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The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defines as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the C3 to C7 disc levels using autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Amendia Interbody Fusion Devices consist of multiple components comprised of sterile and/or non-sterile, single-use implants fabricated from Titanium alloy (Ti6AI4V ELI, ASTM F136) or Invibio PEEK-Optima® LT1 or Solvay Advanced Polymers Zeniva™ ZA-500 PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers. The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation.

The Amendia Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surqical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The surface of the ridges on the titanium implants are roughened.

The provided text is a 510(k) Summary for Amendia Interbody Fusion Devices, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC comparative effectiveness studies cannot be extracted from this document. This document primarily addresses the mechanical and material equivalence of the device to previously approved devices.

Here's what can be inferred about "acceptance criteria" in the context of this 510(k) and the "study" that proves it:

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

• Acceptance Criteria (Implied for 510(k) Clearance): The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This is typically achieved by showing similar intended use, indications for use, materials, performance (mechanical), and fundamental scientific technology.
• Reported Device Performance: The document states: "The substantial equivalence of the Amendia Lumbar Interbody Fusion Devices to the predicate is shown by similarity in intended use, indications for use, materials, performance and fundamental scientific technology."
  • Performance aspects mentioned (though no specific numerical criteria or results are given): The device is made of specific materials (Titanium alloy, PEEK, Tantalum), has various sizes/shapes, a hollow center for bone graft, and ridges for gripping endplates. "Performance testing" is mentioned, implying mechanical and material characterization, but no results are provided.

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/Not provided. Clinical performance testing on a test set (as would be done for an AI device) is not detailed in this document. The "test set" here refers to the device itself and its components undergoing mechanical/material testing.

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/Not provided. Ground truth establishment by clinical experts for a performance study is not described.

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

• Not applicable/Not provided.

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/Not provided. This is a medical device (interbody fusion device), not an AI diagnostic/imaging device that would typically undergo MRMC studies.

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

• Not applicable/Not provided. This is a physical medical device.

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

• For the purpose of substantial equivalence, the "ground truth" would be the established performance and safety profile of the predicate devices, along with adherence to relevant ASTM standards for material and mechanical properties. No clinical ground truth is discussed.

8. The sample size for the training set

• Not applicable/Not provided. The document does not describe a machine learning algorithm or training set.

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

• Not applicable/Not provided.

In summary: This document focuses on demonstrating substantial equivalence for a physical medical implant (Interbody Fusion Device) based on its design, materials, and mechanical properties compared to already cleared predicate devices. It does not present clinical performance data or details about studies that would evaluate diagnostic accuracy or compare human reader performance, which are typical for AI/software devices. The "studies" implied are likely non-clinical (e.g., bench testing for mechanical properties, material biocompatibility, etc.) to show consistency with predicate devices and relevant standards.

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The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The Subject Amendia Interbody Fusion Devices (LLIF and OLLIF) are multiple component systems comprised of sterile, single-use implants, designed to treat the lumbar spine.

The Subject Amendia Interbody Fusion System lumbar (LLIF and OLLIF) implants are fabricated from PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Amendia Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

This document describes the Amendia Interbody Fusion Devices and their substantial equivalence to predicate devices, focusing on the mechanical testing performed. However, it does not contain information regarding an AI/ML device study or performance against acceptance criteria in the context of an AI/ML device.

Therefore, I cannot provide the requested information in the format of acceptance criteria for an AI/ML device, as the document is about a physical medical device (intervertebral body fusion device) and its mechanical performance testing.

The document discusses:

• Device Description: Amendia Interbody Fusion Devices, including materials (PEEK, tantalum, Titanium alloy) and design features (hollow center for autograft, ridges for grip).
• Indications for Use: Intervertebral body spinal fusion procedures for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, with or without Grade I spondylolisthesis/retrolisthesis, used with autogenous bone graft and supplemental fixation, and after at least six months of non-operative treatment.
• Performance Testing: Non-clinical mechanical testing, including static and dynamic axial compression and compression shear (ASTM F2077), subsidence (ASTM F2267), and expulsion testing.
• Conclusion: The device was shown to be substantially equivalent to predicate devices based on design, intended use, material composition, function, and mechanical performance.

To directly answer your numbered points regarding an AI/ML device study, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes mechanical test standards (ASTM F2077, ASTM F2267) but does not provide a table of acceptance criteria and detailed performance results for these. It just states that performance testing "demonstrated the Subject Device is substantially equivalent to the predicate device."
2. Sample sized used for the test set and the data provenance: Not applicable for an AI/ML device. For the mechanical testing, the document states "Non-clinical mechanical testing for the Subject Device was performed on the worst case subject device," implying a limited number of physical samples for mechanical tests, but specific numbers are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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: Not applicable.
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: Not applicable for an AI/ML device. For the physical device, "ground truth" would be established by the physical testing results and engineering standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone and supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Amendia Interbody Fusion Devices consist of multiple components comprised of nonsterile, single-use implants fabricated from Invibio PEEK-Optima® LT1 or Solvay Advanced Polymers Zeniva™ ZA-500 PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation.

The Amendia Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The provided document is a 510(k) premarket notification for Amendia Interbody Fusion Devices, which are medical devices used in spinal fusion procedures. This type of regulatory document focuses on establishing substantial equivalence to existing legally marketed devices, rather than proving efficacy or meeting specific diagnostic performance criteria through clinical studies in the same way a diagnostic AI device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data specific to an AI/diagnostic device is not applicable to this document.

This document describes a medical device (surgical implants) and its intended use, material composition, and mechanical performance testing (engineering analysis and ASTM standards) to demonstrate equivalence to predicate devices, not the diagnostic performance of a software algorithm.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document assesses substantial equivalence based on intended use, indications, material, and mechanical performance (engineering analysis, ASTM F2077, ASTM F1877), not diagnostic accuracy metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance: Not applicable. There is no diagnostic "test set" in the context of an interbody fusion device. The document refers to "performance testing" based on engineering analysis and ASTM standards, which would involve physical specimens of the device, not a dataset of patient images or information.
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 diagnostic accuracy is not relevant for an interbody fusion device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is for resolving discrepancies in diagnostic interpretation, which is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant, not an AI-powered 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 consensus, pathology, outcomes data, etc): Not applicable. Ground truth for diagnostic accuracy is not relevant.
8. The sample size for the training set: Not applicable. There is no training set for a physical implant.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) and does not contain the type of information requested about acceptance criteria and studies typical for AI/diagnostic software performance.

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