(84 days)
The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from:
- Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- Spondylolisthesis, .
- Trauma (i.e. fracture or dislocation), .
- Spinal Stenosis.
- Deformity (i.e., scoliosis, kyphosis, and/or lordosis),
- . Tumors.
- . Pseudoarthrosis as a result of failed spine surgery,
- Failed previous fusions, ●
- Symptomatic cervical spondylosis, ●
- Instability following surgery for the above indications. .
Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
Warning: This device is not approved or intended for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-constrained plate, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The AIS Cervical Plating System is manufactured from Titanium Alloy/Phynox and will be provided non-sterile.
Here's a summary of the acceptance criteria and study findings based on the provided document:
This 510(k) submission (K121801) is for minor changes to the Quintex Cervical Plating System and seeks to demonstrate substantial equivalence to a previously cleared device (K100243). Therefore, the "acceptance criteria" are generally that the modified device performs similarly to or better than the predicate device in specified biomechanical tests.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Premarket Notification Purpose: Minor changes to Quintex screw and screwdriver should maintain or improve existing performance. | Device remains substantially equivalent to the current Quintex Cervical Plating System (K100243). |
| Overall Performance: The modified device must be substantially equivalent to the predicate device (K100243). | Biomechanical testing found the subject device to be similar in performance to the previously cleared system. |
| Specific Biomechanical Tests: The device must perform adequately in: |
- Off-axis screw insertion
- Redirection of screw trajectory
- Intentional pry-out | The results of these tests showed that the subject device meets or exceeds the performance of the predicate device, and is therefore found to be substantially equivalent. |
Regarding the study proving the device meets acceptance criteria:
The study referenced is a non-clinical biomechanical testing program.
-
Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size (e.g., number of screws, plates, or constructs tested) for each biomechanical test.
- The data provenance is not explicitly stated beyond being "non-clinical testing" conducted as recommended by FDA Guidance for Spinal System 510(k)s. It's safe to assume this testing was conducted in a laboratory setting, likely in the US or a country with similar regulatory standards, but the specific location is not provided. The data is prospective in the sense that the tests were specifically designed and executed for this submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in this context. Biomechanical testing of a medical device (like a spinal plating system) does not typically involve human experts establishing a "ground truth" for the test set in the way that image interpretation or diagnostic performance studies do. The "ground truth" here is the physical performance under controlled mechanical conditions, measured against engineering standards and comparison to a predicate device.
-
Adjudication method for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies where human interpretation or clinical outcomes need to be resolved. For biomechanical testing, the "adjudication" is based on objective, quantifiable measurements and engineering analysis.
-
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices, not for a spinal implant system undergoing biomechanical testing for substantial equivalence.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This device is a passive mechanical implant, not an algorithm or a device with AI components.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study is the objective, quantitative performance data obtained from standardized biomechanical tests (e.g., force, displacement, failure load, rigidity, etc.), as measured and analyzed by engineers and compared against the performance characteristics of the predicate device and relevant engineering standards.
-
The sample size for the training set:
- This question is not applicable. There is no "training set" in the context of biomechanical testing for a mechanical implant. Training sets are used in machine learning for AI algorithms.
-
How the ground truth for the training set was established:
- This question is not applicable as there is no training set for this type of device and study.
§ 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.