(86 days)
The CORMED NV , SOLAS™, Spinal System is a pedicle screw based spinal fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (15 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the SOLAS™ is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudoarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the SOLAS™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
The SOLAS™ Spinal System is a top-loading anterior / posterior spinal fixation system which consists of Mono and Polyaxial pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The SOLAS™ implant components are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The SOLAS'" Spinal system can be used in both the anterior and posterior planes providing unilateral and bilateral modes of fixation.
The SOLAS™ design allows adjustment in both the saggital and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a preassembled washer in the housing component between the screw and the rod which tightens against the head of the pedicle screw upon connection of the set screw with the rod.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the SOLASTM implants.
The provided document is a 510(k) premarket notification for the SOLAS™ Spinal System. It does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it detail any clinical studies, sample sizes, expert involvement, or adjudication methods.
The document primarily focuses on:
- Device Description: What the device is, its components, and materials.
- Intended Use/Indications for Use: What the device is designed to treat.
- Potential Risks: General risks associated with spinal fixation devices.
- FDA Communication: The FDA's determination of substantial equivalence to predicate devices, allowing the product to be marketed.
In the context of 510(k) submissions for Class II devices like the SOLAS™ Spinal System, substantial equivalence is often demonstrated through:
- Bench Testing: Mechanical, fatigue, and material testing to ensure the device meets recognized standards (e.g., ASTM F136 for titanium alloy) and performs comparably to predicate devices.
- Comparison to Predicate Devices: Showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to an already legally marketed device.
Since no clinical study information is present in the provided text, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance.
Here's a table based on the absence of information regarding acceptance criteria and performance studies in the provided document:
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments / Source |
|---|---|---|---|
| Clinical Efficacy | Not specified | Not specified | No clinical studies or performance data are provided in the document. The 510(k) pathway for this device relies on substantial equivalence to predicate devices, which typically involves bench testing rather than new clinical efficacy studies for this type of implant. |
| Device Safety | Not specified | Not specified | Potential risks are listed (e.g., component failure, infection), but no specific safety performance metrics or study results are presented. |
| Mechanical Performance | Not specified | Not specified | The device is made of Titanium Alloy (Ti-6Al-4V ELI) conforming to ASTM F 136. While mechanical testing would have been implicit for a spinal implant, specific acceptance criteria (e.g., fatigue strength, pull-out strength) and reported performance values are not detailed in this summary. |
| Material Compatibility | ASTM F 136 | Conforms to ASTM F 136 | Stated in Device Description for Titanium Alloy. This is a material standard, not a performance criterion in itself, but ensures material quality. |
Detailed Answers to Specific Questions:
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A table of acceptance criteria and the reported device performance
- As shown above, the document does not provide specific acceptance criteria or quantitative reported device performance data from clinical studies. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which typically involves comparing device features, intended use, and general performance through non-clinical means (like bench testing against standards, which are not detailed here).
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information about test set sample sizes or data provenance (country, retrospective/prospective) is available in the provided text. This type of detail would be found in a clinical study report, which is not part of this 510(k) summary.
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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)
- No information about experts creating ground truth for a test set is provided. This suggests there wasn't a clinical performance study involving expert assessment for this 510(k) submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No adjudication method is mentioned, as there is no described test set or clinical study requiring such a process.
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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
- No MRMC or comparative effectiveness study is mentioned. This device is a mechanical spinal implant, not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a mechanical spinal implant; it does not involve an algorithm, nor a "standalone" or "human-in-the-loop" performance study in the context of AI or diagnostic imaging.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- No ground truth is mentioned, as there are no clinical studies or diagnostic assessments detailed in the provided document. For a 510(k) of a spinal implant, "ground truth" often relates to successful fusion rates or absence of device-related complications, typically assessed in post-market surveillance or larger clinical trials (not usually required for 510(k)).
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The sample size for the training set
- No training set information is provided or relevant, as this is a physical medical device, not an AI model.
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How the ground truth for the training set was established
- Not applicable, as there is no training set for an AI model.
§ 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.