Search Results

The MIS Anterior Cervical Plating System is intended for anterior fixation to the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with:

1. Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);
2. Spondylolisthesis
3. Trauma (including fractures or dislocations);
4. Spinal cord stenosis;
5. Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis);
6. Tumors;
7. Pseudarthrosis;
8. Failed previous fusions.

The MIS Anterior Cervical Plating System components are temporary implants that are intended for anterior fixation to the cervical spine during the development of a cervical spinal fusion.

The MIS Anterior Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.

Manufactured from medical grade titanium alloy as described by ASTM F136.

The provided text describes the "MIS Anterior Cervical Plating System," a medical device, and its acceptance criteria, which are primarily based on mechanical testing and substantial equivalence to predicate devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Dynamic Compression
• Static Compression and Torsion | All mechanical test results are presented in Appendix E (though Appendix E is not provided in the input text). The conclusion states: "The test results demonstrate that the MIS Anterior Cervical Plate is substantially equivalent to the predicate devices, Nuvasive Helix-Mini ACP (K073275) and NEO SL Anterior Cervical Plate (K070285)." |
  | Substantial Equivalence to Predicate Devices (Nuvasive Helix-Mini ACP (K073275) and NEO SL Anterior Cervical Plate (K070285)) in:
• Indications for Use
• Design
• Function
• Materials Used | The device is claimed to be substantially equivalent to the predicate devices in these aspects. This is the primary "performance" metric for a 510(k) submission where direct comparative clinical or performance metrics are often not required if substantial equivalence can be demonstrated through other means (like mechanical testing and design comparison). |

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

The provided text does not specify a sample size for a test set in the context of clinical data or patient data. The "test set" refers to mechanical tests performed on the device itself.

• Sample Size for Mechanical Testing: Not explicitly stated (e.g., number of plates or screws tested).
• Data Provenance: The mechanical testing was performed by an "independent third party test facility." The country of origin for the data is not specified, but the submission is to the U.S. FDA. The testing is not described as retrospective or prospective clinical data; it is laboratory-based mechanical testing.

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

This section is not applicable to this type of device submission. Ground truth, in the context of expert consensus, is typically relevant for studies involving diagnostic accuracy or clinical outcomes where human interpretation is involved. For this mechanical device, the "ground truth" for the test set is established by adherence to a standardized test method (ASTM 1717) and engineering principles, not expert clinicians establishing a "diagnosis."

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or studies to resolve discrepancies in expert opinions or interpretations of data. The "test set" here refers to mechanical tests, which are objective measurements, not subject to human interpretation requiring adjudication.

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

This is not applicable. An MRMC study is relevant for AI-powered diagnostic or screening devices where the performance of human readers (e.g., radiologists, pathologists) is being evaluated, often with or without AI assistance. The "MIS Anterior Cervical Plating System" is a physical implant, not an AI diagnostic tool, and therefore, no such study was performed or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This question pertains to AI algorithms. The device is a physical medical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of this device is based on mechanical engineering standards (ASTM F136 for material, ASTM 1717 for testing methods) and the established performance of legally marketed predicate devices. The primary "ground truth" is that the device's mechanical properties meet the established benchmarks for safety and effectiveness as demonstrated by the predicate devices. There is no biological or diagnostic "ground truth" in the clinical sense mentioned (e.g., pathology slide, patient outcome).

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of machine learning or AI for this mechanical medical device submission.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

Ask a specific question about this device