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When used as a vertebral body replacement, the TASMIN® R devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumaffracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.

When used as an intervertebral fusion device, the TASMIN® R devices are intended for use at one level 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 in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

The basic shape of the TASMIN® R devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open with peaked teeth that assist in anchoring and seating the implant between the vertebral bodies. There are lateral fenestrations for bony in-growth. The device is available in a variety of sizes and angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

The TASMIN® R device is a spinal intervertebral body fixation orthosis and intervertebral body fusion device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The documentation refers to "worst case TETRIS™ and TASMIN® R devices" for finite element analysis and "worst case TASMIN® R devices" for physical testing. It does not specify the exact number of devices or scenarios considered. It is implied that representative "worst-case" configurations were selected for the evaluation.
• Data Provenance: The studies are described as "Finite element analysis simulations" and "Static and dynamic compression testing." This indicates the data was generated from engineering analyses and laboratory bench testing performed by the sponsor, SIGNUS Medizintechnik GmbH. The country of origin of the data is not explicitly stated, but the sponsor is based in Germany. The data is prospective in the sense that it was generated specifically for the premarket submission.

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

This information is not applicable as the studies performed were bench testing and finite element analysis, not clinical studies requiring expert consensus on patient data. The "ground truth" for these types of studies is established by adherence to recognized ASTM standards and engineering principles.

4. Adjudication Method for the Test Set

This information is not applicable for bench testing and finite element analysis. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of imaging or clinical outcomes.

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

An MRMC comparative effectiveness study was not conducted. The device is a medical implant, not an AI-assisted diagnostic or therapeutic tool.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies was derived from:

• Recognized Industry Standards: ASTM F2077 (for compression, torsion, compression-shear) and ASTM F2267 (for subsidence properties). These standards define the methodology and expected performance for intervertebral body fusion devices.
• Engineering Principles: Finite element analysis relies on established biomechanical and engineering principles to simulate mechanical behavior.
• Material Specifications: ASTM F2026 for PEEK-OPTIMA® LT1 and ASTM F560 for Tantalum, defining the accepted properties of the materials.

8. The Sample Size for the Training Set

This information is not applicable. The studies performed were bench testing and simulations, not machine learning studies that require a training set.

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

This information is not applicable as there was no training set for a machine learning algorithm. The "ground truth" for the device's performance was established by adherence to ASTM standards and engineering principles as described in point 7.

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When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Integrity Spine Core System is a cervical intervertebral body fusion system comprised of parallel and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.

The Integrity Spine Core System implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The Integrity Spine Core System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

The provided text describes a 510(k) Premarket Notification for the Integrity Spine Core System, an intervertebral body fusion device. The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices through non-clinical mechanical testing, rather than a clinical study evaluating device performance in humans.

Therefore, many of the requested items related to clinical study design, such as acceptance criteria based on human performance, sample size for test sets (in a clinical context), expert ground truth establishment for diagnostic performance, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable to this 510(k) submission.

This submission primarily relies on bench testing to show mechanical equivalence.

Here's the information that can be extracted and a clear indication of what is not applicable:

1. Table of acceptance criteria and the reported device performance

Explanation of Acceptance Criteria: The acceptance criteria for this 510(k) submission are implicitly defined as demonstrating "substantially equivalent results" in non-clinical mechanical testing compared to the identified predicate devices. This means the Integrity Spine Core System's mechanical performance in these standardized tests must fall within expected ranges relative to the predicates, indicating no new questions of safety or effectiveness are raised.

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

• Sample Size for Test Set: Not applicable in the context of human data. For the mechanical tests, the sample sizes would be determined by the ASTM standards (e.g., number of constructs tested for compression, torsion, subsidence, and expulsion). The document does not specify these exact numbers, but it states the tests were "conducted in accordance with" the respective ASTM standards.
• Data Provenance: Not applicable as this submission is based on non-clinical (bench) testing, not human data. The tests were performed in a lab setting to assess the device's physical properties.

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

• Not Applicable. Ground truth, in the sense of expert diagnosis or outcome labeling from human data, is not established for this type of non-clinical mechanical testing. The "ground truth" here is the adherence to mechanical performance standards and comparison to predicate devices.

4. Adjudication method for the test set

• Not Applicable. This is relevant for studies involving human data where there might be disagreements in interpretation (e.g., reading medical images). For mechanical testing, outcomes are typically measured objectively based on physical properties.

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 an intervertebral body fusion device, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

• Not Applicable. This is a physical medical implant, not an algorithm or AI system.

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

• Not Applicable / Bench Test Standards. The "ground truth" for this submission are the established ASTM standards for mechanical testing of spinal implants (F2077-11 for static and dynamic mechanical testing, F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion) and the performance characteristics of the predicate devices. The aim is to demonstrate that the new device performs equivalently in these controlled mechanical environments.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this 510(k) submission for a physical implant device. This concept applies to 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 corresponding ground truth to establish.

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Intervertebral Body Fusion Device: The Eminent Spine Interbody Fusion (Sidewinder. Python and Cottonmouth) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion. The Eminent Spine Interbody Fusion System (Copperhead) is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. Vertebral Body Replacement Device: The Eminent System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Eminent Spine System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.

The Eminent Spine Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options. The Eminent Spine Interbody Fusion System will be offered in four (4) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) Copperhead, anterior cervical approach 2) Sidewinder, transforaminal lumbar approach 3) Python, posterior lumbar approach and 4) Cottonmouth, anterior lumbar approach.

Here's an analysis of the provided text regarding the Eminent Spine Interbody Fusion System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) premarket notification and subsequent FDA clearance letter. For interbody fusion devices (Class II medical devices), clearance is typically based on demonstration of substantial equivalence to a previously legally marketed predicate device, rather than a full clinical trial with "acceptance criteria" in the sense of a new drug or novel high-risk device. The primary "study" referred to here is generally a mechanical test study to demonstrate that the new device performs equivalently to the predicate devices in terms of biomechanical properties.

Eminent Spine Interbody Fusion System: Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

As per the nature of a 510(k) submission for this type of device, explicit "acceptance criteria" for clinical outcomes (e.g., fusion rates, pain reduction scores) and specific "reported device performance" in a clinical trial are not provided nor required. Instead, the acceptance is based on demonstrating substantial equivalence through mechanical testing.

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

• Test Set (Mechanical Testing): The document states "Mechanical test results demonstrate that the proposed Eminent Spine Interbody Fusion is substantially equivalent to the predicate device." However, specific sample sizes (e.g., number of implants tested) for these mechanical tests are not provided in this summary document.
• Data Provenance: The mechanical test data would have been generated in a prospective manner, specifically for this submission, likely within a laboratory setting. The origin is implicitly the applicant (Eminent Spine). This is not human clinical data, so country of origin for patients is not applicable.

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

• For mechanical testing, the "ground truth" is established through standardized engineering test protocols (e.g., ASTM standards for spinal implants) and objective measurements. There isn't a concept of "experts" establishing ground truth in the same way as in clinical image interpretation. The testing itself, conducted by engineers or technicians in a certified lab, provides the data supporting substantial equivalence.

4. Adjudication Method for the Test Set

• Adjudication methods like "2+1" or "3+1" are relevant for clinical studies, particularly those involving subjective assessments or disagreements among readers/experts. Since the "study" referred to here is mechanical testing, no such adjudication method is applicable or mentioned. The results are based on objective physical measurements and adherence to engineering standards.

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 typically evaluates the performance of human readers (e.g., radiologists) with and without AI assistance in interpreting medical images. For a spinal implant system like the Eminent Spine Interbody Fusion System, such studies are not part of the 510(k) clearance process. The device itself is a physical implant, not an imaging or diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, this is not applicable. A "standalone" performance study refers to the isolated performance of an algorithm or AI system without human intervention. The Eminent Spine Interbody Fusion System is a physical medical device.

7. The Type of Ground Truth Used

• The "ground truth" for the mechanical performance claim is derived from objective physical measurements and engineering standards (e.g., ASTM) applied to the device and predicate devices. These standards define the expected biomechanical behavior for interbody fusion devices in terms of strength, fatigue, and other relevant properties. The comparison against predicate devices establishes the basis for substantial equivalence.

8. The Sample Size for the Training Set

• This concept is not directly applicable to a 510(k) for a physical implant based on mechanical testing. "Training set" refers to data used to train an algorithm or AI model.
• If we consider the design and manufacturing process, the "training" aspect would relate to the iterative design and engineering process, where prototypes are tested, refined, and potentially re-tested, drawing upon established engineering principles and data from similar devices. However, this isn't a "training set" in the context of AI.

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

• As explained in point 8, the concept of a "training set" and associated "ground truth" in the AI/machine learning sense is not relevant for this medical device clearance based on pre-clinical mechanical testing for substantial equivalence. The "ground truth" for evaluating the design of such a device is rooted in biomechanical principles, material science, and the performance characteristics of previously cleared, safe, and effective predicate devices.

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The ROI-C is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1-to L5) and is intended for use with supplemental internal fixation. The ROI-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.

The ROI-C Implants are D-shaped blocks in a variety of heights and length x width combinations. The ROI-C implants feature a closed graft space and the inferior and superior surface of the devices have a patter n of teeth to provide increased stability. The devices are manufactured from radiolucent PEEK, and are compatible with titanium anchor plates available for use with the ROI-C system. The purpose of this submission is to obtain clearance for a modified design of the ROI-C implants.

The provided text describes a medical device, the LDR Spine ROI-C Partial Vertebral Body Replacement System, and its clearance through the 510(k) process. However, it does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, or adjudication methods.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with acceptance criteria.

The relevant section, "8. Non-Clinical Performance Data," states: "Results of the non-clinical analysis and verification activities indicate that the proposed ROI-C system is substantially equivalent to the predicate device system." This suggests that the evaluation primarily involved non-clinical testing (e.g., mechanical, materials testing) to ensure it met pre-defined engineering or performance standards that align with the predicate device. However, the specific acceptance criteria and the detailed results are not presented in this summary.

Therefore, I cannot populate the requested table or answer most of your questions based on the provided text.

Here's what can be inferred:

• Type of Study: Implicitly, a non-clinical performance study was conducted. It was a comparative study against a predicate device.
• Ground Truth: For non-clinical studies of this type, the "ground truth" would typically refer to established engineering standards, material properties, and performance benchmarks derived from the predicate device.

Information Not Found in the Document:

• Table of Acceptance Criteria and Reported Device Performance: Not detailed.
• Sample size for the test set and data provenance: Not specified.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for a non-clinical study description.
• Adjudication method for the test set: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted, as this is a non-clinical device.
• Standalone (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical implant, not an AI algorithm.
• Type of ground truth used: Implied to be engineering standards/predicate device performance for non-clinical aspects.
• Sample size for the training set: Not applicable for a non-clinical device.
• How the ground truth for the training set was established: Not applicable.

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