Search Results

The VERTEBRON SSP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine 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), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The SSP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The modified VERTEBRON SSP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components, The modified VERTEBRON SSP™ Cervical Plate System attaches to the vertebral body by means of self tapping, self drilling or rigid cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a rigid cervical screw.

The acceptance criteria for the VERTEBRON SSP™ Cervical Plate System are based on demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing. The study demonstrating this involved performing tests in accordance with ASTM F1717.

Here's the detailed breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size used for the mechanical tests. The "test set" in this context refers to the physical samples of the VERTEBRON SSP™ Cervical Plate System with the added rigid cervical screw that underwent mechanical testing.

• Sample Size: Not specified. Standard practice for such tests involves a sufficient number of samples to ensure statistical validity and representativeness of the device's performance.
• Data Provenance: The data comes from prospective mechanical testing conducted on the modified VERTEBRON SSP™ Cervical Plate System to evaluate its performance against established standards and predicate devices. No specific country of origin for the data generation is mentioned, but it would have been conducted by or for VERTEBRON Inc. in the US, given the submission to the FDA.

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

This information is not applicable as the acceptance criteria and study in question are for a medical device (spinal implant) and pertain to mechanical performance rather than diagnostic accuracy or clinical outcomes requiring expert interpretation of data. The "ground truth" here is the pass/fail criteria defined by the ASTM F1717 standard for mechanical properties.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing according to a defined standard like ASTM F1717 involves objective measurements and predefined pass/fail thresholds. There is no need for expert adjudication in the way it would be applied to clinical image interpretation or diagnostic accuracy studies.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The VERTEBRON SSP™ Cervical Plate System is a physical implant, and its acceptance is based on mechanical performance, not diagnostic effectiveness.

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

This is not applicable. The device is a physical medical implant, not an algorithm or AI system. Its performance is evaluated intrinsically, not as an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for this study is defined by the mechanical performance specifications and limits outlined in the ASTM F1717 standard. This standard dictates the testing methodology and acceptance criteria for spinal intervertebral body fixation devices. The device's performance (e.g., strength, fatigue resistance) is measured and compared against the predefined limits within this standard.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this submission. The device is a physical product, not a machine learning model.

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

This is not applicable. As there is no training set for a machine learning model, there is no ground truth established for it. The "ground truth" for the device's mechanical performance is defined by the established and validated ASTM F1717 standard.

Ask a specific question about this device

The Modified VERTEBRON SSP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical soins fue tempor patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic shudies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordnois, ar scoliosis), pseudoarthriosis, and/or failed previous fusions. The SSP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The modified VERTEBRON SSP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The modified VERTEBRON SSP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.

The provided text describes a medical device submission for the VERTEBRON SSP™ Cervical Plate System. However, it does not include information about acceptance criteria for a study, nor does it detail a study proving the device meets specific performance metrics.

The document primarily focuses on establishing "substantial equivalence" of a modified device to a previously cleared predicate device. This is a regulatory pathway that relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a legally marketed device, rather than requiring a new, independent performance study with specific acceptance criteria.

Therefore, many of the requested sections regarding acceptance criteria and study details cannot be filled based on the provided text.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided. The document does not describe specific acceptance criteria (e.g., minimum tensile strength, fatigue life) or quantitate device performance against such criteria. It states that "Testing in accordance with ASTM F1717 was performed and demonstrated that the modified VERTEBRON SSP™ Cervical Plate System is substantially equivalent" to the predicate device. This implies that the device met the requirements of ASTM F1717, but the specific acceptance criteria of that standard and the numerical performance results are not reported.

2. Sample size used for the test set and the data provenance:

• Cannot be provided clearly. The document only mentions "Testing in accordance with ASTM F1717 was performed." It does not specify the sample size used for this testing or the provenance of any data (e.g., country of origin, retrospective/prospective). ASTM F1717 is a standard test method for spinal implant constructs, which would involve laboratory testing of physical samples, not clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This question pertains to studies involving expert review for establishing ground truth, typically in imaging or diagnostic device studies. The described submission is for a physical orthopedic implant and its substantial equivalence, not a diagnostic or AI-driven device. Ground truth, in this context, would relate to the physical properties measured in laboratory tests, not expert consensus on clinical findings.

4. Adjudication method for the test set:

• Not applicable. Similar to point 3, adjudication methods (like 2+1, 3+1) are relevant for studies where expert disagreement needs to be resolved, typically in clinical interpretation or diagnostic accuracy studies. This is not described for the physical testing of an implant.

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 submission is for an orthopedic implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance evaluation is mentioned or relevant.

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

• Not applicable. This submission is for an orthopedic implant, not an algorithm or AI-driven device.

7. The type of ground truth used:

• Cannot be explicitly stated with detail, but inferred. For the "Testing in accordance with ASTM F1717," the ground truth would be the physical measurements obtained from the mechanical tests (e.g., stiffness, strength, fatigue life) as defined by the ASTM standard. This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This submission is not about an AI/ML algorithm that requires a training set.

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

• Not applicable. This submission is not about an AI/ML algorithm that requires a training set.

In summary, the provided document details a 510(k) submission for a physical medical device (cervical plate system) seeking market clearance based on substantial equivalence to a predicate device, as demonstrated through testing in accordance with ASTM F1717. It does not contain the kind of performance data, acceptance criteria, or study design information typically associated with AI/ML device evaluations or detailed clinical performance studies, which your questions are geared towards.

Ask a specific question about this device