(65 days)
The In-Line Orthopedic Cable Cerclage System is intended for use in general orthopedic trauma surgery involving olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction during open reduction internal fixation (ORIF) procedures.
The In-Line Orthopedic Cable Cerclage System consists of a cable and crimp assembly to allow cerclage fixation of various long bone, pelvic and acetabular fractures as well as tension band fixation of the patella, olecranon, ankle and shoulder. The implants are manufactured from medical grade stainless steel per ASTM 138. The implants are provided sterile. Instrumentation has been designed for use with this implant system.
This document is a 510(k) premarket notification for the "Frontier Medical Devices In-Line Orthopedic Cable Cerclage System." It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with acceptance criteria and device performance as one might find for a novel AI/software device.
Therefore, the requested information regarding acceptance criteria, study details, and related elements will largely be absent or inapplicable in the context of this document. However, I can extract the relevant information that is present:
1. A table of acceptance criteria and the reported device performance:
This document describes a medical device, not an AI or software algorithm. Therefore, there are no "acceptance criteria" in the sense of performance metrics like sensitivity, specificity, or accuracy for an AI system. The "performance" assessment is based on demonstrating substantial equivalence through non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Device performs in a manner substantially equivalent to predicate system concerning safety and effectiveness. | "Static and dynamic testing supports that the In-Line Orthopedic Cable Cerclage System performs in a manner substantially equivalent to that of the predicate system; no new issues of safety or effectiveness were raised." |
| No new types of safety or efficacy issues raised by technological characteristics. | "The minor differences in technological characteristics that do exist do not raise any new types of safety or efficacy issues." |
| No significant differences compared to predicates that would adversely affect product use. | "Any differences were not considered significant based on mechanical bench testing." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This document does not describe a test set or data provenance in the context of an AI/software study. The "testing" mentioned refers to mechanical bench testing of the physical medical device. The exact sample sizes or specific details of these non-clinical tests are not provided in this summary.
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):
This is not applicable as the submission pertains to a physical medical device and not an AI/software algorithm requiring expert ground truth for a diagnostic task.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable for the reasons stated above.
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:
This is not applicable as the submission pertains to a physical medical device and not an AI/software algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the submission pertains to a physical medical device and not an AI/software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a physical device like this, "ground truth" relates to the mechanical properties and performance established through engineering standards and testing protocols (e.g., ASTM standards for material strength and fatigue testing). The specific details of these standards and results are not fully disclosed in this 510(k) summary but are fundamental to demonstrating substantial equivalence.
8. The sample size for the training set:
This is not applicable as the submission pertains to a physical medical device and not an AI/software algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.