(15 days)
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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.