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The FortiVy™ OsteoVy™ Lumbar 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. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The FortiVy™ OsteoVy™ Lumbar IBF System is also 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 1 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.

Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.

The FortiVy™ OsteoVy™ Lumbar IBF System device is intended to be used as an intervertebral body fusion device. The device is surgically implanted between vertebral bodies from an anterior, lateral, or posterior surgical approach. The FortiVy™ OsteoVy™ Lumbar IBF System device is available in multiple anatomical shapes and sizes to accommodate various vertebral bodies. These include smaller cylindrical and rectangular shapes, elongated elliptical shapes, and larger hemi-cylindrical shapes. The FortiVy™ OsteoVy™ Lumbar IBF components are additively manufactured using Titanium 6Al-4V ELI conforming to ASTM F3001-14. The FortiVy™ OsteoVy™-Ti NanoVy™-HA Lumbar IBF device has been treated with a 20-40 nanoscale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.

The provided text is a 510(k) summary for a medical device (FortiVy™ OsteoVy™ Lumbar IBF System). It describes the device, its intended use, and states that non-clinical testing was performed to demonstrate substantial equivalence to predicate devices.

However, this document does not contain information about studies involving AI or software, nor does it mention acceptance criteria related to AI performance, sample sizes for AI model validation, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/software device. The document explicitly states: "This device does not contain software or electrical equipment."

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The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.

The Vy Spine™ VyLam™ Laminoplasty System is comprised of implant and instrument components. The implant components, plates and screws, will hold the decompression after a laminoplasty procedure. The implant components are manufactured from Ti-6Al-4V ELI per ASTM F136 and are available in multiple anatomical sizes to accommodate various vertebral bodies. The instruments are manufactured from stainless steel per ASTM F899, high grade plastic, and silicone rubber.

The provided document is a 510(k) summary for the Vy Spine™ VyLam™ Laminoplasty System. It focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and a comparison of technological characteristics. It does not describe a study involving human subjects, AI/algorithm performance, or the establishment of ground truth by expert consensus for diagnostic purposes.

Therefore, most of the requested information about acceptance criteria, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and ground truth types cannot be found in this document.

However, I can extract information related to the performance data and the "acceptance criteria" (in this context, demonstrating equivalent mechanical strength).

Here's what can be extracted based on the provided text:

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a Finite Element Analysis (FEA) for the additional implant plates.

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

The document states: "FEA analyses for the additional plates' four-point bending (based on ASTM F2193) were performed to compare the strength of the additional plates to the standard plate in the predicate Vy Spine™ VyLam™ Laminoplasty System (K232471). The performance data verifies that the subject is substantially equivalent to the predicate Vy Spine™ Laminoplasty System (K232471)."

While a specific table is not provided, the "acceptance criteria" implicitly relates to the additional plates demonstrating equivalent or superior mechanical strength to the standard plate of the predicate device, as verified by FEA. The "reported device performance" is the conclusion that the performance data verifies substantial equivalence in strength.

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

• Sample Size: This was a computational study (FEA) rather than a study with a "test set" in the sense of patient data or a large number of physical parts tested. The "sample" would be the computational models of the specific new plates: VyLam™ Double Hook Plate, VyLam™ Inline Double Hook Plate, and VyLam™ Support Plate. The number of models is not explicitly stated beyond "additional plates."
• Data Provenance: Not applicable as this is a computational analysis, not patient data.

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

• Not applicable. This is a mechanical engineering analysis (FEA), not a medical image interpretation study. "Ground truth" in this context would be derived from accepted engineering principles and standards (ASTM F2193).

4. Adjudication method for the test set:

• Not applicable. This is a computational analysis.

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:

• No. This is not an AI/diagnostic device.

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

• No. This is not an AI device.

7. The type of ground truth used:

• For the mechanical performance, the "ground truth" is based on established engineering standards (ASTM F2193) and the mechanical properties of the predicate device, against which the new designs were compared via FEA.

8. The sample size for the training set:

• Not applicable. This is not an AI device trained on data.

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

• Not applicable. This is not an AI device.

In summary, the document describes a mechanical performance study using Finite Element Analysis (FEA) to demonstrate substantial equivalence of new implant plates to an existing predicate device based on their mechanical strength. It does not involve patient data, expert interpretations, or AI algorithm performance.

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The LumiVy™ Lumbar 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. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The LumiVy™ Lumbar IBF System is also 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 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.

Additional supplemental fixation is not necessary for the Lumi Vy™ -AS implants if the integrated screws are implanted for cages with a lordosis of less than or equal to 20°.

The purpose of this 510(k) submission is to introduce the LumiVy™ OsteoVy™ PEKK Lumbar IBF configuration. The LumiVy™ Lumbar IBF System device is intended to be used as an intervertebral body fusion device. The device is surgically implanted between vertebral bodies from an anterior, lateral, or posterior surgical approach. These devices also contain Tantalum wires to aid in fluoroscopic visualization. The LumiVy™ Lumbar IBF System device is available in multiple anatomical shapes and sizes, to accommodate various vertebral bodies. These include smaller cylindrical and rectangular shapes, elongated elliptical shapes, and larger hemi-cylindrical shapes. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The LumiVy™ NanoVy™ Ti Lumbar IBF components are made of PEEK Optima LT1 with CP Titanium coating. The LumiVy™ OsteoVy™ PEKK Lumbar IBF is made from OXPEKK. The LumiVy™ Lumbar IBF System may also include bone screws manufactured from Titanium alloy to secure the device to the vertebral body. Additionally, this submission adds hyper-lordotic options to the LumiVyTM System.

The provided text is a 510(k) summary for the LumiVy™ Lumbar IBF System, a medical device for spinal fusion. This document describes the device, its intended use, and substantial equivalence to predicate devices, primarily through non-clinical mechanical testing.

Crucially, there is no mention of an AI/ML component or associated clinical study for the device's performance or acceptance criteria related to AI/ML. The document focuses solely on the physical device itself (intervertebral body fusion system) and its mechanical performance.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving device performance related to an AI component, as the provided text does not contain any information about an AI/ML aspect of the LumiVy™ Lumbar IBF System.

The sections of your prompt that I cannot address based on this document include:

• A table of acceptance criteria and the reported device performance (for an AI component)
• Sample size used for the test set and data provenance (for an AI component)
• Number of experts used to establish ground truth and qualifications (for an AI component)
• Adjudication method (for an AI component)
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done (for an AI component)
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done (for an AI component)
• The type of ground truth used (for an AI component)
• The sample size for the training set (for an AI component)
• How the ground truth for the training set was established (for an AI component)

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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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The VyLink™ Spinal Screw System is a pedicle screw system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The VyLink™ Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the VyLink™ Spinal Screw System is also a hook and sacraliliac screw fixation system of the noncervical spine indicated for: spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

When used in a percutaneous, posterior approach with MIS instrumentation, the VyLink™ Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.

The VyLink™ Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous- failed fusion (pseudarthrosis).

The Vy Spine™ VySpan™ PCT System can also be linked to the Vy Spine™ VyLink™ Screw System using the dual diameter rods.

The 06.5mm and larger screws may be used for sacroiliac joint fusion. The VyLink™ Spinal Screw System when used in the sacroiliac joint is intended for sacroiliac joint fusion for the following conditions:

· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint

The VyLink™ Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, MIS screws, cannulated screws, fenestrated screws, hooks, reduction hooks, set screws, and transverse connectors.

The VyLink™ Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications.

The provided text is a 510(k) summary for the VyLink™ Spinal Screw System, a medical device for spinal fixation, not a software or AI/ML-driven device. As such, it does not involve acceptance criteria, performance studies, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance as described in the prompt.

The document explicitly states:

• "No new performance testing has been performed on the subject VyLink™ Spinal System."
• "The subject VyLink™ Spinal System has similar design, materials, sizes, indication of use & biocompatibility as the predicate devices."
• "This device does not contain software or electrical equipment."

Therefore, I cannot provide the requested information for acceptance criteria and study details based on the given text, as these concepts are not applicable to the clearance pathway described for this particular mechanical medical device.

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The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.

The Vy Spine™ VyLam™ Laminoplasty System is comprised of implant and instrument components. The implant components, plates and screws, will hold the decompression after a laminoplasty procedure. The implant components are manufactured from Ti-6Al-4V ELI per ASTM F136 and are available in multiple anatomical sizes to accommodate various vertebral bodies. The instruments are manufactured from stainless steel per ASTM F899, high grade plastic, and silicone rubber.

This document is a 510(k) premarket notification for a medical device (Vy Spine™ VyLam™ Laminoplasty System). The information provided focuses on the regulatory aspects and substantial equivalence to predicate devices, rather than a study proving the device meets specific performance acceptance criteria in the way a clinical or diagnostic AI study would.

Therefore, many of the requested categories related to AI/diagnostic study design (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of submission.

However, I can extract information related to the mechanical performance data that was conducted to demonstrate substantial equivalence.

Here's the breakdown of the available information:

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

2. Sample size 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: This information is not provided in the document. Mechanical testing typically involves a certain number of specimens per test, but the specific quantity is not reported here.
• Data Provenance: Not applicable for mechanical testing. This is lab-based testing of device components.

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 mechanical testing to established standards, not a diagnostic study requiring expert ground truth.

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

Not applicable. This is 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 mechanical testing, not an AI or diagnostic imaging study.

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

Not applicable. This is mechanical testing.

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

The "ground truth" for mechanical performance in this context is the established ASTM standards (ASTM F2193 and ASTM F543). The device's performance must meet the requirements defined within these standards.

8. The sample size for the training set

Not applicable. This is mechanical testing, not a machine learning study with a training set.

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

Not applicable.

Study Proving Device Meets Acceptance Criteria:

The study referenced is the mechanical testing detailed in the "Performance Data and Substantial Equivalence" section.

• Tests Conducted: Static four-point bend testing per ASTM F2193, dynamic four-point bend testing per ASTM F2193, and axial pullout testing per ASTM F543.
• Conclusion: "The performance data indicates that the subject device is substantially equivalent to predicate devices and has met all mechanical test requirements based on worst-case construct testing and the engineering rationale."

This statement confirms that the results of these mechanical tests demonstrated that the Vy Spine™ VyLam™ Laminoplasty System met the acceptance criteria defined by the relevant ASTM standards, thereby supporting its substantial equivalence to predicate devices for regulatory clearance.

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The VySpan™ PCT System, which is used to promote fusion of the cervical spine and the cervicothoracic (C1-T3), and is indicated for the following:

· ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

• Spondylolisthesis
• · Spinal stenosis
• Fracture/dislocation
• · Revision of previous cervical spine surgery
• Tumors

The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The VySpan™ PCT System can also be linked to the VyLink™ Screw System using the dual diameter rods and rod-to-rod connectors.

The VySpan™ PCT System is comprised of implant and instrument components. The implant component, the VySpan™ device, consists of posterior attachments with a set screw and The VySpan™ pedicle screw component is offered in both poly-axial and mono-axial rod. configuration. In addition to these components, there are also ancillary components such as hooks, connectors, cross-links, and lateral offset connectors. All of the components discussed above are fabricated from Titanium alloy, or Cobalt Chrome, and should not be used with implants of different materials. The purpose of this submission is to add additional connectors and rods to the VySpan™ PCT System.

This document pertains to the 510(k) premarket notification for the VySpan™ PCT System, a medical device for spinal fixation. The submission focuses on adding new components to an existing system, and as such, relies on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting new performance study data.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria (including specific details about sample sizes, expert involvement, ground truth establishment, MRMC studies, standalone performance, and training sets for an AI/algorithm) cannot be provided based on the provided text.

The document explicitly states:
"Engineering rationale was used to determine no new worse-case was introduced; therefore, no new performance testing has been performed on the subject VySpan™ PCT System. The subject VySpan™ PCT System has the same design, sizes, indication of use & biocompatibility as the predicate devices."

This indicates that the submission did not involve new clinical, software, or algorithm performance studies. The substantial equivalence was established through an engineering rationale and comparison of technological characteristics to predicate devices. The device described also does not contain software or electrical equipment, as stated in the document.

In the context of this specific product (VySpan™ PCT System), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" would primarily refer to the demonstration of substantial equivalence to a predicate device based on design, materials, intended use, and other characteristics, as opposed to performance metrics from a new, specific study.

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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."

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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The UniVy™ OsteoVy™-Ti Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices 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 UniVy™ OsteoVy™-Ti Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The UniVy™ OsteoVy™ Ti Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

The UniVy™ OsteoVy™-Ti Cervical IBF System is comprised of implant components. The implant component is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The subject UniVy™ OsteoVy™-Ti Cervical IBF System spacer is comprised of additively manufactured Titanium 6Al-4V ELI conforming to ASTM F3001-14. The UniVy™ Osteo Vy™-Ti NanoVy™-HA Cervical IBF components' surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.

The provided text describes a 510(k) premarket notification for a medical device called the UniVy™ OsteoVy™-Ti Cervical IBF System. It establishes substantial equivalence to predicate devices based on non-clinical testing. However, the document does not contain information related to acceptance criteria, device performance metrics, sample sizes for test sets or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. These types of studies are typically associated with performance claims for AI/ML-driven devices or diagnostics, which this device is not.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence for a physical medical implant through mechanical and material testing, not through clinical performance metrics involving AI or expert review.

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The VySpan™ PCT System, which is used to promote fusion of the cervical spine and the cervicothoracic (C1-T3), and is indicated for the following: ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), Spondylolisthesis, Spinal stenosis, Fracture/dislocation, Revision of previous cervical spine surgery, Tumors. The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Hooks and Rods: The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The VySpan™ PCT System can also be linked to the VyLink™ Screw System using the dual diameter rods and rod-to-rod connectors.

The VySpan™ PCT System is comprised of implant and instrument components. The implant component, the VySpan™ device, consists of posterior attachments with a set screw and rod. The VySpan™ pedicle screw component is offered in both poly-axial and mono-axial configuration. In addition to these components, there are also ancillary components such as hooks, connectors, crosslinks, and lateral offset connectors. All of the components discussed above are fabricated from Titanium alloy and should not be used with implants of different materials. The purpose of this submission is to add additional connectors to the VySpan™ PCT System.

The provided text is a 510(k) summary for the VySpan™ PCT System, which is a spinal fixation device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria for a diagnostic or AI-based medical device.

Therefore, many of the requested points, such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable or available in this document.

The document states that "Engineering rationale was used to determine no new worse-case was introduced; therefore, no new performance testing was performed on the subject VySpan™ PCT System." This indicates that the device's substantial equivalence is based on its similarity to a predicate device and not on new, specific performance studies directly demonstrating its efficacy against defined acceptance criteria.

Here's an attempt to address the applicable points based on the provided text:

1. Table of acceptance criteria and the reported device performance

Not applicable. The document states "no new performance testing was performed on the subject VySpan™ PCT System." The basis for clearance is substantial equivalence to a predicate device in terms of material, intended use, levels of attachment, size range, and strength.

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. No new performance testing was conducted.

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. No ground truth was established for a test set as no new performance testing was conducted.

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

Not applicable. No test set was used.

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 mechanical spinal fixation system, not an AI-based diagnostic tool.

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

Not applicable. This device is a mechanical spinal fixation system, not an algorithm.

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

Not applicable. No ground truth was established as no new performance testing was conducted.

8. The sample size for the training set

Not applicable. No training set was used as this is not an AI/algorithm-based device.

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

Not applicable. No training set was used.

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