(107 days)
The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments 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).
The Zenius 146 Spinal System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Zenius ™ Spinal System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Zenius "" Spinal System implants.
The provided text describes a 510(k) summary for a spinal system and its modification, focusing on substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical or even extensive non-clinical testing beyond basic mechanical and sterilization validation.
This document specifically states: "Clinical tests: No clinical tests conducted on either the subject system nor the predicate system." The purpose of this submission was for the clearance of the redesign of the custom sterilization trays, not for assessing the clinical performance or efficacy of the spinal system itself beyond its substantial equivalence to the previously cleared predicate.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated based on the text, with clear limitations:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: Adherence to ASTM F 1717-04 standards for: - Static Compression Bending - Static Tension Bending - Static Torsional Testing | All testing performed per ASTM F 1717-04. (However, this particular submission did not include these tests for the redesigned sterilization trays, as they were not considered "worst case" for mechanical performance of the implant itself. The predicate device and previous submissions would have covered this.) |
| Sterilization Validation: Achieve a Sterility Assurance Level (SAL) equal to at least 1 x 10⁻⁶ according to AAMI ST77 and AAMI ST79 guidelines for redesigned sterilization trays. | Validation was satisfactorily performed on the re-designed sterilization trays, achieving the required SAL. |
| Material: Fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. | Explicitly stated as conforming to ASTM F 136. |
| Substantial Equivalence: To predicate device Zenius™ Spinal System (K093104) and Zenius™ Spinal System (K103272) for performance, safety & effectiveness requirements. | Found substantially equivalent. |
Important Note: The document focuses on demonstrating substantial equivalence to a previously cleared device, particularly for a modification to sterilization trays. It does not present new performance data for the implant itself beyond the scope of that modification.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Mechanical Testing: Not specified for this submission, as the mechanical tests (ASTM F 1717-04) were already performed for the predicate device, and the current submission primarily concerned sterilization trays. For the sterilization validation, the sample size and provenance are not detailed in this summary; it just states it was "satisfactorily performed."
- Clinical Data: No clinical tests were conducted for either the subject system or the predicate system (as stated in the document).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical tests were performed, and thus no expert ground truth was established from clinical data for this submission. The "ground truth" for mechanical testing would be the ASTM standards, and for sterilization, the AAMI guidelines.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical tests were performed and no human adjudication of results is mentioned for the non-clinical tests.
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:
- No MRMC comparative effectiveness study was done. This device is a mechanical spinal implant, not an AI-assisted diagnostic or therapeutic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical properties: ASTM F 1717-04 standards.
- For material properties: ASTM F 136 standard for titanium alloy.
- For sterility: AAMI ST77 and AAMI ST79 guidelines.
- No clinical ground truth (expert consensus, pathology, outcomes data) was used or generated for this specific submission because no clinical studies were performed.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning algorithm.
9. How the ground truth for the training set was established:
- Not applicable. This is a mechanical device, not a machine learning algorithm.
§ 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.