(29 days)
RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disease (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 stcnosis: curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor: pscudarthrosis: and/or failed previous fusion.
Except for hooks, when used as an anterolatcral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.
Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pediale screw fixation is limited to a posterior approach.
The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consist of pedicle screws, rods, locking set screws, hooks. rod connectors and transverse connectors.
Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.
The purpose of this submission is to add 6.35mm implants to the system.
This FDA submission describes a spinal fixation system, not an AI/ML powered device. As such, the typical acceptance criteria and study designs for AI/ML devices (like accuracy, sensitivity, specificity, and MRMC studies) are not applicable.
The submission focuses on establishing substantial equivalence to previously marketed devices based on design features and material properties. The primary way this device meets its "acceptance criteria" is by demonstrating it is as safe and effective as existing, legally marketed spinal systems.
Here's an analysis based on the provided document, addressing the original prompt's categories where applicable for a non-AI device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (for this type of device) | Reported Device Performance (from the document) |
|---|---|
| Material Composition Conformity | Manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards. |
| Mechanical Performance (Static Compression Bending) | Worst case components previously tested in static compression bending in accordance with ASTM F1717. Proposed implants determined not to represent a new worst case. |
| Mechanical Performance (Static Torsion) | Worst case components previously tested in static torsion in accordance with ASTM F1717. Proposed implants determined not to represent a new worst case. |
| Mechanical Performance (Dynamic Compression) | Worst case components previously tested in dynamic compression in accordance with ASTM F1717. Proposed implants determined not to represent a new worst case. |
| Design Feature Substantial Equivalence | Design features of components were compared to predicate devices and found to be substantially the same. |
| Intended Use Substantial Equivalence | Indications for use are the same as predicate devices; the submission specifically adds 6.35mm implants to the existing system. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of clinical "test sets" for AI/ML performance. For mechanical testing, the "worst case components" were selected for testing, implying a representative sample of components or configurations were tested to cover the range of mechanical properties. The specific number of components or implants tested is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data provenance. The mechanical test data would be generated in a laboratory setting (likely within the company or a certified testing facility).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic tool requiring expert interpretation of outputs to establish ground truth. Substantial equivalence for this device is based on technical comparisons and mechanical testing against recognized standards.
4. Adjudication method for the test set
- Not applicable. There is no "adjudication" in the sense of reconciling clinical interpretations for this type of device. The determination of "worst case" for mechanical testing would be an engineering assessment.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance evaluation was not done. This device is a physical medical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For mechanical testing, the "ground truth" is defined by established engineering standards (ASTM F1717) and successful performance within those standards, demonstrating adequate strength and durability.
- For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices.
8. The sample size for the training set
- Not applicable. This device does not use an AI/ML "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no AI/ML component, there is no "training set" or ground truth for it.
Summary regarding the device's "acceptance":
The Range Spinal System gained FDA clearance (K141147) by demonstrating substantial equivalence to predicate devices already on the market. This means the FDA concluded that the new device is as safe and effective as the existing devices. The key elements for this determination were:
- Design and Material Comparison: The new components (6.35mm implants) were found to be "substantially the same" in design features and materials (Titanium Alloy and Cobalt Chrome per ASTM/ISO standards) as predicate devices.
- Mechanical Performance: The "worst case components" of the system were previously tested against established standards (ASTM F1717) for static compression bending, static torsion, and dynamic compression. The proposed new implants were determined by engineering analysis not to represent a "new worst case," implying they perform comparably or better than previously tested components and meet the required mechanical integrity.
- Intended Use: The indications for use are consistent with those of the predicate devices.
Essentially, the "study" for this device was a combination of engineering analysis and mechanical testing against industry standards, alongside a direct comparison of its technical characteristics and intended use to already cleared predicate devices.
§ 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.