Search Results

The Sonoma Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastic malignant tumors; deformity (defined as kyphosis, lordosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.

The Sonoma Anterior Cervical Plate System includes titanium alloy anterior cervical plates and bone screws. The anterior cervical plates will be available in levels 1 through 4 and in 31 sizes that range from 12.0 to 84.0mm. The cervical plate bone screws will be offered in 4.0mm and 4.5mm fixed and variable angles and come in sizes ranging from 10mm to 20mm. All screws will also be available with a single or double lead. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The Sonoma Anterior Cervical Plate System also utilizes a variety of instruments to assist in placement of the devices. These instruments include a cervical awl, removal tool, tap, plate bender, driver, standard fixed/variable drill guide, and drills. The instruments will be fabricated from stainless steel and Radel. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The provided text describes the Sonoma™ Anterior Cervical Plate System, a medical device for spinal fixation. It is a 510(k) submission, meaning it aims to demonstrate substantial equivalence to a legally marketed predicate device rather than undergoing a new PMA (Premarket Approval) process based on extensive clinical trials.

Therefore, the documentation does not include a study demonstrating the device meets a specific set of acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) using a defined test set, expert ground truth, or comparative effectiveness studies with human readers.

Here's an analysis based on the information provided, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, there are no acceptance criteria for diagnostic or clinical performance (e.g., sensitivity, specificity, accuracy) or a corresponding reported device performance. The 510(k) submission focuses on demonstrating substantial equivalence to predicate devices for mechanical strength and intended use.

The closest to "acceptance criteria" are the characteristics compared in Table 1 for substantial equivalence, specifically "Mechanical Strength." The document states "See test results" under Sonoma ACPS for Mechanical Strength, implying these results were used to show substantial equivalence to the predicate devices, but the specific criteria or results are not detailed in this summary.

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

Not applicable. This device is a mechanical implant, and the submission is a 510(k) claiming substantial equivalence. It does not involve a "test set" of patient data or images in the way a diagnostic AI device would. The performance evaluation would have primarily involved mechanical bench testing to demonstrate similar strength and durability to the predicate devices. The document explicitly states: "A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration."

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

Not applicable. As no clinical studies or diagnostic test sets were used, there was no need for experts to establish ground truth in this context. The "ground truth" for mechanical testing would be established by engineering standards and comparative analyses with predicate device specifications and performance.

4. Adjudication Method for the Test Set:

Not applicable. There was no diagnostic "test set" 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:

Not applicable. This device is a spinal implant, not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used:

For the purpose of the 510(k) submission, the "ground truth" implicitly used was the established characteristics and performance of the predicate devices (Synthes Anterior Cervical Vertebrae Plates and Howmedica Osteonics' Reflex Anterior Cervical Plate System). The submission aims to show that the Sonoma system is substantially equivalent in terms of intended use, indications for use, design, materials, and mechanical strength to these legally marketed devices.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of an AI device.

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

Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (spinal implant). It focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and mechanical performance, rather than clinical or diagnostic performance evaluated through studies involving patient data or AI algorithms. As such, many of the questions related to AI device evaluation are not applicable to this submission.

Ask a specific question about this device