(60 days)
The Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M™ Spinal Fixation System are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used for posterior non-cervical screw fixation in pediatric patients, the Rexious System, Statera™ Spinal Fixation System, and Statera-MTM System are indicated as an adjunct to fusion to treat: adolescent idiopathic scoliosis, progressive spinal deformities (i.e., scolosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, spondylolisthesis, spondylolysis, pseudarthrosis, failed prior fusion, and fracture caused by tumor and/or trauma in pediatric patients. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
When used as an anterolateral thoracolumbar system, the Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M™ Spinal Fixation System are intended for anterolateral screw (with staples) fixation for the following indications: degenerative discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, set screws, connectors, hooks, washers, staples, and transverse (cross) linking mechanisms.
The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The implant components are supplied non-sterile, single use and fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. Various sizes of these implants are available.
This document describes the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System, which are spinal fixation systems. However, the provided text does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical or performance study for AI/software devices.
Instead, this is a 510(k) summary for a medical device (spinal hardware), which focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than fulfilling specific performance acceptance criteria through clinical trials or software validation studies. The "performance data" referred to is primarily mechanical testing of the physical implants, comparing them to the predicate device.
Therefore, many of the requested sections (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance) are not applicable to this type of device and submission.
Here's an analysis based on the provided text, while acknowledging its limitations for the requested AI/software-centric details:
1. Table of Acceptance Criteria and Reported Device Performance
For this spinal fixation system, "acceptance criteria" and "reported device performance" are primarily focused on mechanical integrity and equivalence to the predicate device, not on diagnostic accuracy or AI performance.
| Acceptance Criteria (Implied for Substantial Equivalence via Mechanical Testing) | Reported Device Performance (Mechanical Testing) |
|---|---|
| Material Equivalence: Materials of construction meet established standards (ASTM F67, F136, F1295, F1537) for titanium/titanium alloy and Cobalt-Chromium-Molybdenum. | The implants are fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295, and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. |
| Mechanical Performance Equivalence: Static and dynamic mechanical properties (compression bending, torsion) are equivalent to the predicate device per ASTM F1717. | Non-clinical testing was performed in accordance with ASTM F1717 for: |
- Static compression bending
- Dynamic compression bending
- Static Torsion
These tests "demonstrate that the Statera™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the legally marketed predicate devices." |
| Design and Functionality Equivalence: The device design (components, principle of operation) is substantially equivalent to the predicate device. | The subject device has "the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device." "There are no technological differences between the Subject device and its predicate devices." |
Note: For the Rexious Spinal Fixation System (part of the submission), no performance testing was required because it is identical to a system already cleared under K222415.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable in the context of clinical/AI test sets. For mechanical testing, the "sample size" would refer to the number of physical implants tested. This specific number is not provided in the document, but it would have followed the requirements of ASTM F1717 for mechanical samples.
- Data Provenance: The data is from non-clinical bench testing of physical device components, performed to demonstrate mechanical equivalence. Country of origin is not specified, but it's typically internal lab testing or third-party accredited labs. It is not prospective or retrospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. This submission does not involve ground truth established by medical experts for diagnostic or AI performance. The "ground truth" for mechanical testing is adherence to engineering standards and comparison to the predicate device's mechanical properties.
4. Adjudication Method for the Test Set
- Not applicable. There is no adjudication method in the context of expert consensus or diagnostic disagreements, as this is bench testing of physical hardware.
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 hardware medical device, not an AI/software device intended to assist human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical spinal fixation system, not a standalone algorithm.
7. The Type of Ground Truth Used
- Mechanical Performance Standards and Predicate Device Data: The "ground truth" for this device's performance demonstration is based on established ASTM mechanical testing standards (specifically ASTM F1717) and comparative data from the legally marketed predicate devices. The goal is to show that the subject device performs similarly to or better than the predicate device in these mechanical tests.
8. The Sample Size for the Training Set
- Not applicable. There is no training set as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this type of 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.