(64 days)
The Foundation Spinal System is intended for thoracolumbar (T4-L4) anterolateral screw fixation and posterior, non-cervical (T1-S1) pedicle and non-pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
The Foundation Spinal System consists of rods, hooks, staple plates, monoaxial and multiaxial screws with set screws and crosslinks with fastening set screws. Rods are available either straight or pre-contoured in a variety of lengths. Hooks and staple plates are offered in a variety of sizes. Solid and cannulated screws are available in standard and reduction versions in a variety of diameter-length combinations to accommodate differing patient anatomy.
The provided text describes the "Foundation Spinal System," a spinal fixation system, and its FDA 510(k) summary. For devices seeking 510(k) clearance, the primary acceptance criterion is substantial equivalence to a predicate device, rather than explicit performance metrics against predefined thresholds. The "study" that proves this acceptance is a comparison of technological characteristics and mechanical performance testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for 510(k) – Substantial Equivalence) | Reported Device Performance (Foundation Spinal System) |
|---|---|
| Same intended use as predicate devices | Intended Use: Thoracolumbar (T4-L4) anterolateral screw fixation and posterior, non-cervical (T1-S1) pedicle and non-pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for treatment of degenerative disc disease, spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion. This is reported as "the same intended use (as described above)" as the predicate devices. |
| Same technological characteristics as predicate devices | Technological Characteristics: Basic design (rod-based fixation system having monoaxial and multiaxial screws and various hook and staple plate sizes), material (titanium alloy), sizes (rod and screw sizes encompassed by those offered by predicate systems). Reported as "the same technological characteristics as the predicates." |
| Performance as good as or better than predicate devices (mechanical testing) | Performance Data: Static compression bending and torsion, and dynamic compression bending of the worst-case Foundation construct was performed to ASTM F1717. The mechanical test results demonstrated that the Foundation Spinal System performs as well as or better than the predicate devices. |
| Does not raise new questions of safety and effectiveness | Based on the above, the conclusion states, "and so does not raise new questions of safety and effectiveness." |
2. Sample size used for the test set and the data provenance
The document describes mechanical testing of device constructs, not a clinical study with patients. Therefore, the concept of a "patient sample size" or "data provenance" (country of origin, retrospective/prospective) in the traditional clinical sense does not apply here. The "test set" would refer to the number of device constructs tested. The specific number of constructs tested for static and dynamic compression bending and torsion is not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. "Ground truth" established by experts typically pertains to clinical diagnostic devices where expert interpretation is compared to an algorithm's output. For a spinal fixation system undergoing mechanical testing, the "truth" is determined by established engineering standards (ASTM F1717) and physical measurements of strength and durability.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when multiple readers interpret data to establish a consensus "ground truth." For mechanical tests, the results are quantitative and objective, based on physical measurements against engineering standards.
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
This question is not applicable. An MRMC study is relevant for diagnostic imaging devices involving human readers and AI assistance. This document describes a spinal implant, which does not involve human readers or AI in its primary performance assessment for 510(k) clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical performance data, the "ground truth" is based on established engineering standards (ASTM F1717) and the measured physical properties of the tested constructs. The comparison is made against the performance of predicate devices as determined by similar mechanical testing.
8. The sample size for the training set
This question is not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/machine learning device.
§ 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.