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The SpineFrontier® Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc.

The SpineFrontier® Arena-C® Cervical IBFD is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The purposed of this submission is to add titanium coating to the existing Arena-C® product line. The Arena-C Cervical Intervertebral Body Fusion Device with Titanium Coating is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The system is comprised of devices made of Peek Optima® with titanium coating, with various heights to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist the device movement following implantation.

The implants are provided in two configurations: straight and lordotic (6°) implant sizes for both configurations are offered in three footprints (12x14mm, 11x17mm) and heights from 5mm - 12mm. in 1mm increments.

The SpineFrontier Arena-C Cervical Intervertebral Body Fusion Device with Titanium Coating is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Arena-C Cervical Intervertebral Body Fusion Device with Titanium Coating implants are supplied sterile, are single use, and are fabricated from PEEK-OPTIMA® LT1® with titanium coating and tantalum markers for radiographic visualization.

This document is a 510(k) premarket notification for a medical device. It does not contain information about the acceptance criteria and study results for an AI/ML powered medical device. Therefore, I cannot fulfill your request based on the provided text.

The document discusses a cervical intervertebral body fusion device and its substantial equivalence to predicate devices based on mechanical performance data. It outlines the device's description, indications for use, and technological characteristics, but it does not mention any AI/ML components or related performance studies.

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The SpineFrontier Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc.

The SpineFrontier® Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The system is comprised of devices made of PEEK OPTIMA® HA, with various heights to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist the device movement following implantation.

The implants are provided in two configurations: straight and lordotic (6°) implant sizes for both configurations are offered in three footprints (12x14mm, 11x17mm) and heights from 5mm - 12mm, in 1mm increments.

The SpineFrontier Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device components are supplied non-sterile, are single use, and are fabricated from PEEK-OPTIMA® HA and contain tantalum markers for radiographic visualization.

This document is an FDA 510(k) premarket notification for a medical device called the Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own clinical performance against acceptance criteria in the way an AI/ML device would. Therefore, most of the questions about acceptance criteria, sample sizes, ground truth, and expert adjudication are not applicable (N/A) in this context.

Here's an analysis based on the provided text, addressing the questions where information is available or applicable:

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

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

• Sample size for test set: The document describes non-clinical performance testing (mechanical and material characterization). It does not specify sample sizes for these tests, which are typically determined by engineering standards rather than statistical clinical trial sample size calculations.
• Data provenance: N/A. The data is from laboratory performance testing, not human patient data.
• Retrospective or prospective: N/A. This refers to a study design on human subjects, which is not applicable here.

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)

• N/A. This device is an implant, and its performance is evaluated through mechanical testing and material characterization, not by human experts establishing ground truth for diagnostic imaging or similar.

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

• N/A. No human adjudication is involved in the performance testing of this device type.

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

• N/A. This is not an AI/ML medical device, and therefore, an MRMC study is not relevant.

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

• N/A. This is not an AI/ML medical device.

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

• For mechanical testing, the "ground truth" is defined by the physical properties and performance metrics established by industry standards (e.g., ASTM F2077, F2267).
• For material characterization and biocompatibility, the "ground truth" is established by relevant ISO standards (e.g., ISO 10993) and scientific principles, potentially including animal studies for in-bone assessment.

8. The sample size for the training set

• N/A. This is not an AI/ML device, so there is no "training set."

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

• N/A. This is not an AI/ML device.

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The Arena-C® Cervical Intervertebral Body Fusion System is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc.

The SpineFrontier Arena-C® Cervical Intervertebral Body Fusion System is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment with an intervertebral cage.

This 510(k) Submission is seeking add new sizes to the previously cleared Arena-C device. The SpineFrontier Cervical Interbody Fusion Device System (Arena-C® Cervical Intervertebral) is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The system is comprised of devices made of Peek Optima®, with various heights to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist the device movement following implantation.

This document is a 510(k) summary for the SpineFrontier Arena-C® Cervical Intervertebral Fusion System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically reported for AI/ML devices (e.g., sensitivity, specificity, AUC). This document is for a physical medical device, an intervertebral body fusion system, not a software or AI/ML device.

Therefore, many of the requested fields cannot be answered from the provided text as they pertain to the evaluation of AI/ML software.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot be provided. This document does not specify quantitative acceptance criteria for device performance (e.g., success rates, complication rates) that would typically be seen in a clinical study for a physical implant, nor does it present a clinical study with detailed performance results against such criteria. The "performance testing summary" refers to "engineering rationale and finite element analysis" to show that modifications don't create new worst-case scenarios compared to a predicate device, which is a different type of "performance" than what's implied by the request.

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

• Cannot be provided. This document describes a submission for an add-on to an existing cleared device ("seeking add new sizes to the previously cleared Arena-C device"). It references "engineering rationale and finite element analysis" rather than a clinical study with human subjects for the new sizes. There is no mention of a "test set" in the context of clinical data.

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)

• Cannot be provided. No clinical "test set" and corresponding ground truth establishment is described.

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

• Cannot be provided. No clinical "test set" and adjudication method is described.

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

• Cannot be provided. This section pertains to AI/ML software evaluation. This document is for a physical implantable device.

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

• Cannot be provided. This section pertains to AI/ML software evaluation. This document is for a physical implantable device.

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

• Cannot be provided. No clinical study or ground truth establishment is described. The "ground truth" for this type of device (spinal implant) would typically be successful fusion or long-term patient outcomes, evaluated through clinical trials, which are not detailed here for the size additions.

8. The sample size for the training set

• Cannot be provided. This section pertains to AI/ML software evaluation. This document is for a physical implantable device.

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

• Cannot be provided. This section pertains to AI/ML software evaluation. This document is for a physical implantable device.

Summary of available information from the document:

The document focuses on demonstrating substantial equivalence to predicate devices for a physical implant rather than proving performance against specific acceptance criteria through a clinical study for the new sizes. The core of the submission for the new sizes relies on:

• Identical Indications for Use.
• Identical Materials of manufacture (Peek Optima®).
• Identical Structural support mechanism.
• "Engineering rationale and finite element analysis were used to demonstrate that the modifications to the Arena-C Cervical Intervertebral Fusion Device do not generate new worst case compared to the predicate device."

Essentially, the "study" demonstrating that the device meets criteria is primarily a biomechanical and materials equivalence assessment, not a clinical study with patient outcomes or expert reads, as would be expected for AI/ML performance evaluation.

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The Arena-C™ Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc.

The SpineFrontier Arena-C™ Cervical Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The SpineFrontier Cervical Interbody Fusion Device System (Arena-C™ Cervical Intervertebral) is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The system is comprised of devices made of Peek Optima®, with various heights to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist the device movement following implantation.

The provided text describes a 510(k) premarket notification for a medical device called the Arena-C™ Cervical Intervertebral Body Fusion System. The submission states that clinical data was not required for this device, and therefore, a study evaluating device performance against acceptance criteria in a clinical setting, as one might find for an AI/ML device, was not performed or submitted.

Instead, the basis for substantial equivalence was established through mechanical testing and comparison of indications for use, function, operating principles, and materials to predicate devices.

Given this, I cannot provide the information requested in points 1-9 as they pertain to clinical or AI/ML-based device performance studies, which were explicitly stated as "not required" for this submission.

Here's what I can extract regarding the device's evaluation:

1. Table of acceptance criteria and the reported device performance:

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. This was a mechanical testing study, not a clinical study with a test set of patient data. The materials used for mechanical testing are not described in terms of "provenance."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth based on expert review was established for a test set in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method was used as there was no test set requiring ground truth establishment by experts.

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 not an AI/ML device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The evaluation was based on mechanical test standards, not clinical ground truth.

8. The sample size for the training set:
Not applicable. There was no training set, as this is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. There was no training set or ground truth establishment for a training set.

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