(226 days)
The Halm Zielke Instrumentation System is an anterior spinal fixation system indicated for spinal deformities such as scoliosis, kyphosis, and lordosis and thoracolumbar spinal instability caused by fracture.
The principal components of the MICOMED Halm Zielke Instrumentation, which is a low profile spinal fixation system, are as follows: Halm plates, screws, threaded rods, standard hex nut for threaded rods, fluted rods, vertebral clamps (double hole). Additional instrumentation includes: an awi, insertion instruments (Halm plates, threaded rod screws), screw wrench for hex nut, rod pusher for fluted rod, rod benders, in situ rod bender, grip tongs (threaded rod, fluted rod), and hook grasp tong.
The principal components of the MICOMED - Halm Zielke Instrumentation are utilized in the following manner. First, the most cranial and caudal Halm plates are each attached to the lateral aspect of the vertebral body with two screws (countersunk, Zielke), and then additional plates are attached as needed. The threaded rod is then connected to the top of the Zielke screws, and anchored with the standard hex nuts. Once the threaded rod is properly connected to the Halm plates, partial correction of the scoligtic deformity is performed before attaching the pre-bent fluted rod by closing the lid of the Halm plate and securing with the head screws. The secured fluted rod can then be rotated around its longitudinal axis to achieve an appropriate level of derotation and relordosation. If this system is used in the thoracic spine, rod rotation is performed in reverse to produce or enhance physiological kyphosis. Additionally, segmental compression or distraction can be used to increase or decrease lordosis or kyphosis as desired.
The provided 510(k) summary for the MICOMED - Halm Zielke Instrumentation describes a spinal fixation system, not an AI/ML device, and therefore does not contain the information typically required for evaluating the acceptance criteria and study proving an AI/ML device meets those criteria.
However, based on the information available regarding the performance testing of the mechanical device, I can extract and structure the relevant data.
Here's an analysis of the provided text, modified to fit the requested format as much as possible for a mechanical device:
Description of the MICOMED - Halm Zielke Instrumentation
The MICOMED - Halm Zielke Instrumentation is a low-profile anterior spinal fixation system. Its principal components include Halm plates, screws, threaded rods, hex nuts, fluted rods, and vertebral clamps. The system is designed to correct spinal deformities (scoliosis, kyphosis, lordosis) and treat thoracolumbar spinal instability caused by fracture. The components are manufactured from implant-grade stainless steel (316LS) or titanium (ASTM F136).
1. Table of Acceptance Criteria and Reported Device Performance
For a mechanical medical device like this, acceptance criteria typically relate to mechanical strength, durability, and equivalent performance to predicate devices. The document frames performance in terms of "inherent stability (stiffness)" and resistance to "deformational forces" and "fatigue."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Stability (Stiffness): Demonstrates superior or equivalent stability compared to predicate devices under various loads. | Compared to Zielke-VDS: "the calf and artificial spines were much more resistant to various deformational forces (axial compression, flexion, extension, lateral bending, torsion) after the MICOMED - Halm Zielke Instrumentation was applied as opposed to Zielke-VDS." (Implies superior stiffness/stability). |
| Fatigue Resistance/Durability: Withstands physiological loading for a significant number of cycles without device failure. | Fatigue Testing: "when the call spines were subjected to one million cycles of axial compression at loads of 1400 Newtons (N) and 2600 N, none (of the calf spines) exhibited any evidence of device failure." This demonstrates robust fatigue resistance under significant and prolonged stresses. |
| Substantial Equivalence: Performance is at least equivalent to legally marketed predicate devices. | The device is deemed "Substantially Equivalent to the Zielke-Ventral Derotation Spondylodesis, Kaneda SR™ Anterior Spinal System, and Anterior Isola Spinal System." This is a regulatory finding based on the overall data, implying that the performance data supported equivalence to these established devices (which would have their own established performance profiles). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a numerical sample size for "calf and artificial spines." The phrasing "the calf and artificial spines" suggests a limited, but not explicitly quantified, number of specimens were used. For the fatigue testing, it states "when the call spines were subjected to one million cycles of axial compression," implying a set of calf spines.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be a laboratory-based biomechanical study, which is typical for spinal implant testing. It is a prospective test in the sense that the experiment was designed and conducted to evaluate this specific device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This question is not applicable to this type of device and study. Biomechanical testing of spinal implants does not typically involve human experts establishing "ground truth" in the way an AI/ML diagnostic device does for image interpretation. The "ground truth" here is the physical measurement of deformation, failure, and resistance, determined by mechanical testing protocols and sensors.
4. Adjudication Method for the Test Set
This question is not applicable. There is no "adjudication method" in the context of mechanical testing. The results are quantitative measurements from instruments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This question is not applicable. This is a biomechanical performance study of a physical implant, not a study involving human readers or AI assistance.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)
This question is not applicable. There is no algorithm or AI component to this device. The performance study refers to the standalone mechanical performance of the implant itself.
7. Type of Ground Truth Used
For the biomechanical study:
- Mechanical Measurement Data: The "ground truth" is derived from direct physical measurements of mechanical properties such as resistance to deformational forces (axial compression, flexion, extension, lateral bending, torsion) and assessment of device integrity after fatigue cycling (absence of device failure).
8. Sample Size for the Training Set
This question is not applicable. As a mechanical device, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. There is no "training set" for this mechanical device.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.