(68 days)
The MBD Plate System is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
The MBD Plate System is a titanium plating system comprised of various length plates and screws. The plates are low profile straight plates ranging in length from 72mm to 136mm. The plate thickness and width are 3mm and 11mm, respectively. Plate sizes are from 6 to 11 holes and each plate hole and/or slot accepts 4.0mm non-locking bone screws. Bone screws range from 12 to 24mm in length. Additionally, the system comprises low-profile 2.5mm diameter fragment screws in lengths from 10 to 24mm.
Here's a breakdown of the acceptance criteria and study information for the MBD Plate System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Requirements) | Reported Device Performance |
|---|---|
| Meet fatigue performance requirements | Met fatigue requirements |
| Meet static performance requirements | Met static requirements |
| Meet four-point bend testing requirements | Met four-point bend testing requirements |
The document states: "The testing demonstrated that the MBD Plate system components met four-point bend testing. performance requirements and are as safe and effective as their predicate devices." This implies that meeting these performance requirements is the acceptance criteria for safety and effectiveness in comparison to predicates.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated within the provided text. The document refers to "non-clinical performance testing for fatigue and static" but does not give a specific number of samples tested.
- Data Provenance: The document implies the data was generated through laboratory "non-clinical performance testing." There is no indication of human or animal data, retrospective or prospective studies, or country of origin for the data generation. It's a bench test, so provenance is generally less complex than clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth for this device is based on objective engineering measurements from mechanical testing (fatigue, static, four-point bend), not expert interpretation of medical data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As the "ground truth" is defined by objective mechanical testing results against predetermined performance requirements, there is no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This is a mechanical orthopedic implant (bone plate system), not an imaging device or AI-driven diagnostic tool that would typically involve a multi-reader multi-case study.
- Effect size of human readers with vs. without AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? Yes, in a sense. The "Performance Data" section describes non-clinical performance testing of the device itself, without human interaction influencing the results of the mechanical tests. This is essentially a standalone performance evaluation of the physical product.
7. Type of Ground Truth Used
- Type of Ground Truth: Objective engineering measurements and predetermined performance requirements (e.g., fatigue life, static strength, four-point bend deflection/load at failure) derived from industry standards or benchmarks against predicate devices.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is a physical medical device, not a software algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable.
§ 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.