(91 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is a single use device for monoand 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.
This document is a 510(k) premarket notification for the Spartek™ Variable Angle Pedicle Screw Posterior Fusion System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a comprehensive study demonstrating direct device performance against specific metrics in the way a clinical trial or algorithm performance study would.
However, based on the provided text, I can extract the relevant information regarding performance testing and regulatory acceptance:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static Compression Bending | Substantial equivalence to predicate device (K094402) | Testing performed indicates substantial equivalence to predicate devices per ASTM F1717. |
| Static Torsion | Substantial equivalence to predicate device (K094402) | Testing performed indicates substantial equivalence to predicate devices per ASTM F1717. | |
| Dynamic Compression Bending | Substantial equivalence to predicate device (K094402) | Testing performed indicates substantial equivalence to predicate devices per ASTM F1717. | |
| Regulatory Compliance | General Controls Provisions of the Act | Compliance with annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration. | FDA determined the device is substantially equivalent and can be marketed subject to general controls provisions of the Act. |
| Special Controls (for Class II/III) | Compliance with relevant Class III regulations and potentially further announcements. | Device is Class III. FDA advises it "may be subject to additional controls." |
Explanation of "Acceptance Criteria (Implicit)": The document states that the performance testing "indicates the Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is substantially equivalent to predicate devices..." This implies that the acceptance criteria for these mechanical tests were that the device's performance met or exceeded the performance of the predicate device, as demonstrated through the specified ASTM standard. The FDA's issuance of the 510(k) clearance acts as the ultimate regulatory acceptance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "testing performed" but does not detail the sample sizes for the mechanical tests (e.g., number of screws, rods tested) or the methodology of how these samples were selected. The nature of these tests (mechanical performance of a physical device) typically involves in-vitro lab testing, not human subject data. Therefore, questions of "country of origin of the data" or "retrospective/prospective" are not applicable in this context.
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)
This is not applicable and not provided in the document. This device is a physical pedicle screw system, not an AI or diagnostic imaging device that requires expert review for ground truth establishment. The "ground truth" for this device's performance is established by standardized mechanical testing methods (ASTM F1717).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies or AI performance evaluations involving human interpretation. The testing described here is mechanical and objective.
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 is not applicable and not provided in the document. An MRMC study is relevant for AI-powered diagnostic or assistive devices. This document describes a physical medical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided in the document. This question pertains to AI algorithms, not a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is established by the results of standardized mechanical testing according to ASTM F1717. This standard provides objective, quantifiable metrics for the structural integrity and performance of pedicle screw systems. Essentially, the "truth" is adherence to established engineering and biomechanical principles and performance benchmarks defined by the standard.
8. The sample size for the training set
This is not applicable and not provided in the document. Training sets are relevant for machine learning algorithms. This document describes a physical medical device submitted for 510(k) clearance based on substantial equivalence.
9. How the ground truth for the training set was established
This is not applicable and not provided in the document, for the same reasons as point 8.
§ 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.