(222 days)
When used for anterior screw fixation or as a posterior, non-pedicle system of the U.L.I.S.™ and LUMISTM systems are indicated for:
· degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- · spondylolisthesis
- · fracture
- · spinal stenosis
- · curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- tumors
- · failed previous fusion (pseudoarthrosis)
The U.L.I.S.™ and LUMIS™ systems are pedicle screw systems indicated for skeletally mature patients who:
- · have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- · receive fusions using autogenous bone graft only;
- · have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
- · have the device removed after the development of a solid fusion.
In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1):
- · degenerative spondylolisthesis with objective evidence of neurologic impairment
- · fracture
- · curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- · spinal tumor
- · failed previous fusion (pseudoarthrosis)
The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied non-sterile.
The purpose of this submission is to include design modification and new diameters and lengths of the LUMIS™ Cannulated Polyaxial Pedicle Screws and U.L.I.S.™ Polyaxial Pedicle Screws, creation of LUMIS™ Cannulated Monobloc Pedicle Screws and U.L.I.S.™ Monobloc Pedicle Screws, addition of CoCr Spinal Rods, and new lengths of UNI-Thread® rods.
The provided text describes a medical device submission (K133575) for the SpineVision LUMIS™ Cannulated Pedicle Screw Fixation System and U.L.I.S.™ Pedicle Screw Fixation System. The submission focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, not through clinical or AI-powered studies. Therefore, many of the requested elements (like sample size for test sets, expert qualifications, and AI-specific metrics) are not applicable or cannot be extracted directly from this document.
Here's the information that can be extracted and a clear indication where certain information is not provided:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SpineVision LUMIS™ and U.L.I.S.™ systems are primarily based on demonstrating comparable mechanical properties to legally marketed predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Properties Comparability: Must demonstrate mechanical properties comparable to predicate devices. This is assessed via specific ASTM standards. | Met. Mechanical testing was conducted per ASTM F1717-13 "Standard Test Methods for Spinal Implant Constructs in Vertebrectomy Model" (including Static Compression, Static Torsion, and Dynamic Compression) and ASTM F1798-13 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants" (Transverse Test Apparatus for Subassembly). The results "demonstrate comparable mechanical properties to the predicate devices." |
| Material Compliance: Materials used must conform to specified ASTM and ISO standards for biocompatibility and strength. | Met. The devices are manufactured in Titanium Ti-6Al-4V ELI per ASTM F136 (ISO 5832-3) and Cobalt Chromium (CoCr) alloy per ASTM F1537. |
| Special Control Conformance: Must conform to special controls established for Pedicle Screw Spinal Systems and to the "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on May 3, 2004. | Met. The devices conform to these guidelines. |
| Substantial Equivalence: Device must be substantially equivalent to predicate devices in terms of intended use, material, design, mechanical properties, and function. | Met. The submission concludes "[the devices] are substantially equivalent to their predicate devices in terms of intended use, material, design, mechanical properties and function." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This information is not provided. The study involved mechanical testing of device components, not a test set of patient data.
- Data Provenance: Not applicable in the context of mechanical testing. The testing was conducted in a laboratory setting as part of the device's engineering analysis and design validation/verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no "ground truth" derived from expert consensus on patient data. The "truth" in this context is established by engineering standards and measurements from mechanical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human-reviewed data, not mechanical testing results where outcomes are quantifiable and objectively measured against engineering standards.
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. This device is a pedicle screw fixation system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted, and the concept of "human readers improve with AI" is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating the device's safety and effectiveness relies on engineering standards and direct measurements from mechanical testing. The comparability to predicate devices, as assessed through these tests, serves as the basis for the substantial equivalence determination. There is no clinical ground truth (like pathology or outcomes data) mentioned in this summary for the purpose of demonstrating equivalence.
8. The sample size for the training set
Not applicable. This submission concerns a physical medical device and its mechanical properties, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning 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.