Search Results

The uCerv Flux ™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion. The hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are additively manufactured interbody fusion devices for cervical implantation. The implants are designed having porous surfaces to provide surgical stabilization of the spine. Each interbody has a central cavity that can be packed with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material and lateral windows for radiographic visualization. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.

The provided FDA document is a 510(k) clearance letter for a medical device, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI algorithms is not present in this document.

The document describes the uCerv Flux™-C 3D Porous Titanium Cervical Interbody, an intervertebral body fusion device. The acceptance criteria and "study" described relate to the mechanical performance of this physical device, not a digital diagnostic or AI-driven system.

Here's the relevant information based on the provided text:

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

Explanation: The document states that "Mechanical testing of the worst case Flux-C devices was relied upon in support of the original uCerv Flux™-C 3D Porous Titanium Cervical Interbody clearance. The testing included static and dynamic axial compression and static torsion according to ASTM F2077 and subsidence according to ASTM F2267. An engineering rationale was used to demonstrate that the additional cervical interbody sizes did not introduce a new worst case." It further mentions, "Mechanical testing of the worst case subject uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants included dynamic torsion according to ASTM F2077 and expulsion tests. The mechanical test results demonstrate that the uCerv Flux™-C 3D Porous Titanium Cervical Interbody performance is substantially equivalent to the predicate devices." The acceptance criteria are implicit in meeting the standards (ASTM F2077, ASTM F2267) and demonstrating substantial equivalence to predicate devices. Specific numerical thresholds for acceptance are not provided in this summary.

Regarding the remaining points (2-9), the provided document does not contain information about an AI algorithm or a study involving human readers, so these points cannot be addressed. The document is for a physical orthopedic implant.

Here's why the other points are not applicable:

• 2. Sample size used for the test set and the data provenance: Not applicable. This document is about a physical device's mechanical performance, not an AI test set with data.
• 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 for an AI test set is mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for an AI algorithm is mentioned.
• 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. No AI assistance or human reader study is discussed.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for the device is its mechanical integrity and performance as per ASTM standards, compared to predicate devices.
• 8. The sample size for the training set: Not applicable. No AI training set is mentioned.
• 9. How the ground truth for the training set was established: Not applicable. No AI training set is mentioned.

Ask a specific question about this device

The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are additively manufactured interbody fusion devices for cervical implantation. The implants are designed having porous surfaces to provide surgical stabilization of the spine. Each interbody has a central cavity that can be packed with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material and lateral windows for radiographic visualization. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.

The given text describes a medical device, the uCerv Flux™-C 3D Porous Titanium Cervical Interbody, and its 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device through performance testing. However, it does not contain information related to acceptance criteria or studies involving AI or human-in-the-loop performance.

Therefore, for the information requested regarding acceptance criteria, AI studies, human experts, and ground truth for AI model development, I must state that this information is not present in the provided document.

The document details mechanical testing for the interbody device to demonstrate substantial equivalence to predicate devices, but this is a different type of evaluation than what is asked for in the prompt.

Here's a breakdown of what is available in the document related to performance, even though it's not about AI:

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

The document states that the performance data for the uCerv Flux™-C 3D Porous Titanium Cervical Interbody included:

• Static and dynamic axial compression according to ASTM F2077.
• Static and dynamic torsion according to ASTM F2077.
• Subsidence according to ASTM F2267.
• Expulsion tests.

The reported performance is that "The mechanical test results demonstrate that the uCerv Flux™-C 3D Porous Titanium Cervical Interbody performance is substantially equivalent to the predicate devices."

However, specific numerical acceptance criteria (e.g., "must withstand X N of force") and detailed numerical results are NOT provided in the text. It only states the tests performed and the conclusion of substantial equivalence.

2. Sample sized used for the test set and the data provenance

Not applicable, as the evaluation is mechanical testing of physical device units, not a dataset for an AI model. The document does not specify the number of devices tested in the mechanical studies.

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

Not applicable, as the evaluation is mechanical testing, not expert-based assessment.

4. Adjudication method for the test set

Not applicable, as the evaluation is mechanical testing, not a read study 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

No, this type of study was not done or mentioned. The device is a cervical interbody fusion device, not an AI diagnostic tool.

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

No, this is not an AI algorithm.

7. The type of ground truth used

For the mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices. The document implies compliance with ASTM standards, which provide established methodologies and expected performance ranges for such devices.

8. The sample size for the training set

Not applicable, as there is no mention of an AI training set.

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

Not applicable, as there is no mention of an AI training set.

Ask a specific question about this device