(266 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 disc 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 stenosis: curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor: pseudarthrosis: and/or failed previous fusion.
Except for hooks, when used as an anterolateral 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 and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The RANGE / DENALI / MESA Spinal Systems are top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation systems which consists of pedicle screws, rods, hooks and rod connectors.
The K2M Modular Hook is comprised of a hook body and a variety of adjustable blade options.
The provided document describes the acceptance criteria and the study that proves the device meets those criteria for the K2M Modular Hooks, an addition to the RANGE (DENALI/MESA) Spinal System.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Type) | Device Performance (Worst Case K2M Modular Hook) |
|---|---|
| Static Compression Bending (ASTM F1717) | Demonstrates substantial equivalence to predicate MESA Spinal System performance. |
| Dynamic Compression Bending (ASTM F1717) | Demonstrates substantial equivalence to predicate MESA Spinal System performance. |
| Static A-P (ASTM F1798) | Demonstrates substantial equivalence to predicate MESA Spinal System performance. |
| Disassembly (ASTM F1798) | Demonstrates substantial equivalence to predicate MESA Spinal System performance. |
The document also states that the K2M Modular Hooks have the same technological characteristics (basic design, material, anatomic location, and sizes within the predicate range) as the predicate devices, and any different characteristics (not specified in detail beyond the hook body and adjustable blade options) have been supported by descriptive information and/or performance data demonstrating safety and effectiveness have not been diminished.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number. The document mentions "The worst case K2M Modular Hook" was evaluated, suggesting a representative selection rather than a large statistical sample for each test.
- Data Provenance: Not explicitly stated. The tests are specified as mechanical tests (ASTM F1717, ASTM F1798), implying laboratory testing rather than human subject data. Therefore, country of origin of data, retrospective or prospective, are not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This study involves mechanical testing of a medical device (spinal system components), not the assessment or interpretation of medical images or patient data. Ground truth in this context refers to the established mechanical standards (ASTM F1717 and ASTM F1798).
4. Adjudication method for the test set:
- Not applicable. This was a mechanical performance study against established ASTM standards, not a clinical or expert-based adjudication process.
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 comparative effectiveness study was not done. This submission is for a spinal implant system component and does not involve AI or human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission is for a mechanical spinal implant component.
7. The type of ground truth used:
- Mechanical Performance Standards: The ground truth for this study was the established mechanical performance specified by ASTM F1717 (for static and dynamic compression bending) and ASTM F1798 (for static A-P and disassembly tests). The device's performance was compared to that of a legally marketed predicate device (MESA Spinal System) to establish substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is a mechanical performance substantial equivalence study, not a machine learning or AI algorithm development study that would involve a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there was no training set.
§ 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.