(263 days)
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples are indicated for foot bone fragments osteotomy fixation and joint arthrodesis.
arcad® 2.0 Duo & Quadro osteosynthesis compressive staple implants with two-leg and four-leg configurations with multiple bridge and leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant ready to implant assembled in open legs position on its dedicated disposable insertor forceps and instruments for implantation. The implant is designed to facilitate bone fusion with Nitinol pseudoelastic behavior.
This is a medical device submission, not a submission for an AI-powered device or software. Therefore, the provided information does not contain the details typically associated with acceptance criteria and study designs for AI systems. The document describes a traditional medical device, specifically osteosynthesis compressive staples.
However, I can extract the acceptance criteria related to the device's performance as tested and the general approach to proving substantial equivalence.
Acceptance Criteria and Device Performance (based on non-clinical testing for substantial equivalence):
| Acceptance Criteria Category | Device Performance (as reported) |
|---|---|
| Mechanical Properties | |
| Static Bending | Demonstrated substantial equivalence to predicate. |
| Bending Fatigue | Demonstrated substantial equivalence to predicate. |
| Pullout Strength | Demonstrated substantial equivalence to predicate. |
| Material Properties | |
| Corrosion Resistance | Demonstrated substantial equivalence to predicate. |
| Thermal Analysis (DSC) | Demonstrated substantial equivalence to predicate. |
Study Information (Non-Clinical Performance Testing):
The device is a physical medical implant (osteosynthesis compressive staples), not an AI system. Therefore, the questions related to AI-specific study design (test set size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set) are not applicable.
Here's the relevant information based on the provided text:
- Sample size used for the test set and data provenance: The document does not specify exact sample sizes for each non-clinical test conducted (static bending, fatigue, pullout, corrosion, thermal analysis). The testing was conducted by the manufacturer, Novastep SAS, in France.
- Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth for mechanical and material properties of an implant is established through standardized testing methodologies, not expert consensus as in AI image interpretation.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not applicable to a physical implant.
- If a standalone performance study was done: The "standalone" performance here refers to the device's intrinsic mechanical and material properties. The non-clinical tests (bending, fatigue, pullout, corrosion, thermal analysis) are essentially standalone performance evaluations against established standards and comparison to a predicate device.
- The type of ground truth used: The ground truth is defined by recognized industry standards (e.g., ASTM F564-17 for mechanical properties, ASTM F2129-19a for corrosion, ASTM F2004-17 for thermal analysis) and comparison to the performance of a legally marketed predicate device (ARCAD compressive osteosynthesis staple, K142111).
- The sample size for the training set: Not applicable (no training set for a physical implant).
- How the ground truth for the training set was established: Not applicable.
Summary of Non-Clinical Performance Testing Approach:
The manufacturer conducted functional testing to demonstrate that the arcad® 2.0 Duo & Quadro osteosynthesis compressive staples are substantially equivalent to their predicate device (ARCAD compressive osteosynthesis staple, K142111). This was done by evaluating the device's properties against relevant FDA guidance for Nitinol products ("Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol") and established ASTM standards. The tests covered:
- Mechanical properties: Static bending, bending fatigue, and pullout strength (referencing ASTM F564-17).
- Material properties: Corrosion resistance (referencing ASTM F2129-19a) and thermal analysis by Differential Scanning Calorimetry (referencing ASTM F2004-17).
The document explicitly states: "Performance testing and engineering analysis demonstrated substantial equivalence to the predicate device in the following..." meaning the device met the criteria for similarity in performance to the predicate device under these tests.
Clinical Study Information:
The document explicitly states: "Not applicable. Clinical studies were not required for this submission." This means that the FDA determined that the non-clinical testing was sufficient to establish substantial equivalence for the 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.