(130 days)
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is intended for immobilization and stabilization of the thoracic, lumbar, and sacral spine in skeletally mature patients as an adjunct to fusion with autogenous.bone graft for the following indications: degenerative disc disease (DDD) (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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is a single use device for mono- and multi-segmented stabilization of the lumbar and thoracic vertebrae to facilitate fusion, per the indications for use. The system consists of post and fixed head screws, washers, rods, set screws, and locking nuts.
The provided text describes a 510(k) summary for the "Spartek™ Variable Angle Pedicle Screw Posterior Fusion System." This document is a premarket notification for a medical device and, as such, outlines the device's intended use, description, and comparison to predicate devices, rather than presenting a detailed study with acceptance criteria and performance data in the typical sense of AI/software performance studies.
Therefore, the requested information elements related to a study proving device meets acceptance criteria, such as sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable to this type of regulatory submission for a physical medical device like a pedicle screw system. These elements are typically found in submissions for diagnostic AI/ML software or other assessment tools.
Here's how the available information from the document translates to your request:
1. Table of Acceptance Criteria and Reported Device Performance
For this physical medical device, "acceptance criteria" are typically defined by recognized standards (like ASTM F1717) for mechanical performance and a demonstration of substantial equivalence to existing predicate devices. The "reported device performance" is its ability to meet these standards and be equivalent.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Performance | Static Compression Bending (ASTM F1717) | Device tests indicate substantial equivalence to predicate devices. |
| Static Torsion (ASTM F1717) | Device tests indicate substantial equivalence to predicate devices. | |
| Dynamic Compression Bending (ASTM F1717) | Device tests indicate substantial equivalence to predicate devices. | |
| Other special controls (not explicitly detailed in the summary) | Device tests indicate substantial equivalence to predicate devices. | |
| Substantial Equivalence | Same Indications For Use as predicate devices | Device has the same indications for use as predicate devices. |
| Similar Design, Function, and Materials as predicate devices | Device has similar design, function, and materials as predicate devices. |
2. Sample size used for the test set and the data provenance
Not Applicable. This is a physical medical device. Testing involved mechanical characterization of device components and assemblies, not a "test set" of patient data in the context of an AI/software study. The data provenance would be laboratory testing results, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. Ground truth, in the context of this device, is established by adherence to engineering standards and mechanical testing results, not by expert medical image interpretation or clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As there is no "test set" in the sense of patient cases needing interpretation, there is no adjudication method.
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
Not Applicable. This is a physical orthopedic implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a physical device like a pedicle screw system, the "ground truth" for proving performance typically refers to:
- Compliance with recognized industry standards (e.g., ASTM F1717 for spinal implant mechanical testing).
- Demonstration of mechanical integrity and strength under simulated physiological loads.
- Confirmation of biocompatibility (though not detailed in this summary).
- Verification of design specifications and material properties.
The summary explicitly states: "Testing performed indicates the Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is substantially equivalent to predicate devices as demonstrated through static compression bending, static torsion, and dynamic compression bending as described in ASTM F1717, and other special controls." This indicates that the ground truth for mechanical performance was adherence to the ASTM F1717 standard.
8. The sample size for the training set
Not Applicable. This is a physical medical device, not an AI/ML model that is "trained."
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
§ 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.