(90 days)
TriMed Ulnar Osteotomy Plates are indicated for use in osteotomy procedures of the Ulna.
TriMed Ulnar Osteosystem System includes plates and screws indicated for osteotomies of the ulna. TriMed Ulnar Osteotomy System plates and screws are manufactured from medical grade stainless steel. Ulnar Osteotomy Compression Plates accept 3.2mm locking and non-locking screws. The lag screw hole in the plate accepts a 3.2mm lag screw that helps achieve additional compression across the osteotomy site.
This 510(k) clearance letter pertains to a medical device, specifically an Ulnar Osteotomy System (plates and screws), not an AI/software device. Therefore, the information typically required for describing the acceptance criteria and study proving an AI/software device meets those criteria (such as MRMC studies, ground truth establishment for AI training sets, sample sizes for test sets, expert consensus, etc.) is not applicable to this document.
The document discusses non-clinical testing performed on the physical implants (plates and screws) to demonstrate their safety and effectiveness.
Here's a breakdown of the relevant information provided in the letter regarding how the device meets acceptance criteria:
Acceptance Criteria and Device Performance (for a Medical Device - Implants)
Since this is a physical medical device (implants), the acceptance criteria are met through non-clinical testing (mechanical, material, and performance testing) rather than clinical studies or AI algorithm performance metrics.
1. A table of acceptance criteria and the reported device performance:
The document broadly states that the devices met acceptance criteria based on established FDA guidance documents for orthopedic implants. A detailed table of specific acceptance criteria values and reported performance values is not provided in this summary, as it would typically be part of the full submission, not the clearance letter.
| Acceptance Criteria Category | Guidance Document Cited | Reported Performance |
|---|---|---|
| Ulnar Osteotomy Plates | FDA Guidance Document, "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff" | "All test samples met the acceptance criteria." |
| Ulnar Osteotomy Screws | FDA Guidance Document, "Orthopedic Non-Spinal Metallic Bone Screws and Washers –Performance Criteria for Safety and Performance Based Pathway" | "All test samples met the acceptance criteria." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the clearance letter. For non-clinical testing of medical devices, sample sizes are typically determined by statistical rationale to demonstrate a high degree of confidence in the device's performance, but specific numbers are not always included in the public-facing clearance summary.
- Data Provenance: Not applicable in the context of clinical data for AI. This refers to laboratory non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This is not an AI/software device. The "ground truth" for physical implants is established through engineering standards, material science, and biomechanical principles, not expert human interpretation of images or clinical outcomes in the same way as AI.
4. Adjudication method for the test set:
- Not Applicable: This pertains to clinical data interpretation or AI model output, not mechanical testing of physical implants. The "adjudication" for mechanical tests would involve adherence to standardized test protocols and data analysis by qualified engineers.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No: This type of study is relevant for diagnostic AI/software to assess human reader performance with and without AI assistance. Clinical studies, including MRMC, were explicitly not conducted for these physical devices.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is an AI/software concept. The device is a set of physical implants.
7. The type of ground truth used:
- Engineering Standards and Biomechanical Principles: For physical implants, "ground truth" refers to meeting established performance benchmarks (e.g., strength, fatigue resistance, corrosion resistance) as defined by international and national standards (like ASTM, ISO) and specific FDA guidance documents for orthopedic devices. The materials used (medical grade stainless steel) and manufacturing processes also form part of this "ground truth" for safety and effectiveness.
8. The sample size for the training set:
- Not Applicable: This is for AI/software. The design and manufacturing of physical implants do not involve "training sets" in the AI sense.
9. How the ground truth for the training set was established:
- Not Applicable: As above, this is an AI/software concept. For physical devices, design validation and verification against engineering requirements and established specifications are the equivalent processes.
Summary of the Study Proving the Device Meets Acceptance Criteria (as described in this document):
The manufacturer, TriMed, Inc., performed non-clinical tests on the TriMed Ulnar Osteotomy System components (plates and screws). These tests were conducted according to the recommendations and criteria outlined in specific FDA guidance documents for orthopedic fracture fixation plates and metallic bone screws.
- Ulnar Osteotomy Plates: Tested per "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff."
- Ulnar Osteotomy Screws: Tested per "Orthopedic Non-Spinal Metallic Bone Screws and Washers –Performance Criteria for Safety and Performance Based Pathway."
The core finding reported is that "All test samples met the acceptance criteria" for both the plates and screws, as specified in the respective FDA guidance documents. This indicates that the physical and mechanical properties of the devices (e.g., strength, fatigue life, material compatibility) were demonstrated to be safe and effective for their intended surgical use, based on these standardized engineering tests.
Clinical studies were explicitly stated as "not conducted" for these devices, meaning the clearance was based entirely on the non-clinical (laboratory) testing, comparison to a predicate device, and the established regulatory pathway for such orthopedic implants.
§ 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.