(60 days)
Synthes LCP Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia.
Synthes LCP Ankle Arthrodesis Plates are minimally contoured metal plates that utilize locking screw technology to promote fusion or "arthrodesis" of the ankle. The plates will be offered in stainless steel and commercially pure titanium and will be available in sterile and non-sterile versions.
The provided document is a 510(k) summary for the Synthes LCP Ankle Arthrodesis Plate. This type of regulatory submission is for medical devices that are substantially equivalent to a surgically marketed predicate device. This document does not describe a study involving device performance against acceptance criteria in the way typically associated with AI/ML-based medical devices or complex diagnostic tools requiring clinical validation.
Instead, the document focuses on demonstrating that the new Synthes LCP Ankle Arthrodesis Plate is substantially equivalent to a previously marketed device (Synthes Ankle Arthrodesis Plates). The "acceptance criteria" here is not about diagnostic accuracy (like sensitivity, specificity, or AUC) but rather about meeting regulatory standards for safety and effectiveness by being comparable to an already approved device.
Therefore, most of the requested information (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set) is not applicable to this type of medical device submission.
Here's an attempt to answer the questions based on the provided text, highlighting what is and isn't applicable:
1. A table of acceptance criteria and the reported device performance
For this type of device (a metallic bone fixation appliance), "acceptance criteria" and "reported device performance" are not typically presented as diagnostic metrics with specific thresholds. Instead, the acceptance criterion is substantial equivalence to a predicate, meaning the device's technological characteristics and intended use do not raise different questions of safety and effectiveness.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as per 510(k) Submission) |
|---|---|
| Intended Use | Intended for arthrodesis of the ankle joint and distal tibia. (Matches predicate's general use for ankle arthrodesis) |
| Technological Characteristics (Material, Design) | Minimally contoured metal plates, utilizing locking screw technology. Offered in stainless steel and commercially pure titanium in sterile and non-sterile versions. (Assumed to be comparable or an improvement not raising new safety/effectiveness questions compared to predicate). |
| Performance (e.g., mechanical properties) | Not explicitly detailed in this summary, but would have been demonstrated in the full 510(k) submission to be equivalent or superior without new risks. This would typically involve bench testing (fatigue, strength, etc.) rather than clinical outcomes studies for substantial equivalence. |
| Safety & Effectiveness | "Information presented supports substantial equivalence." (Meaning the device is deemed as safe and effective as the predicate.) |
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 submission for a mechanical implantable device, not a diagnostic algorithm. There is no "test set" of patient data for performance evaluation in the context of diagnostic accuracy. Clinical studies with patient data are generally not required for 510(k) substantial equivalence for devices like this, unless the proposed device introduces new technology or raises new safety/effectiveness questions.
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 for diagnostic purposes is not relevant for this device. The "truth" for this device relates to its mechanical integrity, biocompatibility, and ability to achieve arthrodesis, which are evaluated through engineering tests, material science, and comparison to predicate devices, not expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set in the context of diagnostic performance that would require adjudication.
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 not an AI/ML device, nor is it a diagnostic tool where human reader performance would be assessed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the diagnostic sense. The "ground truth" for this device relies on engineering principles, material science, bench testing results, and regulatory comparison to an existing predicate device deemed safe and effective. For the 510(k) process, the "ground truth" is that the predicate device is legally marketed and generally safe and effective, and the new device performs comparably in its intended use.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set or associated ground truth for this 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.