(34 days)
DSSTM Stabilization System - Rigid: The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrac in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.
DSSTM Stabilization System - Slotted: The DSS™ Stabilization System - Slotted 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, kyphosis, and failed previous fusion (pseudarthrosis). In addition, the DSS™ Stabilization System - Slotted 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. Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.
The DSS™ Stabilization System is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6AI4V).
The provided text describes a 510(k) submission for the DSS™ Stabilization System, a medical device. However, it does not include information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement as typically found in clinical validation studies for AI/software devices.
This document describes a spinal pedicle screw system, which is a physical implant, not an AI or software-based device. The approval process for such devices relies heavily on demonstrating substantial equivalence to predicate devices through design, function, material comparison, and mechanical testing, rather than clinical efficacy studies with ground truth derived from expert consensus or pathology, as would be the case for AI systems.
Therefore, many of the requested categories are not applicable to the information contained in this 510(k) summary for the DSS™ Stabilization System.
Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical soundness comparable to predicate devices | "Testing performed indicate that the DSS™ is as mechanically sound as predicate devices." |
| Same indications for use as predicate devices | DSS™ Stabilization System has "the same indications for use" as predicate devices. |
| Same design as predicate devices | DSS™ Stabilization System has "the same design" as predicate devices. |
| Same function as predicate devices | DSS™ Stabilization System has "the same function" as predicate devices. |
| Same materials used as predicate devices | DSS™ Stabilization System has "the same materials used" (medical grade titanium alloy) as predicate devices. |
| FDA clearance for marketing | Device received 510(k) clearance, allowing it to proceed to market. |
| Compatibility with specific surgical procedures | Intended as an adjunct to fusion, used with autograft and/or allograft. |
Explanation: For a physical device like a pedicle screw system, "acceptance criteria" primarily revolve around demonstrating substantial equivalence to already-approved predicate devices in terms of safety and effectiveness. This is typically achieved through comparisons of design, materials, function, and mechanical testing results against established benchmarks or the predicate devices themselves. The document states that the device was shown to be "substantially equivalent" and "as mechanically sound" as predicates.
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document describes mechanical testing, not a clinical study involving human patients or data sets. "Sample size" in this context would refer to the number of devices or components subjected to mechanical tests, which is not specified. There is no "data provenance" in the sense of patient data.
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 / Not provided. This device's approval involved mechanical engineering assessments and regulatory review, not expert consensus on clinical data to establish a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are relevant for clinical studies where human experts interpret data, which is not described here.
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. This is a physical medical device, not an AI system. Therefore, no MRMC study or assessment of AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for clinical ground truth. The "truth" for this device's approval revolved around engineering specifications, materials science, and mechanical performance validation, demonstrated to be equivalent to existing, legally marketed devices.
8. The sample size for the training set
- Not applicable. This device does not use a training set as it is not an AI/machine learning system.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.