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The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The CAPSTONE PTC™ Spinal System is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. 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 six months of non-operative treatment. Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.

The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These implants are to be used autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with supplementation which has been cleared by the FDA for use in the lumbar spine.

The CRESCENT™ Spinal System Titanium is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The subject ELEVATE™ Spinal System consists of bullet nose expandable cages with teeth. The top of the cage is made of Polyetheretherketone (PEEK) and the base is made of Titanium Alloy (Ti-6Al-4V). The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The ELEVATE™ implants are provided in both standard and an extra-lordotic design. The devices can be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The implants also contain hollow geometry which allows them to be packed with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

The subject CAPSTONE PTC™ Spinal System consists of convex cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone (PEEK) and coated with Commercially Pure Titanium (CP Ti). The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The CAPSTONE PTC™ implants are provided in various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

The subject CRESCENT™ Spinal System consists of banana shaped cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone (PEEK) and contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The CRESCENT™ implants are provided in various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

The subject CRESCENT™ Spinal System Titanium consists of banana shaped cages with a bullet nose and angular teeth. The CRESCENT™ Titanium implants are made of Titanium Alloy (Ti-6Al-4V) and are provided in various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

I am sorry, but based on the provided document, there is no information about acceptance criteria and a study that proves the device meets those criteria. The document is a 510(k) premarket notification for an intervertebral body fusion device, and it primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

The key points from the document regarding "testing" are:

• Bacterial Endotoxin Test (LAL test): This was performed on worst-case subject implants to verify they meet the 20 endotoxin units (EU)/device pyrogen limit specification, as outlined in ANSI/AAMI ST72 and USP . This is a non-clinical test related to sterility and safety, not a performance study of the device's clinical efficacy.
• Retrospective Clinical Data: The document mentions published retrospective clinical data for lumbar interbody fusion devices cleared in K151128 (CAPSTONE® and CLYDESDALE® Spinal System). This data demonstrated that the use of allogenic bone graft (with or without autogenous bone graft) is commonly used and poses no new risks. However, this is not a study specifically assessing the performance or acceptance criteria of the current devices (ELEVATE™, CAPSTONE PTC™, CRESCENT™, CRESCENT™ Titanium) against specific metrics. Instead, it supports the expansion of indications for use to include allogenic bone graft as an option, based on existing clinical practice and prior clearances.

Therefore, I cannot provide the requested table or details about a study proving the device meets acceptance criteria, an MRMC study, standalone algorithm performance, or ground truth establishment relevant to clinical performance, as this information is not present in the provided text.

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The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The ELEVATE™ Spinal System consists of polyetheretherketone (PEEK) with tantalum markers and titanium expandable cages of various length and heights, which can be surgically implanted between two lumbar or lumbarsacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. This system also includes stainless steel and silicone instruments used to facilitate the implantation of the subject cages. Finally, the subject system includes case, trays, and lids used to package, ship and can be used to sterilize the non-sterile instruments in the subject system. The case, trays, and lids are manufactured from aluminum with either silicone or nylon coated brackets.

This document, K142559, is a 510(k) premarket notification for the ELEVATE™ Spinal System, which is an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data, rather than providing details of a study against specific acceptance criteria for a new clinical claim or an AI algorithm.

Therefore, many of the requested sections (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set size and ground truth establishment) are not applicable or cannot be extracted from this document as it does not describe a study involving clinical performance or an AI device with such evaluation metrics.

However, I can extract information related to the acceptance criteria for the mechanical and biocompatibility testing that was performed to support substantial equivalence.

Here's the information that can be extracted:

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

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

• Not Applicable. This document describes engineering (mechanical, materials) testing, not a clinical study involving a test set of patients or medical data.

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

• Not Applicable. Ground truth, in the context of clinical or AI studies, is not relevant here as this document describes physical product testing.

4. Adjudication method for the test set:

• Not Applicable. Adjudication is not relevant for the type of engineering testing 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 device is a physical spinal implant, not an AI-assisted diagnostic or therapeutic device.

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

• Not Applicable. This is not an algorithm or AI device.

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

• For Biocompatibility: The "ground truth" was established by prior regulatory clearances of predicate devices and the well-documented safe use of the specific materials (PEEK, tantalum, titanium alloy, medical grade stainless steel, silicone) in medical implants.
• For Mechanical and MR-Safety Testing: The "ground truth" was the specified requirements and methodologies defined in the referenced ASTM standards. Meeting these standards serves as the acceptance criterion.

8. The sample size for the training set:

• Not Applicable. No training set as this is not an AI or machine learning device.

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

• Not Applicable. See above.

Summary of the study that proves the device meets the acceptance criteria (from the document):

The ELEVATE™ Spinal System demonstrated substantial equivalence by undergoing a series of non-clinical performance tests.

• Biocompatibility Evaluation: This was addressed by leveraging the known biocompatibility of the materials (PEEK, tantalum, titanium alloy, stainless steel, silicone). The materials are identical to those used in previously cleared predicate devices and conform to relevant ASTM standards (ASTM F2026, F560, F136, F899, A564, A693). The evaluation adhered to FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993". No new biocompatibility testing was performed due to the long history of safe use of these materials.
• Mechanical Testing: This involved design verification testing on the subject device according to ASTM F2077-11 ("Test Methods for Intervertebral Body Fusion Devices") and ASTM F2267-4 (2011) ("Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression"). Specific tests performed included Static Compression, Compression Fatigue, Static Compression-Shear, Compression-Shear Fatigue, and Subsidence. The document states that all these tests "met the predetermined acceptance criteria."
• Radiographic Verification Testing: Additional radiographic verification testing was completed to further demonstrate substantial equivalence. (Details on criteria not provided, but implies visual and structural integrity under imaging).
• MR-Safety Evaluation: The device's MR-safety was evaluated in accordance with FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" and specific ASTM standards (F2052, F2213, F2119, F2182) for magnetic displacement, torque, artifact, and radio frequency induced heating.

The conclusion drawn from this performance data, along with risk analysis and other supporting documentation, was that the ELEVATE™ Spinal System is "as safe and effective" as the listed predicate devices.

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