Search Results

The Cayenne Medical, Inc. Quattro® Bolt Tenodesis Screws are intended to be used for the reattachment of soft tissue to bone for the following indications:

Shoulder

• Acromioclavicular separation repairs
• Deltoid repairs
• Rotator cuff repairs
• Biceps tenodesis

Elbow, Wrist, and Hand

• Biceps tendon reattachment
• Ulnar or radial collateral ligament reconstruction
• Lateral epicondylitis repair

Knee

• Extra-capsular repairs
• Medial collateral ligament
• Lateral collateral ligament
• Posterior oblique ligament
• Patellar realignment and tendon repairs
• Illiotibial band tenodesis

Foot and Ankle

• Hallux valgus repairs
• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions
• Midfoot reconstructions
• Metatarsal ligament/tendon repairs/reconstructions
• Bunionectomy

The Quattro® Bolt Tenodesis Screw is a sterile (using gamma radiation method), manually operated, single procedure device for reattachment of soft tissue to bone. The Quattro® Bolt screw is preloaded on a disposable driver. Quattro® Bolt device incorporates design features that facilitate screw placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.

The Quattro® Bolt tenodesis screw is offered in 5 different sizes, 5mm×10mm, 6mm×12mm×14mm, 8mm×16mm, 9mm×16mm. The screws are made out of PolyEtherEtherKetone (PEEK).

The disposable driver has a working shaft length of 14cm with an outer shaft diameter of 3.0 mm. The driver shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic.

The provided text is a 510(k) summary for the Cayenne Medical, Inc. Quattro® Bolt Tenodesis Screw. It describes the device, its intended use, and claims substantial equivalence to a predicate device based on non-clinical testing.

However, the document does not contain the detailed information necessary to answer your request about acceptance criteria and a study that proves the device meets those criteria, specifically:

• Acceptance criteria table: No such table is present.
• Reported device performance: While pull-out strength is mentioned as "comparable," no specific performance metrics or thresholds (e.g., in a table) are provided.
• Sample size for the test set: Not mentioned.
• Data provenance: Not mentioned.
• Number of experts and their qualifications: Not applicable, as this is non-clinical mechanical testing, not a study involving expert assessment of images or clinical outcomes.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted; this is a non-clinical mechanical test.
• Standalone algorithm performance: Not applicable; this is a physical medical device, not an AI algorithm.
• Type of ground truth: For mechanical testing, the "ground truth" would be the measured physical properties, but the document doesn't detail how these were established beyond stating "mechanical testing (pull-out strength) was performed."
• Sample size for the training set: Not applicable as there is no AI or ML training set.
• How ground truth for the training set was established: Not applicable.

The document states:

• "Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. Mechanical testing (pull-out strength) was performed on the Quattro® Bolt tenodesis screw and the predicate device. Testing showed that the Quattro® Bolt tenodesis screw ultimate pull-out strength was comparable to that of the predicate device."

This indicates that a non-clinical mechanical testing study was performed, specifically measuring pull-out strength. The acceptance criterion for this test appears to be "comparable to that of the predicate device" in terms of ultimate pull-out strength. However, the specific numerical thresholds or target values for "comparable" are not provided in this summary.

In summary, based on the provided document, I cannot fulfill your request for a detailed table of acceptance criteria and associated study information because the document primarily focuses on demonstrating substantial equivalence through non-clinical mechanical testing, without providing the specific quantitative details you're asking for.

Ask a specific question about this device