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(171 days)
The Toro-L Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Toro-L Interbody Fusion System is intended for use in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracy disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Toro-L Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis.
Integrity Implants' Toro-L Interbody Fusion System incorporates a bi-directional expandable interbody fusion device and a monolithic interbody fusion device intended for use in the thoracolumbar spine.
Once implanted, the Toro-L interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The Toro-L interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The Toro-L Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.
The Toro-L Interbody Fusion System implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and Ti-6Al-4V per ASTM F2924) and are offered in a range of sizes and lordotic options to accommodate variations in patient anatomy.
The Toro-L Interbody Fusion System expandable implant has integrated ramps and a threaded actuator that allow the implant to be inserted in a non-expanded form, and then subsequently expanded to full width and desired height through continuous expansion. When the desired height is achieved, the locking system is engaged to secure the construct in its final expanded configuration. The implant is then post-packed with bone graft.
The monolithic implant is a non-expanding conventional spacer with the interior space of the device divided into two compartments for bone graft containment.
Both the expandable and monolithic configurations have protrusions on the superior and inferior surfaces of the endplates of the implant to grip the adjacent vertebral endplates to resist expulsion.
The subject implant and instruments are offered non-sterile and are intended to be steam sterilized by the user prior to use.
This is a medical device 510(k) summary for the Toro-L Interbody Fusion System, which is a spinal implant. The document does not contain information related to AI/ML device performance, acceptance criteria for such, or studies involving human readers or ground truth as it pertains to AI/ML.
Therefore, I cannot fulfill your request for the specific information regarding AI/ML device performance, acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The provided text focuses on the mechanical and biological testing of the physical implant to demonstrate substantial equivalence to previously cleared devices.
Here's what the document does provide:
- Device Name: Toro-L Interbody Fusion System
- Regulatory Class: Class II (Product Codes MAX, PHM)
- Intended Use: Intervertebral body fusion of the spine in skeletally mature patients, with
autogenous and/or allogeneic bone graft and supplemental internal spinal fixation systems. Intended for use in the thoracic spine (T1-T12) and thoracolumbar junction (T12-L1), and lumbar spine (L1-S1) for symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation. Can also be used as an adjunct to fusion in patients with multilevel degenerative scoliosis. - Predicate Devices:
- Non-Clinical Tests Conducted (Bench Performance Testing):
- Static Axial Compression in accordance with ASTM F2077
- Dynamic Axial Compression in accordance with ASTM F2077
- Static Compression Shear in accordance with ASTM F2077
- Dynamic Compression Shear in accordance with ASTM F2077
- Wear Debris and Particle Characterization in accordance with ASTM F1877
- Subsidence in accordance with ASTM F2267
- Biocompatibility Assessment: In accordance with ISO 10993-1, including cytotoxicity testing in accordance with ISO 10993-5.
The conclusions state that based on these bench tests and biocompatibility assessment, the device demonstrates substantial equivalence and that any differences do not impact safety and effectiveness. This entire document describes a physical medical device, not an AI/ML-driven one.
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