(99 days)
Synthes 3.5mm LCP Periarticular Proximal Humerus Plates are indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
The Synthes 3.5mm LCP Periarticular Proximal Humerus Plates are low-profile, pre-contoured bone fixation plates intended for the treatment of fractures of the humerus. The plates are offered sterile and non-sterile and are available in stainless steel and titanium.
The provided documents are a 510(k) summary and FDA clearance letter for the Synthes (USA) 3.5mm LCP Periarticular Proximal Humerus Plates. This is a medical device, specifically a bone fixation appliance, and the clearance process for such devices relies on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance studies in the way one might evaluate a new diagnostic or AI-driven system.
Therefore, the requested information elements related to AI/algorithm performance, sample sizes for test/training sets, expert adjudication, and ground truth establishment (as typically applied to diagnostic or AI studies) are not applicable to this type of device submission.
Here's a breakdown of what is available and relevant to the substantial equivalence determination:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices seeking 510(k) clearance, "acceptance criteria" are typically met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is usually achieved through comparing design features, materials, mechanical properties, and intended use. Performance is then "reported" by demonstrating that these aspects are equivalent to or better than the predicate.
| Acceptance Criteria (Demonstration of Safe & Effective Equivalence) | Reported Device Performance (Synthes 3.5mm LCP Periarticular Proximal Humerus Plates) |
|---|---|
| Intended Use Equivalence: Indicated for similar conditions as predicate. | Indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. (Matches predicate's general use for humerus fixation). |
| Technological Characteristics Equivalence: Similar design, materials, and operating principles. | Low-profile, pre-contoured bone fixation plates. Offered sterile and non-sterile. Available in stainless steel and titanium. (Implied similar design/materials to predicate LCP Proximal Humerus Plates and Small Fragment Dynamic Compression Locking Plates). |
| Performance Data (Bench/Mechanical Testing, if applicable): Often involves showing comparable mechanical strength, fatigue life, etc., to the predicate. | The 510(k) summary states "Information presented supports substantial equivalence," which typically includes bench testing and design comparisons to demonstrate comparable mechanical integrity and fit-for-purpose to the predicate devices. Specific quantitative data is not provided in this summary but would have been part of the full 510(k) submission. |
| Safety and Effectiveness Equivalence: No new safety or effectiveness concerns raised compared to the predicate. | No new safety or effectiveness issues identified by the FDA, as evidenced by the clearance letter. Device is considered "substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This is a hardware medical device, not a diagnostic or AI algorithm that uses test sets of data. Evaluation is based on design, materials, and mechanical testing, not analysis of patient data in a "test set" in the traditional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. As above, there is no "test set" in the context of diagnostic/AI performance. The expertise involved would be engineering and regulatory professionals at Synthes, and FDA reviewers (e.g., engineers, clinicians, toxicologists) who assess the technical documentation against regulatory standards for substantial equivalence.
4. Adjudication Method for the Test Set
- Not Applicable. No test set or human adjudication process for diagnostic/AI performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is a bone fixation plate, not a diagnostic imaging device or an AI assistant for human readers.
6. Standalone (Algorithm Only) Performance Study
- Not Applicable. No algorithms are involved in the function of this bone plate.
7. Type of Ground Truth Used
- For a device like this, "ground truth" relates to the performance specifications (e.g., strength, durability, biocompatibility) of the device and its predicate. The "truth" is established by adherence to recognized standards (e.g., ASTM, ISO for medical implants) and demonstrating that the new device meets or exceeds the critical performance characteristics of its predicate through engineering analyses, material characterization, and mechanical testing (benchtop studies). This demonstrates that it functions as intended for its stated use.
8. Sample Size for the Training Set
- Not Applicable. This device does not involve a "training set" in the AI/machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set.
In summary: The Synthes 3.5mm LCP Periarticular Proximal Humerus Plates received 510(k) clearance by demonstrating substantial equivalence to existing predicate devices (Synthes LCP Proximal Humerus Plates and Synthes Small Fragment Dynamic Compression Locking Plates). This demonstration relies on comparing the new device's intended use, technological characteristics (design, materials, mechanical properties), and performance (typically through bench testing) to those of the legally marketed predicates, ensuring that no new questions of safety or effectiveness are raised. The concepts of "acceptance criteria," "test sets," "training sets," and "expert ground truth" as applied to AI/diagnostic algorithms are not relevant to this type of device submission.
§ 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.