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The CODA™ Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: 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, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile and sterile, single use plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes non-sterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.

The provided text is related to a 510(k) premarket notification for a medical device called the CODA™ Anterior Cervical Plate System. It details the regulatory review process, indications for use, and a comparison to a previously cleared predicate device.

However, the document does not contain information about acceptance criteria for a device, a study that proves the device meets specific performance criteria against those acceptance criteria, sample sizes for test or training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance. The document explicitly states: "Clinical data was not necessary for the determination of substantial equivalence." This means that rigorous performance studies involving clinical data or human-in-the-loop assessments as typically seen for AI/ML-based devices or diagnostics were not conducted or required for this submission.

The 510(k) submission for the CODA™ Anterior Cervical Plate System focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily addressing a change in the sterilization and packaging configuration ("to introduce sterile implants to the CODA™ Anterior Cervical Plate System"). The non-clinical testing mentioned was to show that this change "does not impact the safety or performance" compared to the predicate, rather than meeting specific performance metrics for a novel AI/ML application.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving device performance using the provided text, as the necessary information is not present.

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The DVR® Crosslock Wrist Spanning Plate is indicated for skeletally mature patients for fixation of fractures, osteotomies and non-unions of the distal radius.

The DVR® Crosslock Wrist Spanning Plate is a single-use plate for the fixation of fractures, osteotomies and non-unions of the distal radius. The plate spans the patient's wrist and is placed from the radial shaft to the second or third metacture pattern and patient anatomy. The plate provides ligamentotaxis on a temporary basis while the distal radius heals. The DVR® Crosslock Wrist Spanning Plate consists of a single, sterile-packed plate and is manufactured from titanium alloy (Ti-6AL-4V). The plate features hole clusters consisting of locking screw holes, a central screw cluster, and K-wire holes for preliminary fixation. There is a dorsal bend at the distal end of the plate to accommodate patient anatomy.

The provided document describes a medical device called the "DVR® Crosslock Wrist Spanning Plate" and its clearance through the FDA 510(k) pathway. This pathway does not typically involve clinical studies proving novel efficacy, but rather substantial equivalence to a predicate device. Therefore, the information requested regarding acceptance criteria and studies specifically proving the device's performance in a clinical context (e.g., effect size with AI assistance, expert consensus, training set details) will not be present.

Instead, the document details non-clinical testing to demonstrate substantial equivalence to a predicate device.

Here's the information extracted from the document, focusing on the available details:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not applicable. The testing described is non-clinical, involving mechanical testing of the device itself, not human subjects or patient data.
• Data Provenance: Not applicable. The testing was laboratory-based mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The ground truth for mechanical testing is established by engineering standards and measurements, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This concept applies to human interpretation or clinical trials, not mechanical performance testing.

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

• No MRMC comparative effectiveness study was done for this device, as it is a bone fixation plate, not an AI-powered diagnostic or assistive technology.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• The "ground truth" for this device's performance evaluation was based on accepted engineering standards and the performance of a predicate device as defined by ASTM F382-17 (Standard Specification and Test Method for Metallic Bone Plates).

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a "training set."

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

• Not applicable. This device does not involve machine learning or a "training set."

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