatile screw fixation. The fixation is provided by Titanium screws available in two different design : locking screws and variable angle screws. The locking screws have threaded heads adapted to the threaded holes of the plate whereas the other design provides a variable angle for a versatile fixation. The range of screws include a diameter of 3.5 mm and a length from 20 mm to 45 mm (by 5 mm). The fixation screws are self tapping with a smooth tip to protect soft tissues. The screw head design enables a low profile screw/plate/bone interface. Both plates and screws present a color code for size identification. The lot number and the reference are marked for easier product traceability.
The Calcanẽa™️-Plate is a titanium low-profile anatomical plate for calcaneal fracture fixation.
Here's an analysis of the provided information regarding its acceptance criteria and supporting study:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Characteristics | Satisfactory. The various tests performed on the CALCANEA™ Plate were satisfactory and allowed marketing of this device. |
| Torsion Strength | At least as good as competitors. The device has mechanical characteristics at least as good as those of competitors, including the Synthes Calcaneus Locking Plate (K991407), which was defined as a predicate. |
| Bending Strength | At least as good as competitors. The device has mechanical characteristics at least as good as those of competitors, including the Synthes Calcaneus Locking Plate (K991407), which was defined as a predicate. |
| Comparison with Predicate Devices | Equivalent. The device was found to have mechanical characteristics at least as good as the Synthes Calcaneus Locking Plate (K991407) and is considered similar in design and function to other predicate devices like SYNTHES Locking Calcaneal Plates (K991407 - K020401) and DEPUY ACE Calcaneal Peri-Articular Plate (K993465 - K981775). |
| Intended Use | Same as predicate devices. The CALCANEA™-PLATE, the Synthes Locking calcaneal plates, and the DePuy ACE calcaneal plate have the same intended use and are indicated for fixation of fractures and osteotomies of the calcaneus. |
| Material (Titanium Alloy TiAI6V4) | Meets specification (matches DePuy ACE). Both the CALCANEA™-PLATE and DePuy ACE calcaneal plate are made of Titanium alloy TiAI6V4, while the Synthes locking calcaneal plates are manufactured in Stainless steel 316 L. |
| Fixation Screws Compatibility | Compatible with 3.0mm, 3.5mm, or 4.0mm screws (matches predicate devices). All systems (CALCANEA™-PLATE and predicate devices) are fixed with 3.0mm, 3.5mm or 4.0mm screws. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set in the context of human data or clinical trials. The "tests performed" refer to mechanical characteristic determinations of the device itself. Therefore, concepts like country of origin or retrospective/prospective data are not applicable here. This appears to be a pre-market notification (510(k)) based on bench testing and comparison to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of study described. The ground truth for mechanical characteristics would be established by industry standards, engineering specifications, and validated testing methodologies, not by clinical experts.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical data, where there's potential for inter-observer variability. The study focuses on objective mechanical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, And the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. This submission is for a medical device (bone plate) and not for an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
This information is not applicable. This is a physical medical device, not an algorithm, so "standalone algorithm-only performance" is not a relevant concept.
7. The Type of Ground Truth Used
The ground truth used for the study of the Calcanẽa™️-Plate was primarily mechanical and material specifications, and comparative performance against legally marketed predicate devices. This means:
- Mechanical Standards: Implied adherence to engineering standards for torsion strength and bending strength.
- Predicate Device Performance: The mechanical characteristics of existing, approved devices (SYNTHES Locking Calcaneal Plates and DEPUY ACE Calcaneal Peri-Articular Plate) served as a benchmark for "at least as good as" performance.
- Material Composition: Verification of the use of Titanium alloy TiAI6V4.
- Design and Function Equivalency: Demonstrated similarity in intended use, design (anatomical, low profile, screw fixation), and screw compatibility.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of mechanical testing for a physical device. This term is relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device submission.
§ 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.