(120 days)
The Altus Spine Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins 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 in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins 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 in skeletally mature patients.
The Altus Spine Pedicle Screw System is a multiple component, posterior fusion spinal fixation system which consists of pedicle screws, cannulated pedicle screw, reduction screws, extended tab implants, cross-connectors, locking caps, hooks, and rods Altus Spine Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136. The device is supplied non-sterile and is intended for sterilization by hospital personnel.
This document is a 510(k) premarket notification for the Altus Spine Pedicle Screw System, outlining its substantial equivalence to previously marketed devices. However, it does not describe an AI/ML device or a study that evaluates its performance against specific acceptance criteria.
The document discusses a medical device (pedicle screw system), not an AI/ML system. Therefore, most of the requested information (AI/ML performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable to this submission.
Here's an analysis based on the provided document, reinterpreting the request for a non-AI/ML medical device submission:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit): Substantial equivalence to predicate devices, meaning the device's technological characteristics, materials, and intended use do not raise new questions of safety or effectiveness compared to legally marketed devices.
- Reported Device Performance:
- Materials: Titanium Alloy conforming to ASTM F136.
- Design & Function: Multiple component, posterior fusion spinal fixation system consisting of pedicle screws, cannulated pedicle screws, reduction screws, extended tab implants, cross-connectors, locking caps, hooks, and rods. Attaches to the vertebral body using screws to stabilize the spinal operative site during fusion.
- Indications for Use: Immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. Specifically for noncervical pedicle and nonpedicle fixation for conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion. Also, for a posterior percutaneous approach with MIS instrumentation for similar indications.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a 510(k) submission for a non-AI/ML implantable device, which typically relies on mechanical testing and comparison to predicate devices, not clinical data sets in the way an AI/ML algorithm would. The submission explicitly states: "There are no new worst case components to this system; therefore no new mechanical testing is warranted." The substantial equivalence is based on engineering design, materials, and similarity to previously cleared devices.
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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)
- Not applicable. Ground truth for an AI/ML test set is not relevant here. The "ground truth" equivalent for this device is its adherence to material standards (ASTM F136) and its functional design principles, assessed by the manufacturer's engineers and reviewed by FDA engineers/scientists.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to AI/ML clinical study design, not the mechanical and design review of a pedicle screw system.
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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
- Not applicable. This is for AI/ML devices that assist human readers (e.g., radiologists). The Altus Spine Pedicle Screw System is a physical implant, not a diagnostic aid.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to AI/ML algorithm performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" for demonstrating safety and effectiveness is implicitly established through:
- Material Standards: Conformance to ASTM F136 (Titanium Alloy).
- Mechanical Performance (Implicit): Assumed to be equivalent to predicate devices which have undergone mechanical testing. The document states "no new mechanical testing is warranted" because there are no new worst-case components.
- Clinical Efficacy/Safety (Implicit): Demonstrated by the long-standing safe and effective use of the predicate devices for similar indications.
- For this device, the "ground truth" for demonstrating safety and effectiveness is implicitly established through:
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The sample size for the training set
- Not applicable. This is for AI/ML algorithms.
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How the ground truth for the training set was established
- Not applicable. This is for AI/ML algorithms.
In summary, this document is a regulatory submission demonstrating substantial equivalence for a conventional medical device (pedicle screw system), not an AI/ML device. Therefore, the requested information geared towards AI/ML performance evaluation is largely irrelevant to the content of this specific FDA 510(k) summary.
§ 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.