Search Results

The Innovasis Ax Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The Ax Stand-Alone interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.

The Innovasis Ax Stand-Alone ALIF implant will be provided in two configurations. The first is an HA PEEK caqe with an integrated titanium faceplate. The second is an all titanium version of the same implant. Both designs will feature screws, a locking mechanism, and instruments. The implant is a stand-alone anterior intervertebral body fusion device indicated for use in patients with degenerative disk disease (DDD) at one or two contiquous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s).
The interior of the device will be packed with autograft.
Intended to support restoration of the sagittal balance.
It is intended to be used with bone screws and will not require additional supplementary fixation for implants with a lordotic angle less than 20°.
Implants with a lordotic angle ≥20° are indicated for use with supplementary fixation, such as the Excella Spinal System.
It is intended for use with the standard anterior approach

The provided document is a 510(k) premarket notification from the FDA for a medical device called the Ax™ Stand-Alone ALIF System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes.

Therefore, the document does not contain the information requested for acceptance criteria and the study that proves the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance (in terms of diagnostic metrics).
• Sample size used for a test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Information on a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document details non-clinical performance data (mechanical testing) demonstrating substantial equivalence to predicate devices.

Here's what the document does provide regarding performance data and substantial equivalence:

1. Acceptance Criteria and Device Performance (Non-clinical):

2. Sample size used for the test set and the data provenance: Not applicable. The document discusses non-clinical mechanical testing, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) 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: Not applicable. This is not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical testing, the "ground truth" is defined by the established industry standards (ASTM F2077-14 and F2267-04) and the performance of the predicate device.

8. The sample size for the training set: Not applicable.

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

Ask a specific question about this device

The NuVasive CCX-L Interbody System is intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.

The CCX-L Interbody System is intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CCX-L Interbody System. The CCX-L Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The CCX-L Interbody intervertebral fusion device is designed to address lumbar pathologies utilizing interbody placement through a standard posterolateral approach. The NuVasive CCX-L Interbody System is manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3, and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

Ask a specific question about this device

The NuVasive CoRoent XL-F System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent XL-F System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to L5, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The system is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle or facet screws) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The NuVasive CoRoent XL-F System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, MP35N conforming to ASTM F562, and titanium alloy conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided text describes a 510(k) premarket notification for the NuVasive CoRoent XL-F System, which is an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a study with performance metrics in the typical sense of a novel medical AI/software device.

Therefore, the requested information elements related to performance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to this document. The submission relies on non-clinical performance data (engineering analyses and cadaveric study) to demonstrate safety and effectiveness relative to existing devices.

Here's a breakdown of what can be extracted and why other elements are not applicable:

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

• Not Applicable in the traditional sense. For a 510(k) for an intervertebral body fusion device, "acceptance criteria" are typically related to meeting established performance standards for mechanical properties and biocompatibility, as demonstrated through engineering analyses and material testing, rather than clinical performance metrics (like sensitivity, specificity, accuracy) for an AI/software device. The document states that the objective was to demonstrate substantial equivalence to predicate devices.
• Reported Device Performance (based on non-clinical studies):
  • Axial Compression Finite Element Analysis: "Results demonstrate that the subject CoRoent XL-F System presents no new worst-case for performance testing."
  • Compression Shear Finite Element Analysis: "Results demonstrate that the subject CoRoent XL-F System presents no new worst-case for performance testing."
  • Wear Debris Analysis: No specific performance reported, but implied to be acceptable for substantial equivalence.
  • Subsidence Analysis: No specific performance reported, but implied to be acceptable for substantial equivalence.
  • Clinical Literature Analysis: Used for comparison, not direct performance measurement of the device itself.
  • Cadaveric Study: "Did not identify any new risks associated with the subject device."

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

• Not Applicable. No test set in the context of an AI/software device performance study was used. The studies conducted were engineering analyses (Finite Element Analysis) and a cadaveric study.
  • For the cadaveric study, the sample size is not specified in the provided text.
  • Data provenance for FEA is theoretical modeling; for the cadaveric study, the source/provenance is not detailed.

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 device is a physical implant, not an AI/software device that requires human expert annotation for ground truth establishment. Engineering analyses and cadaveric studies are evaluated by engineers and medical professionals specialized in those fields, but not in the context of "ground truth" for a test set.

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

• Not Applicable. There was no "test set" in the context of a diagnostic or predictive performance study, and therefore no adjudication method as described.

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 a physical intervertebral body fusion device, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant.

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

• Not Applicable. This device does not contain software or electrical equipment, as explicitly stated in section F. It is a physical implant.

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

• Not Applicable in the typical sense of AI/software device. For this physical device, the "ground truth" for its safety and effectiveness is established through adherence to engineering standards (e.g., ASTM F2026, F562, F136, ISO 5832-3 for material composition), and the findings of the finite element analyses and cadaveric study which confirm it performs similarly to predicate devices without introducing new risks. Clinical literature analysis also contributes to supporting the established safety and effectiveness of similar devices.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not Applicable. As there is no training set for machine learning involved with this device.

Ask a specific question about this device