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The IdentiTi™ II Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the IdentiTi II System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The IdentiTi II Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

AMP™ II Anti-Migration Plate may be used with IdentiTi II LIF interbody spacers to provide integrated fixation. IdentiTi II LIF spacers with >20° lordosis must be used with AMP II Anti-Migration Plate in addition to supplemental fixation.

The IdentiTi II Interbody System is a thoracolumbar intervertebral body fusion system designed to be inserted through anterior and posterior surgical approaches. The interbody implants are additively manufactured from titanium powder per ASTM F3001 using a powder bed fusion method. The endplates of the interbody implants contain roughened surface features to mitigate the risk of expulsion. Additionally, the IdentiTi II implants are offered with a microporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The internal lattice structure provides additional space for graft packing. The IdentiTi II LIF implants may be used with the AMP II anti-migration plate and bone screws. The AMP II plate and bone screws are manufactured from titanium alloy per ASTM F136.

Based on the provided text, the document is a 510(k) clearance letter for a medical device (IdentiTi™ II Interbody System), not a study report proving the device meets specific acceptance criteria based on AI/software performance. Therefore, the information required for a study proving acceptance criteria for a device involving AI or complex algorithm performance is not present in this document.

The document discusses the substantial equivalence of the IdentiTi™ II Interbody System to existing predicate devices based on:

• Intended Use & Indications for Use: Spinal fusion procedures.
• Design, Function, and Technology: Specifically mentions additive manufacturing from titanium powder, roughened surface features, microporous lattice structure, and an anti-migration plate.
• Non-clinical Performance Data: Lists various ASTM standards for static and dynamic mechanical testing, gravimetric analysis, particle analysis, static push-out, stereological analysis, static screw push-out, and bacterial endotoxin testing. These are standard tests for intervertebral body fusion devices, not for AI or software performance.

Since this document is entirely focused on a traditional hardware medical device and its mechanical/biocompatibility testing, it lacks all the requested information pertaining to AI/software acceptance criteria and a study proving those criteria.

Therefore, I cannot fill out the requested table or answer the specific questions about AI/software performance, ground truth, expert adjudication, or MRMC studies.

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Calibrate LTX Interbody System

The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the Calibrate LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Calibrate LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Calibrate LTX spacers expanded greater than 20° have integrated fixation tabs and must be used with LTX bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.

Calibrate NanoTec LTX Interbody System

The Calibrate LTX Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/ or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the Calibrate NanoTec LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Calibrate NanoTec LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Calibrate NanoTec LTX spacers expanded greater than 20° have integrated fixation tabs and must be used with AMP-LTX bone screws in addition to supplemental fixation. Calibrate NanoTec LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.

The subject Calibrate LTX Interbody Systems are lordotic expandable thoracolumbar intervertebral body fusion systems designed to be inserted through a lateral or anterolateral surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELD per ASTM F136. The subject Calibrate NanoTec LTX Interbody System interbody implant endplate surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The Calibrate LTX Interbody Systems consist of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create lordotic expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with anti-migration teeth and grit-blast treatment on the bone-contacting endplate surfaces. Certain Calibrate LTX Interbody Systems' offerings also accept fixation bone screws manufactured from titanium alloy per ASTM F136.

The purpose of this Traditional 510(k) is to receive clearance for the new sizes of the modified design of the interbody spacer, including a sterile offering of interbody spacer with hydroxyapatite surface treatment, sterile offering of AMP-LTX anti-migration plate and expanded indications for use for the Calibrate LTX Interbody System, previously cleared in K223611.

This looks like a 510(k) clearance letter and summary for a medical device, specifically the "Calibrate LTX Interbody System" and "Calibrate NanoTec LTX Interbody System". This type of document declares substantial equivalence to predicate devices, meaning it doesn't typically include acceptance criteria or detailed study results for a new device's performance against specific metrics in the way a PMA application or a clinical trial report would.

Here's an explanation based on the provided text:

• No acceptance criteria or study data for the device's performance against predefined metrics are present in this document.
• The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This strongly indicates that a clinical study designed to test the device's performance against specific acceptance criteria (like sensitivity, specificity, accuracy, etc.) was not performed or submitted for this 510(k) clearance.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study details.

Instead, I can explain why this information is absent in this document and what was used for clearance:

This 510(k) submission relies on "Substantial Equivalence" to previously cleared predicate devices. This means the manufacturer demonstrated that the new device (Calibrate LTX Interbody System) is as safe and effective as a legally marketed predicate device (e.g., NuVasive Thoracolumbar Interbody Systems and NuVasive Attrax Putty - K203714, among others).

The "performance data" section in the document, under "VII. PERFORMANCE DATA", states:

• "An engineering analysis was utilized to determine that no new worst-case implants are being introduced compared to the predicate devices to support clearance of Calibrate LTX Interbody Systems."
• "The engineering analysis demonstrates that the subject Calibrate LTX Interbody Systems are substantially equivalent to other predicate devices for nonclinical testing."

This implies that the clearance was based on:

1. Bench testing and non-clinical performance data: This would typically involve mechanical testing (e.g., static and fatigue strength, expulsion resistance), material characterization, and potentially biocompatibility testing to ensure the device meets established standards and performs comparably to or better than the predicate devices. The document refers to "engineering analysis" and "nonclinical testing" as the basis for demonstrating substantial equivalence. It does not provide specific acceptance criteria or results from these tests in this summary, but they would have been submitted to the FDA.
2. Comparison of technological characteristics: The document explicitly states, "The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent."

In summary, based on the provided document:

• No acceptance criteria or specific device performance data (like sensitivity, specificity, accuracy for an AI system) are detailed because this is a 510(k) clearance based on substantial equivalence, not a new clinical efficacy study.
• No information on sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for clinical performance is available here. This type of data would be required for devices where clinical performance is a primary metric for safety and effectiveness, often under a PMA pathway or for novel AI/software as a medical device (SaMD) requiring significant de novo clinical validation.

This document focuses on the mechanical and material equivalence of spinal implants to existing ones, rather than the performance of a diagnostic or AI algorithm.

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