(76 days)
When used as a pedicle screw fixation system, the SHIRAZ Posterior System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by mutogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
When used as a pedicle screw fixation system, the SHIRAZ Posterior System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Spine Next Posterior System is designed to aid the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with the bone graft. These implanted are intended to be the avvelopment of a solid fusion mass. The system includes screws, rods, connectors and secondary sacral connectors.
All implants are manufactured from Titanium Alloy (Ti6Al4V) meeting the requirements of ASTM F136/ISO 5832 or commercially pure Titanium (cpTi, Grade 4) meeting requirements of ASTM F67/ISO 5832.
This document describes a 510(k) submission for the "Spine Next SHIRAZ Posterior System," a pedicle screw fixation system. The primary goal of the submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove predefined acceptance criteria through a standalone study in the same way a novel high-risk device might.
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1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Manufactured from Titanium Alloy (Ti6Al4V) meeting ASTM F136/ISO 5832 or commercially pure Titanium (cpTi, Grade 4) meeting ASTM F67/ISO 5832. |
| Mechanical Strength/Stability | Biomechanical testing, including static and dynamic testing, was performed in accordance with ASTM F1717 and ASTM F1798. |
| Substantial Equivalence to Predicate Device | FDA concluded the device is substantially equivalent to the predicate device (Moss Miami [K021880]) for its stated indications for use. |
- Comment: The document does not explicitly state "acceptance criteria" with numerical thresholds or specific performance metrics (e.g., "device must withstand X load for Y cycles"). Instead, for a Class II device like this, the "acceptance criteria" are generally implied to be meeting recognized international standards for materials and mechanical testing, and demonstrating substantial equivalence to a legally marketed predicate device. The performance data section confirms that testing according to relevant ASTM standards was performed, and the FDA's clearance letter confirms substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of this 510(k) submission for mechanical testing. "Sample size" typically refers to the number of patients or cases in clinical studies. Here, it refers to the number of test articles (implants) tested in a laboratory setting. The document does not specify the number of individual screws, rods, or construct combinations tested.
- Data Provenance: Not applicable. The testing described (biomechanical) is laboratory-based, not clinical data 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. This submission focuses on the mechanical and material properties of an orthopedic implant, not on diagnostic accuracy or clinical judgment that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth (e.g., presence or absence of a disease). This is a biomechanical and materials-focused submission.
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 submission is for a physical orthopedic implant, not an AI/software device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As mentioned, this is not an AI/software device. Performance is assessed through mechanical testing of the physical implant components.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is material specifications (ASTM F136/ISO 5832, ASTM F67/ISO 5832 for Titanium alloys) and biomechanical performance standards (ASTM F1717, ASTM F1798). The implant is expected to meet or exceed the performance requirements defined by these standards, and to perform comparably to the predicate device.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this type of device submission. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" in this context refers to the biomechanical testing and materials characterization performed on the Spine Next SHIRAZ Posterior System.
- Testing Conducted: Biomechanical testing, including static and dynamic loading, was performed.
- Standards Used: This testing was conducted in accordance with recognized industry standards: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ASTM F1798 (Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Post. Pedicle Screw Spinal Instrumentation). The materials used were also certified to meet ASTM F136/ISO 5832 (titanium alloy) and ASTM F67/ISO 5832 (commercially pure titanium).
- Proof of Meeting Criteria: By demonstrating that the device components are made from specified, compliant materials and that the assembled system can withstand the forces and cycles defined in the relevant ASTM standards, the manufacturer provides evidence that the device is safe and effective for its intended use and substantially equivalent to the predicate device. The FDA's clearance (K033947) confirms that based on this data, the device meets the regulatory requirements for market entry.
§ 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.