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The SDB Cerclage System devices will be offered in two sizes of cable constructs. The large cable construct shall be indicated for general orthopedic trauma surgery involving the following: olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral and ankle fractures; acromioclavicular dislocations; prophylactic banding during total joint procedures; and temporary reduction during ORIF (Open Reduction Internal Fixation) procedures. The small cable size shall be contraindicated for use in the femur ORIF and prophylactic banding during total joint procedures. These devices are intended as single use items.

The SDB Cerclage System consists of two diameter cable sizes each in association with a double holed crimp. The cable is routed around the bone through a Cable Passer and back through the adjacent hole in the crimp. The free end of the cable is passed through the Tensioner instrument and tensioned to the desired level of construct compression with guidance provided by the tensioner scale. A Crimper instrument is introduced and interfaced with the crimp followed by the squeezing of the instruments handles and the release of the pawl indicating a full crimping cycle has been obtained. The excess cable is then trimmed with a cutter.

The SDB Cerclage System shall be supplied with the cable and crimp assembled and packaged sterile as a single-use item.

Acceptance Criteria and Study for Pioneer Surgical Technologies SDB Cerclage System

1. Table of Acceptance Criteria & Reported Device Performance

Note: The document explicitly states that "the cerclage cable was the failure mode" for both the SDB Cerclage System and the predicate device in both tests. This implies that the failure mechanism was consistent, and the SDB system performed comparably to the predicate.

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for the static yield and fatigue tests. It generally refers to "each type of construct" suggesting multiple tests were conducted for both the SDB Cerclage System and the predicate device.

Data Provenance: The study appears to be a retrospective bench test comparison. The "country of origin of the data" is not specified but is implied to be from a testing facility, likely in the US, given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This was a bench test comparative study, not a study involving human expert assessment of clinical data.

4. Adjudication Method

Not applicable. This was a bench test comparative study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This was a bench test study comparing the mechanical performance of a medical device to its predicate, not a clinical study involving human readers.

6. Standalone Performance (Algorithm Only) Study

Not applicable. This is a mechanical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth for this study was established through objective bench testing (static yield and fatigue tests) comparing the mechanical performance of the SDB Cerclage System to a legally marketed predicate device.

8. Sample Size for the Training Set

Not applicable. This was a physical device testing study, not a machine learning or data-driven study that would involve a "training set."

9. How Ground Truth for the Training Set was Established

Not applicable. There was no training set in the context of this device's testing. Ground truth was established through direct physical and mechanical testing as described above.

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