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510(k) Data Aggregation
(130 days)
ClariVy Cervical IBF System
The ClariVy" Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The ClariVy™ Cervical IBF System is intended for use at one level in the cervical spine, from C3 to Tl, for treatment of cervical degenerate disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The ClariVy™ Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
The purpose of this 510(k) submission is to introduce the ClariVy™ OsteoVy™ PEKK Cervical IBF configuration. The ClariVy™ Cervical IBF System is comprised of implants components. The implant component, the ClariVy™ Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The ClariVy™ NanoVy™ Ti Cervical IBF components are made of PEEK Optima LT1 with CP Titanium coating. The ClariVy™ Cervical IBF and ClariVy™ NanoVy™ Ti may also include Titanium alloy bone screws to secure the device to the vertebral body. The ClariVy™ OsteoVy™ PEKK Cervical IBF is made from OXPEKK.
I am sorry, but the provided text does not contain the information required to fulfill your request. The document is an FDA 510(k) clearance letter for a medical device (ClariVy™ Cervical IBF System), which focuses on the administrative aspects of regulatory clearance and comparison to predicate devices, rather than a detailed study report on acceptance criteria, device performance, or clinical trial methodology.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Information on sample size, data provenance, or expert involvement for a test set.
- Details on adjudication methods, MRMC studies, or standalone algorithm performance.
- Information on the type of ground truth used.
- Details regarding the training set, including its sample size or how its ground truth was established.
The "Non-Clinical Testing" section
{4} mentions mechanical testing according to ASTM standards, but it doesn't provide specific performance results against acceptance criteria. There's no mention of any study involving AI or human readers, or any other kind of clinical or image-based performance evaluation that would necessitate the information requested in your prompt.
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(85 days)
ClariVy Cervical IBF System
The ClariVy™ Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The ClariVy™ Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerate disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The ClariVy™ Cervical IBF System is to be used in patients who have six weeks of nonoperative treatment.
The ClariVy™ Cervical IBF System is comprised of implants components. The implant component, the ClariVyTM Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The ClariVy™ NanoVy™ Ti Cervical IBF components are made of PEEK Optima LT1 with CP Titanium coating. The ClariVyTM Cervical IBF System may also include Titanium alloy bone screws to secure the device to the vertebral body.
This document is a 510(k) summary for the ClariVy™ Cervical IBF System. It is focused on demonstrating substantial equivalence to predicate devices for a medical implant, not an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria, studies, ground truth establishment, expert involvement, and reader studies are not applicable to the information provided.
The document describes the device, its intended use, and substantial equivalence to legally marketed predicate devices primarily based on non-clinical testing of the implant's physical and mechanical properties.
Here's the relevant information that can be extracted from the provided text, while noting the inapplicability of AI/ML specific questions:
1. A table of acceptance criteria and the reported device performance
Since this is a medical implant and not an AI/ML device, the "acceptance criteria" are related to mechanical and material performance standards for intervertebral body fusion devices, rather than diagnostic accuracy metrics. The document states that non-clinical testing was performed using "various ASTM Standards" at a third-party facility. However, specific acceptance criteria values (e.g., minimum compression strength, fatigue life) and reported performance values are not detailed in this summary. It only states that the tests "demonstrate that the ClariVy™ Ti Cervical IBF is as safe, as effective, and performs as well or better than a legally marketed predicate device."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ASTM Standards for intervertebral body fusion devices (e.g., mechanical properties, material biocompatibility, structural integrity, fatigue performance). Specific standards are not listed. | Passed non-clinical testing demonstrating safety, effectiveness, and performance equivalent to or better than predicate devices. No specific quantitative performance data is provided in this summary. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This question relates to clinical or imaging study data. As this is for a medical implant and its clearance relies on non-clinical (mechanical and material) testing, the concept of a "test set" in the context of clinical/imaging data or data provenance is not applicable. The "testing" referred to is laboratory-based mechanical and material testing of the device itself.
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)
This question relates to studies involving human interpretation or clinical diagnosis. For a medical implant undergoing non-clinical testing, there is no concept of "experts establishing ground truth" in this manner. The "ground truth" for the device's performance is determined by established engineering and material science testing protocols and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This refers to clinical study result adjudication, which is not relevant for the non-clinical testing of a medical implant as 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
Not applicable. This question concerns AI/ML diagnostic performance studies. The ClariVy™ Cervical IBF System is a physical medical implant, not an AI/ML device, and no such study was conducted or is relevant for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This question concerns AI/ML device performance. The ClariVy™ Cervical IBF System is a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing described, the "ground truth" implicitly refers to the established scientific and engineering principles and standards (e.g., ASTM standards) against which the mechanical and material properties of the implant are measured. There is no biological or diagnostic "ground truth" as would be found in clinical or imaging studies.
8. The sample size for the training set
Not applicable. This question relates to AI/ML model training. The ClariVy™ Cervical IBF System is a physical medical implant.
9. How the ground truth for the training set was established
Not applicable. This question relates to AI/ML model training. The ClariVy™ Cervical IBF System is a physical medical implant.
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(116 days)
Vy Spine ClariVy Cervical IBF System
The Vy Spine™ ClariVy™ Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used supplemental spinal fixation cleared for the implanted level.
The Vy Spine™ ClariVy™ Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerate disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Vy Spine™ ClariVy™ Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
The Vy Spine™ ClariVy™ Cervical IBF System is comprised of implants components. The implant component, the Vy Spine™ ClariVy™ Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Vy Spine™ ClariVy™ Cervical IBF System may also include Titanium alloy bone screws to secure the device to the vertebral body.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vy Spine™ ClariVy™ Cervical IBF System:
Based on the provided text, the device does not involve artificial intelligence or algorithms, and therefore, the typical acceptance criteria and study design elements requested (such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable.
The submission is for an intervertebral body fusion (IBF) device, which is a physical implant. The "Non-Clinical Testing" section describes mechanical testing to assess the device's physical properties, not its diagnostic or predictive performance.
Therefore, many of the specific questions cannot be answered from the provided document as they pertain to AI/software device evaluation, not a physical implant.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device (intervertebral body fusion system), the "acceptance criteria" are related to mechanical performance, material properties, and biocompatibility, rather than diagnostic accuracy metrics like sensitivity or specificity. The text describes the testing performed but does not explicitly state numerical acceptance criteria in a table. It implies that meeting the standards outlined in the ASTM protocols demonstrates acceptable performance.
| Acceptance Criteria Category | Reported Device Performance / Assessment Method |
|---|---|
| Mechanical Performance | - Tested per ASTM F-2077 (Standard Test Methods for Intervertebral Body Fusion Devices) |
| - Tested per ASTM F-2267 (Standard Test Method for Measuring Load Displacement of Spinal Implants Under Static and Dynamic Compression and Transverse Load) | |
| - Tested per ASTM Draft F-04.25.02.02 standards (specifications not fully detailed in the document, but implies relevant mechanical tests for spinal implants) | |
| - Mechanical tests included: static axial compression, dynamic axial compression, static axial torsion, dynamic axial torsion, static compressive shear, dynamic compressive shear, expulsion, and subsidence. | |
| Material Composition | - The subject device has the "same material" (PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers) as the predicate devices, which is presumed to be acceptable. |
| Biocompatibility | - The subject device has the "same... biocompatibility" as the predicate devices, implying it meets established biocompatibility standards. |
| Design and Sizes | - The subject device has the "same... design, sizes" as the predicate devices, indicating substantial equivalence in these aspects. |
| Intended Use | - The subject device has the "same... indication of use" as the predicate devices, affirming its suitability for the specified clinical application (intervertebral body fusion of the cervical spine for DDD). |
| Function | - The subject device was shown to have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. (This implies functional equivalence based on mechanical and material properties compared to a legally marketed predicate). |
| Substantial Equivalence | - The device is considered substantially equivalent to the predicate device (Reliance Cervical IBF K173102) in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation, based on the non-clinical testing and comparison of technological characteristics. This is the primary "acceptance criterion" for 510(k) clearance, rather than a quantifiable performance metric for a diagnostic AI device. |
Unavailable Information (Due to Device Type)
The following information is not applicable or available in the provided document because the Vy Spine™ ClariVy™ Cervical IBF System is a physical implant, not an AI/software device. The questions are structured for AI/diagnostic product evaluations, which is not what this FDA clearance describes.
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 pertains to clinical data for diagnostic/AI devices. For this physical implant, the "test set" would be physical samples of the device undergoing mechanical testing. The document refers to "various ASTM Standards" and testing "at a third party facility," but does not detail the number of physical units tested or their "provenance."
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. Ground truth, in this context, usually refers to clinically confirmed diagnoses or outcomes for evaluating AI/diagnostic performance. For a mechanical device, performance is evaluated against engineering standards and material properties, not expert-adjudicated clinical "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used to establish a consensus ground truth for diagnostic studies, typically with human readers. This concept does not apply to the mechanical testing of a physical implant.
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. MRMC studies are for evaluating the performance of diagnostic systems (often AI) with and without human interaction, which is irrelevant for an intervertebral body fusion implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not contain any algorithms or software. The document explicitly states: "This device does not contain software or electrical equipment."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For mechanical testing, the "ground truth" is defined by the physical behaviors and measurements against established engineering standards (e.g., how much load a device can withstand before deformation or failure), not clinical diagnostic truths.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/software device that learns from data.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth establishment for it.
Summary regarding the device:
The Vy Spine™ ClariVy™ Cervical IBF System is a Class II physical medical device intended for intervertebral body fusion. Its clearance (K212715) relies on demonstrating substantial equivalence to a previously cleared predicate device (Reliance Cervical IBF K173102) through:
- Comparison of technological characteristics (material, design, size, intended use).
- Non-clinical mechanical testing performed according to ASTM standards to ensure its safety and effectiveness are comparable to the predicate.
The document very clearly states: "This device does not contain software or electrical equipment." This is why the questions related to AI/software performance evaluation are not relevant.
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