(19 days)
The Range Spinal System is a:
Non-cervical spinal fixation device intended for posterior, non-pedicle fixation for the following indications: 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; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Range Spinal System is also intended for:
Non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.
The Range Spinal System is a top-loading, multiple component, posterior system which consists of pedicle screws, rods, hooks, and transverse connectors. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from Ti6A1-4V ELI alloy , CP titanium and CoCrMo alloy per ASTM and ISO standards.
Function: The system functions as an adjunct to provide immobilization and stabilization of spinal segments of the thoracic, lumbar and / or sacral spine.
The provided text is a 510(k) Summary for the Range Spinal System, a medical device. It describes the device, its intended use, and its comparison to predicate devices, focusing on demonstrating substantial equivalence. However, the document does not contain information about acceptance criteria, specific device performance, or human-in-the-loop studies (such as MRMC studies, standalone algorithm performance, or ground truth establishment details for training or testing sets).
The evaluation is based on biomechanical testing to ASTM F1717 standards and a comparison of design features and materials to predicate devices. The document concludes that the device performed "equal to or better than" predicate systems in this testing.
Therefore, the requested table and detailed information regarding acceptance criteria and study particulars cannot be fully populated from the provided text.
Here's an attempt to answer based on the available information:
Description of Acceptance Criteria and Study Findings
The Range Spinal System underwent biomechanical testing to demonstrate its safety and effectiveness. The primary study mentioned is a comparison against predicate systems and other currently marketed systems using ASTM F1717 standards. The acceptance criterion appears to be that the device performs "equal to or better than" these existing, legally marketed systems in the specified ASTM testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical performance "equal to or better than" predicate systems and other currently marketed systems when tested to ASTM F1717. (Implied acceptance based on a demonstration of substantial equivalence to existing devices for safety and effectiveness). | The Range Spinal System "performed equal to or better than these systems in ASTM testing to F1717." |
| Design features and sizing "substantially the same" as predicate systems. | Design features and sizing were compared and found to be "substantially the same as these systems." |
| Manufactured from the same FDA recognized materials as predicate systems. | Manufactured from "the same FDA recognized materials." |
| Indicated for the same intended uses as predicate systems. | Indicated for "the same intended uses as these systems." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. Biomechanical testing typically involves a specific number of samples for each test condition, but the exact count is not provided in this summary.
- Data Provenance: Not specified. Biomechanical testing is usually conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For a biomechanical study, the "ground truth" is typically established by the physical testing apparatus and measurement instruments according to established standards (like ASTM F1717), not by expert consensus on clinical data.
4. Adjudication method for the test set
- Not applicable. This concept typically applies to studies involving human review or interpretation of data (e.g., medical imaging), not standalone biomechanical testing.
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. An MRMC study was not described. This device is a spinal implant, and the study described is a biomechanical performance test, not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in the context of a physical device. The biomechanical testing of the Range Spinal System is a standalone performance evaluation of the physical device itself, without human-in-the-loop interaction for performance measurement. It's not an algorithm, but the concept of standalone performance for the device applies.
7. The type of ground truth used
- Biomechanical Standards/Measurements: The "ground truth" for this study is derived from the objective measurements obtained during the ASTM F1717 biomechanical testing, compared against the performance of predicate devices. This standard specifies how to conduct static and fatigue testing of spinal implant constructs.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is a physical device being evaluated biomechanically, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for a machine learning algorithm.
§ 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.