Search Results

The Lanx Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The Lanx Anterior Cervical Plate System is suitable for use to provide temporary stabilization of the anterior spine while awaiting bony fusion (healing) in patients with degenerative disc disease (neck or radicular pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), or pseudoarthrosis and/or failed previous fusion between C1 and C6.

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.

General description of the new plate.
Materials:
Titanium Alloy ASTM F136-92 ISO 5832-3
Titanium ASTM F67 GR2-95 ISO 5832-2
Cervical plates are offered for the following levels/configurations. These are offerings as detailed in the original submission.
One Level Two Level Three Level Four Level Five Level
Anatomically curved metallic plate
Manually applied locking mechanism

The provided document describes the Lanx Anterior Cervical Plate System's 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria. This type of submission is common for Class II medical devices and typically relies on design, material, and performance comparisons to a previously cleared device. Therefore, much of the requested information (like specific acceptance criteria, sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) is not usually part of a 510(k) summary for such a device.

However, based on the provided text, I can infer and extract some relevant details pertaining to "acceptance criteria" through the lens of substantial equivalence and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the new plates' performance is "equivalent to the previously cleared anterior cervical plates." The criteria for this equivalence are not explicitly numerical acceptance values in the text but are implied through the performance tests conducted.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document states "Samples were tested according to accepted engineering and scientific principals." However, it does not specify the exact number of samples used for fatigue and static testing.
• Data Provenance: The testing was conducted by LANX, LLC (the manufacturer), based on "accepted engineering and scientific principals." There is no information provided on the country of origin of data beyond the fact that LANX, LLC is based in Boulder, CO, USA. The testing described is retrospective (performed as part of the device development and submission process).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• This information is not applicable or not provided in this 510(k) summary. For mechanical tests on a physical device, "ground truth" is established by direct measurement and established engineering principles and standards, not typically by expert review panels in the way it would be for diagnostic AI.

4. Adjudication Method for the Test Set:

• This information is not applicable or not provided. Since the testing involves mechanical performance rather than subjective interpretation, there would be no "adjudication method" in the conventional sense (e.g., 2+1 review).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or algorithms where human readers interpret medical images. The Lanx Anterior Cervical Plate System is an orthopedic implant, and its evaluation focuses on mechanical performance and substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• This question is not applicable. The device is a physical medical implant, not an algorithm. Therefore, "standalone" performance in this context refers to the device's mechanical integrity and function, which was evaluated through fatigue and static testing.

7. The Type of Ground Truth Used:

• The ground truth for the performance claim (equivalence) is based on established engineering and scientific principles, including specific ASTM and ISO material standards, and the mechanical performance of previously cleared predicate devices. The "ground truth" for the device's actual mechanical properties (e.g., fatigue life, static strength) would be the physical measurements obtained during the tests.

8. The Sample Size for the Training Set:

• This information is not applicable. There is no "training set" for physical mechanical devices in the way there is for AI/ML algorithms. The device's design and manufacturing process are informed by engineering principles, material science, and the performance of existing devices, not by a data-driven training process.

9. How the Ground Truth for the Training Set Was Established:

• This information is not applicable as there is no training set in the context of this device. The design and validation of the device rely on adherence to established engineering standards and comparison to predicate devices, where the "ground truth" for those comparisons is derived from their own validated performance and specifications.

Ask a specific question about this device