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The STRETTO™ Cable System is indicated for use in: general orthopedic trauma surgery (e.g., fractures of the olecranon, patella, femur - including periprosthetic, pelvis, acetabulum, humerus and ankle, and acromioclavicular dislocations); prophylactic banding during total joint procedures; and, temporary reduction techniques for ORIF (Open Reduction Internal Fixation) procedures.

STRETTO™ Screw Anchors are indicated for fractures that may not be securely held by either a screw or a cerclage device alone, and where cerclage is used in combination with bone screws and/or plates to provide internal fixation of fractured bone.

STRETTO™ Press-In Anchors are indicated for use with a cerclage cable and plate to augment long bone fracture fixation, particularly when the use of screws would be inhibited, as in the presence of intramedullary implants.

The STRETTO™ Cable System implants are comprised of cables, crimps and anchors. Anchors include a thru hole for the cables to pass through, and are available in multiple styles. Press-in anchors mate with ANTHEM fracture plates and screw anchors mate with the hex recess of ANTHEM screws. The cable is secured with the crimp and may be used with the anchors. STRETTO™ Implants are manufactured from titanium alloy, commercially pure titanium, cobalt chromium alloy, cobalt chromium molybdenum alloy, or stainless steel.

The provided text is a 510(k) summary for the STRETTO™ Cable System to the FDA. It details the device, its indications for use, and a brief summary of performance data to establish substantial equivalence to predicate devices. However, it does not contain the specific information requested about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth
4. Adjudication method
5. MRMC comparative effectiveness study details (effect size, improvement)
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document states:

• Performance Data: "Mechanical testing (static and dynamic tension) was conducted using ASTM E8 as a guide. Performance data demonstrate substantial equivalence to the predicate devices. An engineering analysis was conducted for the anchors to demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST72:2011."

This indicates that mechanical and endotoxin testing were performed, and the results demonstrated substantial equivalence. However, the specific acceptance criteria, detailed test results, actual performance metrics, sample sizes, or methods for establishing ground truth (which would be relevant for clinical or diagnostic AI/ML devices but not typically for mechanical implants) are not provided in this summary.

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