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The InterFuse® Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse device is indicated for use with autogenous bone graft and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.

The implantable portion of VT's IFD device is made of PEEK (Poly ether ether ketone), a polymer with a history of use in interbody fusion devices, and which has a compressive modulus similar to bone. Each segment of the device has embedded tantalum beads that aid in visualizing the implanted device under x-ray and to aid in position retention when assembled in the disc space. Each segment has an integral rail and / or slot which slide through or over the rail or slot in the adjacent segment to complete the device. Each segment incorporates a stop to help ensure that it is properly aligned with the adjacent segment. The exposed rail, with a stainless steel tail, of each seqment is removed after the adjacent segment is installed. The modular system allows for as few as three segments to be used, although most patients will require between four and six segments for optimum coverage of the vertebral endplate. Each segment has a vertical slot through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in four heights (8, 10, 12 and 14 mm) and two anterior-posterior dimensions (20 mm and 25 mm) to fit a range of potential disc spaces. The device will also be produced in flat and 5 angled (lordotic) shapes to fit the anqular geometry of the disc at each disc level.

The provided document is a 510(k) premarket notification for a medical device, specifically an Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing data from a clinical study on device performance against specific acceptance criteria.

As such, it does not contain the following information that would typically be found in a clinical study report:

• A table of acceptance criteria and reported device performance: The document only states that "All devices exceeded the minimum strength requirement which was used in the original validation testing referenced in K080673." It does not specify the minimum strength requirement or provide detailed performance data.
• Sample sizes used for the test set and data provenance: No information on a test set (in the context of clinical or image-based AI studies) is provided. The "test" here refers to bench testing of the device itself.
• Number of experts used to establish ground truth and their qualifications: Not applicable, as this is a device clearance based on bench testing, not an AI or diagnostic tool requiring ground truth from experts.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study information: Not applicable for this type of device clearance.
• Standalone (algorithm-only) performance: Not applicable, as this is a physical implantable device, not an algorithm.
• Type of ground truth used: For the bench testing, the "ground truth" would be the established engineering standards (ASTM F2077-03) and the performance of the predicate device.
• Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

Acceptance Criteria and Study Details from the Provided Document:

The study described is a bench test to demonstrate that a modification to the InterFuse® Intervertebral Body Fusion Device (specifically the delivery system's tail and the sterilization method) does not negatively impact the device's performance compared to the predicate device.

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

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

• Sample Size: Not explicitly stated for the mechanical, sterility, or cytotoxicity tests. The document only states "All devices" regarding the mechanical test.
• Data Provenance: The tests are "nonclinical tests submitted" and were performed by the manufacturer, Vertebral Technologies, Inc., to support their 510(k) submission. The exact location of testing (e.g., in-house lab, third-party lab) is not specified, but it would be considered internal company data for regulatory submission.

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

• Not applicable in the context of this bench testing for a physical device. The "ground truth" or standard for performance is the ASTM standard and the predicate device's established performance.

4. Adjudication method for the test set:

• Not applicable. The tests are objective measurements against specified engineering and biological standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, this type of study was not done. This is a physical implantable device, not a diagnostic or interpretative system that would involve human readers.

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

• Not applicable. This is a physical implantable device, not an algorithm.

7. The type of ground truth used:

• Mechanical Strength: Established engineering standards (ASTM F2077-03) and the previously validated performance of the predicate device (K080673).
• Sterility: Industry-accepted standards for achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
• Biocompatibility: Standardized cytotoxicity testing methods to determine non-toxicity.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device.

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

• Not applicable.

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The InterFuse™ Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.

VTI's IFD device is made of PEEK, a polymer with a history of use in interbody fusion device designs, and which has modulus similar to bonc. Each segment of the device has embedded metal beads (tantalum) that aid in visualizing the implanted device under x-ray and to aid in position retention when assembled in the disc space. Each segment has an integral rail and / or slot which slides through the rail or slot in the adjacent segment to complete the device. Each segment incorporates a stop to help ensure that it is properly aligned with the adjacent segment. The exposed rail of each segment is removed after the adjacent segment is installed. The modular system allows for as few as three segments to be used, although most patients will require between four and six segments for optimum coverage of the vertebral end plate. Each segment has a vertical slot through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in four heights and two anterior-posterior dimensions to fit a range of potential disc spaces. The device will also be produced in flat and angled (lordotic) shapes to fit the angular geometry of the disc at each disc level.

The provided text describes the "InterFuse™ Intervertebral Body Fusion Device" and its 510(k) submission to the FDA. The submission focuses on establishing substantial equivalence to previously approved predicate devices through bench testing and cadaver evaluations, not clinical studies or AI/software performance evaluations. Therefore, many of the requested categories related to clinical study design, ground truth establishment, expert adjudication, and AI performance metrics are not applicable to this document.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes "acceptance criteria" through successful bench testing and cadaver evaluations, verifying physical attributes, durability, and performance requirements. Specific quantitative thresholds for these criteria are not provided in this 510(k) summary. The performance is reported qualitatively as meeting these criteria.

2. Sample Size for Test Set and Data Provenance

• Test Set Description: The "test set" in this context refers to the samples used for bench testing and cadaver evaluations.
• Sample Size: Not specified in the document.
• Data Provenance:
  • Bench Testing: Performed according to a Master Test Plan, referencing voluntary standards (e.g., ISO, EN). The specific location or country of origin for the testing is not mentioned.
  • Cadaver Testing: Performed, but the number of cadavers or the specific source (e.g., country) is not specified.
  • Retrospective/Prospective: Not applicable, as no clinical data was used.

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

• Not applicable: The "ground truth" in this context is defined by objective engineering and biological standards (e.g., ISO, EN for biocompatibility and sterility) and physical measurements demonstrated through bench and cadaver testing. It does not involve expert interpretation of medical images or patient data that would require a panel of medical experts to establish a "ground truth" in the way it's understood for AI/diagnostic devices. The "surgical technique and instrument performance" was verified by cadaver evaluation, implicitly involving surgical expertise, but the number and qualifications of these experts are not provided.

4. Adjudication Method for the Test Set

• Not applicable: No adjudication method is described, as the evaluation relied on objective measurements and compliance with standards rather than subjective expert consensus on complex medical data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: A MRMC comparative effectiveness study was not performed. The device is a physical intervertebral fusion device, not an AI or diagnostic tool where such a study would be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable: This device is a physical implant, not an algorithm or software. No standalone algorithm performance study was conducted.

7. Type of Ground Truth Used

• Bench Testing Standards & Physical Measurements: For bench testing, the "ground truth" was defined by internationally recognized standards (ISO 10993 for biocompatibility, EN550 for sterility) and the physical properties and durability measured during load deflection and cyclic fatigue tests.
• Cadaveric Evaluation: For cadaver testing, the "ground truth" for device stability, resistance to expulsion/disassembly/subsidence, and surgical technique performance was established through direct observation and measurement in a simulated surgical environment.

8. Sample Size for the Training Set

• Not applicable: This document pertains to the evaluation of a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in this context.

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

• Not applicable: As there is no training set for an AI model, this question is not relevant to the provided text.

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