(183 days)
The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are the pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-Sl vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis ).
aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are intended to used for Minimal Invasive Surgery (MIS).
The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, and nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) and Cobalt Chromium ally that conforms to ASTM F136 and ASTM F1537 respectively. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.
This document details the FDA 510(k) clearance for several spine fusion systems. It primarily describes a comparison of the new devices to a previously cleared predicate device (K202498). The information provided focuses on the physical and mechanical properties of the medical devices, not on an AI/software-based diagnostic or treatment system.
Therefore, many of the requested details related to AI/software performance criteria (such as data provenance, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training/test set sample sizes for AI) are not applicable to this submission.
The document discusses "acceptance criteria" in the context of mechanical performance testing for spinal implants.
Here's an extraction of the relevant information regarding acceptance criteria and performance, as can be gleaned from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria Mentioned | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | ASTM F1717 (on worst-case construct) | Not explicitly detailed in criteria column, but implicitly required to "meet performance requirement against predicates." | "Static Compression Bending, Dynamic Compression Bending, Static Torsion, and Static Tension tests results meet performance requirement against predicates." |
| Biocompatibility | FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" | Classified as body contacting devices requiring biological evaluation. | "The subject implants are manufactured from identical materials as the predicate devices, in accordance with the ASTM F136... The materials used for manufacturing the subject device have a long history of safe and effective use identical to predicate devices and biocompatibility testing is not required." (Conclusion that prior successful use of materials negates need for new specific test data) |
| Material Conformance | ASTM F136 (Titanium Alloy), ASTM F1537 (Cobalt Chromium Ally) | Conformance to these standards. | "Implant components are... fabricated from titanium alloy (Ti-6A1-4V ELI) and Cobalt Chromium ally that conforms to ASTM F136 and ASTM F1537 respectively." Also, "system is composed of the same material as the predicate- K202498 devices conforming to recognized industry standards for permanent implants (titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136) and surgical orthopedic instruments." |
| Sterilization | Non-sterile single use | Supplied non-sterile for single use. | "The implant components are supplied non-sterile single use." And "Also they are provided non-sterile for single use only." |
| Intended Use/Indications | Equivalence to predicate's indications. | New devices should have similar indications for use as the predicate. | "The 4CIS WILL PEDICLE SCREW SYSTEM, aBle Xt SPINAL FIXATION SYSTEM & aBle SPINAL FIXATION SYSTEM have similar indications as compare to cleared 4CIS SARA Spine System and 4CIS VERTU Spine System." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as this relates to mechanical testing of physical components rather than a dataset for AI. The text refers to testing "on the worst case construct," implying a representative sample of device configurations.
- Data Provenance: Not applicable in the context of patient data for AI. The "data" pertains to mechanical test results of the physical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. Ground truth for mechanical devices is established through engineering standards and physical testing, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set:
- Not applicable as it's not an AI system being evaluated against human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
- Not applicable. This is not a human-in-the-loop AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used:
- For mechanical performance, the "ground truth" is measured physical properties and performance against established ASTM (American Society for Testing and Materials) standards.
- For biocompatibility, the "ground truth" is established through the long history of safe and effective use of the materials conforming to ASTM standards.
- For intended use/indications, the "ground truth" is the regulatory clearance of predicate devices with similar indications.
8. The Sample Size for the Training Set:
- Not applicable, as this is not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as this is not an AI system. Ground truth for the device's design and manufacturing is based on engineering principles, materials science, and regulatory standards.
§ 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.