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IVA-C (ACIF):
The IVA-C Cage System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

AEON-C (ACIF):
The AEON-C Cage System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C Cage System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.

IVA-L (ALIF, PLIF, DLIF, TLIF) & AEON-L (ALIF):
The IVA-L Cage System and AEON-L Cage System are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AEON-L Cage System is designed for use with or without the bone screws, depending on the surgeon's discretion. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The IVA & AEON Cervical and Lumbar Cage System are cervical and lumbar intervertebral fusion cages that are implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The cages are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method). The cages are manufactured from titanium alloy powder per ASTM F3001 or titanium alloy per ASTM F136 or PEEK per ASTM F2026. The screws are manufactured from titanium alloy per ASTM F136. They are provided non-sterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.

This FDA 510(k) Clearance Letter is for the IVA & AEON Cervical and Lumbar Cage System, which are intervertebral body fusion devices. It is a Class II device.

Crucially, this document focuses on the substantial equivalence of a physical medical device (intervertebral cages) based on engineering performance tests, materials, and design features, not on the performance of an AI/ML software.

Therefore, most of the requested information regarding AI/ML device performance (acceptance criteria table, study details, human reader improvement, ground truth, training set, etc.) is not applicable to this specific submission.

The document states:

• "Summary of Performance Data (Nonclinical and/or Clinical):" and then lists "Non-Clinical Tests" such as Static/Dynamic Compression Bending, Static/Dynamic Compression Shear Bending, Static/Dynamic Torsion, and Subsidence, all referencing ASTM standards.
• "Clinical Tests: - N/A"

This means that the device was cleared based on non-clinical (laboratory/mechanical) testing, not on clinical performance studies involving patient data or AI/ML algorithm evaluation.

To answer your specific questions in the context of this document:

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

   • Not Applicable (N/A) for AI/ML performance.
   • For the physical device, the acceptance criteria would be defined by the referenced ASTM standards (e.g., ASTM F2077, ASTM F2267) for specific mechanical properties (e.g., strength, durability, resistance to subsidence). The document states that the "Results of the non-clinical tests indicate that the device will perform within the intended uses," implying these criteria were met, but specific numerical performance data is not provided in this public summary.

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

   • N/A for AI/ML performance.
   • For the mechanical tests, the "sample size" would refer to the number of physical devices tested to ASTM standards. This information is not provided in this summary. Data provenance is also N/A as it's not patient data.

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

   • N/A. Ground truth establishment by experts is relevant for diagnostic or AI/ML interpretation performance, not for the mechanical testing of a physical implant.

4. Adjudication method:

   • N/A. Adjudication is relevant for expert consensus in AI/ML or clinical studies.

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:

   • N/A. This is a physical implant, not an AI-assisted diagnostic tool.

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

   • N/A. This is not an algorithm.

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

   • N/A for AI/ML. For the device, the "ground truth" would be established mechanical properties as defined by the ASTM standards (e.g., material properties, structural integrity under load).

8. The sample size for the training set:

   • N/A. There is no training set as no AI/ML algorithm is involved.

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

   • N/A. There is no training set.

In summary, the provided FDA 510(k) clearance letter pertains to a surgical implant, not an AI/ML software. Therefore, the questions related to AI/ML device performance and associated studies are not applicable to this document. The clearance is based on the substantial equivalence to predicate devices and adherence to mechanical performance standards, as indicated by the non-clinical tests section.

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The IVA Cage (ACIF, Ti ACIF) are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage

The IVA Cage (PLF, TLIF, DLIF, Ti PLIF, Ti TLIF, Ti DLIF and Ti ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level of two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The IVA Cage Ti (ACIF, PLIF, TLIF, DLIF and ALIF) is intended for intervertebral body fusion in skeletally mature patients. The intended operation of these devices are concentrated around disc levels from the C2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbar spine.

The provided text does not contain information about the acceptance criteria and performance of a device based on a study with AI in the loop. The document is a 510(k) premarket notification for an intervertebral body fusion device (IVA Cage Ti) and focuses on demonstrating substantial equivalence to a legally marketed predicate device.

The document discusses:

• Device Name: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
• Regulation Number: 21 CFR 888.3080
• Regulatory Class: Class II
• Product Code: MAX, ODP
• Indications for Use: Intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical and lumbar spine, with specific disc levels mentioned.
• Performance Data: States "The addition of components to the system did not introduce a new worst case construct as evaluated based on an engineering analysis. Dynamic axial compression test per ASTM F2077 was performed."
• Predicates: IVA (ACIF, PLIF, TLIF, DLIF, and ALIF) Cage (K162220) and SUSTAIN® & SUSTAIN® - R (K130478).
• Substantial Equivalence Determination: Based on technical characteristics, performance, and intended use to the predicate system(s).

There is no mention of:

• Acceptance criteria for an AI-powered device.
• A study evaluating AI performance (standalone or with human-in-the-loop).
• Sample sizes for test or training sets related to AI.
• Experts or ground truth establishment for AI.
• MRMC comparative effectiveness study or related effect sizes.

Therefore, I cannot provide the requested information based on the given input text.

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IVA scans are intended for the visualization or quantitative assessment of vertebral bone deformities. IVA also allows the visualization of abdominal aortic calcification, and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.

IVA (MXA -II) software option for the X-Ray bone densitometers.

The provided text is a 510(k) summary for the IVA (MXA-II) software option for X-Ray bone densitometers. It focuses on a modified indication for use, specifically for the visualization of abdominal aortic calcification in addition to vertebral bone deformities. However, it explicitly states that no changes were made to the software's operation or performance specifications for this modification. Therefore, the document does not contain information about acceptance criteria or a study proving that the device meets those criteria for the detection of abdominal aortic calcification, as it relies on the predicate device's established performance for a new indication without altering the core functionality.

The document emphasizes substantial equivalence to predicate devices (Hologic Vertebral Morphometry Software Option and Hologic Vertebral Morphometry Software II Option, and general use x-ray systems like the Toshiba KXO-80G x-ray generator). This suggests that previous studies conducted for the predicate devices likely established their performance for vertebral morphometry, which the IVA (MXA-II) software inherits.

Therefore, based solely on the provided text, I cannot complete the requested information regarding acceptance criteria and a study demonstrating the device meets those criteria for the new indication of abdominal aortic calcification visualization. The document explicitly states: "No changes to the manner in which the MXA or MXA-II software operates will be made for the modification to the intended use, nor will any changes be made in the device's performance specifications."

To fully answer your request for this specific modification, additional documentation detailing the validation of the new indication (abdominal aortic calcification visualization) would be required.

However, I can extract the general information presented in the 510(k) summary:

• Device Trade Name: IVA (MXA -II) software option for the X-Ray bone densitometers.
• Device Common Name: X-Ray Bone Densitometer
• Intended Use: IVA scans are intended for the visualization or quantitative assessment of vertebral bone deformities. IVA also allows the visualization of abdominal aortic calcification, and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.
• Predicates: Hologic Vertebral Morphometry Software Option (K941362), Hologic Vertebral Morphometry Software II Option (K992775), General use x-ray systems (e.g., Toshiba KXO-80G x-ray generator; K945668).

Without a study specifically evaluating the IVA (MXA-II) software against acceptance criteria for abdominal aortic calcification visualization, I cannot provide the requested details.

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