(39 days)
The Marauder™ Cervical-Thoracic Spinal Fixation System implants are intended to be used as a temporary construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of hooks and screws joined with spinal rods and should be removed after fusion.
The Marauder™ Cervical-Thoracic Spinal Fixation System is intended to promote fusion of the cervical and thoracic spine (C1-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; and/or tumors.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.
The use of screws is limited to placement in TI-T3 vertebrae for treating thoracic conditions only. Screws.are not intended to be placed in the cervical spine.
The Marauder™ Cervical-Thoracic Spinal Fixation System consists of a polyaxial bone screw with a spherical-shape head, and a standard thread for interfacing bone. Screws are available in 3.5 mm and 4.0 mm diameters and lengths from 10mm to 30mm.
In addition to polyaxial screws, hooks are provided for use in the cervical and thoracic spine. Three hook geometry variations are offered with the Marauder™ Cervical-Thoracic Spinal Fixation System. The hooks use the same rod locking means as the polyaxial screw implants.
Titanium rods are provided in various lengths and are used to connect pedicle screws and create a rigid structure. The rods are connected to the implants by interference with the rod saddle and held into position by the locking caps.
All implant components of the Marauder™ Cervical-Thoracic Spinal Fixation System are manufactured from Ti-6Al-4V alloy, conforming to ASTM F136.
The provided text describes a medical device, the "Marauder™ Cervical-Thoracic Spinal Fixation System," and its performance testing. However, it does not describe an AI/ML powered device or software. Therefore, many of the requested fields related to AI/ML device evaluations (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from the provided document.
The document discusses the mechanical performance testing of a physical spinal fixation system.
Here's an attempt to answer the applicable parts based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Testing per ASTM F1798-08: | |
| Static Flexion-Extension Strength Requirement | "The mechanical testing revealed that the Marauder™ Cervical-Thoracic Spinal Fixation System behaves as expected and is typical of competitive systems. In all instances, the Marauder™ Cervical-Thoracic Spinal Fixation System functioned as intended and the testing results observed were as expected." |
| Static Rod Gripping Capacity Strength Requirement | (Same as above) |
| Static A-P Pullout Strength Requirement | (Same as above) |
| Testing per ASTM F1717-12: | |
| Static Compression Bending Requirement | (Same as above) |
| Static Torsional Bending Requirement | (Same as above) |
| Dynamic Compression Bending Requirement | (Same as above) |
Note: The document states that the testing was conducted according to methods defined in ASTM F 1798 and ASTM F 1717. It then lists the types of tests performed. The "acceptance criteria" are implied to be meeting the requirements of these standards, and the "reported device performance" is a general statement that the device performed "as expected" and "typical of competitive systems," and "functioned as intended." Specific numerical performance data or pass/fail thresholds for each test are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This refers to the number of physical components or constructs tested in the mechanical performance evaluations. The document does not specify the exact sample size for each test (e.g., "n=5 constructs for static flexion"). It only lists the types of tests performed.
- Data Provenance: Not applicable in the context of mechanical device testing for substantial equivalence. The tests are laboratory-based mechanical tests, not clinical or observational data.
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)
Not applicable. This is a mechanical device, not an AI/ML system requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a mechanical device, not an AI/ML system requiring adjudication of expert interpretations.
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
Not applicable. This is a mechanical device, not an AI/ML system, so no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical testing is defined by the ASTM F1798 and ASTM F1717 standards themselves, which specify test methods, fixtures, loading conditions, and acceptance criteria for spinal implant constructs. The device's direct performance against these standards constitutes the "ground truth" in this context.
8. The sample size for the training set
Not applicable. This is a mechanical device; there is no "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
Not applicable. As there's no AI/ML training set, the concept of establishing its ground truth does not apply.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.