(233 days)
The Medyssey Co. Ltd. Zenius, Iliad and Kora Spinal Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograff and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Medyssey Co. Ltd., Cannulated Pedicle Screws are intended to be used with their respective (e.g. Zenius) top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Medyssey Co. Ltd., Cannulated Pedicle Screw implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. The Medyssey Co. Ltd., Cannulated Pedicle Screws can be used in the posterior plane providing unilateral and bilateral modes of fixation. The Medyssey Co. Ltd., Cannulated Pedicle Screw Spinal design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a mobile and non-mobile housing component which houses the screw and the rod which accepts a setscrew which tightens against the rod which tightens head of the pedicle screw upon secure tightening interface of the set screw assembly with the rod. The Cobalt Chrome Rods are for use with the Zenius or Iliad System. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Medyssey Co. Ltd. Cannulated Pedicle Screw implants.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medyssey Cannulated Pedicle Screws and Cobalt Chrome Rods:
1. Acceptance Criteria and Reported Device Performance
The provided document describes non-clinical (bench) testing for the Medyssey Cannulated Pedicle Screws and Co-Cr-Mo rods. The acceptance criteria are implicitly defined by the chosen ASTM standard and the comparison to predicate devices, which means the new device must perform at least as well as the legally marketed predicates.
| Acceptance Criteria Category | Specific Criteria (Implicitly from ASTM F1717-04 and Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | - Static Compression Strength | "Analysis has shown that the proposed screws and rods are equivalent to the predicate devices." (Implies meeting or exceeding predicate performance for all tests listed below) |
| - Static Torsion Strength | ||
| - Static Tension Strength | ||
| - Dynamic Compression Performance (Fatigue) | ||
| Material Compatibility | - Use of biocompatible materials (Titanium alloy [Ti-6Al-4V ELI], Co-Cr-Mo) conforming to ASTM F 136. | "fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136." and "proposed rods are manufactured from Co-Cr-Mo" |
| Design Equivalence | - Minor differences in design (cannulation of screws, Co-Cr-Mo rods instead of titanium) do not impact safety or effectiveness. | "Analysis has shown that the proposed screws and rods are equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of devices (screws/rods) tested for each non-clinical test (static compression, torsion, tension, dynamic compression). Standard test methodologies for medical devices like ASTM F1717-04 typically require a minimum number of samples for statistically valid results, but these specific numbers are not detailed in this summary.
- Data Provenance: The data is from non-clinical (bench) testing performed by Medyssey Co. Ltd. The country of origin of the testing data is not explicitly stated, but Medyssey is a Korean company with a US-based contact for regulatory purposes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is non-clinical (bench testing) of physical device properties, not a clinical study involving human patients or expert interpretation of medical data. The "ground truth" here is the measured mechanical performance of the device against established engineering standards and predicate device performance.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is non-clinical (bench testing). Adjudication methods are typically employed in clinical studies or studies involving expert review of medical images/data to resolve discrepancies in interpretation.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (spinal pedicle screws and rods), not an AI/software device. Therefore, there is no mention of human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" used for this non-clinical study is:
- Engineering Standards and Specifications: Adherence to ASTM F1717-04.
- Predicate Device Performance: The mechanical performance of the new device was compared to that of legally marketed predicate devices. The implicit ground truth is that the predicate devices are safe and effective, and therefore, a device demonstrating equivalent or superior mechanical properties would also be considered safe and effective for the stated indications.
8. The Sample Size for the Training Set
This information is not applicable as the study described is non-clinical (bench testing) of a physical device. There is no concept of a "training set" for this type of evaluation.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this non-clinical study.
§ 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.