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The VerteFIT™ Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFIT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or autograft. The VerteFIT implants are intended to be used with supplemental spinal fixation systems that have been cleared by FDA for use in the thoracic and/or lumbar spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).

VerteFIT Corpectomy Cages are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include central PEEK cores and titanium-coated PEEK endcaps which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endcaps can be intraoperatively assembled to best fit patient anatomy requirements. Each endcap has a central axial chamber to allow autogenous bone graft or allograft to be packed inside of the spacer. Unidirectional teeth on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. VerteFIT endcaps (superior and inferior) have slots to accommodate VerteBRIDGE anchoring plates.

This document describes the VerteFIT™ Corpectomy Cage System, a vertebral body replacement device. The provided text outlines the device's indications for use and non-clinical performance data, but it does not describe an acceptance criteria table, a study proving device adherence to acceptance criteria, nor does it contain information typically associated with studies of AI/ML devices (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).

The information provided pertains to the non-clinical performance data which focuses on mechanical testing to demonstrate substantial equivalence to predicate devices, rather than clinical performance data or AI/ML-specific study details.

Here's a breakdown of the available information based on your request:

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

• Acceptance Criteria: Not explicitly stated in a table format. The document implies compliance with standards and guidance documents, such as "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s., May 3, 2004" and various ASTM standards (F2077, F2267, F2129).
• Reported Device Performance: The document states that "Mechanical testing was conducted... to demonstrate substantial equivalence to the predicate system(s)." Specific numerical performance results or whether these results "met" an explicit acceptance criterion are not detailed 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)

• Sample Size: Not applicable. The document refers to mechanical testing, not clinical studies involving patient data.
• Data Provenance: Not applicable. No patient data or clinical data is mentioned.

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 a mechanical device, and "ground truth" as typically understood in AI/ML clinical studies is not relevant. Mechanical testing relies on engineering standards and measurements.

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

• Not applicable. No form of adjudication is mentioned as it's not a clinical study involving human interpretation.

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 document pertains to a physical medical device (spinal implant), not an AI/ML diagnostic or assistive device. No MRMC study or human reader performance is mentioned.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering specifications and performance within defined limits of the ASTM standards mentioned.

8. The sample size for the training set

• Not applicable. There is no AI/ML component; therefore, no training set.

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

• Not applicable. There is no AI/ML component; therefore, no training set ground truth.

Summary of Non-Clinical Performance Data (as provided):

• Tests Conducted:
  • Static & dynamic compression (ASTM F2077)
  • Static & dynamic shear compression (ASTM F2077)
  • Static & dynamic torsion (ASTM F2077)
  • Subsidence (ASTM F2267)
  • Cage and anchor expulsion (F-04.25.05.02)
  • Corrosion testing (ASTM F2129)
• Purpose: To demonstrate substantial equivalence to predicate device(s) based on mechanical performance.
• Clinical Performance Data: "Clinical testing was not required to demonstrate substantial equivalence."

This document focuses on the regulatory clearance for a physical medical device through a 510(k) pathway, which typically involves demonstrating substantial equivalence to a legally marketed predicate device, often through non-clinical performance testing and comparison of technical characteristics, rather than extensive clinical efficacy studies or AI/ML performance evaluations.

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The Avenue T TLIF Cage System 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 or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T cage is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T cage is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T cages have a hollow central cavity to contain autogenous or allogenic bone graft for fusion.

After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T cages via an integral locking pin.

The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and ASTM F2063 wrought nickel-titanium shape memory alloy anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.

The Avenue T cages are designed in 30mm and 34mm lengths, 8mm to 19mm heights, and an 11mm width with lordosis angles ranging from 0° to 9°.

This looks like a 510(k) submission for a medical device, specifically an intervertebral body fusion device (Avenue T TLIF Cage). The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. Therefore, much of the information you've requested regarding AI algorithm performance, ground truth, expert consensus, and reader studies is not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily refers to general performance criteria through mandated ASTM standards and other non-clinical tests. It doesn't present precise numerical acceptance criteria with corresponding performance values in a direct table format as might be seen for an AI algorithm. Instead, it states that the device "is sufficient for its intended use" and "conformance to endotoxin limits."

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

This question is not applicable as there is no "test set" in the context of an AI algorithm or clinical study with human patients used for demonstrating performance in this 510(k) submission. The non-clinical tests would have their own sample sizes (e.g., number of devices tested for mechanical properties), but these are not specified in the summary.

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

This question is not applicable. There is no "ground truth" establishment in the context of medical image interpretation or diagnosis by experts as this submission is for a physical implant device, not a diagnostic AI tool.

4. Adjudication Method for the Test Set:

This question is not applicable for the same reasons as (3).

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:

This question is not applicable. This submission is for a physical medical device (spinal cage), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This question is not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used:

This question is not applicable. For an intervertebral body fusion device, "ground truth" would relate to successful fusion or clinical outcomes, which are not assessed in this non-clinical submission. The "truth" for the bench tests is adherence to engineering specifications and performance standards.

8. The Sample Size for the Training Set:

This question is not applicable. This is not an AI algorithm.

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

This question is not applicable. This is not an AI algorithm.

Summary of Relevant Information from the Document:

• Device Type: Avenue® T TLIF Cage (Intervertebral body fusion device with integrated fixation, lumbar).
• Purpose of Submission: To demonstrate substantial equivalence to a predicate device via non-clinical performance data.
• Performance Data Provided: Non-clinical bench testing, including:
  • Finite Element Analysis
  • Dynamic compressive shear testing per ASTM F2077-11
  • Static anchoring plate expulsion testing
  • Wear testing & debris analysis
  • Corrosion testing
  • Limulus Ameebocyte Lysate (LAL) endotoxin testing
• Conclusion: The non-clinical testing demonstrated that the Avenue T TLIF Cage is sufficient for its intended use, conforms to endotoxin limits, and is substantially equivalent to legally marketed predicate devices.
• Clinical Data: "Clinical testing was not required to demonstrate substantial equivalence." (Page 5)

This document is a typical 510(k) clearance letter and summary for a Class II medical device, relying heavily on engineering and material performance tests rather than clinical trials or AI performance evaluations.

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The FacetBRIDGE® System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. This system is intended for use only with bone graft material. This system is not to be used with bone cement. The FacetBRIDGE® System is indicated for treatment for any or all of the following:

• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity.

· Spondylolisthesis,

· Spondylolysis.

· Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies,

· Degeneration of the facets with instability,

· Trauma including spinal fractures and/or dislocations.

The FacetBRIDGE® System is a set of screws used for translaminar or transfacet fixation in the spine as an adjunct to fusion.

Each FacetBRIDGE® System construct consists of a screw and optional polyaxial washer both manufactured from Ti-6AI-4V ELI. The screw is cannulated to aid in placement via a guide wire. This system is not to be used with bone cement. The safety and effectiveness of using bone cement with this system has not been established.

This document is a 510(k) premarket notification for the FacetBRIDGE® System, specifically for a line extension that includes an additional washer design. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study of the device itself.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is largely not applicable/provided in this document in the context of device performance as typically defined for new medical devices requiring extensive clinical data.

Here's what can be extracted based on the provided text, and where information is missing:

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

Explanation: The document states that the purpose of the submission is to introduce a line extension and that the non-clinical performance bench testing conducted was to support substantial equivalence. The "performance" described here is in the context of ensuring the new washer design does not negatively impact existing functionality or mechanical strength. No specific quantitative performance metrics (e.g., maximum load, fatigue cycles, specific dimensional tolerances) or their corresponding acceptance thresholds are provided in this summary. Instead, a general statement of compliance or completion of these tests is made.

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

• Test Set Sample Size: Not specified. The document mentions "functional verification study utilizing sawbones" but does not give a sample size (e.g., number of sawbones tested, number of devices tested on sawbones).
• Data Provenance: Not specified. Given it's non-clinical bench testing, geographical provenance is less relevant than for clinical data. The study appears to be proprietary data from the manufacturer (LDR Spine USA, Incorporated). It is a non-clinical, prospective bench study.

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

• Number of Experts: Not applicable/provided. This was a non-clinical bench study. Ground truth in this context would typically refer to objective measurements from engineering tests rather than expert interpretation.

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

• Adjudication Method: Not applicable/provided. This was a non-clinical bench study.

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

• MRMC Study: No. This is not applicable to a non-clinical submission for a spinal implant. It's a physical medical device, not an AI or diagnostic software.

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

• Standalone Performance Study: No. This is not applicable to a physical medical device.

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

• Type of Ground Truth: For the non-clinical bench testing, the "ground truth" would be established by engineering specifications, material standards, and verifiable physical measurements. For example, during dimensional analysis, "ground truth" would be the engineering drawings and metrology results. For endotoxin testing, it would be a validated assay and defined pass/fail criteria.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device. The non-clinical tests would involve specific samples for each test type mentioned.

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

• Ground Truth for Training Set Establishment: Not applicable/provided, as there is no "training set."

Summary of Device and Study Context:

This 510(k) submission, K161798 for the FacetBRIDGE® System, is for a line extension (new washer design) to an already cleared device. The regulatory strategy applied here is to demonstrate "substantial equivalence" to a predicate device (K152137), meaning the new design does not introduce new questions of safety or effectiveness. For such a submission, extensive de novo clinical trials are often not required. The clinical performance data section explicitly states: "Clinical testing was not required to demonstrate substantial equivalence." The non-clinical data primarily consists of engineering analysis, functional verification using sawbones, and endotoxin testing, which are standard for changes to mechanical devices to confirm continued safety and performance without needing full clinical re-validation.

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The Avenue® L Lateral Lumbar Cage system 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 or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Avenue® T TLIF Cage System 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 or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

The ROI-A® ALIF Cage System is indicated for intervertebral body fusion of the from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use 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 radios. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

The ROI-T® Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in sketally mature patients who have had six months of non-operative treatment. The device is intended for use at either one 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 radios. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

When used as a vertebral body replacement device, the ROI-T® Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. 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 fixation. Supplemental internal fixation is required to properly utilize the system. These devices are intended to be used with autograft or allograft bone.

The Avenue L Lateral Lumbar Cage is intended for use as an interbody fusion device in the lumbar spine. The device consists of intervertebral cages manufactured from medical grade PEEK OPTIMA " LT1 (ASTM F2026) with embedded titanium alloy markers (ASTM F136) to facilitate visibility in x-ray imaging. The Avenue L Lateral Lumbar Cage is available with VerteBRIDGE® titanium alloy anchoring plates which facilitate fixation to the superior and inferior vertebra, which may be used in addition to supplemental fixation. The Avenue L Lateral Lumbar Cage is designed for placement using a lateral surgical approach.

The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T TLIF Cage System is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T TLIF Cage System is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T TLIF Cage System have a hollow central cavity to contain autogenous bone graft for fusion.

After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T TLIF Cage System via an integral locking pin.

The Avenue T TLIF Cage System is manufactured from PEEK-OPTIMA LT1 with embedded ASTM F136 titanium alloy radiographic markers and anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy. The Avenue T TLIF Cage System are designed in a variety of length, and lordosis combinations to best fit varying patient anatomies.

The ROI-A ALIF Cage System is intended for use as an interbody fusion device in the lumbar spine. The device is manufactured from medical grade PEEK OPTIMA LT1 in accordance with ASTM F2026 and has tantalum markers conforming to ASTM F560 embedded in the implant to facilitate visibility in x-ray imaging. The subject device is designed for placement using either an anterior or anterolateral approach. The ROI-A ALIF Cage System implants feature two slots which allow for use with device-specific integrated fixation - the ROI-A VerteBRIDGE anchoring plate. The ROI-A ALIF Cage System VerteBRIDGE anchoring plate is made of titanium alloy (Ti-6Al-4V, ASTM F136) and can be inserted to obtain fixation to the vertebral bone and create a standalone lumbar interbody fusion cage construct.

The ROI-T Implant System consists of crescent shaped cages in a variety of heights and lordotic angles. The ROI-T Implant System implant has an enclosed graft space design. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and to prevent movement of the implants. The ROI-T Implant System PEEK cages are designed to be inserted via a transforaminal approach. The ROI-T Implant System cages are manufactured from medical grade PEEK OPTIMA LT1 in accordance with ASTM F2026 and has tantalum markers (ASTM F560) embedded in the implant to facilitate visibility during x-ray imaging.

The provided document is a 510(k) premarket notification from the FDA regarding several intervertebral body fusion devices. It does not describe a study to prove a device meets acceptance criteria, but rather a submission for expanding indications for use of existing devices.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in this document.

However, I can extract the following relevant information:

1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states that a "comprehensive clinical literature review was conducted to assess any additional safety concern for the use of this device with the use of allograft in the lumbar spine. The review of the literature concluded that there were no additional risks due to the modification for this device and that the devices was substantially equivalent to the predicate devices." This implies that the acceptance criteria revolved around demonstrating substantial equivalence and lack of additional risks when using allograft, rather than specific performance metrics against a predefined threshold. No specific performance data is reported.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set or associated sample size is mentioned. The assessment was based on a "clinical literature review," not a specific study in this submission. Therefore, data provenance is not applicable in the context of a new study.

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. There was no test set or ground truth established by experts in the context of this submission. The determination was made through a literature review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set.

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 not a study involving AI or human readers, but rather a regulatory submission for medical implants.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not directly applicable in the terms of a new study. The "ground truth" for the expanded indication was established through "comprehensive clinical literature review" demonstrating "substantial equivalence" and "no additional risks" compared to predicate devices. This relies on existing medical knowledge and regulatory precedent rather than a newly established ground truth for a test set.

8. The sample size for the training set:
Not applicable. This submission does not involve a training set for an algorithm.

9. How the ground truth for the training set was established:
Not applicable. This submission does not involve a training set for an algorithm.

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The FacetBRIDGE® System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. This system is intended for use only with bone graft material. This system is not to be used with bone cement. The FacetBRIDGE® System is indicated for treatment for any or all of the following:
· Pseudoarthrosis and failed previous which are symptomatic or which may cause secondary instability or deformity,
· Spondylolisthesis,
· Spondylolysis,
· Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.
· Degeneration of the facets with instability,
· Trauma including spinal fractures and/or dislocations.

The FacetBRIDGE System is a set of screws used for translaminar or transfacet fixation in the spine as an adjunct to fusion. Each FacetBRIDGE construct consists of a screw and polyaxial washer both manufactured from Ti-6A1-4V ELI. The screw is cannulated to aid in placement via a guide wire. This system is not to be used with bone cement. The safety and effectiveness of using bone cement with this system has not been established.

This document describes the regulatory submission for the FacetBRIDGE® System, a spinal facet screw system. It focuses on non-clinical (bench) performance data rather than clinical studies or those involving AI. Therefore, most of the requested information regarding AI-specific criteria, human expert involvement, and ground truth establishment from clinical data is not available in the provided text.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that non-clinical performance bench testing was conducted to support substantial equivalence. The acceptance criterion is that the device "demonstrates the device is substantially equivalent to legally marketed predicate devices." The reported performance is that the FacetBRIDGE® System met this requirement.

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

This information is not applicable and not provided. The study conducted was non-clinical bench testing, not a clinical test set with patient data.

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

This information is not applicable and not provided. The "ground truth" in this context would refer to the performance standards set by the ASTM methods for bench testing, not expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are relevant for clinical studies involving human interpretation or outcome assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence."

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

This information is not applicable. This device is a physical spinal implant system, not a software algorithm or AI device.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" or reference standard would be the engineering specifications and performance standards defined by the ASTM (American Society for Testing and Materials) standards referenced (e.g., ASTM F1264-14, ASTM F543e1).

8. The Sample Size for the Training Set

This information is not applicable and not provided. The study conducted was non-clinical bench testing; there was no "training set" in the context of machine learning.

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

This information is not applicable. There was no training set for an AI model. For the non-clinical testing, the performance standards (ground truth) were established by the relevant ASTM test methods.

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The LDR Spine ROI-C Titanium-Coated Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The ROI-C Implants are to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

The ROI-C Titanium-Coated Implant System consists of 'D' shaped blocks in two profiles, anatomic and lordotic, a variety of footprints within each profile, and features an enclosed graft space. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat portion of the 'D' shape represents the anterior most portion of the device and includes features for attachment to instrumentation for insertion and slots for VerteBRIDGE® integrated fixation anchoring plates. The D-shaped ROI-C PEEK implants (PEEK OPTIMA LT1) are coated with plasma-sprayed commercially pure titanium on the inferior and superior surfaces and feature two slots which allow for use with specially designed (and optional) supplemental fixation described below. The ROI-C Titanium-Coated Implant also features a tantalum radiographic marker on the posterior edge of the device. The VerteBRIDGE Anchoring Plates are made of titanium alloy (TiAl6V4) and can be inserted to obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct. The VerteBRIDGE Anchoring Plate used with ROI-C is curved, allowing it to be inserted into the ROI-C device in-line with the cage and then seated into the superior and inferior vertebral endplates. The ROI-C VerteBRIDGE Anchoring Plates are provided in two sizes: an 8mm length plate (intended for use with ROI-C devices height 4.5mm – 7mm) and a 9.5mm length plate (intended for use with ROI-C devices height 8mm -10mm). The anchoring plate locks into the ROI-C cage and provides stability to the construct via incorporated antiback out tabs and a central retaining ridge.

The provided document is a 510(k) premarket notification for the LDR Spine ROI-C Titanium-Coated Implant System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data (bench testing), rather than clinical studies proving efficacy in a human population. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device meets acceptance criteria in the context of clinical performance, ground truth, expert consensus, or AI/human reader studies.

Here's what the document does provide regarding performance and testing:

Non-Clinical Performance Data: The document details the non-clinical (bench) testing performed to support substantial equivalence. These tests are conducted to ensure the physical and mechanical properties of the device are adequate for its intended use and comparable to predicate devices.

1. A table of acceptance criteria and the reported device performance:
The document does not provide a table specifying quantifiable acceptance criteria and reported device performance values for the non-clinical tests. It only lists the types of tests performed. To report this, I would need access to the detailed test reports that accompanied the 510(k) submission.

• Acceptance Criteria (Example for a fictional scenario): For Static Compression Testing, acceptance criteria might be "device must withstand X Newtons of force without permanent deformation or failure."
• Reported Device Performance (Example for a fictional scenario): For Static Compression Testing, reported performance might be "device withstood Y Newtons of force, exceeding the acceptance criteria."

2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes used for the non-clinical bench tests. The data provenance is "Non-clinical performance bench testing" conducted by the manufacturer, LDR Spine USA. These are laboratory tests, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. Non-clinical bench testing does not involve human subjects or expert consensus for ground truth on clinical outcomes. The "ground truth" for these tests would be the established engineering standards (e.g., ASTM standards) and the physical properties observed in the laboratory.

4. Adjudication method for the test set:
This information is not applicable to non-clinical bench testing. Adjudication methods are typically used in clinical studies involving human interpretation or outcome assessment.

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:
This information is not applicable. The device is an intervertebral body fusion implant, not an AI software/diagnostic tool that would involve human readers.

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 surgical implant, not an algorithm.

7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by established engineering standards like ASTM F2077-11 for mechanical testing, and the observed physical properties of the materials and device. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:
This information is not applicable. There is no "training set" in the context of non-clinical bench testing for a surgical implant. Training sets are relevant for machine learning algorithms.

9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.

Summary of available information from the document:

• Device: ROI-C Titanium-Coated Implant System (intervertebral body fusion device)
• Indication: Degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1) in skeletally mature patients.
• Purpose of Submission: To extend the line of currently available ROI-C cages to include cages that incorporate a titanium coating.
• Performance Data Provided: Non-clinical (bench) testing only.
  • Static and dynamic compression testing per ASTM F2077-11
  • Static and dynamic compressive shear testing per ASTM F2077-11
  • Static and dynamic torsion testing per ASTM F2077-11
  • Subsidence testing and engineering analysis
  • Static cage expulsion testing
  • Static anchoring plate expulsion testing
  • Wear testing & debris analysis
  • Coating characterization
  • MRI compatibility testing
• Conclusion of Non-Clinical Testing: "The results of this non-clinical testing demonstrate that the strength and performance of the ROI-C Titanium-Coated Implant System are sufficient for its intended use and the device is therefore substantially equivalent to legally marketed predicate devices."
• Clinical Performance Data: "Clinical testing was not required to demonstrate substantial equivalence."

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The LDR Spine ROI-C Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine ROI-C Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

The LDR Spine ROI-C Cervical Cage System consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an enclosed graft space. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the anchors.

The D-shaped ROI-C PEEK implants (PEEK OPTIMA LT1) feature two slots which allow for use with specially designed supplemental fixation - the ROI-C VerteBRIDGE anchoring plate. The anchoring plate, made of titanium alloy (TiA16V4) can be inserted to obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct. The anchoring plate locks securely in place to the PEEK implant via locking tabs on either side of the anchoring plate.

The ROI-C PEEK cages are available in two shapes - an anatomic design with a curved superior surface and a lordotic design with flat superior and inferior surfaces to create 7° of lordosis. The device is manufactured from medical grade PEEK OPTIMA® LT1

The purpose of the subject 510(k) was to expand the indications to include use with allograft.

This document is a 510(k) summary for the LDR Spine ROI-C Cervical Cage System, a medical device. It describes an expanded indication for use of an existing device to include allograft. Therefore, the device in question is a physical implant, not an AI/ML device.

Based on the provided text, there is no information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria. The document focuses on demonstrating substantial equivalence for an intervertebral body fusion device and its expanded use with allograft based on clinical literature review.

The sections you requested (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set information) are all relevant to the evaluation of AI/ML-driven medical devices. Since this document concerns a physical implant and not an AI/ML device, these specific details are not present.

The "Performance Testing" section states:

• "Comprehensive, clinical literature review data have been provided to investigate the risks and benefits associated with using allogenic bone graft with the LDR Spine ROI-C Cervical Cage System."
• "The published clinical outcomes demonstrated that the use of allograft (i.e., cancellous and/or corticocancellous bone graft) in cervical interbody fusion devices to treat patients diagnosed with cervical degenerative disc disease as defined above, poses no new risks to patients."
• "No new mechanical tests were performed since there were no design changes to the device."

This indicates that the "study" for this submission was a literature review, not a performance study of an AI/ML algorithm.

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The Avenue® T TLIF Cage system 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 or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft to facilitate fusion.

The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T cage is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T cage is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T cages have a hollow central cavity to contain autogenous bone graft for fusion.

After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T cages via an integral titanium locking pin.

The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.

The Avenue T cages are designed in a variety of length, and lordosis combinations to best fit varying patient anatomies.

The provided text describes a medical device (Avenue T® TLIF Cage) and its FDA clearance. However, it does not include information about a study proving the device meets acceptance criteria related to AI/algorithm performance, which is what your request is focused on. This document is a 510(k) summary for a physical medical implant, not an AI or software as a medical device.

Therefore, I cannot provide the detailed information you requested about acceptance criteria and study particulars for AI-related performance. The document explicitly states:

• "Clinical testing was not required to demonstrate substantial equivalence." This means no human clinical trials were performed to assess patient outcomes or the device's clinical effectiveness in a real-world setting.
• "Non-clinical performance bench testing conducted to support substantial equivalence for the Avenue T TLIF Cage included: ... The results of this non-clinical testing demonstrate that the strength of the Avenue T TLIF Cage is sufficient for its intended use and is therefore substantially equivalent to legally marketed predicate devices." The "acceptance criteria" here refer to engineering and biomechanical tests comparing the device to existing predicate devices, not performance against clinical endpoints or AI metrics.

The information you are asking for, such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, and ground truth types, are standard for AI/software medical devices undergoing regulatory review, but are not applicable to the documentation provided for this physical implantable device.

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The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device intended for single-level use only in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:

• . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• Trauma (fracture or dislocation) .
• . Tumor
  The InterBRIDGE® system is not intended for stand-alone use.

The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion.
The system is implanted via a posterior approach to the spine. The InterBRIDGE® System includes various sizes of titanium plate constructs. The implants are provided sterile and single use. The instrumentation is non-sterile and reusable.

This 510(k) summary describes a medical device, the InterBRIDGE Interspinous Posterior Fixation System, which is a physical implant, not an AI/software device. Therefore, the typical acceptance criteria and study designs relevant to AI devices (such as those involving sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies) are not applicable here.

Instead, this document focuses on the mechanical and material performance of the physical implant to demonstrate its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information, framed within the context of a physical medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" relate to mechanical and material properties, and "reported performance" indicates that the device met these criteria. The document states that the testing demonstrated sufficient strength and substantial equivalence to predicates. Specific numerical acceptance criteria are not explicitly listed in this summary but would be detailed in the full submission.

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

• Sample Size: Not applicable in the context of an AI/software device. For a physical device, this refers to the number of test articles (implants) subjected to mechanical testing. This information is not provided in the summary.
• Data Provenance: Not applicable in the context of an AI/software device. For a physical device, the data provenance relates to the testing facility and the standards followed (e.g., ASTM F1717-12a).

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

• Not applicable. This question pertains to subjective assessments or diagnostic interpretations typically associated with AI/software performance. For a physical implant, ground truth is established through objective, quantifiable mechanical tests against established engineering standards.

4. Adjudication Method for the Test Set

• Not applicable. This question is relevant to situations where multiple human readers or classifiers make subjective judgments that need to be resolved. Mechanical testing of a physical device does not involve adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, not applicable. This type of study is specifically designed for AI-assisted diagnostic tools that involve human readers. The InterBRIDGE system is a physical surgical implant.

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

• No, not applicable. This concept applies to AI algorithms. The InterBRIDGE system is a physical implant.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is established by:

• Objective Mechanical Testing Standards: Performance against established ASTM (American Society for Testing and Materials) standards (modified ASTM F1717-12a) for spinal implants. These standards define the expected biomechanical behavior for such devices.
• Comparison to Predicate Devices: The key "ground truth" for substantial equivalence is the
  demonstrated performance being comparable (equivalent) to legally marketed predicate devices that have already been deemed safe and effective.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" for a physical medical implant in the way there is for an AI algorithm. Design and development are based on engineering principles and preclinical testing, not machine learning training data.

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

• Not applicable. As there is no training set in the AI sense, this question is not relevant. The design and validation of the InterBRIDGE system relied on established engineering principles, material science knowledge, and biomechanical testing methods rather than ground truth data for training.

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The Easyspine® Posterior Spinal System is a posterior, non-cervical pedicle and non-pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine:

• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
• Spondylolisthesis .
• Trauma (i.e., fracture or dislocation) .
• Spinal stenosis .
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• . Tumor
• Pseudoarthrosis .
• Failed previous fusion ●

The Easyspine Spinal System is a side-loading posterior spinal pedicle fixation system consisting of various implant components. The 4.25 mm pedicle screws and curved rods represent a line extension to the previously cleared Easyspine Spinal System (K043094, K063794, and K082592). The subject devices are identical to their predicates with respect to general technological characteristics and intended use.

The provided document describes the LDR Spine Easyspine Posterior Spinal System, a medical device for spinal fixation. However, the document does NOT contain information about acceptance criteria for device performance, nor does it detail a study proving the device meets such criteria in terms of clinical or algorithm performance.

Instead, the document focuses on:

• Device Description: The Easyspine Spinal System is a side-loading posterior spinal pedicle fixation system. The K123134 submission is for a line extension of 4.25 mm pedicle screws and curved rods to an existing system.
• Indications for Use: The system is intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion for various spinal instabilities.
• Non-Clinical Testing: This section states that non-clinical testing was performed on the proposed 4.25 mm pedicle screws in accordance with ASTM standards (F-1717 and F-1798) for static and dynamic axial compression, static torsion, axial gripping capacity, and flexion-extension cantilever.
• Conclusion: The non-clinical testing results demonstrate that the performance of the proposed LDR Spine Easyspine implants is "substantially equivalent" to their legally marketed predicates. This is the basis for the FDA's 510(k) clearance, which is a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria for device performance and a study proving those criteria are met for a clinical or software-based outcome. The document describes a non-clinical (benchtop) study designed to demonstrate substantial equivalence to predicate devices based on mechanical performance standards, not a study evaluating human-in-the-loop performance, standalone algorithm performance, or using human expert ground truth.

If this were a submission for a software-as-a-medical-device (SaMD) or AI-based device, the requested information would be pertinent. However, for this spinal implant submission, the "study" is the non-clinical mechanical testing, and the "acceptance criteria" are implicitly defined by the chosen ASTM standards and the demonstration of substantial equivalence to predicate devices, rather than a quantifiable clinical performance metric.

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