(274 days)
When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S.TM 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
- tumors
- failed previous fusion (pseudoarthrosis)
The U.L.I.S.TM and LUMISTM 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.TM 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 treatment of 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
- spinal tumor
- failed previous fusion (pseudoarthrosis)
The SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations are composed of cannulated (LUMISTM) and non-cannulated (U.L.I.S.TM) pedicle screws and fixation rods (Spine Vision Unithread TM rods). Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. These constructs are assembled using specific instruments. The components of the U.L.E.S.TM and LUMISTM systems are made from ASTM F136 titanium alloy (Ti-6Al-4V ELI) complying with ASTM F136 (ISO 5832-3). The SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations are manufactured in Titanium alloy complying with ASTM 136. The LUMISTM Pedicle screw system is cannulated. The devices provide correction and rigid stabilization of the spine during development of solid bone fusion following corrective spine surgery for a number of indications (listed above).
The manufacturer, Orgenix LLC, submitted a 510(k) Premarket Notification for the SpineVision LUMIS™ Cannulated Polyaxial Pedicle Screw Fixation System and SpineVision U.L.I.S.™ Polyaxial Pedicle Screw Fixation System. The submission refers to non-clinical testing and published retrospective clinical data to support the substantial equivalence claim.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ASTM F1717 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (worse case) | Test results indicated substantial performance of the worse case in side-by-side testing with the predicate device. |
| ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws (worse case) | Test results indicated substantial performance of the worse case in side-by-side testing with the predicate device. | |
| ASTM F2193 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System (worse case) | Test results indicated substantial performance of the worse case in side-by-side testing with the predicate device. | |
| ASTM F1798 - Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants (worse case) | Test results indicated substantial performance of the worse case in side-by-side testing with the predicate device. | |
| Sterilization Validation | ANSI/AAMI/ISO 17665-1:2006 | Not explicitly stated "met," but listed as a standard the validation was performed to. |
| ANSI/AAMI ST79:2010, A1:2010 and A2:2011 | Not explicitly stated "met," but listed as a standard the validation was performed to. | |
| Clinical Equivalence (Pedicle Screws in Pediatric Patients) | No specific quantitative criteria are provided for clinical performance; the criterion is established through comparison to predicate devices and demonstration of no new risks. | Published retrospective clinical data for similar devices demonstrated pedicle screws posed no new risks to pediatric patients. |
2. Sample Size Used for the Test Set and Data Provenance
- Mechanical Testing: The document mentions "worse case" testing and "side-by-side testing with the predicate device." However, specific sample sizes (e.g., number of implants tested) for these mechanical tests are not provided.
- Clinical Data: The clinical data provenance is described as "Published retrospective clinical data for devices similar to the SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) devices."
- Sample Size: The sample size for this retrospective clinical data is not specified.
- Country of Origin: The country of origin for the clinical data is not specified.
- Retrospective or Prospective: Explicitly stated as retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The mechanical testing standards inherently define the "ground truth" through specified methodologies and expected outcomes (e.g., specific load failures, fatigue cycles, etc.). For the retrospective clinical data, the "ground truth" would be the observed safety profile and outcomes in prior use, often established by treating physicians, but the review process for that data is not detailed here.
4. Adjudication Method for the Test Set
- This information is not provided. For mechanical testing, adjudication typically refers to the interpretation of test results against established pass/fail criteria. For the retrospective clinical data, the adjudication method of the published studies is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or software where human readers interpret cases with and without AI assistance to measure improvement in diagnostic accuracy. The submitted device is a spinal fixation system, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. The device is a mechanical implant (pedicle screw fixation system), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The device's performance is standalone in the sense that it relies on its physical properties when implanted and a surgeon's skill.
7. The Type of Ground Truth Used
- Mechanical Testing: The ground truth is defined by engineering standards and specifications (ASTM F1717, ASTM F543, ASTM F2193, ASTM F1798). These standards establish objective criteria for performance (e.g., force at failure, fatigue life, torsional strength).
- Clinical Data: The ground truth for the clinical data mentioned is based on patient outcomes and safety profiles observed in prior retrospective studies involving similar devices. This would encompass absence of new risks, stability, and effectiveness in achieving fusion, as documented in clinical records.
8. The Sample Size for the Training Set
- Not applicable / Not explicitly provided. This device is a physical implant and not an AI/ML algorithm that requires a "training set" of data in the conventional sense. The design and manufacturing processes are informed by engineering principles, material science, and prior clinical experience, rather than data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not explicitly provided. As noted above, there is no "training set" for this type of medical device in the context of AI/ML. The "ground truth" for the device's design and engineering is established through fundamental scientific and engineering principles, material properties, and established biomaterial/biomechanical testing methodologies.
§ 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.