(24 days)
When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation 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, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Silhouette Spinal Fixation System is indicated for use in patients:
a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
b) who are receiving fusions with autogenous graft only
c) who are having the device fixed or attached to the lumbar or sacral spine
d) who are having the device removed after the development of a solid fusion mass
When used as a hook and sacral screw system, the Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette Spinal Fixation System are intended for sacral illiac attachment only. Hook and transverse of the Silhouette Spinal Fixation System are intended for posterior thoracic only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws and are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varying diameters and lengths; fixed screws of varying diameters and lengths; rods in varying lengths; hooks in varying designs; and transverse connectors in the various configurations of fixed, adjustable, variable angle offset and axial. All implant components are either top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.
The provided text is a 510(k) Summary for the Silhouette™ Spinal Fixation System, which is a medical device. This type of regulatory submission in the United States focuses on establishing substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study or extensive analytical testing.
Therefore, the supplied document does not contain the information requested regarding acceptance criteria and a study demonstrating that the device meets those criteria. The 510(k) summary primarily addresses:
- Device Description: What the device is and what it's made of.
- Intended Use: The medical conditions and anatomical locations for which the device is designed.
- Statement of Technological Comparison: A qualitative comparison to a legally marketed predicate device, highlighting that the new device has "similar mechanical properties" based on ISO mechanical testing (not clinical or human-in-the-loop studies).
- Regulatory Classification and Predicate Device: Identifies the classification and the previous devices it is substantially equivalent to.
Based on the provided text, here's an analysis of why the requested information cannot be extracted:
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A table of acceptance criteria and the reported device performance: This information is not found in the summary. The summary mentions "mechanical testing carried out according to ASTM 1717-96 to validate the Variable Angle Connector and the Axial Connector." It states that this testing "demonstrated similar mechanical properties to the previously cleared Silhouette™ Spinal Fixation System components." However, specific acceptance criteria (e.g., minimum tensile strength, maximum displacement) and the exact reported performance values are not detailed.
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Sample size used for the test set and the data provenance: Not applicable for the type of information provided. The "test set" in this context refers to mechanical test samples, not a clinical data set. The document does not specify the number of components tested for the mechanical validation. Data provenance (country, retrospective/prospective) is relevant for clinical studies, not for internal mechanical testing of device components.
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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): Not applicable. "Ground truth" and "experts" are terms related to clinical or diagnostic accuracy studies, not mechanical component testing for spinal implants. The ground truth for mechanical testing would be the physical properties measured against industry standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical trials or diagnostic studies to resolve discrepancies in expert opinions, which is not relevant to mechanical testing.
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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. MRMC studies, AI, and human reader performance are entirely unrelated to the mechanical performance of a spinal fixation system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance, which is not part of this device's evaluation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing mentioned, the "ground truth" would be established engineering standards (ASTM F-136 for material, ASTM 1717-96 for mechanical testing).
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The sample size for the training set: Not applicable. Training sets are relevant for machine learning algorithms, which are not involved here.
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How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through a comparison of device design, materials, and mechanical properties (using ASTM standards) to a predicate device, rather than reporting on clinical performance criteria, diagnostic accuracy, or AI system validation.
§ 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.