(302 days)
The DSSTM Stabilization System - Rigid Coupler is intended for noncervical pedicle fixation from the T4 to S1 vertebrae 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 Coupler is intended to be used with autografl and/or allograft.
The DSS™ Stabilization System – Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae 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 opin of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal sterensis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.
The DSS™ Stabilization System is comprised of a variety of pedicle screws and Rigid Couplers that act as longitudinal spacers. This device is intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion.
The DSS™ Stabilization System consists of:
- DSS™ pedicle screw sets .
- DSS™ Rigid Couplers .
The DSS™ Stabilization System is fabricated from wrought Ti-6AI-4V (ISO 5832-3 and ASTM F136).
The provided text is a 510(k) Summary for the DSS™ Stabilization System - Rigid Coupler, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or performance metrics through a standalone clinical study.
Therefore, the input does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, or adjudication methods for ground truth, as these are typically part of a de novo classification or a Premarket Approval (PMA) application requiring clinical trial data.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not available: The document asserts substantial equivalence to predicate devices based on "the same indications for use, design, function, and materials used." It does not define specific performance acceptance criteria or report quantitative device performance data against such criteria. The "Performance Standards" section only states that "Testing performed indicates the DSS™ Stabilization System is substantially equivalent to predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available: No test set or clinical study data is mentioned in this 510(k) summary. The equivalence is based on design, materials, and established predicate devices, not on a new clinical performance study.
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 available: As no test set from a clinical study is described, there's no mention of experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available: No test set or clinical study is 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/Not available: This device is a pedicle screw spinal system, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available: This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not available: No clinical study or ground truth establishment is described. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable/Not available: No training set for an algorithm is relevant to this device submission.
9. How the ground truth for the training set was established
- Not applicable/Not available: No training set is relevant.
Summary of the Study (as described in the 510(k) summary):
The "study" presented in this 510(k) is a substantial equivalence comparison to legally marketed predicate devices. The manufacturer, Paradigm Spine, LLC, sought to demonstrate that their DSS™ Stabilization System - Rigid Coupler is as safe and effective as existing devices.
- Methodology: The comparison focused on general characteristics like indications for use, design, function, and materials used.
- Predicate Devices: Four predicate devices were identified:
- Materials: The DSS™ Stabilization System is fabricated from wrought Ti-6AI-4V, which is a standard material (ISO 5832-3 and ASTM F136).
- Performance Standards (Testing): The document states that "Testing performed indicates the DSS™ Stabilization System is substantially equivalent to predicate devices." While this implies some form of engineering or mechanical testing was conducted, the specifics (e.g., specific test methods, number of samples, pass/fail criteria, or detailed results) are not provided in this summary. The "tests" would likely relate to mechanical properties, fatigue, and other biomechanical assessments required for spinal implants to ensure they meet established standards and are comparable to predicate devices.
In essence, the "acceptance criteria" here is the FDA's determination of substantial equivalence, which is based on a comparison to predicate devices rather than independent, quantitative performance metrics from a new clinical study.
§ 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.