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The Innovasis® LxHA™ PEEK Lateral IBF 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 Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed using a lateral approach.

This device is intended to be used with internal spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the implant device is intended to be packed with autograft.

The LxHA PEEK Lateral IBF System is Innovasis' next generation intervertebral body fusion device with associated instrumentation for use in Lateral Lumbar Interbody Fusion (LLIF) surgeries. The L-Box IBF was initially submitted to FDA under K121581 in September 2012 and was cleared for sale in the USA on October 17, 2012.

The LxHA implants will be manufactured using Invibio PEEK-Optima HA Enhanced. In this material, hydroxyapatite (HA) is integrated with Invibio's PEEK-OPTIMA Natural. The LxHA implants will be manufactured using HA PEEK and are to be sold sterile.

The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone through-growth, with anti-migration teeth to engage the vertebral endplates and prevent expulsion. The implants are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients, including 0°, 8°, 12°, and 16° of lordosis. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support LLIF surgeries are provided with the implants in sterilization trays.

The provided text is a 510(k) summary for a medical device (LxHA™ PEEK Lateral IBF System) seeking FDA clearance. It describes the device, its intended use, and indicates its substantial equivalence to predicate devices based on non-clinical performance data.

However, the document does not contain any information regarding a study involving AI or human readers, acceptance criteria related to AI performance, or the methodologies for establishing ground truth for AI training/testing. The "Performance Data" section solely refers to non-clinical mechanical testing of the implant itself, not a diagnostic or AI-driven system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI, human readers, or ground truth establishment, as this information is not present in the provided text.

The document discusses the physical device (an intervertebral body fusion device) and its mechanical performance, not a software or AI-driven diagnostic tool.

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CERVICAL INTERBODY FUSION DEVICE

When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, for the treatment of cervical disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, or Aspect Systems.

LUMBAR INTERBODY FUSION DEVICE

When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DD) 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. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System.

VERTEBRAL BODY REPLACEMENT

When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine (TI-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of TI-L5) such as the Streamline TL Spinal Fixation System. Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.

The system includes implantable devices manufactured from PEEK with tantalum or titanium alloy radiographic markers that are available in a variety of different shapes and sizes to accommodate varying patient anatomy and surgical approach. The IBF/VBR implants may be implanted via a variety or open or minimally invasive approaches, including anterior, lateral, posterior and oblique.

This document is a 510(k) premarket notification for the "Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System". It concerns the clearance for the use of allogenic bone graft with the existing C-Plus cervical intervertebral body fusion device.

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

This document does not provide a table of acceptance criteria or specific device performance metrics in numerical form. Instead, the basis for clearance is substantial equivalence to a predicate device (Pioneer IBF/VBR System K133455) and a literature analysis. The "performance" in this context refers to demonstrating that the expanded indication (use of allogenic bone graft) poses no new risks and is equivalent to the established performance with autogenous bone graft.

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

• Sample size for the test set: Not applicable and not explicitly stated. The submission relies on a "literature analysis of published clinical data" rather than a new test set generated for this 510(k). The literature analysis would have encompassed various studies, each with its own sample size.
• Data provenance: Not specified in terms of country of origin or whether the individual studies in the literature analysis were retrospective or prospective. The submission only states it's "published clinical data."

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 submission relies on a literature analysis, not a new study with a ground truth established by experts specifically for this submission. The "ground truth" (clinical outcomes) would have been established within the original published studies by the researchers and clinicians involved.

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

Not applicable. No new test set or adjudication process was performed for this 510(k) submission.

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 spinal implant device, not an AI/imaging device.

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

Not applicable. This is a spinal implant device, not an AI/imaging device.

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

The "ground truth" implicitly referred to in the literature analysis would be the clinical outcomes data from previously published studies on cervical interbody fusion devices using allogenic bone graft. This would include fusion rates, pain reduction, adverse events, etc.

8. The sample size for the training set

Not applicable. No new algorithm or model was trained for this submission. The device is a physical implant.

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

Not applicable. No new algorithm or model was trained for this submission.

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