(34 days)
Synthes 3.5mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.
Synthes 3.5mm LCP Clavicle Plate System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle.
Synthes 3.5mm LCP Clavicle Plate System enhances fracture fixation by providing pre-contoured plates designed to fit the clavicle and design features which allow additional contouring. minimization of soft tissue irritation, and minimization of vascular trauma. The Synthes 3.5mm LCP Clavicle System includes plates with a lateral extension feature specifically designed to enhance the stability of the fixation of fractures in the distal clavicle and plates without the lateral extension feature for fixation of fractures in the clavicle shaft.
Here's an analysis of the provided text regarding the Synthes 3.5mm LCP Clavicle Plate System, focusing on acceptance criteria and study details.
Based on the provided 510(k) summary (K073186), this device is a metallic bone fixation appliance and, as such, its acceptance criteria and the study proving it meets those criteria are not detailed in the context of typical AI/ML device evaluations. This document describes a medical device (a physical implant) cleared through the 510(k) pathway, which relies on demonstrating substantial equivalence to a predicate device rather than performance against defined acceptance criteria in a clinical study as would be detailed for a diagnostic AI/ML product.
Therefore, many of the requested points, particularly those related to AI/ML performance metrics, retrospective/prospective studies, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment (as applied to AI/ML models), are not applicable to this type of device and submission.
However, I can extract information relevant to the substantial equivalence claim:
1. A table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" and "reported device performance" as typically applied to AI/ML models (e.g., sensitivity, specificity, AUC) does not directly apply here. For a metallic bone fixation appliance cleared via 510(k), "acceptance criteria" are implied by the demonstration of substantial equivalence to a legally marketed predicate device. This typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
Acceptance Criteria (Implied by Substantial Equivalence):
| Criterion | Description | Device Performance (How the device is shown to meet the criterion) |
|---|---|---|
| Intended Use Equivalence | The device's intended use must be the same as the predicate device. | "Synthes 3.5mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle." - This is compared to the predicate's indications. The predicate device (Synthes 3.5mm Dynamic Compression Locking (DCL) Plates) is for similar fracture fixation. |
| Technological Characteristics Equivalence | The material composition, design features, and other technological attributes must be similar to the predicate device, or any differences must be shown not to raise new safety/effectiveness concerns. | "Synthes 3.5mm LCP Clavicle Plate System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle." This is similar to the metallic plates and screws of the predicate. Differences in LCP vs. DCL mechanisms and pre-contoured plates are discussed in terms of enhancement and minimization of irritation/trauma, suggesting they do not raise new safety concerns. |
| Performance Data (e.g., Biocompatibility, Mechanical Testing) | The device must meet recognized standards for safety and effectiveness for bone fixation appliances. While not explicitly detailed in this summary, such submissions typically include non-clinical testing data to support mechanical strength, fatigue life, and biocompatibility. | The summarized document states "Information presented supports substantial equivalence." This implies that comprehensive data (e.g., mechanical tests comparing the device to the predicate, or to relevant ASTM/ISO standards, and biocompatibility testing) was submitted to FDA and found acceptable. Specific numerical performance values are not in this summary. |
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 in the context of typical clinical test sets for AI/ML. This is a physical implant. The "test set" would refer to non-clinical mechanical testing, biocompatibility studies, or potentially limited clinical data (if required for differences from the predicate, though often not for 510k). The document does not specify these details.
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. "Ground truth" in the AI/ML sense (e.g., expert-derived medical diagnoses) is not relevant for this physical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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. This is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in the AI/ML sense. For a physical implant, "ground truth" for demonstrating safety and effectiveness would come from:
- Mechanical Testing: Based on engineering principles and established ASTM/ISO standards for strength, fatigue, and stiffness.
- Biocompatibility Testing: According to ISO 10993 series for medical devices.
- Clinical Data (if submitted): Patient outcomes (e.g., fusion rates, complication rates) from comparative studies, if such studies were deemed necessary (which is rare for a device cleared via substantial equivalence for minor modifications like this one). The summary does not indicate clinical data was specifically reviewed for equivalence assertion beyond possibly general clinical use of the predicate.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the AI/ML sense for this device. If physical testing was done, the "sample size" would refer to the number of devices tested mechanically or biologically, but this is not provided in the summary.
9. How the ground truth for the training set was established
- Not Applicable. As no training set in the AI/ML context exists, this question is not relevant.
In summary, this 510(k) submission for the Synthes 3.5mm LCP Clavicle Plate System focuses on demonstrating substantial equivalence to a predicate device based on its intended use, technological characteristics, and performance data (not specifically detailed in the summary but typically including non-clinical mechanical and biocompatibility testing). The framework of AI/ML model evaluation (acceptance criteria, test/training sets, ground truth, expert adjudication, MRMC studies) does not apply to this type of medical 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.