(49 days)
The Salvo™ Spine System is intended to provide immobilization 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
The Salvo™ Spine System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium per ASTM F67, and cobalt-chromium alloy per ASTM F1537. The Salvo™ Spine System consists of a variety of screws, rods, and cross-connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.
This document describes the FDA's 510(k) clearance for the Salvo™ Spine System, a thoracolumbosacral pedicle screw system. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than a standalone study proving novel acceptance criteria for an AI/CAD system. Therefore, I cannot provide information on AI/CAD specific acceptance criteria, sample sizes for test/training sets, expert qualifications, or MRMC studies as these are not relevant to this type of device clearance.
Here is the information directly available from the document regarding the acceptance criteria and study, interpreted for a non-AI medical device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Benchtop Testing per ASTM Standards) | Reported Device Performance (Summary) |
|---|---|
| Static and dynamic axial compression testing per ASTM F1717 | Performed and supported substantial equivalence. |
| Static torsion testing per ASTM F1717 | Performed and supported substantial equivalence. |
| Static pull-apart testing per ASTM F1798 | Performed and supported substantial equivalence. |
Note: The document states "Nonclinical testing was performed on the Salvo™ Spine System to support substantial equivalence to the predicate devices." Implied acceptance criteria for these tests would be that the Salvo™ Spine System performs comparably to or better than the predicate devices under these specific mechanical assessments, or meets predetermined minimum performance standards for spine implants.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes (number of devices/components tested) for the nonclinical benchtop tests. It also does not mention data provenance as these are mechanical tests performed on manufactured devices, not clinical data sets from patients.
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)
Not applicable. Ground truth and expert review are not relevant for mechanical benchtop testing of a pedicle screw system. The "ground truth" for these tests are the physical measurements and standards defined by the ASTM protocols themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human interpretation tasks, not for mechanical 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. This document describes the clearance of a physical medical device (spinal implant), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI algorithm; it is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance data presented (nonclinical testing) is based on the standardized test methods outlined in ASTM F1717 and ASTM F1798. These standards define the parameters and methods for evaluating the mechanical properties of pedicle screw spinal systems.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of a 510(k) submission for a physical medical device.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set mentioned or relevant to this type of device clearance.
§ 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.