(71 days)
When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudoarthrosis),
In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients:
- · Who are receiving fusions with autogenous graft only:
- · Who are having the device fixed or attached to the lumbar or sacral spine;
- · Who are having the device removed after the development of a solid fusion mass.
When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO implant, rod-cord combination implant, and the U&I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.
The Zimmer® Dynesys® Spinal System, including the Dynesys Top-Loading Spinal System, is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the lumbar and sacral areas of the spine. Implants of this system consist of fixed pedicle screws of varying diameters and lengths, set screws, polycarbonate urethane (PCU) spacers, and polyethylene terephthalate (PET) cords.
The Dynesys pedicle screw consists of a top-loading solid or cannulated shank, either uncoated or coated with ceramic hydroxyapatite (HA). The Dynesys Spinal System is also cleared for connection with the Zimmer DTO implant. The Zimmer DTO implant allows the connection of the Dynesys Spinal System to the Optima ZS Spinal System when the two systems are used on contiguous levels.
This document is a 510(k) summary for the Zimmer® Dynesys® Top-Loading Spinal System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study demonstrating performance is not present in this type of regulatory submission.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
- Not available in this document. A 510(k) submission for a spinal fixation system primarily focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices through comparable design, materials, function, and intended use, rather than presenting detailed performance acceptance criteria and results from a clinical or laboratory study with quantitative metrics. Performance data for such devices typically involves mechanical testing (e.g., fatigue, static strength) to ensure safety and functionality, but these specific criteria and results are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- No specific sample size for a test set is provided. This document does not describe a clinical study or a specific test set. The evaluation is based on a comparison to predicate devices.
- Data provenance is not applicable as there is no specific data set described that would have a country of origin or be classified as retrospective/prospective.
3. 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. There is no mention of a test set requiring expert-established ground truth.
- The "experts" involved would be the regulatory reviewers at the FDA and the engineers/scientists at Zimmer Spine who assessed the substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no test set or adjudication method described.
5. 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 spinal implant, not an AI or imaging diagnostic tool. An MRMC study is irrelevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a medical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of an AI/diagnostic study. For this medical device, the "ground truth" for its safety and effectiveness is established through compliance with regulatory standards, mechanical testing (not detailed here), and demonstrated substantial equivalence to predicate devices which have a history of safe and effective use. The FDA's review process ultimately determines if the device is substantially equivalent based on these factors.
8. The sample size for the training set
- Not applicable. This device is a medical implant, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set mentioned.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.