(155 days)
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 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); turnor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.
The DSSTM 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 DSSTM 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 subject systems are comprised of a variety of pedicle screws and Couplers that act as longitudinal spacers. The systems are intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion.
The subject systems are fabricated from wrought Ti-6A1-4V (ISO 5832-3 and ASTM F136).
Here's an analysis of the provided text regarding the DSS™ Stabilization System and its submission for 510(k) clearance:
Important Note: The provided text is a 510(k) Summary for a medical device. 510(k) clearances for devices like this (pedicle screw spinal systems) typically do NOT involve AI, machine learning, or software-based diagnostics. Instead, they focus on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical and material performance testing. Therefore, many of the questions related to AI/ML and human-in-the-loop performance will not be applicable.
Acceptance Criteria and Device Performance (Based on provided text)
| Acceptance Criteria Category | Reported Device Performance (Summary from text) |
|---|---|
| Material Equivalence | Fabricated from wrought Ti-6A1-4V (ISO 5832-3 and ASTM F136), same as predicate. |
| Design Equivalence | Same design as predicate devices. |
| Function Equivalence | Same function as predicate devices. |
| Intended Use Equivalence | Same intended use as predicate devices. |
| Indications for Use Equivalence | Same indications for use as predicate devices. |
| Performance Standards Testing | "Testing performed indicates the subject systems are substantially equivalent to predicate devices." |
Explanation of "Acceptance Criteria" for this device: For a 510(k) pathway for a pedicle screw spinal system, "acceptance criteria" are not typically framed as specific statistical thresholds for diagnostic performance (like sensitivity/specificity for an AI device). Instead, they revolve around demonstrating substantial equivalence to a predicate device. This involves showing that the new device is as safe and effective as a legally marketed device that performs the same function. The primary evidence for this in the provided document is through:
- Material composition: Matching established standards and predicate devices.
- Design, Function, Intended Use, Indications for Use: Being demonstrably similar to predicate devices.
- Performance Testing: While the details are not given, this would involve mechanical testing (e.g., static and dynamic compression, bending, torsion) to ensure the device meets or exceeds the mechanical properties and safety profiles of the predicate, as per relevant ASTM or ISO standards for spinal implants. The "Performance Standards" section vaguely states that testing confirms substantial equivalence.
Study Details (Based on provided text)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of an AI/ML test set. For a mechanical device, testing would involve a sufficient number of devices/components to establish statistical significance for mechanical properties, but the specific number is not provided in this summary.
- Data Provenance: Not applicable for AI/ML. The "data" here would be the results of mechanical and material tests, likely conducted in a controlled laboratory environment.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context refers to regulatory compliance and mechanical performance, not a diagnostic assessment by experts. Design and manufacturing were likely overseen by engineers and quality control personnel.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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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 is a mechanical implant, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical implant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" for substantial equivalence is primarily based on:
- Compliance with recognized standards: Material standards (ISO 5832-3, ASTM F136).
- Reproducibility of mechanical properties: Laboratory-tested mechanical performance comparing the new device to the predicate device and relevant industry standards for spinal implant strength and durability.
- Pre-clinical data: Likely involved bench testing and potentially biomechanical cadaver studies (though not explicitly detailed in the summary).
- For this device, the "ground truth" for substantial equivalence is primarily based on:
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The sample size for the training set:
- Not applicable. There is no AI/ML training set.
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How the ground truth for the training set was established:
- Not applicable. There is no AI/ML training set.
Summary for K090099:
This 510(k) summary is for a pedicle screw spinal system, a mechanical implant. The entire submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices. This means proving that the new device has the same intended use, indications for use, technological characteristics (materials, design, function), and performs as safely and effectively as the predicate. The "study" here refers to the engineering and performance testing that verifies the device's mechanical integrity and material compliance, not a clinical trial or an AI/ML validation 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.