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The InterFuse L - 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 L 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 L 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 InterFuse L - Intervertebral Body Fusion device is made of implant grade Polyetheretherketone (PEEK- OPTIMA®, Grade LT1), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. The device has two modules. Module A has a rail and Module B has a slot. The modules are installed by using VTI's proprietary slot riding the rail technology. Both modules have tantalum beads that aid in visualizing the implanted device under X-ravs. Each module incorporates a ramp lock to help ensure that it is properly aligned and engaged with the other module. Each module has two vertical slots 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 six heights (7 mm, 8 mm, 9 mm, 10 mm, 12 mm and 14 mm) each for parallel and 8 lordotic configurations to fit the angular geometry of the disc at each disc level. Four anterior - posterior (AP) lengths (16 mm, 18 mm, 21 mm and 24 mm) of the device are being offered. The device will be available in 7 Medial - Lateral (ML) dimensions (35 mm, 40 mm, 45 mm, 50 mm, 55 mm 60 mm and 65 mm). VTI will supply a set of Instruments (all non-sterile, re-usable manual instruments) for implantation of InterFuse L by a Direct-Lateral Lumbar Interbody Fusion technique.

The provided text describes the 510(k) summary for the "InterFuse L - Intervertebral Body Fusion Device." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical bench testing. It does not contain information about a clinical study involving human subjects, AI performance, or ground truth establishment in a medical imaging context.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/medical imaging device cannot be extracted from this document.

However, I can provide what is available, specifically related to the non-clinical testing performed for this device.

Acceptance Criteria and Device Performance (Non-Clinical Bench Testing)

Study Information (Based on Non-Clinical Testing):

The provided document describes non-clinical bench testing rather than a clinical study for an AI device. As such, the following requested information is not applicable or not available within this submission:

2. Sample size used for the test set and the data provenance: Not applicable. The testing was bench testing on physical devices, not a dataset of patient images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert clinician consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 MRMC study was done, as this is a physical medical device (intervertebral body fusion device), not an AI/imaging diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical AI/imaging ground truth. For the bench tests, the "ground truth" would be the measured physical properties and performance against established ASTM standards for intervertebral body fusion devices.
8. The sample size for the training set: Not applicable. There is no training set mentioned for this type of device submission.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Bench Testing):

The study described is a series of non-clinical bench tests designed to demonstrate the mechanical and material performance of the InterFuse L - Intervertebral Body Fusion Device. The tests were conducted according to recognized ASTM standards (ASTM F2077-11 for static and dynamic durability, and ASTM F2267-04 for subsidence) and ISO standards (ISO 10993-5:2009 for cytotoxicity). The purpose was to show substantial equivalence to predicate devices (K091988 and K102277) by demonstrating similar performance characteristics under these standardized test conditions. The device also underwent sterilization testing to ensure a sterility assurance level of 10-6.

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The InterFuse® T - 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 T 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 T 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 InterFuse® T - Intervertebral Body Fusion device is made of implant grade PEEK-OPTIMA® (Polyetheretherketone), 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-rav. 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 ramp lock to help ensure that it is properly aligned and engaged with the adjacent segment. The exposed rail of the segments is removed after the middle segment (B) is installed. 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) each for parallel and 10 lordotic configurations to fit the angular geometry of the disc at each disc level. InterFuse T device will be available in two anterior - posterior (AP) lengths of 20 mm and 24 mm. The middle segment (B) comes in two widths (9 mm or 10 mm).

The provided text describes a 510(k) premarket notification for a medical device called the InterFuse® T - Intervertebral Body Fusion Device, which is a spinal implant. This submission is for a modification to an already cleared device, and the primary focus of the document is to demonstrate substantial equivalence to the predicate device through non-clinical testing.

Therefore, the requested information about acceptance criteria and device performance as it pertains to AI/algorithm performance metrics (like sensitivity, specificity, MRMC studies, standalone performance, and ground truth establishment with experts) is not applicable to this submission. This document details a physical medical device, not an AI or software device.

However, I can extract the information relevant to the non-clinical performance claims and the study conducted to demonstrate the modified device's equivalence to its predicate.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for performance in the typical sense of a clinical trial or AI evaluation. Instead, it states that the modified device was tested to ensure it met performance standards for intervertebral body fusion devices, and the results supported substantial equivalence to the predicate. The "acceptance criteria" implicitly are that the modified device's performance is comparable to or better than the predicate device in the specified tests, conforming to relevant ASTM standards.

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

• Sample Size: Not explicitly stated in terms of a number of devices or iterations for each test. The document refers to "bench testing" and "performance data" but does not quantify the number of units tested.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, not with human or animal subjects. Thus, there is no country of origin of data or retrospective/prospective nature to describe in this context.

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

• This is not applicable to the non-clinical bench testing described. "Ground truth" in this context would refer to the validated measurement methods and standards (e.g., ASTM F2077, F2267) used in the mechanical testing. There were no human experts establishing a subjective ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This refers to the process of resolving discrepancies in expert opinions, which did not occur in this bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was not done. This type of study is relevant for evaluating human interpretation of medical images or data, often with AI assistance, which is not the subject of this 510(k) submission.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

• For this mechanical device, the "ground truth" for the non-clinical tests is based on established engineering standards and validated test methodologies as outlined by organizations like ASTM (e.g., ASTM F2077, ASTM F2267). The performance is measured against these objective, quantitative standards.

8. The Sample Size for the Training Set

• Not applicable. This refers to training data for algorithms, which is not relevant for this physical device.

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

• Not applicable for the same reason as above.

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The InterFuse® DA 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 at the involved level(s). The InterFuse DA 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 DA 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 VTI's InterFuse DA interbody fusion device (IFD) is made of implantable grade 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 (see photos below). Each segment incorporates a stop to help ensure that it is properly aligned with the adjacent segment. The exposed rail, with a stainless steel (Grade 304) tail, 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 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 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 a 510(k) premarket notification for a medical device, specifically an Intervertebral Body Fusion Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data that would be typical for proving novel device efficacy or diagnostic accuracy.

Therefore, the document does not contain information regarding the acceptance criteria, study details, or performance metrics typically requested for AI/ML-based devices in the format specified in your prompt.

Specifically, the following information is not available in the provided text:

• Table of acceptance criteria and reported device performance: The document only mentions a minimum strength requirement in Newtons (8,500 N) for static compression testing but doesn't present a comprehensive table of acceptance criteria and reported performance across various metrics.
• Sample size used for the test set and data provenance: The study mentioned is a non-clinical, static compression test. It does not involve a test set of patient data, nor is there any mention of human readers or AI performance.
• Number of experts used to establish ground truth and qualifications: This is not applicable as the study described is a bench test, not an evaluation requiring expert interpretation of medical data.
• Adjudication method for the test set: Not applicable for a non-clinical bench test.
• Multi reader multi case (MRMC) comparative effectiveness study: No MRMC study was conducted or mentioned. The device is a physical implant, not an AI-assisted diagnostic tool.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is not an AI algorithm.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the bench test was the physical measurement of load to failure as per ASTM F2077-03.
• 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.

However, based on the provided text, I can infer the primary acceptance criterion and the study used to meet it:

Acceptance Criterion and Study Information (Based on provided text)

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The InterFuse® T - 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 T 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 T 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 InterFuse® T - Intervertebral Body Fusion device is made of implant grade PEEK-OPTIMA® (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. 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 ramp lock to help ensure that it is properly aligned and engaged with the adjacent segment. The exposed rail of the segments is removed after the middle segment is installed. 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) each for parallel and 10 lordotic configurations to fit the angular geometry of the disc at each disc level. The Anterior - Posterior (AP) length of the device is 24 mm. The middle seament (B) comes in two widths (9 mm or 10 mm).

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the InterFuse® T - Intervertebral Body Fusion Device are based on demonstrating substantial equivalence to the predicate device (InterFuse® Intervertebral Body Fusion Device, K091988) through non-clinical bench testing. The specific tests and their outcomes are summarized below:

Conclusion from Study: The study concludes that the modified device (InterFuse® T) is substantially equivalent to the unmodified InterFuse® device (K091988) based on these performance data.

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

The provided document does not specify exact sample sizes for each test mentioned (e.g., number of devices tested for static compression). However, it implies that performance testing was conducted on the "modified device (InterFuse T)" after gamma irradiation sterilization.

The data provenance is from non-clinical bench testing conducted by the manufacturer, Vertebral Technologies, Inc. This is a prospective set of tests designed to demonstrate the mechanical and biological properties of the device. The country of origin of the data is not explicitly stated but would be presumed to be where the manufacturer is located or where they contracted the testing (Minnetonka, MN, USA).

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

Not applicable. This submission describes non-clinical bench testing of a medical device, not a study involving human readers or clinical data requiring expert review for ground truth establishment. The "ground truth" for these tests is defined by the standards (ASTM and ISO) used.

4. Adjudication method for the test set:

Not applicable. As noted above, this is non-clinical bench testing governed by predefined engineering and biological standards, not a study requiring adjudication of expert opinions.

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 is a 510(k) submission for an intervertebral body fusion device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.

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

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

7. The type of ground truth used:

The "ground truth" for the non-clinical tests described is established by:

• Standardized testing protocols: Adherence to established industry standards such as ASTM F2077-03 (Standard Test Methods for Static and Dynamic Axial Compression and Shear Fatigue Properties of Intervertebral Body Fusion Devices), ASTM F2267-04 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Axial Compression), and ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity).
• Material specifications: The use of implant-grade PEEK-OPTIMA® and tantalum beads, materials with a history of use and defined properties.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The device itself is the "product" being evaluated.

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

Not applicable, as no training set was used.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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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