(96 days)
The Biomet Proximal Humerus Plating System is indicated for fixation of fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.
The Biomet Proximal Humeral Plating System offers two plating families (Low and High) with both left and right configurations in various lengths. Both plating families in the Biomet Proximal Humerus Plating System incorporate the same spatial subchondral support as the Biomet S3 proximal humerus plates (K060290) in the head of the plates. The plates and screws will be manufactured from Titanium Alloy (ASTM F136) and are either type II or color anodized. The system will also include multidirectional screws that are manufactured from Cobalt Chromium (ASTM F1537). The plates are anatomically designed to match the anatomy of the proximal humerus. The system will also include instrumentation to aid the user in alignment and stabilization of fractures to the skeletal system.
The provided text describes the Biomet Proximal Humerus Plating System, a metallic bone fixation device, and states that substantial equivalence was determined based on non-clinical tests. However, it does not provide specific acceptance criteria or details of a study that proves the device meets such criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc., which are typical for AI/diagnostic devices).
The document is a 510(k) summary for a medical device that appears to be a physical implant, not a software or AI-driven diagnostic device. Therefore, the concepts of "acceptance criteria" and "performance" in the context of AI/diagnostic tools (e.g., sensitivity, specificity, MRMC studies, ground truth establishment) are not applicable here. Instead, the "performance" discussed relates to the mechanical and material characteristics of the implant and its substantial equivalence to predicate devices.
Here's an attempt to answer the questions based on the provided text, while noting the difference in device type:
1. A table of acceptance criteria and the reported device performance
Since this is a physical implant and not a diagnostic/AI device, the "acceptance criteria" are not presented in terms of typical performance metrics like sensitivity or specificity. Instead, the criteria are focused on demonstrating substantial equivalence to existing predicate devices in terms of intended use, indications for use, materials, design features, and sterilization. The reported "performance" relates to the results of non-clinical tests that support this substantial equivalence.
| Acceptance Criteria Category (implied for substantial equivalence) | Reported Device "Performance" / Evidence of Equivalence |
|---|---|
| Intended Use Equivalence | The Intended Use of the Biomet Proximal Humerus Plating System is the same as the intended uses cleared in K955472 and K060290 and similar to K101421 (predicate devices). |
| Indications for Use Equivalence | The indications for the Biomet Proximal Humerus Plating System are similar to and based on the Indications for Use cleared in K955472, K060290, and K101421. |
| Materials Equivalence | Plates: Type II anodized Titanium Alloy (Ti-6Al-4V ELI). Locking and non-locking screws: Titanium Alloy (Ti-6Al-4V ELI ASTM F-136), either type II anodized or color anodized. Multi-directional screws: Cobalt Chromium (ASTM F1537). These are "commonly used materials in orthopedic implants and are used in predicate devices cleared via K955472 and K101421." Patient contact instrumentation: Stainless steel (ASTM F-899). |
| Design Features Equivalence | Design features are similar to currently marketed devices K955472, K060290, and K101421. "The design differences have not identified any issues that would impact the safety and effectiveness of the devices." The system incorporates the same spatial subchondral support as the Biomet S3 proximal humerus plates (K060290). |
| Sterilization Equivalence | Implants are offered sterile (gamma irradiation) or non-sterile (steam sterilized by user). "These sterilization configurations are the same as the predicate devices currently marketed and cleared via K060290 and K101421." |
| Mechanical/Physical Performance | Non-clinical performance testing included: |
| • Axial load construct testing | |
| • Engineering evaluations | |
| • Galvanic corrosion assessment | |
| Results indicate that the subject plating system is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness. (No specific numerical results or acceptance thresholds are provided in this summary document.) |
Regarding the specific questions tailored for AI/diagnostic devices:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This is a physical implant, not an AI/diagnostic device that uses a "test set" of data in the common sense for AI. The "tests" were non-clinical mechanical/material tests. The document does not specify a "sample size" for these physical tests in a way that would be relevant to data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: There is no "ground truth" in the context of this device being an implant. The "ground truth" for substantial equivalence is based on engineering principles, materials science, and regulatory comparisons to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No adjudication method is described or relevant for this type of device and its non-clinical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: No MRMC study was conducted or is relevant for this implant device. The concept of "human readers" or "AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an algorithm or AI device; therefore, no standalone performance study in that sense was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: As mentioned, ground truth in the context of an AI/diagnostic device is irrelevant here. The basis for safety and effectiveness is established through comparison to predicate devices, material standards (ASTM), and non-clinical mechanical testing, rather than a clinical ground truth.
8. The sample size for the training set
- Not Applicable: There is no training set for this physical implant device.
9. How the ground truth for the training set was established
- Not Applicable: There is no training set or ground truth in the context of AI for this 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.