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The Spinal Fusion Cage System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.

device intended for use as an intervertebral body fusion device in the lumbosacral region (L2-S1) of the spine. It is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation. The Spinal Fusion Cage System is single component devices used to restore height of disc and to facilitate lumbar intervertebral body fusion with maintaining physiological lordotic angulation of lumbar spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device made withh PEEK Polymer has tantalum (ASTM F560) markers for ease of visualization on radiographs. Vertical square teeth on the top and the bottom surface prevent subsidence of the cage into the vertebral body while they increase the anchoring and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow space in the implant allows autologous bone graft material to be filled. The implant has safety proven structure and material (Polyetheretherketone, ASTM F2026 & Titanium Ti6Al4V Eli ASTM F136) to promote biological synostosis and assures mechanical safety against load.

The provided text is a 510(k) Summary for a medical device (Spinal Fusion Cage System), not a study describing the acceptance criteria and performance of an AI-powered medical device.

This document details the regulatory submission for an intervertebral body fusion device, comparing it to predicate devices to establish substantial equivalence based on material, design, and mechanical performance. It does not contain information related to AI or a study proving an AI device meets acceptance criteria.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, ground truth methods, etc.) from the provided text as it is irrelevant to AI device evaluation.

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NGM WAVE® PLIF cages are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The subject NGM WAVE PLIF Cage is a lumbar interbody fusion device. The NGM WAVE Cage is manufactured from PEEK-Optima™ Natural LT1 and tantalum (pins) per ASTM F560. The NGM WAVE Cage is an expandable interbody fusion device for treatment of lumbar disc degeneration utilizing the posterior lateral approach. NGM WAVE Cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The cranial and caudal side of the implant is rough to provide increased stability and to help prevent movement of the device.

It is not allowed to use NGM WAVE implants in contact with components of other manufacturers with the exception of autograft or allograft materials.

WAVE PLIF Cage is intended for single use only and is provided sterile, using gamma irradiation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NGM WAVE PLIF Cage:

This document is a 510(k) summary for a medical device cleared by the FDA. It does not describe an AI device or a study involving human readers or AI performance metrics like sensitivity/specificity. Instead, it concerns the mechanical and biological performance of an intervertebral body fusion device. Therefore, several points in your requested output format (like MRMC studies, AI effect size, ground truth for training/test sets as typically applied to AI, etc.) are not applicable here.

However, I can extract the relevant information regarding the device's performance testing and acceptance criteria as provided.

Acceptance Criteria and Device Performance for NGM WAVE PLIF Cage

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test, but standard for bench testing of medical devices.
• Data Provenance: The tests are "non-clinical bench performance testing," meaning they were conducted in a laboratory setting. The manufacturer is NGMedical GmbH, located in Nonnweiler, Germany.

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

• Not Applicable. This is a physical medical device (interbody fusion cage), not an AI diagnostic tool. Ground truth in this context refers to established engineering standards (ASTM, ISO) and laboratory measurements, not expert human interpretation of images or clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. Testing involves objective measurements against established standards, not human 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

• Not Applicable. This is a physical medical device, not an AI or diagnostic imaging device. No human readers or AI assistance are involved in the performance evaluation described.

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

• Not Applicable. This is a physical medical device. There is no algorithm.

7. The Type of Ground Truth Used

• Engineering Standards and Measurements: The ground truth for the performance testing is based on established international and American standards for medical device biocompatibility (ISO 10993-1) and mechanical testing (ASTM F2276). Performance is measured objectively and compared against the requirements specified in these standards or against predicate device performance.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of an AI model. Device design and development follow engineering principles and material science, not machine learning training.

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

• Not Applicable. See point 8.

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BEE® PLIF cages are indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplementation, which has been cleared by the FDA for use in the lumbar spine.

The subject BEE® PLIF Cage is a lumbar interbody fusion device. BEE® PLIF Cage is manufactured from titanium alloy per ASTM F3001 via additive manufacturing. The BEE® PLIF Cage is an intervertebral body fusion device for treatment of lumbar disc degeneration utilizing the posterior lateral approach. BEE®PLF Cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The cranial and caudal side of the implant is rough to provide increased stability and to help prevent movement of the device. It is not allowed to use BEE® PLIF implants in contact with components of other manufacturers with the exception of autograft materials. BEE® PLIF Cage is intended for single use only and is provided sterile, using gamma irradiation.

This document is a 510(k) summary for the NGMedical GmbH BEE® PLIF Cage, an intervertebral body fusion device. It details the device's characteristics, indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device "met the predetermined acceptance criteria" without providing specific numerical criteria. It only lists the tests performed and confirms compliance.

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

The document describes bench testing for mechanical performance and biocompatibility. It does not involve a "test set" of patient data or clinical trials in the way an AI/software device would. Therefore, the concepts of sample size for a test set, country of origin, or retrospective/prospective data are not applicable here. The "sample" for testing would refer to the number of physical devices or material samples subjected to the mechanical and biocompatibility tests. This number is not specified in the document.

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

This information is not applicable. The device is a physical implant, not an AI/software device requiring human expert ground truth for a test set. Ground truth for mechanical testing is established by engineering standards and measurements.

4. Adjudication Method for the Test Set:

Not applicable, as this is a physical device and not an AI/software requiring human adjudication of its output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable. This is a physical medical implant, not an AI/software system that assists human readers.

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

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

7. The Type of Ground Truth Used:

For the mechanical testing, the "ground truth" is defined by the objective measurements and engineering standards outlined in ASTM F2077 and ASTM F2276, as well as the specifications for biocompatibility in ISO 10993-1. These are physical and chemical properties measured against established benchmarks.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical implant. There is no "training set" in the context of an AI/software algorithm.

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

Not applicable. There is no training set for this type of device.

In summary, the provided document describes the FDA clearance for a physical medical device (interbody fusion cage) based on substantial equivalence to predicate devices and performance bench testing, not on clinical data involving patient cohorts or AI algorithm performance.

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EIT Cellular Titanium® Cervical Cage: The EIT Cellular Titanium® Cervical Cages with a microscopic roughened surface and nano-scale features are intervertebral body fusion devices intented for use for anterior cervical interbody firsion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The EIT Cellular Titanium Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. EIT Cellular Titanium Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion.

EIT Cellular Titanium® ALIF Cage: The EIT Cellular Titanium® ALIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition reguires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment with the devices.

EIT Cellular Titanium® TLIF Cage: The EIT Cellular Titanium® TLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

EIT Cellular Titanium® LLIF Cage: The EIT Cellular Titanium & LLF Cages with a microscopic roughened surface and micro and nano-scale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two configuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confinued by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. ETT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

EIT Cellular Titanium® T/PLIF Cage: The EIT Cellular Titanium® T/PLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition regures the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondvlolisthesis at the involved level(s). These patients may have had a previous non-firsion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment with the devices.

The EIT Cellular Titanium® Technology platform is a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal/Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes. footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system).

The EIT Cellular Titanium® Cages are made from Ti-6A1-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft.

The 3D Printed EIT Cellular Titanium® Cages have a microscopic roughened surface with micro and nano-scale features. The micro and nano features are on all surfaces of the cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure.

The provided text is an FDA 510(k) summary for EIT Cellular Titanium® Cervical and Lumbar Cages. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices for intervertebral body fusion.

It does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The document primarily addresses:

• Device names and regulation numbers.
• Indications for Use.
• Device description (material, manufacturing process).
• Comparison to predicate devices, asserting that the fundamental scientific technology remains unchanged and there's no change to the intended use.
• Stating that performance data remains unchanged compared to predicate devices.

Therefore, I cannot provide details for the following points as they are not present in the provided text:

• A table of acceptance criteria and the reported device performance: This document is for a physical implant, not an AI/ML device, so such performance metrics (like accuracy, sensitivity, specificity for an AI algorithm) are not relevant or listed.
• Sample size used for the test set and the data provenance: Not an AI study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI study.
• Adjudication method for the test set: Not an AI study.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not an AI study.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not an AI study. The "ground truth" for these devices would typically relate to their mechanical properties, biocompatibility, and clinical outcomes, which are assessed through different types of studies (e.g., mechanical testing, animal studies, clinical trials) not detailed here in terms of acceptance criteria for AI performance.
• The sample size for the training set: Not an AI study.
• How the ground truth for the training set was established: Not an AI study.

In summary, the provided document is a regulatory submission for a spinal implant, not an AI/ML device. Therefore, the specific questions regarding acceptance criteria and study design for an AI/ML device cannot be answered from this text.

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The Omnia Medical TiBrid™ Cervical Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have had at least six weeks of non-operative treatment with intervertebral cages. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

The Omnia Medical TiBrid™ ALIF, PLIF, TLIF and Lateral Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had at least six months of non-operative treatment with intervertebral cages. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

Not Found

This document is a 510(k) clearance letter for the Omnia Medical TiBrid™ Cervical Cage, Omnia Medical TiBrid™ Lateral Cage, Omnia Medical TiBrid™ ALIF Cage, Omnia Medical TiBrid™ PLIF Cage, and Omnia Medical TiBrid™ TLIF Cage. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does NOT contain any information about acceptance criteria, device performance testing, study details (sample size, data provenance, ground truth, expert qualifications, adjudication methods), or multi-reader multi-case comparative effectiveness studies. These types of details are typically found in the 510(k) summary or the full submission, not in the clearance letter itself.

Therefore, I cannot provide the requested information from this document.

To answer your request, I would need to analyze a different part of the 510(k) submission, specifically the sections that detail the performance data and testing conducted to demonstrate substantial equivalence.

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The Spinal Fusion Cage System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.

The Spinal Fusion Cage System is single component devices used to restore height of disc space via posterior, lateral, anterior, oblique approach and to facilitate lumbar intervertebral body fusion with maintaining physiological lordotic angulation of lumbar spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device has tantalum (ASTM F560) markers for ease of visualization on radiographs. Vertical square teeth on the top and the bottom surface prevent subsidence of the cage into the vertebral body while they increase the anchoring and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow space in the implant allows autologous bone graft material to be filled. The implant has safety proven structure and material (Polyetheretherketone, ASTM F2026) to promote biological synostosis and assures mechanical safety against load.

This looks like a 510(k) summary for a medical device (Spinal Fusion Cage System), not an AI/ML device. Therefore, the questions related to acceptance criteria for an algorithm's performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance, are not applicable to this document.

The document discusses performance data in the context of mechanical testing for the spinal fusion cages, comparing them to predicate devices. It states:

• Mechanical testing (static axial compression, static compression-shear, static subsidence and dynamic axial compression) was conducted in accordance with ASTM F2077-14 and F2267-04.
• "The subject device demonstrated equivalent mechanical performance to the cited predicate device under the same test conditions."

However, specific numerical acceptance criteria (e.g., "subsidence must be less than X mm") and the exact results showing the device meets these criteria are not explicitly detailed in the provided text. The document concludes that "The overall technology characteristics and mechanical performance data lead to the conclusion that the subject device is substantially equivalent to legally marketed predicate devices."

To answer the user's request, I would need a 510(k) summary or similar regulatory document for an AI/ML medical device that includes details about its algorithmic performance evaluation. This document only pertains to a physical implantable device.

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UNiD Patient-matched PLIF cage is indicated for lumbar spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels form L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis or Retrolisthesis at the involved level(s). This device is to be used with bone graff.

UNiD Patient-matched PLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The UNiD patient-matched PLIF cage is an intervertebral lumbar device, designed to match the anatomy of an individual patient from patient imaging data (X-Ray, MRI, CT). The implant is manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.

This looks like a 510(k) summary for a medical device called "UNiD Patient-matched PLIF cage". The provided text describes the device, its intended use, and compares it to predicate devices. It also mentions non-clinical testing but explicitly states that no clinical studies were performed.

Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria in the way you've requested, as this submission indicates clinical performance data is not available. This 510(k) relies on substantial equivalence to predicate devices, not on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

If you have a different document that details clinical studies and acceptance criteria, please provide that. Otherwise, based only on the provided text, the answer is that no such study was performed to demonstrate performance against acceptance criteria.

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EIT Cellular Titanium® Cervical Cages: The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The EIT Cellular Titanium® Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The EIT Cellular Titanium® Cervical Cages is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

EIT Cellular Titanium® PLIF Cages: The EIT Cellular Titanium® PLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

EIT Cellular Titanium® TLIF Cages: The EIT Cellular Titanium® TLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

EIT Cellular Titanium® ALIF Cages: The EIT Cellular Titanium® ALIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

The purpose of this 510(k) was to update the indications for use to include use at multiple levels (e.g., up to 4 levels) for the EIT Cellular Titanium® Cervical Cages as well as other miscellaneous labeling updates.

The EIT Cellular Titanium® Cages are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine. The EIT Cellular Titanium® Cages differentiated in Lumbar cages (L2-S1) and Cervical Cages (C2-T1). The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g., using posterior pedicle screws, anterior plate system or anterior screw and rod system).

The EIT Cellular Titanium® Cages are made from Ti-6AI-4V ELI ASTM F136 with an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

Three different types of Lumbar Cages are included in the portfolio. Each cage type has the same intended use, but is designed for a different surgical approach; ALIF (Anterior Lumbar Intervertebral Fusion Cage), PLIF (Posterior Lumbar Intervertebral Fusion Cage) and TLIF (Transforaminal Lumbar Intervertebral Fusion Cage). One type of Cervical Cage, CIF (Cervical Intervertebral Fusion Cage) is included in the portfolio. Each cage type is supplied sterile and is available in a variety of heights, footprints and lordosis angles to accommodate patient anatomy.

The provided text is a 510(k) premarket notification decision letter from the FDA regarding a medical device, specifically intervertebral body fusion devices. It does not describe acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

The document discusses the substantial equivalence of the EIT Cellular Titanium® Cages to previously cleared predicate devices based on indications for use, design, function, materials, and performance. The "Performance Testing Summary" section mentions a "comprehensive, clinical literature review" and "Additional MR-Safety testing" in accordance with ASTM standards, but these are related to the safety and fundamental characteristics of the implantable device, not the performance of an AI/ML algorithm.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's criteria (acceptance criteria for an AI/ML device, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) are specific to AI/ML device evaluation, which is not what this document addresses.

The document does not contain information on:

• Acceptance criteria for an AI/ML device's performance.
• A study proving an AI/ML device meets acceptance criteria.
• Sample size used for a test set or data provenance for an AI/ML study.
• Number of experts or their qualifications for establishing ground truth for an AI/ML study.
• Adjudication method for an AI/ML study.
• MRMC comparative effectiveness study or effect size for AI assistance.
• Standalone performance of an algorithm (AI).
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI study.
• Sample size for a training set in an AI context.
• How ground truth for the training set was established for an AI.

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EIT Cellular Titanium® Cervical Cage: The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The EIT Cellular Titanium® Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

EIT Cellular Titanium® PLIF Cages: The ET Cellular Titanium® PLF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

EIT Cellular Titanium® TLIF Cages: The ETT Cellular Titanium® TLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogemic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

EIT Cellular Titanium® ALIF Cages: The EIT Cellular Titanium® ALIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenc pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

The EIT Cellular Titanium® Cages are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine. The EIT Cellular Titanium® Cages differentiated in Lumbar cages (L2-S1) and Cervical Cages (C2-T1). The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g., using posterior pedicle screws, anterior plate system or anterior screw and rod system).

The EIT Cellular Titanium® Cages are made from Ti-6AI-4V ELI ASTM F136 with an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

Three different types of Lumbar Cages are included in the portfolio. Each cage type has the same intended use, but is designed for a different surgical approach; ALIF (Anterior Lumbar Intervertebral Fusion Cage), PLIF (Posterior Lumbar Intervertebral Fusion Cage) and TLIF (Transforaminal Lumbar Intervertebral Fusion Cage). One type of Cervical Cage, CIF (Cervical Intervertebral Fusion Cage) is included in the portfolio. Each cage type is supplied sterile and is available in a variety of heights, footprints and lordosis angles to accommodate patient anatomy.

The provided text describes a medical device submission (K170503) for various EIT Cellular Titanium® Cages, which are intervertebral body fusion devices. This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in relation to your request:

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

The document states that the devices were subjected to mechanical testing. The acceptance criteria are implicitly the standards outlined in ASTM F2077-14 and F2267-04. The reported device performance is that the "results demonstrate that the devices are substantially equivalent to the predicate devices." No specific numerical results or detailed performance metrics are given in this summary.

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

The document does not specify the sample size for the mechanical testing (e.g., number of devices tested for each type of cage and test). The provenance of the data (country of origin, retrospective/prospective) is also not mentioned, as this is a regulatory submission summary focusing on equivalence rather than a clinical trial. The testing is described as "Performance Testing Summary," indicating laboratory mechanical tests rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This document describes mechanical testing of medical implants, not a diagnostic or prognostic device that would require human expert-established ground truth. Therefore, this information is not applicable and not provided.

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

As this involves mechanical testing of physical devices against material and performance standards (ASTM standards), there is no adjudication method in the context of expert review for ground truth establishment. The evaluation is based on whether the devices physically meet the specified mechanical requirements.

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 MRMC study was conducted. This device is an intervertebral body fusion cage, not an AI-powered diagnostic or assistive tool.

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

No standalone algorithm performance study was done. This document pertains to a physical medical implant, not an algorithm or AI system.

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

The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards, specifically ASTM F2077-14 and F2267-04 for mechanical properties, and bacterial endotoxin testing for sterility. There is no biological or diagnostic "ground truth" as would be established by pathology or clinical outcomes in the context of a diagnostic device.

8. The sample size for the training set:

Not applicable. This is a medical device (implant) and does not involve AI/machine learning with training sets.

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

Not applicable. This is a medical device (implant) and does not involve AI/machine learning with training sets and ground truth for them.

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

The SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE are 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 devices are intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

1. Cervical Interbody Fusion Device (SYNSTER® CERVICAL CAGE), which may be implanted as a single device via an anterior approach.
2. Lumbar Interbody Fusion Device [SYNSTER® (ALIF, PLIF, PTLIF, and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE], which may be implanted
   As a single device via an Anterior or Anterolateral or Lateral (ALIF) approach;
   Bi-laterally via a posterior (PLIF) approach;
   As a single device via a posterior transforaminal (PTLIF) approach;
   As a single device via a transforaminal (TLIF) approach.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE components are made of polyether ether ketone (PEEK OPTIMA® LT1) that conforms to ASTM F2026, and is supplied as nonsterile and/or gamma sterile. Additionally, the devices contain titanium makers (ASTM F136) to assist the surgeon with proper placement of the device. The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF, RHEA® PLIF CAGE and TALON® TLIF CAGE are implanted by using the instruments specially designed and manufactured from stainless steel materials that conform to ASTM F899.

The provided text describes a 510(k) submission for an intervertebral body fusion device, focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against specific metrics for diagnostic accuracy.

Therefore, most of the requested information regarding diagnostic device performance, such as sample size, provenance, expert qualifications, and ground truth, is not available in the provided document. This submission primarily focuses on the mechanical and physical properties, sterility, and shelf life of the intervertebral cages, aiming to show they are equally safe and effective as pre-existing devices.

Here's the information that can be extracted or deduced from the text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable / Not provided. The tests mentioned (sterility, shelf life, mechanical) are typically performed on product samples in a laboratory setting, not on a "test set" of patients or data in the context of diagnostic accuracy.

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

• Not applicable / Not provided. This information is relevant for diagnostic devices that interpret images or other patient data, which is not the primary focus of this submission.

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

• Not applicable / Not provided. Similar to point 3, this is for diagnostic accuracy studies.

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-assisted diagnostic device, so an MRMC study is irrelevant here.

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

• No. This is a physical intervertebral fusion device, not an algorithm.

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

• For mechanical and material tests: The "ground truth" is defined by the relevant ASTM and ISO standards' specifications and test methodologies.
• For sterility: The "ground truth" is defined by the ISO 11737-1 standard for demonstrating sterility assurance.
• For shelf life: The "ground truth" is determined by the stability of the device over time under specified conditions.

8. The sample size for the training set:

• Not applicable / Not provided. This concept applies to machine learning models, which are not part of this device submission.

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

• Not applicable / Not provided. This concept applies to machine learning models.

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