(30 days)
When intended as an adjunct to fusion in skelctally mature patients using allograft and/or autograft of the occipitocervical spine, cervical spine, and the thoracic spine, (Occipat-T3), the VERTEX Reconstruction System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spinc.
Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.
Hooks and Rods
I he hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Multi-axial Screws/Connectors
The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable System to be used with the VERTEX | Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
The VERTEX Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.
Reconstruction System is fabricated from medical grade titanium. The VERTEX medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and or/cobalt chromium with stainless steel in the same construct. The VERTEX Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. The posted screw connectors and some multi-axial screws contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.
To achieve best results, do not use any of the VERTEX Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedic and neurosurgical implants, none of the VERTEX Reconstruction System components should ever be reused under any circumstances.
The provided document is a 510(k) summary for the VERTEX® Reconstruction System, which is a spinal interlaminal fixation orthosis. This type of regulatory submission in the US is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving clinical effectiveness through full-scale clinical trials with acceptance criteria and detailed device performance metrics typically found in a PMA (Premarket Approval) submission.
Therefore, much of the requested information (acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth characteristics) is not typically included or required in a 510(k) submission like the one provided.
Instead, the acceptance criteria for a 510(k) submission, particularly for devices like spinal fixation systems, are generally related to mechanical testing results demonstrating equivalence to a predicate device, and ensuring that the device's design, materials, and intended use are similar enough that it poses no new questions of safety or effectiveness.
Here's an attempt to address your questions based on the provided text, acknowledging the limitations of a 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred for 510(k) of a spinal fixation device) | Reported Device Performance (as stated in the document) |
|---|---|
| Mechanical Equivalence to Predicate Device: The subject device components should demonstrate equivalent or superior mechanical properties compared to the predicate device components to ensure safety and effectiveness for their intended use. | "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components." (K083071, page 5, Section VI. Substantial Equivalence) |
| Biocompatibility: Materials used should be biocompatible and suitable for implantation. | The system is fabricated from "medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium." "The VERTEX Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi)." (K083071, page 1, Section IV. Description) |
| Functional Equivalence: The subject device's design and function should be comparable to the predicate device, supporting its stated Indications for Use. | The description of the device (plates, rods, hooks, screws, multi-axial screws, connectors) and its indications for use (adjunct to fusion of occipitocervical to thoracic spine for various conditions) are presented as substantially equivalent to existing predicate devices. |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided: This information is not typically part of a 510(k) summary for a mechanical spinal implant, which relies on mechanical bench testing rather than clinical study data with test sets of patients. The "test set" here refers to the actual components tested in a lab. The document states "mechanical testing," but does not specify the number of components tested.
- Data Provenance: The mechanical testing would have been conducted in a laboratory environment, likely by the manufacturer (Medtronic Sofamor Danek). The document does not specify the country of origin for the testing itself, but the manufacturer is based in Memphis, Tennessee, USA. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: For mechanical bench testing of an implantable device, "ground truth" is established by engineering specifications and recognized testing standards (e.g., ASTM standards for spinal implants), not typically by clinical experts in the same way it would be for diagnostic AI. The document does not mention clinical experts establishing ground truth for the mechanical testing results.
4. Adjudication method for the test set
- Not Applicable / Not Provided: Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of clinical data, especially in diagnostic studies. This is not relevant to mechanical bench testing.
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: No MRMC comparative effectiveness study was done or is mentioned. This device is a surgical implant, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The type of ground truth used
- Mechanical Testing Standards and Predicate Performance Data: The ground truth for demonstrating substantial equivalence for this device would be established by validated mechanical testing protocols (e.g., fatigue, static strength) and the known, acceptable performance characteristics of the predicate devices according to these standards. The acceptance criteria would be that the subject device performs equivalently to or better than the predicate device under these standardized tests.
8. The sample size for the training set
- Not Applicable / Not Provided: This is not an AI/algorithm-based device, so there is no "training set." The sample size would refer to the number of components subjected to mechanical testing, which is not specified.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As there is no training set for an algorithm, this question is not relevant. For the mechanical testing, the "ground truth" for evaluating performance would be established by the engineering specifications of the device and comparing its performance to that of the predicate device under standard mechanical test conditions.
Summary of Approach for 510(k) Devices like VERTEX® Reconstruction System:
The VERTEX® Reconstruction System's 510(k) submission primarily relies on demonstrating Substantial Equivalence to legally marketed predicate devices. This is achieved through:
- Comparison of Indications for Use: Showing that the new device has the same or similar intended use as predicate devices.
- Comparison of Technological Characteristics: Demonstrating that the new device has similar design, materials, and principles of operation.
- Mechanical Testing: Providing data from laboratory-based mechanical testing (e.g., static and fatigue testing) to prove that the device performs equivalently to predicate devices in terms of strength, durability, and other relevant physical properties. The "acceptance criteria" here are that the mechanical test results for the new device fall within the expected, safe, and effective range demonstrated by the predicate devices.
The document explicitly states: "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components." This statement is the core evidence provided to meet the acceptance criteria for mechanical performance in a 510(k) for this type of device.
§ 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.