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The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment.

The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and are intended for use with supplemental fixations systems cleared by FDA for use in the lumbar spine.

Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium allov screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The provided text is a 510(k) premarket notification for a medical device called the "Rampart One Lumbar Interbody Fusion Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or diagnostic performance. Therefore, the information typically requested in your prompt (such as a table of acceptance criteria, sample sizes for test/training sets for AI, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not part of this document.

The document primarily addresses the device's design, materials, indications for use, and non-clinical mechanical testing to show that it is as safe and effective as existing predicate devices.

Here's a breakdown of the available information in relation to your request, with an emphasis on what is not present because it's not a required component of a 510(k) for this type of device:

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

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion for a 510(k) is the demonstration of "substantial equivalence" to a predicate device. This is achieved by showing that the new device has the same intended use and technological characteristics as the predicate, or that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance (Non-Clinical): Mechanical testing was conducted. The document states:
  • ASTM F2077: Static and Dynamic Compression, Static and Dynamic Compression Shear tests were performed.
  • ASTM F2267: Subsidence test was performed.
  • ASTM F543-13: Axial Pullout test was performed.
  • Anti-Screw Backout Expulsion: A test was performed.
  • Bacterial endotoxin testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011.
  • Specific performance metrics (e.g., precise load limits, displacement values, or pass/fail thresholds) are NOT detailed in this summary. The FDA review process would have evaluated the raw data and compared it against established standards or predicate device performance, but these specific numbers are not public in this summary document. The "Conclusion" states: "Spineology has demonstrated that the Rampart One Lumbar Interbody Fusion Device is substantially equivalent to the predicate devices."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable in the traditional sense for this type of device: For a mechanical device like an interbody fusion device, "test set" typically refers to the samples of the device itself (e.g., a certain number of devices tested for mechanical properties). The document does not specify the number of devices tested for each mechanical test.
• Data Provenance: The tests were conducted according to ASTM and ANSI/AAMI standards, likely in a laboratory setting. Country of origin for data is not specified, but the submitter is Spineology Inc. in Saint Paul, Minnesota, USA. The testing is prospective in the sense that the manufacturer specifically conducted these tests for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable: This is not a diagnostic device or an AI/ML algorithm that requires expert ground truth labeling. Mechanical properties are measured objectively by instrumentation in a laboratory, not by expert opinion.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable: No expert adjudication is involved in evaluating the primary performance of this mechanical device.

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 mechanical implantable device, not a diagnostic imaging or AI-assisted device. No human reader studies (with or without AI assistance) are relevant or mentioned.

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.

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

• Mechanical Standards: The "ground truth" for the mechanical testing is adherence to established industry standards (ASTM, ANSI/AAMI) for biocompatibility, sterility, and mechanical strength, often compared against performance data from predicate devices. Clinical "outcomes data" is generally part of a PMA (Premarket Approval) process, not a 510(k), unless specific new safety/effectiveness questions arise.

8. The sample size for the training set:

• Not applicable: This is not an AI/ML device that requires a "training set."

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

• Not applicable: As above, no training set is involved.

Summary of what the document does provide:

• Device Name: Rampart One Lumbar Interbody Fusion Device
• Intended Use: Intervertebral body fusion at one or two contiguous levels in the lumbar spine (L2-S1) for patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis, who are skeletally mature and have had six months of non-operative treatment.
• Materials: PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), tantalum (radiopaque markers).
• Mechanisms of Action: Integrated fixation with titanium alloy screws, hollow core for bone graft.
• Non-Clinical Testing Conducted: Mechanical tests (Static/Dynamic Compression/Shear, Subsidence, Axial Pullout, Anti-Screw Backout Expulsion) and Bacterial Endotoxin Testing, all performed according to recognized standards.
• Predicate Devices: Several predicate devices are listed, including other Spineology Rampart devices and devices from Cutting Edge Spine, Synthes Spine, and Biomet Spine. The new device is compared to these predicates to demonstrate substantial equivalence in intended use, indications for use, fundamental scientific technology, principle of operation, biological safety, base materials, and size offering.

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Rampart A is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment.

Rampart A is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Rampart A implants are intervertebral body fusion devices for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are made of PEEK-OPTIMA LT1 with Tantalum markers and are provided in various configurations and heights, containing a hollow core to receive bone autograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The provided text is a 510(k) summary for the Rampart A Lumbar Interbody Fusion Device. This document is a regulatory submission to the FDA for a medical device and does not describe a study involving an AI or an algorithm.

Therefore, I cannot provide information on acceptance criteria or studies proving device performance related to AI/algorithm performance. The document focuses on demonstrating substantial equivalence to a predicate device for a physical medical implant (an intervertebral body fusion device).

Here's an analysis based on the information available in the provided text, specifically highlighting why the requested AI/algorithm-related information cannot be extracted:

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

• Acceptance Criteria (for the physical device): The document doesn't explicitly list numerical acceptance criteria in a table format for this specific submission beyond demonstrating substantial equivalence. The "performance" assessment is based on comparison to predicate devices, focusing on intended use, technological characteristics, materials, sterilization, packaging, and operating principle.
• Reported Device Performance (for the physical device): The document states "No performance testing was required for this change. An engineering rationale, including a finite element analysis (FEA) to compare the Rampart A to the existing predicate testing (conducted in accordance with ASTM F2077) supported the substantial equivalence of the Rampart A device." This indicates that the performance was demonstrated through an engineering rationale and FEA comparing it to performance data of previously cleared, substantially equivalent predicate devices, rather than new, explicit performance metrics for Rampart A itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable as this is not an AI/algorithm study. The "test set" here refers to the engineering analysis and comparison to predicate device data, not a clinical data set for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as this is not an AI/algorithm study. Ground truth in the context of an interbody fusion device would be related to clinical outcomes, which are not detailed in this 510(k) summary as no de novo clinical study was performed. The "ground truth" for the engineering rationale would be established engineering principles and ASTM standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as this is not an AI/algorithm study.

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 as this is not an AI/algorithm study.

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

• Not applicable as this is not an AI/algorithm study.

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

• For the engineering rationale, the "ground truth" would be established engineering principles and the performance data of the predicate devices as per ASTM F2077. For the device's clinical efficacy, it's based on the established safety and effectiveness of substantially equivalent predicate devices for the specified indications for use (L2 to S1 in patients with degenerative disc disease with up to Grade 1 spondylolisthesis).

8. The sample size for the training set

• Not applicable as this is not an AI/algorithm study.

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

• Not applicable as this is not an AI/algorithm study.

In summary, the provided document is a regulatory submission for a physical medical device. It does not contain information about acceptance criteria or studies related to AI or algorithms.

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The Spine Wave Gen II Expandable Interbody System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1 when implanted using a posterior surgical approach and levels L2-L5 when implanted using a lateral surgical approach. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Gen II Expandable Interbody System is composed of wafers that are stacked into an expandable implant to adjust the height of the implants are manufactured of titanium alloy (Ti-6AI-4V, ASTM F136), PEEK-OPTIMA with 6% BaSO4, and commercially pure titanium (ASTM F1580). The Spine Wave Gen II Expandable Interbody System Implants are provided in various configurations to address the anatomical needs of a variety of patients and to accommodate various surgical approaches to the lumbar spine. The implants are to be used with autogenous bone graft material and supplemental fixation. The System also includes a delivery device that is used to both place and expand the implant. The implants are provided sterile.

The provided text does not contain information regarding software or AI device performance, acceptance criteria, or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification summary for a medical device called the "Spine Wave Gen II Expandable Interbody System," which is a physical implant for intervertebral body fusion procedures.

The information provided covers:

• Device Name: Spine Wave Gen II Expandable Interbody System
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral body fusion device
• Regulatory Class: Class II
• Product Code: MAX
• Indications for Use: Intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at specific levels (L2-S1 posterior surgical approach, L2-L5 lateral surgical approach), used with autogenous bone graft and supplemental fixation, after at least six months of non-operative treatment.
• Device Description: Composed of titanium alloy, PEEK-OPTIMA with BaSO4, and commercially pure titanium wafers stacked into an expandable implant. Includes a delivery device and is provided sterile.
• Predicate Devices: Multiple predicate devices from Spine Wave, Globus Medical Inc., LDR Spine USA, Ulrich GmbH & Co. KG, Biomet Spine, and Synthes Spine Co. LP.
• Non-Clinical Performance Data: Lists various ASTM standards for testing coating microstructure, shear testing, shear fatigue testing, tensile testing, abrasion testing, static and dynamic axial compression, static and dynamic compression shear, subsidence, and wear debris analysis. These are mechanical and material property tests for the physical implant, not software.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving a device meets acceptance criteria related to a software or AI device, as that information is not present in the provided document.

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The Solus Anterior Lumbar Interbody Fusion (ALIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin 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. The Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades.

The Solus Anterior Lumbar Interbody Fusion (ALIF) System is an intervertebral body fusion system for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Solus System consists of implants with various sizes and heights available in 7º or 12º lordosis to accommodate individual patient pathology. The implants are manufactured from polyetheretherkeytone (PEEK Optima LT)) material conforming to ASTM F2026 and tantalum radiographic markers (ASTM F560) with internal anchoring blades of titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136.

The provided text describes the Solus Anterior Lumbar Interbody Fusion (ALIF) System, a medical device for spinal fusion. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Here's an analysis of the provided information, specifically addressing the requested fields:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state numerical sample sizes for each mechanical test performed. For instance, it mentions "cadaveric fatigue testing" but doesn't specify the number of cadavers or specimens used. The provenance of the test data (e.g., country of origin, retrospective or prospective) is also not specified, though it would typically be internal testing by the manufacturer or contracted labs.

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

This information is not applicable and is not provided in the document. The "ground truth" for this type of device (spinal implant) is established through standardized mechanical testing according to ASTM standards, not through expert consensus on medical images or patient outcomes in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This is not applicable as the "ground truth" is established through engineering and mechanical testing, not through human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The Solus ALIF System is a physical implant, and its performance is assessed through mechanical testing.

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

This is not applicable. The Solus ALIF System is a physical medical device, not an algorithm. Its "standalone performance" refers to its mechanical integrity and function as tested in a laboratory setting.

7. The Type of Ground Truth Used

The "ground truth" for the Solus ALIF System's performance is established through standardized mechanical testing. This includes:

• Physical testing according to ASTM standards (e.g., ASTM 2077-03 for axial compression, dynamic compression; ASTM 2267 for subsidence; draft standard ASTM F-04.25.02.02 for static push-out).
• Cadaveric fatigue testing.
• Finite Element Analysis (FEA) for the blade/vertebral body interface.

The performance is then compared to predicate devices to demonstrate substantial equivalence, implying that the established "ground truth" for the predicate devices (which have been deemed safe and effective) serves as the benchmark.

8. The Sample Size for the Training Set

This is not applicable. The Solus ALIF System is a physical medical device, not an AI or machine learning model that requires a "training set."

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

This is not applicable, as there is no "training set" for this type of device.

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DYNAMIK Lumbar Interbody Device is indicated for intervertebral body 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 DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. DYNAMIK Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

DYNAMIK range of products consists of lumbar Interbody cages available in various models to adapt to anatomical variations and surgical techniques. DYNAMIK cages are manufactured as single solid-machined piece made of PEEK conforming ASTM F2026. Markers made of titanium conforming ASTM F136 are used to visualize the position of the implant in the disc space. DYNAMIK Lumbar Interbody Devices are made of PEEK conforming ASTM F2026 with a titanium marker made of TA6V 4 ELI conforming to ISO 5832.3 and ASTM F 136 and are supplied sterile. DYNAMIK Lumbar Interbody Devices are supplied with DYNAMIK Lumbar Interbody Device is indicated for

The provided text describes the DYNAMIK Intervertebral Body Fusion Device, but it does not contain any acceptance criteria or a study that proves the device meets specific performance metrics in the way typically associated with AI/ML device validation.

The document is a 510(k) summary for a medical device (spinal implant), not an AI/ML diagnostic tool. Therefore, information regarding sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth for training was established is not applicable to this type of device submission and is not present in the provided text.

Instead, the performance data provided is related to the mechanical properties and substantial equivalence of the implant, not to diagnostic accuracy or AI performance.

Here's a breakdown of what is available based on your request, highlighting the differences for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. This is a physical implant, not an AI/ML device requiring a diagnostic test set. The "testing" refers to mechanical properties in a lab.

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

• Not applicable. The "ground truth" for this device relates to its mechanical integrity and biocompatibility, which are assessed through material science and engineering tests, not expert interpretation of diagnostic images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication is not relevant for mechanical testing.

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 spinal implant, not an AI-assisted diagnostic tool.

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

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

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

• The "ground truth" for this device's safety and effectiveness is established through adherence to recognized industry standards (ASTM F2026, ASTM F136, ISO 5832.3) for materials, and mechanical testing standards (ASTM F 2077-03 and ASTM F 2267-04). Additionally, biocompatibility and substantial equivalence to previously cleared devices serve as the basis for approval.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

In summary: The provided document is a regulatory submission for a traditional medical device (intervertebral body fusion device), not an Artificial Intelligence/Machine Learning (AI/ML) powered device. As such, the performance criteria and supporting "study" relate to mechanical properties, material conformance, and substantial equivalence to predicate devices, rather than diagnostic accuracy or AI algorithmic performance metrics.

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The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF and TLIF system. Two devices are used per intervertebral space for the PLIF system.

The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The Spinal USA Interbody Fusion Device consists of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. All components are manufactured from medical grade polyetheretherketone (Peek, LT1). The products are supplied clean and "NON-STERILE".

The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it describes a 510(k) summary for an Intervertebral Body Fusion Device, focusing on its intended use, device description, and substantial equivalence to predicate devices. There is no mention of specific performance metrics, test sets, ground truth establishment, or clinical studies involving AI or human readers.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the questions regarding sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided document.

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