(69 days)
The InFix System is a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
InFix is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The InFix is intended to be used with bone graft.
InFix® is manufactured from implantable grade titanium 6AL-4V alloy that conforms to ASTM F-136, and is available in various sizes and dimensions. The device is comprised of two opposing endplates supported by vertical members or "struts" that can be varied in height such that the surgeon can fix the vertebrae in a proper anatomical alignment and lordosis.
Each of the struts includes a load-sharing mechanism that allows a limited amount of strain across the fusion mass while supporting the load bearing surfaces. An Ultra High Molecular Weight Polyethylene (UHMWPE) end cap may be placed inside the device prior to packing of bone graft to effectively block the posterior opening in the device and contain the material inside.
Holes in the titanium endplates provide space for bone in-growth while angled spikes (teeth) penetrate the vertebral endplates and provide resistance to rotation and migration.
The provided text describes a 510(k) summary for a medical device called the "Spinal Concepts Inc. InFix® System". It does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/readership performance perspective.
The document is a premarket notification for a traditional medical device (a spinal implant) and focuses on demonstrating substantial equivalence to predicate devices through mechanical testing. It does not involve any AI components, human reader performance evaluations, or diagnostic accuracy studies typically associated with the questions posed in the prompt.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training/testing data sets as these concepts are not relevant to the provided text.
The only "study" mentioned is mechanical testing to demonstrate substantial equivalence, which is a different type of evaluation.
Summary of available information related to performance criteria, even though it's not AI-related:
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Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implicit): The device (InFix® System) is designed to be "substantially equivalent" to predicate devices (Interpore Cross GEO™ Structure and Interpore Cross International Anterior Fixation Device (AFD)) based on mechanical performance. This implies that its mechanical properties must be comparable or superior to the predicate devices.
- Reported Device Performance: "Mechanical testing demonstrates that InFix® is substantially equivalent to the Interpore Cross GEO™ Structure and Interpore Cross International Anterior Fixation Device (AFD) predicate devices."
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Sample size used for the test set and the data provenance: Not applicable. The "test set" here would refer to the physical devices subjected to mechanical testing, not a dataset of images or clinical cases. The provenance of the data is that it was generated through mechanical testing, presumably in a lab setting by the device manufacturer, Spinal Concepts, Inc.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is typically established by engineering specifications and objective measurements, not clinical expert consensus.
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Adjudication method: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not applicable as the device is a physical implant, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.
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The type of ground truth used: For the mechanical testing, the ground truth would be quantitative measurements of material strength, load-bearing capacity, fatigue resistance, etc., against established industry standards and/or the performance of the predicate devices.
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The sample size for the training set: Not applicable. "Training set" refers to data used to train an AI model.
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How the ground truth for the training set was established: Not applicable.
In conclusion, the provided document is a regulatory submission for a physical medical implant, and the questions posed are primarily relevant to AI/diagnostic software. Therefore, most of the requested information is not present or applicable.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.