(190 days)
PMT Expandable Cage (PMT EXP) is an integrated construct comprised of a CAVUX Cage-E and a single ALLY Screw-E.
PMT EXP is placed bilaterally through a posterior surgical and spans the facet interspace with points of fixation at each end of the construct.
PMT EXP is intended for temporary stabilization as an adjunct to single level posterior cervical fusion in skeletally mature patients. PMT EXP is only intended for use with a single level anterior cervical fusion at the same spinal level that utilizes FDA cleared/approved spine stabilization hardware for anterior cervical fusion procedures.
PMT EXP is indicated for the treatment of patients with cervical degenerative disc disease (DDD) with radiculopathy from C3-C7.
PMT EXP is indicated for use with autogenous and/or allogenic bone graft.
The PMT Expandable Cage (PMT EXP) is comprised of a CAVUX Cage-E and an ALLY Expansion Screw as an integrated construct, manufactured from medical grade titanium alloy, and supplied sterile for single use only. The components are provided with a pre-attached disposable delivery handle/inserter. The device achieves facet fixation by spanning the interspace with points of fixation at each end of the construct and provides temporary, bilateral, rigid fixation as an adjunct to fusion.
CORUS® Spinal System is recommended to access the site and perform posterior cervical fusion.
The threads of the Expansion Screw interface with the slot features of the Cage-E to increase the height of the Cage-E and promote strength of the total construct. The profile of the Cage-E provides contact area between the device and adjacent bony surfaces to fixate the segment. The Expansion Screw is made of 6AL 4V ELI Titanium (ASTM F136) and the washer is made of Commercially Pure Titanium Grade 2 (ASTM F67).
This FDA K-number document refers to a Class II medical device, the PMT Expandable Cage (PMT EXP), which is an integrated construct for temporary stabilization as an adjunct to single-level posterior cervical fusion. This document does not describe an AI/ML powered device, therefore no information about acceptance criteria or supporting studies related to AI/ML device performance is available.
The document primarily focuses on the device's substantial equivalency to predicate devices based on:
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Device Description:
- The PMT Expandable Cage is made from medical-grade titanium alloy, supplied sterile for single use.
- It consists of a CAVUX Cage-E and an ALLY Expansion Screw.
- It is designed to achieve facet fixation by spanning the interspace with fixation points at each end, providing temporary, bilateral, rigid fixation.
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Indications for Use:
- Temporary stabilization as an adjunct to single-level posterior cervical fusion in skeletally mature patients (C3-C7).
- Only for use with a single-level anterior cervical fusion at the same spinal level, utilizing FDA cleared/approved spine stabilization hardware.
- Treatment of cervical degenerative disc disease (DDD) with radiculopathy.
- Indicated for use with autogenous and/or allogenic bone graft.
Performance Data and Conclusion (for the physical device, not AI/ML):
- Mechanical Tests: Static and dynamic axial compression using a custom setup, and axial pullout testing per ASTM F543 were performed.
- Biomechanical Studies: Cadaver fatigue and kinematic studies were conducted to assess spinal stability and risk of device migration.
- Clinical Data: Clinical data were provided comparing the subject device to other cervical fusion techniques. This included radiographic and CT evaluations, peri-operative findings, patient-reported outcomes, and assessments of safety and effectiveness. The conclusion was that the clinical and radiographic data supported satisfactory clinical outcomes for the specified use.
Absence of AI/ML Specific Information:
The document does not mention any AI/ML components, algorithms, or software. Therefore, the requested information regarding AI/ML device acceptance criteria, performance tables, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies for AI/ML assistance is not applicable and not present in this submission.
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