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 Acro Composites Interbody System is intended for interbody fusion. The devices are designed for use 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 and are to be used with supplemental fixation cleared for the implanted level.
The Acro Composites cervical devices are intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The cervical devices are indicated to treat 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 hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate.
The Acro Composites lumbar devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The lumbar devices are indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRI). Additionally, the lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The hyperlordotic implants (≥ 20°) should be used with anterior supplemental fixation.

The Acro Composites Interbody System includes interbody fusion devices for cervical and lumbar implantation manufactured from AcroPek – a carbon fiber reinforced PEKEKK polymer (CFRP) material. The implants are designed as a solid frame to provide surgical stabilization of the spine. Each interbody incorporates a central cavity that can be packed bone graft material. 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 implants are sold sterile.

The provided document is a 510(k) summary for the Acro Composites Interbody System, a medical device for spinal fusion. It details the device's indications for use, materials, and a declaration of substantial equivalence to predicate devices. However, this document does not describe an AI or software device study. It describes the mechanical performance testing of an intervertebral fusion device to demonstrate its safety and effectiveness.

Therefore, most of the information requested in your prompt, which pertains to AI/software device studies (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth for AI), is not present in the provided text.

Based on the information provided, here's what can be extracted:

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

Note: The reported device performance is stated as "The mechanical test results demonstrate that the Acro Composites Interbody System performance is substantially equivalent to the predicate devices" and that it aligns with the specified ASTM standards. Specific numerical values for acceptance criteria or performance are not provided in this summary.

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

• Sample Size: Not specified in the document. Mechanical testing typically involves a specific number of samples for each test type (e.g., several devices for compression, shear, and torsion).
• Data Provenance: Not specified. These are laboratory-based mechanical tests, not clinical data from patients.

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. This is not an AI/software device and does not involve human expert interpretation for "ground truth". The "ground truth" here is compliance with engineering standards (ASTM).

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

• Not applicable. (See answer to point 3).

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 is not an AI/software device.

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

• Not applicable. This is not an AI/software device.

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

• The "ground truth" in this context is compliance with established engineering and biocompatibility standards, specifically:
  • ASTM F2077 (Standard Test Methods for Static and Dynamic Axial Compression, Compression-Shear, and Torsion Testing of Spinal Implants)
  • ASTM F2267 (Standard Test Method for Measuring Load Between Parallel Platens for Intervertebral Body Fusion Devices)
  • ASTM F1876 (PEKEKK resin material standard)
  • ASTM B562 (Gold wire material standard)
  • ASTM F899 (Medical grade stainless steel material standard)

8. The sample size for the training set

• Not applicable. This is not an AI/software device and does not involve a "training set."

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

• Not applicable. (See answer to point 8).

Summary of what the document IS about:

The document describes the submission of a 510(k) premarket notification for the Acro Composites Interbody System. The intent is to demonstrate "substantial equivalence" to existing, legally marketed predicate devices. This equivalence is primarily shown through:

• Identical Intended Use: Interbody fusion for cervical and lumbar spine.
• Similar Technological Characteristics: Basic design (structural column), material (reinforced polymer), and sizes comparable to predicate systems.
• Performance Data: Mechanical testing (static & dynamic axial compression, compression-shear, torsion, and subsidence) was performed according to ASTM F2077 and F2267 standards. The results demonstrate that the device's performance is substantially equivalent to the predicate devices and meets these standards.

Ask a specific question about this device

The ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System is indicated to treat 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 ZSFab Cervical Interbody System is designed for use 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 and to be used with supplemental fixation cleared for use in the cervical spine. Implants having a lordotic angulation >10° are required to be used with an anterior cervical plate as the form of supplemental fixation.

The ZSFab Cervical Interbody System includes additively manufactured interbody fusion devices for cervical implantation. The implants are designed with lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with minor axis length of 500-920μm and maior axis length of 810-1390μm. Each interbody has a bone graft window that can be packed with bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.

This document describes a 510(k) premarket notification for the ZSFab Cervical Interbody System. The filing is for the addition of new sizes to an existing device (K202488). The document does not describe a study involving an AI/CADe device or a study with specific acceptance criteria that would include metrics like sensitivity, specificity, or AUC, as it is a filing related to a physical medical device (interbody fusion system) and not an AI-based diagnostic or imaging tool.

Therefore, most of the requested information regarding acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth, and training set would not be applicable to this type of device submission.

The "Performance Data" section in the document refers to mechanical testing for the physical device, not an AI/CADe system.

Here's a breakdown of why each item is not applicable:

1. A table of acceptance criteria and the reported device performance: Not applicable. The "Performance Data" section mentions mechanical testing (static/dynamic axial compression, torsion, subsidence, expulsion) according to ASTM standards and sterilization validations (AAMI ST79). These are material and physical performance criteria, not clinical performance metrics for an AI/CADe system. The document states an "engineering rationale was used to demonstrate that the additional cervical interbody sizes did not introduce a new worst case." This is a justification for not repeating full mechanical testing for new sizes, not an acceptance criterion table for an AI.

2. Sample size used for the test set and the data provenance: Not applicable. There is no test set of patient data for an AI/CADe system. The "worst case" in mechanical testing refers to the most challenging physical configuration of the device, not a patient sample.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for an AI/CADe system in this submission.

4. Adjudication method for the test set: Not applicable. No test set for AI/CADe.

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 is not an AI-assisted device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no ground truth for an AI/CADe system in this submission. The "ground truth" for a physical device like this would relate to its structural integrity and biocompatibility, typically established through material testing and established medical standards.

8. The sample size for the training set: Not applicable. There is no algorithm or training set for an AI/CADe system.

9. How the ground truth for the training set was established: Not applicable. No training set.

Ask a specific question about this device