Search Results

The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• Spondylolisthesis;
• Trauma (i.e., fracture or dislocation);
• Spinal stenosis;
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• Tumor:
• Pseudoarthrosis; and
• Failed previous fusion.
  The Titanium and Vitallium® rods from the Stryker Spine RADIUS® Spinal System are intended to be used with the other components of MANTIS® Spinal System and MANTIS® Redux Spinal System.

This 510(k) is intended to introduce a line extension to the existing MANTIS® Redux Spinal System. The line extension consists of additional sizes of the MANTIS® Redux Long Arm Polyaxial Screws. The additional sizes include the 7.5 mm and 8.5 screw diameter, ranging 30 - 90 mm in length for the MANTIS Redux Spinal System. No modifications were made to the MANTIS Spinal System.

The provided text is a 510(k) summary for a medical device (Stryker Spine MANTIS® Spinal System and MANTIS® Redux Spinal System). It focuses on demonstrating substantial equivalence to predicate devices for a line extension. It does not contain information on acceptance criteria, a study proving device performance against acceptance criteria, or any of the detailed study parameters you've requested (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, or training set details).

This type of submission typically relies on non-clinical (bench) testing to show that the new components meet established performance standards and are comparable to existing, legally marketed devices. It does not involve clinical studies with human participants or the assessment of AI algorithm performance as described in your prompt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device performance because that information is not present in the provided document.

The document discusses:

• Device Modification: Additional sizes (7.5 mm and 8.5 mm diameter, 30-90 mm length) for MANTIS® Redux Long Arm Polyaxial Screws.
• Intended Use: Percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for various indications (e.g., DDD, spondylolisthesis, trauma).
• Technological Characteristics: Substantial equivalence in terms of material, design, and indications for use to predicate devices.
• Testing: Static Compression Bending testing, Static Torsion testing, and Fatigue Compression Bending testing per ASTM F1717 were conducted on the subject components and compared to a predicate system to demonstrate substantial equivalence.

In summary, the provided text describes a regulatory submission for a medical device line extension, not a study evaluating AI performance or clinical efficacy against specific acceptance criteria for diagnostic or therapeutic accuracy.

Ask a specific question about this device