(31 days)
The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic. lumbar and/or sacral spine. The System is intended for use with autograft or allograft.
The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, 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; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI-SI). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondvlolisthesis: trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.
The purpose of this 510(k) submission is to add modified plates to the Lanx Spinal Fixation System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.
The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.
The Lanx Spinal Fixation System implants are fabricated from medical grade titanium alloy and/or cobalt chrome alloy per ASTM F67. ASTM F136 and ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.
The provided text is for a 510(k) premarket notification for a medical device, the Lanx Spinal Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and detailed performance studies typically associated with AI/ML devices or novel technologies.
Therefore, the information requested in your prompt (acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable or available within this document.
Here's why and what information is provided:
Explanation Regarding Missing Information:
This 510(k) submission for the Lanx Spinal Fixation System is for an orthopedic implant. For such devices, regulatory clearance is typically based on:
- Substantial Equivalence: Demonstrating that the new device has the same intended use, technological characteristics, and principles of operation as legally marketed predicate devices, and that any differences do not raise new issues of safety or effectiveness.
- Performance Testing (Benchtop): This usually involves mechanical and material testing to ensure the device meets engineering specifications and is comparable to predicates. It does not involve "performance" in the sense of predictive accuracy or diagnostic capability, which is relevant for AI/ML.
Information Extracted from the Document (and why other items are not applicable):
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Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical or diagnostic performance, as this relates to a mechanical device.
- Reported Device Performance:
- Performance Test: Static torsion tests using modified ASTM F 1717 methods.
- Outcome: "The modified device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device."
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Sample Size Used for the Test Set and Data Provenance:
- N/A: The "test set" in this context refers to physical test specimens for mechanical testing, not a dataset for evaluating an algorithm. The document does not specify the number of physical components tested.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- N/A: Not applicable for mechanical device testing.
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Adjudication Method for the Test Set:
- N/A: Not applicable for mechanical device 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:
- N/A: This is not an AI/ML device, so MRMC studies are irrelevant.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A: This is not an AI/ML device.
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The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- N/A: For mechanical testing, the "ground truth" would be the engineering specifications and established mechanical properties of the materials and design.
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The Sample Size for the Training Set:
- N/A: This is not an AI/ML device, so there is no training set.
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How the Ground Truth for the Training Set was Established:
- N/A: This is not an AI/ML device.
Additional Relevant Information from the Document:
- Device Type: Spinal Fixation System (orthopedic implant).
- Purpose of Submission: To add modified plates to an existing system.
- Materials: Medical grade titanium alloy and/or cobalt chrome alloy (ASTM F67, ASTM F136, ASTM F1537).
- Basis for Clearance: Substantial Equivalence to previously-cleared Lanx Spinal Fixation Systems (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K100935, K103091, K103237, K120399, K120682).
- Conclusion: "The modified Lanx Spinal Fixation System has the same intended use, indications, technological characteristics, and principles of operation as the predicate system. The differences in the modified components do not raise any new issues of safety or effectiveness. Testing also demonstrated comparable properties to the previously cleared Lanx Spinal Fixation System. Thus, the modified Lanx Spinal Fixation System is substantially equivalent to the predicate device."
§ 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.