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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CDTM Spinal System is indicated for one or more of the following: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD TM Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (13 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CDTM Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. The components can be rigidly locked into a variety of configurations, with each construct tailor-made for the individual case.

The provided document is a 510(k) summary for the CD™ Spinal System from 1998, which is a premarket notification to the FDA for a medical device. This type of document establishes substantial equivalence to a predicate device rather than presenting detailed studies with acceptance criteria for device performance as would be expected for a novel device or a more recent submission.

Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 of your prompt regarding acceptance criteria and a detailed study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for training and test sets.

Instead, it states:

V. Substantial Equivalence
The CD™ Spinal System is substantially equivalent to itself and other predicate or preamendments devices. Mechanical testing and historical data were provided or referenced to demonstrate substantial equivalence.

This indicates that the device was deemed substantially equivalent based on mechanical testing and historical data, rather than a clinical study evaluating specific performance metrics against defined acceptance criteria in the manner you've outlined. The focus of a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, not necessarily to prove efficacy or performance against a set of predefined quantitative acceptance criteria with a detailed clinical study.

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When used as a pedicle screw fixation system with CD screws attached to the non-cervical posterior spine, the CD Spinal System is indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system, the CD Spinal System is also indicated for Grade III and IV spondylolisthesis. For this indication only, the spondylolisthesis must be at L5-S1 in patients who are receiving fusions using autogenous bone graft only and who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint for these severe spondylolisthesis cases, the levels of pedicle screw fixation may be L3 to the sacrum.

When used as a posterior non-pedicle screw fixation system, the CD Spinal System is intended for the indications given above as well as spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture, pseudarthrosis, tumor resection, and unsuccessful previous attempts at spinal fusion. For non-pedicle screw use, the levels of fixation for the CD Spinal System are T1 to sacrum, with the screws limited to sacral fixation.

The CD" Spinal System consists of rods, hooks, screws, connectors, and cross connectors, and other components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CD " Spinal System is to provide stabilization during the development of a solid spinal fusion.

The provided document is a 510(k) summary for the CD™ Spinal System, and it describes a medical device (spinal implant system), not an AI/ML device. Therefore, the acceptance criteria and study information requested, which are typically relevant for AI/ML device performance evaluation, are not applicable here.

The document discusses:

• Description of the Device: Components and purpose of the CD™ Spinal System.
• Indications for Use: Specific medical conditions for which the device is intended.
• Substantial Equivalence: The primary basis for FDA clearance, comparing it to a preamendments device.
• Bridging Data: Mention of clinical data, mechanical testing, and theoretical safety profile analysis used to support substantial equivalence.

It does not contain information on:

• Acceptance criteria in the context of an AI/ML model's performance metrics (e.g., sensitivity, specificity, AUC).
• Any study involving a test set, training set, ground truth established by experts, multi-reader multi-case studies, or standalone algorithm performance.

The FDA 510(k) clearance process for this type of medical device largely relies on demonstrating substantial equivalence to a legally marketed predicate device, often through mechanical testing, biocompatibility testing, material characterization, and sometimes clinical data for specific indications, rather than the AI/ML-specific performance metrics you've asked for.

Therefore, I cannot populate the table or answer the questions as they are designed for an AI/ML device evaluation, which is not the subject of this document.

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