(188 days)
The Zeus Spinal System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studes); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor, pseuudarthrosis; and/or failed previous fusion.
In addition, when used as a pedicle screw fixation system, the Zeus Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion
The Zeus Spinal System is a modification of the previously cleared Adena-Zina Spinal System which consists of a variety of shapes and sizes of screws and Ø5.35mm rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include the originally cleared (K152781) straight and pre-bent rods, fixed and fixed angle reduction screws, multi-axial reduction screws, T-links, domino connectors, sacro-illiac connectors, as well as the Duetto dual headed screws and connectors, along with associated set screws (K212066). The subject submission seeks to add new Ø5.5mm pre-bend rods, single head and dual head polyaxial (multi-axial) screws, dual head reduction screws, polyaxial reduction screws (fixed polyaxial fixed screws, dual head monoaxial (fixed) screws, cannulated reduction screws (multiaxial and monoaxial), coronal and sagittal uniplanar screws, preferable angle screws, iliac screws, monoaxial Screw, associated set screws, connector and Ø5.5mm crosslinks, as well as additional sizes of existing components and cobalt chrome tulips for associated screws.
The provided text describes a 510(k) premarket notification for the "Zeus Spinal System," a thoracolumbosacral pedicle screw system. This document focuses on demonstrating substantial equivalence to predicate devices through bench performance testing of the device itself (implants), rather than evaluating the performance of an AI/software component in a human-in-the-loop or standalone study with a ground truth established by experts.
Therefore, many of the typical acceptance criteria and study details relevant to AI/software device performance (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission as described.
Here's a breakdown based on the provided text:
Subject of Evaluation: Physical medical device (spinal implants and their mechanical performance), not an AI/software algorithm.
Type of Study: Bench performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that performance bench testing was performed "per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and "per ASTM F1798 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanism and Subassemblies Used in Spinal Arthrodesis Implants."
While the specific numerical acceptance criteria and reported performance values are not explicitly detailed in this public summary, the conclusion states: "performance bench testing had been performed and shows that the subject Zeus Spinal System performs equivalent to or better than the primary predicate device."
| Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|
| Meet or exceed performance standards of ASTM F1717 | Performed equivalent to or better than the primary predicate device |
| Meet or exceed performance standards of ASTM F1798 | Performed equivalent to or better than the primary predicate device |
| Static axial compression strength | Performed equivalent to or better than the primary predicate device |
| Dynamic axial compression strength | Performed equivalent to or better than the primary predicate device |
| Static torsion resistance | Performed equivalent to or better than the primary predicate device |
| Screw dissociation resistance (static and fatigue) | Performed equivalent to or better than the primary predicate device |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the document. For bench testing of physical devices, sample sizes are typically defined by engineering standards (like ASTM) to ensure statistical significance for mechanical properties.
- Data Provenance: Not applicable in the context of clinical data. This is mechanical testing of manufactured devices in a lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Ground truth for mechanical device performance is established by standardized testing protocols and measurements, not by expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set:
- Not applicable. No expert adjudication of clinical data is involved.
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 not an AI-assisted diagnostic or clinical decision support device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used:
- Bench Testing Standards/Specifications: The "ground truth" for the device's mechanical performance is defined by the requirements outlined in the ASTM F1717 and ASTM F1798 standards, and comparison to the performance of the predicate device. These standards specify how the device should perform under various loads and conditions.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set is involved.
In summary: The provided document is a regulatory submission for a physical medical device (spinal system) based on material and mechanical performance equivalency to predicate devices, conducted via standardized bench testing. It does not involve AI or software performance evaluation, and thus, metrics related to clinical data, expert review, or machine learning model performance are not relevant or present in this specific regulatory summary.
§ 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.