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The REGENT Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

• Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Trauma (including fractures).
• Tumors
• Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusion
• Spondylolisthesis
• Spinal Stenosis
  THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS.
  WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.

The REGENT Anterior Cervical Plate System is composed of various cervical plates and screws made from a Titanium alloy (Ti-6Al-4V, ASTM F-136/ISO 5832-3). The REGENT Anterior Cervical System contains multiple level plates (1 Level, 3 Level, and 4 Level) and various diameter screws that are either fixed or variable in nature. The plates and screws are anodized.

Here's an analysis of the provided text regarding the acceptance criteria and study for the REGENT Anterior Cervical Plate System:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission is for a modification to an already cleared device, primarily the addition of a self-drilling screw. The acceptance criteria are implicitly linked to demonstrating substantial equivalence to the predicate device (K091134), particularly in terms of mechanical performance and material properties. Since it's a modification, the "acceptance criteria" are not absolute performance thresholds but rather a demonstration that the new component (self-drilling screw) does not negatively impact the overall system's safety and effectiveness compared to the predicate.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the mechanical tests. It states "The self drilling screws and the cleared REGENT Anterior Cervical Plates were tested..." This suggests a sufficient number of samples were tested to meet the requirements of ASTM F1717.
• Data Provenance: The data is based on non-clinical (mechanical) testing conducted by Custom Spine, Inc. The country of origin for the testing itself is not explicitly stated, but the company is based in Parsippany, NJ, USA. The study is prospective in the sense that the new self-drilling screws were manufactured and then tested.

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

Not applicable. This is a submission for a medical device which relies on objective mechanical testing data and comparison to a predicate device, not on expert-established ground truth for a diagnostic algorithm.

4. Adjudication Method for the Test Set

Not applicable. This refers to adjudication of discrepancies in human interpretation, which is not relevant for mechanical testing results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is a mechanical device, not a diagnostic algorithm that involves human readers interpreting cases. Therefore, an MRMC study was not performed.

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

Not applicable. This is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence is based on objective mechanical test standards (ASTM F1717) and direct comparison of material, design, and indications for use to a previously cleared predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning model; therefore, there is no training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, there is no ground truth for a training set to establish.

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The REGENT Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

• . Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• . Trauma (including fractures)
• . Tumors
• . Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• . Pseudoarthrosis
• . Failed previous fusion
• . Spondylolisthesis
• Spinal Stenosis
  THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS
  WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE

The REGENT Anterior Cervical Plate System is composed of various cervical plates and the screws in made from a Titanium alloy (Ti-6Al-V, ASTM F-136/ISO 5832-3). The REGENT Anterior Cervical System contains multiple level plates (1 Level, 3 Level, and 4 Level) and various diameter screws that are either fixed or variable in nature. The plates and screws are anodized.

The provided text describes a medical device, the REGENT Anterior Cervical Plate System, and its regulatory submission. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a clinical or standalone study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/device performance study is not available in the provided text.

The document explicitly states "Clinical Testing Not Applicable" and "Animal Testing Not Applicable," indicating that the submission primarily relied on bench testing and comparison to predicate devices for substantial equivalence.

Here's what can be extracted from the text in relation to your request, but with the understanding that it doesn't align with a typical AI device performance evaluation:

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

Note: The "acceptance criteria" here are inferred from the mention of ASTM F 1717-04 and the substantial equivalence claim. Actual specified criteria are not provided in detail.

2. Sample sized used for the test set and the data provenance:
Not applicable. No test set for device performance as per an AI study is mentioned. The submission refers to "Bench Testing" data, but details about sample size or data provenance for these bench tests are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment for a test set is discussed in the context of an AI/device performance study.

4. Adjudication method for the test set:
Not applicable.

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. The document states "Clinical Testing Not Applicable."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
For the bench testing, the "ground truth" would be the engineered specifications and performance standards defined by ASTM F 1717-04.

8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device.

9. How the ground truth for the training set was established:
Not applicable.

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