(60 days)
The MESA and DENALI Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications:
Posterior 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; pseudoarthosis; 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 MESA. DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST 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 and Mesa) Spinal Systems are top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation systems consisting of pedicle screws, rods, hooks and rod connectors. The purpose of this 510(k) is to add revision connectors and rods to the system.
Function: The systems function as spinal fixation devices to provide support and stabilization of the posterior thoracic and lumbar spine.
This FDA 510(k) summary describes the Range (Denali and Mesa) Spinal Systems. However, it does not contain the kind of detailed information about acceptance criteria and a study that proves the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices.
The document pertains to a traditional medical device (spinal fixation system) and thus the "acceptance criteria" and "study" refer to mechanical performance evaluations, not AI/ML performance.
Based on the provided text, the answer is that the document does not contain the requested information regarding acceptance criteria and a study proving an AI/ML device meets them.
Here's a breakdown of why the requested information cannot be extracted from this document, and what is present:
- 1. A table of acceptance criteria and the reported device performance: This document reports that "Mechanical testing in accordance with ASTM F1717 (including static torsion, static compression and dynamic compression bending) was conducted on constructs representing the worst case components." It states, "The test results revealed that the proposed implants were substantially the same as the predicate devices."
- Missing: Specific numerical acceptance criteria (e.g., minimum torque, maximum displacement) and the corresponding numerical results from the K2M device. The report only states "substantially the same."
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing: This information is not relevant to a mechanical test of a spinal implant and is therefore not provided.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Missing: This information is not relevant to mechanical testing, which relies on physical measurements and established ASTM standards, not expert interpretation.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing: Not applicable for a mechanical performance study.
- 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:
- Missing: This is relevant for AI/ML diagnostic or assistive devices, not for a spinal fixation system.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing: Not applicable for a traditional medical device.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Existing (for mechanical testing): The "ground truth" would be the established acceptable ranges or performance levels defined by the ASTM F1717 standard for spinal implant mechanical properties and comparison to predicate devices' performance.
- 8. The sample size for the training set:
- Missing: No training set is involved for a mechanical implant.
- 9. How the ground truth for the training set was established:
- Missing: No training set or ground truth in the AI/ML sense is established for this device.
In summary, the provided document is for a traditional spinal implant and reports mechanical testing for substantial equivalence, not performance criteria or studies related to AI/ML algorithms, expert review, or clinical data interpretation.
§ 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.