(84 days)
The MSD CABLE REDUCTION SYSTEM screws and hooks are only intended for use in the thoracic and lumbar spine. The system provides an alternative to sublaminar and intraspinous process wiring for trauma applications. Another application is the use of the MSD CABLE REDUCTION SYSTEM for instrumentation involved in the correction of scoliotic, kyphotic, and lordotic deformities. The system may also be used with other spinal implants such as the MSD Unit Rod, the ATLAS™ CABLE System or the Luque Rod, or wherever "wiring" may help secure the attachment of other implants.
The MSD CABLE REDUCTION SYSTEM is a temporary implant for the use in orthopaedic surgery. The system is intended to help provide temporary stabilization, augment the development of solid bony fusion and/or aid in the repair of bone fractures. The system consists of a multi-stranded cable and ancillary components used in several different configurations. The MSD CABLE REDUCTION SYSTEM implant components are made of medical grade stainless steel described by ASTM Standard F-138 or ISO 5832-1 or ISO 5832-9. Alternatively, the system may be made out of titanium alloy or titanium, as described in ASTM F-136 or ISO 5832-3 for the surgical grade titanium alloy and ASTM F 67 or ISO 5832-2 for pure titanium. The MSD CABLE REDUCTION SYSTEM may be sold sterile or non-sterile.
This document is a 510(k) summary for the Medtronic Sofamor Danek CABLE REDUCTION SYSTEM, approved in 2003. It primarily details the device's description, indications for use, and a declaration of substantial equivalence to a predicate device.
Crucially, this document does not include information about acceptance criteria or a study demonstrating the device meets those criteria in the context of device performance metrics or clinical outcomes.
Instead, the "acceptance criteria" here refers to the FDA's regulatory acceptance, which is based on demonstrating substantial equivalence to a legally marketed predicate device. The "study" that "proves" the device meets these "acceptance criteria" is the 510(k) submission itself, which primarily focuses on demonstrating that the new device is as safe and effective as the predicate, often through material comparisons, design similarities, and sometimes mechanical testing to show performance parity, rather than clinical efficacy studies with human subjects.
Therefore, I cannot fill in the requested table and sections regarding device performance, sample sizes, ground truth, or MRMC studies because the provided text does not contain that level of detail for this type of medical device submission. The 510(k) process for devices like spinal fixation systems typically relies heavily on demonstrating substantial equivalence to a predicate device that is already on the market, rather than requiring new clinical efficacy trials for every new iteration.
Here's what I can extract and what is explicitly missing:
Acceptance Criteria and Device Performance (Based on "Substantial Equivalence")
| Acceptance Criteria Category | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Safety and Effectiveness | Equivalent to the predicate ATLAS™ CABLE System in terms of intended use, materials, and design principles. The 510(k) process implicitly accepts that if the device is substantially equivalent to a legally marketed device, it is also safe and effective for its indicated uses. |
| Indications for Use | Matches the predicate device: temporary stabilization in orthopaedic surgery, augment bony fusion, aid in fracture repair. Specifically for thoracic and lumbar spine, as an alternative to sublaminar/intraspinous process wiring for trauma, correction of scoliotic, kyphotic, and lordotic deformities, and with other spinal implants. |
| Material Composition | Medical grade stainless steel (ASTM F-138 or ISO 5832-1/5832-9) or titanium/titanium alloy (ASTM F-136, ISO 5832-3, ASTM F 67, ISO 5832-2). This is presumably equivalent to the predicate or within accepted material standards for such devices. |
| Device Design | Consists of multi-stranded cable and ancillary components, used in various configurations (implied to be similar or functionally equivalent to predicate). |
| Sterilization Status | May be sold sterile or non-sterile (implies equivalence to predicate's options or standard practice). |
Missing Information (Not Present in the Provided 510(k) Summary)
The following information regarding a detailed study with specific performance metrics is not available in the provided text. The 510(k) summary focuses on regulatory approval via substantial equivalence rather than a detailed performance study with quantifiable metrics as typically seen for AI/diagnostic devices.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of 510(k) submission which relies on substantial equivalence rather than clinical study data. Any 'testing' would likely be mechanical bench testing, not clinical human data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" for this device would refer to its mechanical properties or ability to fulfill its function, likely assessed through engineering tests, not expert consensus on images or outcomes.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant, not an AI diagnostic tool or imaging system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Ground truth for a device like this would typically involve mechanical testing (e.g., tensile strength, fatigue testing, pull-out strength) and potentially animal studies, which are not detailed here. Clinical outcomes data or pathology results from human trials are not described in this summary as a basis for equivalence.
- The sample size for the training set: Not applicable. This device is not an AI model.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission demonstrating "substantial equivalence" of a medical device (a surgical cable system) to a previously approved predicate device. It does not contain the kind of detailed performance study data you would typically find for an AI/diagnostic device or a device requiring new clinical efficacy trials.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.