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When used as an intervertebral body fusion device, the InterForm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Lumbar Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The InterForm PLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm PLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior approach and used with supplemental fixation and autogenous bone graft.

The InterForm TLIF Interbody Fusion Implants consists of cage footprints widths of 9, 11, 13mm , lengths of 22, 24, 26, 28, 30, 32mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm TLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm OTLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30, 32, 34mm, ranging in height from 7mm to 14mm with lordosis of 0°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm OTLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior or transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm LLIF Interbody Fusion Implants consists of cage footprint widths of 18, 20, 22, 24mm, lengths of 40, 45, 50, 55, 60mm, ranging in height from 8mm to 18mm with lordosis of 0° or 7°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm LLIF Interbody Fusion devices are intended to be implant via a lateral approach and used with supplemental fixation and autogenous bone graft.

The InterForm ALIF Interbody Fusion Implants consists of cage footprints of 30x24mm, and 39x30mm (DxW), ranging in height from 10mm to 20mm with lordosis of 0°, 7° or 12° which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm ALIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, anterior approach and used with supplemental fixation and autogenous bone graft.

All implants are packaged non-sterile to be sterilized at the hospital.

Materials:

PEEK Optima LT1 conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:

Maintain adequate disc space until fusion occurs.

The InterForm Interbody Cage System is intended for spinal fusion procedures.
Here's a breakdown of the acceptance criteria and the study done:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The documentation explicitly states that the device is considered "substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances." The acceptance criteria, while not explicitly numerical, are therefore met by demonstrating performance comparable to the already legally marketed predicate devices. The study concludes that the results indicate the InterForm Interbody Cage System is equivalent.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The studies listed are non-clinical tests (mechanical testing), not studies involving human or animal subjects that would generate a "test set" of data in the typical sense of evaluating AI or clinical outcomes. The provenance of the samples (e.g., specific batches of PEEK and tantalum used in testing) is not detailed, nor is it relevant given the mechanical nature of the tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies are non-clinical mechanical tests, not clinical evaluations requiring expert interpretation or ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical mechanical tests.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This device is a physical medical implant, not an AI or imaging device that would typically involve human reader studies.

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

This information is not applicable as the device is a physical medical implant and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established mechanical properties and performance standards outlined in the ASTM F2077 and ASTM F2267 standards, and the performance characteristics of the predicate devices. For mechanical tests, the ground truth is objectively measured physical properties and behaviors of the material and device under specific conditions.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical implant and would not have a "training set" in the context of machine learning or AI. For mechanical testing, the "samples" would be the manufactured devices or materials subjected to the tests. The exact number of units tested for each non-clinical test (static compression, dynamic compression, subsidence, expulsion) is not specified, but it would typically be a statistically significant number of physical samples to ensure reliability and reproducibility of the results according to the ASTM standards.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reasons as #8. The "ground truth" for material and device properties in mechanical testing is established through standardized testing procedures and validated measurement techniques, as defined by organizations like ASTM.

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The Reliance VBS System is intended for use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture) in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Reliance VBS is designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time.

The Reliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.

The Reliance VBS System is comprised of implant and instrument components. The implant component, the Reliance VBS device, is a spacer, which replaces a portion of the vertebral bodies in the anterior column of the thoracic and lumbar spine. The spacer may be made of PEEK with Tantalum markers, or made of Titanium alloy.

The provided text is a 510(k) Summary for a medical device called the "Reliance VBS System." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to previously marketed devices, often through comparison of design, materials, and intended use.

*Crucially, this document does not describe acceptance criteria, performance metrics, or any study results typical of an AI/ML or diagnostic device.

The Reliance VBS System is a spinal implant (a spacer to replace a portion of a vertebral body). Its "performance" is primarily assessed through its design, materials, and mechanical properties, not through a clinical study that would have a "test set," "ground truth," or "expert readers" in the way one might evaluate an AI-powered diagnostic tool.

Therefore, I cannot provide the requested information in the table or the detailed points about studies, sample sizes, and ground truth establishment, as these concepts are not applicable to the information contained in this 510(k) summary for a physical orthopedic implant.

The document states:

• Device Description: The Reliance VBS device is a spacer, which replaces a portion of the vertebral bodies in the anterior column of the thoracic and lumbar spine. It may be made of PEEK with Tantalum markers, or made of Titanium alloy.
• Intended Use/Indications for Use: For use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression, restore height, and biomechanical integrity. It is to be used with a cleared supplemental fixation device and bone graft.
• Substantial Equivalence: The device is stated to be substantially equivalent to several legally marketed predicate devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.

To reiterate, this is a hardware device approval, not a software or AI approval. Therefore, the concepts requested in the prompt (acceptance criteria for a study, device performance results, sample sizes for test/training sets, ground truth, expert adjudication, MRMC comparative effectiveness studies, and standalone algorithm performance) are not present in this type of regulatory submission and are not relevant to the approval of this spinal implant.

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The VERTE-STACK™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, the DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, the GDLH® Spinal System and/or their successors. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.

The VERTE-STACK™ device is a stackable spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK™ device is fabricated and manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT) along with a tantalum marker. Alternatively the device may be manufactured from titanium alloy. The design of the VERTE-STACK™ device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology. The VERTE-STACK™ device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy. The VERTE-STACK™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK™ constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTF-STACK™ constructs may not be used with stainless steel supplemental fixation devices. The purpose of this submission is to include additional components to the previously cleared VERTE-STACK™ Spinal System.

The provided text is a 510(k) summary for the VERTE-STACK™ Spinal System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance results as typically seen for AI/ML-based medical devices or diagnostics.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided document. The 510(k) summary is a regulatory submission demonstrating that a new device is as safe and effective as an existing, legally marketed device (predicate device). It does not typically include detailed performance studies with acceptance criteria in the way a clinical trial or a study for a novel device would.

The document states:
"Documentation was provided which demonstrated the VERTE-STACK™ Spinal System to be substantially equivalent to the previously cleared VERTE-STACK™ Spinal System components found in K030736, K030735, K023570 and K021791."

This means the acceptance criteria and performance are implicitly met by virtue of being similar enough to established predicate devices that have already undergone regulatory scrutiny. No new clinical or performance studies are detailed in this summary.

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The VERTE-STACK™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, the Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the Titanium TSRH® Spinal System, the Titanium CD HORIZON® Spinal System, the Titanium GDLH® Spinal System or their successors. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.

The VERTE-STACK™ device, is a stackable PEEK spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK™ device is fabricated and manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT) as described by ASTM F-1579. The tantalum marker used for this product is made to the voluntary standard of ASTM F-560.

The design of the VERTE-STACK™ device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK™ device mav be used individually. or two or more mav be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability.

The purpose of this submission is to include additional sizes to the VERTE-STACK™ Spinal System.

This 510(k) premarket notification for the VERTE-STACK™ Spinal System describes a device that is substantially equivalent to previously cleared devices. Therefore, it does not present new acceptance criteria or a study demonstrating device performance against new criteria. Instead, the submission relies on the established equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text, indicating where information is not applicable or not provided for an equivalence submission:

Acceptance Criteria and Study for VERTE-STACK™ Spinal System (K030601)

This submission (K030601) is a 510(k) premarket notification claiming substantial equivalence to previously cleared VERTE-STACK™ Spinal System devices (K023570 and K021791). In such an application, the primary "acceptance criterion" is generally demonstrating that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness, compared to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Not applicable / Not provided. This is a substantial equivalence claim based on the device's design, materials, and intended use being similar to existing cleared devices. It does not involve a clinical study with a distinct "test set" of patients or data in the way an AI/software device would. The "test" is the comparison to the predicate device and relevant standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable / Not provided. Given that this is a product submission for a physical medical device (spinal implant) based on substantial equivalence, there is no "ground truth" derived from expert interpretation of data in the manner of an AI diagnostic device. The "ground truth" is typically established by engineering design, material specifications, and performance testing against recognized standards.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. As there is no "test set" in the context of expert review for diagnostic accuracy, no adjudication method is relevant here.

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 submission is for a physical spinal implant, not an AI or software-as-a-medical-device (SaMD). Therefore, no MRMC study or AI assistance evaluation was performed.

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

• Not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

• Engineering Specifications and Standard Compliance: The "ground truth" for this type of device relies on established engineering principles, material specifications (e.g., ASTM F-1579 for PEEK, ASTM F-560 for Tantalum), and a demonstration that the device's design and intended performance are safe and effective, typically through mechanical testing and validation of material properties. For a substantial equivalence claim, the primary "ground truth" is the previously cleared predicate devices and the accepted safety and effectiveness established for them.

8. The Sample Size for the Training Set

• Not applicable / Not provided. This is not an AI/ML device where a training set size would be relevant. The "training" for such a device is in its design, manufacturing processes, and adherence to quality systems.

9. How the Ground Truth for the Training Set was Established

• Not applicable / Not provided. There is no "training set" in the context of an AI/ML workflow. For a physical device, the "ground truth" for its design and manufacturing is established through adherence to recognized standards, quality control, and pre-clinical testing that establishes its safety and performance characteristics.

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