(27 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.
The Dynesys Spinal System is comprised of a variety pedicle screws sizes, tensioning cords and longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws are manufactured from medical grade titanium alloy. The tensioning cords are manufactured from Sulene-PET (polyethylene-terephthalate). The longitudinal spacers are manufactured from Sulene-PCU (polycarbonateurethane). The pedicle screws are provided with or without hydroxyapatite coating.
The provided text describes a 510(k) summary for the Dynesys® Spinal System, focusing on the addition of hydroxyapatite coated pedicle screws. The submission seeks to demonstrate substantial equivalence to previously cleared Dynesys® Spinal System devices.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds. Instead, the "acceptance criteria" appear to be based on demonstrating substantial equivalence to predicate devices. The performance reported is that "there are no fundamental technological differences" and that the new components are "substantially equivalent ... based on intended use, design, and function" to the original Dynesys® Spinal System pedicle screw components.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No fundamental technological differences compared to predicate device. | "Testing and analysis... demonstrated that the there are no fundamental technological differences between the proposed hydroxyapatite pedicle screws and the pedicle screw components of the current Dynesys Spinal System." |
| Substantial equivalence in intended use, design, and function to predicate device. | "The hydroxyapatite coated pedicle screws of Dynesys Spinal System are substantially equivalent to the original Dynesys Spinal System pedicle screw components based on intended use, design, and function." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Testing and analysis of proposed hydroxyapatite coated pedicle screw components." However, it does not specify the sample size used for this testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This submission appears to be based on bench testing and analysis rather than clinical data from a human test set.
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)
This information is not provided in the document. Given that the submission focuses on demonstrating substantial equivalence through technological characteristics and intended use, and likely involves bench testing, the concept of "ground truth" as established by medical experts for a diagnostic or clinical test set is not directly applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As noted above, the submission does not seem to involve a clinical test set requiring adjudication of findings by multiple experts.
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
No MRMC comparative effectiveness study was done. This device is a spinal fixation system, not a diagnostic imaging device with an AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The Dynesys® Spinal System is a medical device (spinal implant), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic or AI studies is not directly relevant to this 510(k) submission. The "truth" in this context is established through engineering principles, material science testing (e.g., mechanical properties, biocompatibility), and comparison to the design and performance of the predicate device, rather than clinical outcomes or expert consensus on medical images. The core ground truth for this submission is whether the new components are materially and functionally similar to the existing, cleared components.
8. The sample size for the training set
This is not applicable. The Dynesys® Spinal System is a medical device, not an AI model, and therefore does not have a "training set."
9. How the ground truth for the training set was established
This is not applicable. As there is no AI model or training set, this question is not relevant.
§ 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.