(267 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 Medyssey Co. Ltd., Zenius ™ 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 Medyssey Co. Ltd., 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 Medyssey Co. Ltd., Zenius ™ Spinal System implants.
This document describes a 510(k) premarket notification for a spinal fixation system, not an AI/ML powered medical device. Therefore much of the requested information, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, and MRMC studies, is not applicable to this submission type.
Here’s an analysis based on the provided text, focusing on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The Medyssey Co. Ltd., Zenius™ Spinal System was found to be "substantially equivalent" to the U&I Corporation OPTIMA™ Spinal System and Medyssey's Co. Ltd., NOVEL™ Spinal System. |
| Mechanical Performance (Static & Fatigue per ASTM F 1717-04) | Mechanical testing (Static Compression Bending, Static Tension Bending, and Static Torsional Testing) was performed per ASTM F 1717-04. The subject device "performed substantially equal or better in the above mentioned testing to that of the predicated devices." |
| Material Compatibility | Implants are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. |
| Indications for Use | The device meets the stated Indications for Use, which are identical to predicate devices: "for skeletally mature patients receiving fusion by autogenous bone graft... 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)." |
| Equivalence in Principles of Operation, Labeling, and Regulation | Principles of operation, indications, contraindications, warnings, and precautions within labeling are similar to predicate devices. The device is classified as Class II (88.3390) under Spinal Pedicle Screw (MNI) and Spondylolisthesis Spinal Fixation Device System (MNH) 21 CFR § 888.3070. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The device is a physical medical implant (spinal fixation system), and its performance was evaluated through mechanical testing, not clinical data or a test set in the context of AI/ML. The provenance of the data is the mechanical testing conducted according to ASTM standards.
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)
This information is not applicable. Ground truth, in the AI/ML sense, is not relevant for this type of device submission. Performance was established through standardized mechanical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable, as there was no test set requiring human adjudication for ground truth.
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 study was done, nor would it be relevant for this type of physical implant device. The submission explicitly states: "Clinical tests: No clinical tests conducted on either the subject system nor the predicate systems."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for proving performance was based on:
- Adherence to Material Standards: Conformance to ASTM F 136 for titanium alloy.
- Mechanical Testing Standards: Performance against established benchmarks and predicate devices in static and fatigue testing protocols as defined by ASTM F 1717-04.
- Predicated Device Equivalence: The performance of existing, legally marketed devices (U&I Corporation OPTIMA™ Spinal System and Medyssey's Co. Ltd., NOVEL™ Spinal System) served as the benchmark for "substantial equivalence."
8. The sample size for the training set
This information is not applicable, as there was no training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not applicable, as there was no training set for an AI/ML 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.