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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 1 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 Intervertebral Body Fusion device is made of PEEK (Poly ether ether ketone), a polymer with a history of use in interbody fusion device designs, 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 or sior in the unjudent cogment 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 suction's and lew as three segments to be used, annough most politics. Each segment has a vertical slott segments for uptimatir coverage or the vertise and that will provide a path for solid Infough the belice for the Salgeon to mi With Bategis produced in four heights (8, 10, 12 and 14 bone grown during the foston process. " The (2011-11 and 25 mm) and two antenor-posicilion allifensity (is and 5 angled (lordotic) shapes to fit the angular geometry of the disc at each disc level.

This document refers to a Special 510(k) Pre-market Notification for the InterFuse® Intervertebral Body Fusion Device, which is essentially a modification of an already cleared device. Therefore, the "study" described is primarily focused on demonstrating that the modified device remains substantially equivalent to its predicate, rather than an entirely new clinical efficacy study.

Here's an analysis of the provided information, structured around your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the acceptance criteria for seal integrity, performance, and cytotoxicity were "specified in the shelf-life testing protocol" but does not provide the specific criteria themselves. It only states that the tests were performed and implies successful adherence to these criteria to claim substantial equivalence. The primary change and therefore the primary acceptance criteria for this specific 510(k) was the extension of the shelf-life from 6 months (of the predicate) to 2 years.

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

• Sample Size for Test Set: Not explicitly stated. The tests were performed on "packages" and "aged devices" at the end of the accelerated aging process. The number of samples tested for seal integrity, performance, and cytotoxicity is not provided.
• Data Provenance: Not applicable in the traditional sense of patient data. The data is from bench testing and laboratory testing (accelerated aging, seal integrity, mechanical performance, cytotoxicity) conducted on the manufactured devices.

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

• This is not applicable for this type of submission. Ground truth, in the context of this 510(k) for a physical implant, is established by laboratory measurements against recognized standards (like ASTM F2077-03, ISO 10993) and internal protocols. There is no expert consensus on a "ground truth" for shelf-life, seal integrity, or material cytotoxicity in the way there would be for image interpretation.

4. Adjudication Method for the Test Set

• Not applicable. This was a series of laboratory tests with objective pass/fail criteria based on established standards and internal protocols, not an expert panel adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC comparative effectiveness study is typically relevant for interpretative diagnostic devices (e.g., AI for medical imaging) where human readers are involved. This device is an implantable medical device, and the submission is about confirming its shelf-life and continued substantial equivalence, not its effectiveness in a reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

• The "ground truth" here is based on objective measurements against established engineering and biocompatibility standards.
  • Mechanical Integrity: Conformity to ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices).
  • Biocompatibility: Conformity to ISO 10993 (Biological Evaluation of Medical Devices) for cytotoxicity.
  • Packaging Integrity: Testing standards such as dye penetration and bubble test (implied, specific ASTM or ISO standard not mentioned but recognized tests for seal integrity).
  • Shelf-life: Based on accelerated aging results correlated with real-time stability (ASTM F1980-07 for accelerated aging).

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this device. A training set is used for machine learning algorithms.

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

• Not applicable. As there is no training set, there is no ground truth for it to be established.

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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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