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510(k) Data Aggregation
(88 days)
When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:
- o Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- . Spinal Stenosis
- Trauma/Fracture/Dislocation
- Atlanto-Axial Fracture with Instability .
- . Occipito-Cervical Dislocation
- Failed Previous Fusion .
- . Tumor
The use of occipital bone screws is limited to placement in the occiput only.
The use of polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various titanium alloy screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.
The provided text describes a 510(k) premarket notification for the "Lanx Posterior Cervicothoracic Spinal Fixation System," a Class II medical device. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing specific acceptance criteria and proving performance through detailed clinical or standalone studies with statistical endpoints as might be required for a PMA or novel device.
Therefore, the information requested regarding acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment, is largely not present in this 510(k) summary. The provided document emphasizes mechanical testing to show comparable properties to predicate devices.
Here's an attempt to answer based on the given text, noting when information is unavailable:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the "acceptance criteria" are implicitly based on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis and performance testing showing comparable mechanical properties. Specific quantified acceptance criteria (e.g., "sensitivity > X%", "accuracy > Y%") for diagnostic performance are not applicable to this type of device and submission.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Mechanical properties comparable to predicate devices. | "The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices." |
| Intended use and indications for use are the same or similar to predicate devices. | "The Lanx Posterior Cervicothoracic Spinal Fixation System has the same or similar intended use, indications...as the predicate systems." |
| Technological characteristics and principles of operation are the same or similar to predicate devices. | "The Lanx Posterior Cervicothoracic Spinal Fixation System has the same or similar...technological characteristics, and principles of operation as the predicate systems." |
2. Sample size used for the test set and the data provenance
The document mentions "Performance testing and engineering analysis was conducted." This typically refers to benchtop mechanical tests. The specific "sample size" (i.e., number of devices or components tested) is not specified. The "data provenance" (country of origin, retrospective/prospective) is not applicable as there is no human subject data or clinical data described here. The testing is laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a spinal fixation system, not a diagnostic AI device requiring expert-established ground truth for its performance evaluation in this context. The "ground truth" for mechanical testing would be established by engineering standards and measurements.
4. Adjudication method for the test set
This information is not applicable as there is no diagnostic test set or human interpretation being adjudicated.
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
An MRMC study is not applicable here. This is a spinal fixation system, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a spinal fixation system, not an algorithm. Performance of the device is assessed through mechanical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing mentioned, the "ground truth" would be based on engineering specifications and measurements from mechanical testing (e.g., material strength tests, fatigue tests, torsional tests), benchmarked against established standards and predicate device performance. It is important to note that specific ground truth metrics (e.g., specific load at failure) are not detailed in this summary.
8. The sample size for the training set
This information is not applicable as the device is a hardware spinal fixation system, not an AI/machine learning model that uses a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above; there is no training set for a hardware device.
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