(18 days)
The following are osteosynthesis configurations that may be applicable to the TriMed Fusion Cups and Screws:
- Arthrodesis of joints in the midfoot
- Arthrodesis of the wrist and hand
The TriMed Fusion Cup System is used as an aid to the treatment of certain types of small bone arthrodesis. Fusion cups are manufactured from implantable medical grade polyetheretherketone (PEEK) and allow biaxial locking of screws. The cups are designed to be used with TriMed 2.4mm compression screws made of Ti6Al-4V ELI. Variation in implant size, diameter, and shape are intended to allow the implants to accommodate differences in patient size and sites of application. This special 510(k) is submitted to allow market release of additional sizes of fusion cups and compression screws.
The provided FDA 510(k) clearance letter describes the TriMed Fusion Cup System, a device used for osteosynthesis in small bone arthrodesis, specifically in the midfoot, wrist, and hand. The document provides information on the device description, intended use, and a summary of non-clinical tests.
However, the letter does not contain explicit acceptance criteria in the format of specific numerical thresholds or performance metrics that are typically expected in a comprehensive study report. Instead, it refers to successful verification testing and meeting performance requirements defined in FDA Guidance documents.
Here's an attempt to extract and infer the information based on the provided text, while acknowledging the limitations of what is explicitly stated:
Acceptance Criteria and Device Performance Study
The document indicates that the device's performance was evaluated through non-clinical testing. The "acceptance criteria" are implied by the statement that the "new Fusion Cup designs successfully passed verification testing following the same protocol executed on the original device" and that "new screws successfully met performance requirements defined within the FDA Guidance, 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway.'"
Since specific numerical acceptance criteria and reported performance values are not provided in the clearance letter, the table below will reflect the general statements made.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Fusion Cup Performance | Successfully pass verification testing following the same protocol as the original device. | "New Fusion Cup designs successfully passed verification testing following the same protocol executed on the original device." |
| Screw Performance | Successfully meet performance requirements defined within the FDA Guidance, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway." | "The new screws successfully met performance requirements defined within the FDA Guidance, 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway.'" |
| Material Equivalence | Use of the same materials as the predicate devices. | "They are made of the same materials as the predicate devices..." |
| Principle of Operation Equivalence | Have the same principle of operation as the predicate devices. | "...and have the same principle of operation." |
| Safety and Efficacy (Overall) | Design changes do not impact safety and efficacy, nor introduce new risks. | "Design control activities including performance testing following FDA Guidance and product evaluation prove that the design changes do not impact safety and efficacy, nor do they introduce new risks." |
| Specific Tests | Not explicitly stated, but includes static and endurance construct compression testing for PEEK cups, and ASTM F543 testing for screws. | "Static and endurance construct compression testing was performed on the PEEK cups and ASTM F543 testing was performed on the screws." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set. It refers to "verification testing" and "performance testing" but does not provide numbers of devices or test conditions.
- Sample Size: Not specified.
- Data Provenance: The tests are explicitly described as "Non-Clinical," indicating laboratory-based testing rather than human clinical data. The country of origin for the data is not specified, but the submission is for FDA clearance in the United States. It's a prospective evaluation for the updated device sizes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the clearance letter focuses on a mechanical device (implants) and its non-clinical performance. The "ground truth" for such devices typically relies on engineering specifications and validated test methods, not expert human interpretation in the way it would for AI-powered diagnostic devices. Therefore, there's no mention of experts establishing ground truth in this context.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations (e.g., in medical image analysis), which is not relevant to the non-clinical mechanical testing described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure the effect size of AI on their performance. The TriMed Fusion Cup System is a mechanical implant, not a diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The TriMed Fusion Cup System is a physical medical device (implants and screws), not a software algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product.
7. The Type of Ground Truth Used
For the described non-clinical tests, the "ground truth" would be established by:
- Engineering Specifications: The design parameters and material properties that the device is intended to meet.
- Predicate Device Performance: The original device's performance under similar test protocols, serving as a benchmark.
- FDA Guidance Document Standards: The specific performance criteria outlined in documents like "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway" and ASTM standards (e.g., ASTM F543). These documents provide standardized methods and expected performance ranges for such devices.
8. The Sample Size for the Training Set
This question is not applicable. The concept of a "training set" refers to data used to train machine learning models. The TriMed Fusion Cup System is a mechanical device, not an AI/ML product, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated in point 8.
§ 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.