(117 days)
The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and or thoracic disc herniation (myelopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the Calibrate LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Calibrate LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
Calibrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation features may be used with AMP-X System as integrated fixation in addition to supplemental fixation.
The subject Calibrate LTX Interbody System is a lordotic expandable thoracolumbar intervertebral body fusion system designed to be inserted through a lateral or anterolateral surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Calibrate LTX System consists of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create lordotic expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with anti-migration teeth and grit-blast treatment on the bone-contacting endplate surfaces. Certain Calibrate LTX Interbody System offerings also accept fixation bone screws manufactured from titanium alloy per ASTM F136.
This purpose of this 510(k) is to receive clearance for an anti-migration plate ("AMP-X") which may be used with certain LTX interbody offerings. AMP-X includes fixation plates. center locking screws, and bone screws manufactured from titanium alloy per ASTM F136. Additionally, the purpose of this 510(k) is to receive clearance for expanded indications for the treatment of degenerative spondylolisthesis, multilevel degenerative scoliosis, spinal stenosis, and sagittal deformity, and use of allogenic bone consisting of cortical bone, as well as allogenic bone consisting of demineralized allograft bone with bone marrow aspirate.
The provided text does not contain information about acceptance criteria or the study that proves a device (in the context of an AI-powered medical device) meets those criteria. The document is an FDA 510(k) clearance letter for the Calibrate LTX Interbody System, which is a spinal fusion device, not an AI or software device.
Therefore, I cannot populate the table or answer the specific questions related to AI device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.
The document discusses non-clinical testing performed for the interbody system:
- Dynamic Axial Compression (per ASTM F2077)
- Dynamic Compression-Shear (per ASTM F2077)
- Static Screw Push-Out Testing
It concludes that "Since the technological characteristics of the subject Calibrate LTX Interbody System is substantially equivalent to the predicate systems, no further clinical or non-clinical testing is required to support the expanded indications for use of the subject system." and "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This further indicates that the requested information for AI device performance is not present.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.