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The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha - Hyper C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scollosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies at up to two contiguous levels from C2 - T1.

The EVOL® ha – Hyper C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The EVOL® ha – Hyper C Cervical Interbody Fusion System is designed for use as a cervical interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and lordotic and lordotic ande. All sizes have a central window for bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.

The provided FDA 510(k) Clearance Letter for the EVOL® ha - Hyper C Cervical Interbody Fusion System does not contain details about acceptance criteria or specific studies proving device performance against such criteria in the way you've described (e.g., related to AI/ML device performance metrics like sensitivity, specificity, MRMC studies, or ground truth establishment).

This document is a marketing clearance for a traditional medical device (an intervertebral body fusion system, which is a physical implant) and not a software-as-a-medical-device (SaMD) or an AI/ML powered device. The "acceptance criteria" and "studies" you're asking about are typically associated with the rigorous validation of diagnostic accuracy or clinical utility for AI/ML systems.

Instead, for this physical medical device, "acceptance criteria" would primarily relate to its mechanical and material performance to ensure it is substantially equivalent to a predicate device and safe/effective for its intended use. The "studies" mentioned are non-clinical (benchtop) tests to demonstrate this.

Here’s a breakdown based on the information provided, adapted to the context of a physical implant:

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

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

• Sample Size: Not specified in the document. For benchtop mechanical testing (like ASTM F2077 and expulsion testing), sample sizes are typically determined by the specific ASTM standard or internal quality protocols to achieve statistical significance for engineering parameters, but they are generally small (e.g., 5-10 devices per test condition depending on variability).
• Data Provenance: The tests are non-clinical, meaning they are laboratory/benchtop studies. There is no patient data involved (retrospective or prospective) for this type of device validation.

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. For a physical interbody fusion device, "ground truth" in the diagnostic AI sense does not apply. The "ground truth" for mechanical testing is established by the engineering specifications and performance standards defined in ASTM or similar bodies. Expert interpretation might be involved in initial design and test protocol development (e.g., biomechanical engineers), but not in establishing a diagnostic "ground truth" for a test set.

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

• Not Applicable. Adjudication methods are used to establish a consensus "ground truth" for diagnostic labels in medical imaging or pathology, often in the context of human reader studies for AI/ML devices. This is not relevant for the mechanical testing of a physical implant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This type of study (MRMC for AI assistance) is not applicable to a physical intervertebral body fusion system.

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

• No. This is

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The T-FIX™ 3DSI Joint Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including;

• sacroiliac joint disruptions
• degenerative sacroiliitis
• to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar of thoracolumbar fusion and
• acute, non-acute and non-traumatic fractures involving the sacroiliac joint

The T-FIX™ 3DSI Joint Fusion System, a line extension of the EVOL® -SI Fusion System (K190025), is intended to treat dysfunctions of the sacroiliac joint. The T-FIX™ 3DSI Joint Fusion System includes cannulated, 3D printed, titanium alloy bone screws as well as a full complement of instruments to place them in the body. The T-FIX™ screw is headless so that it may be implanted with a zero profile. The distal portion of the screw has a single lead thread and the proximal end has a double lead thread. T-FIX™ is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis thereby preventing motion of the sacroiliac joint. The T-FIX™ screws are made from a titanium alloy Ti-6Al-4V Grade 23 per ASTM 3001 and offered with a HA nano surface treatment when packaged sterile.

This 510(k) summary does not contain information regarding software or AI/ML components, and therefore does not include acceptance criteria or a study proving device performance in that context. The device described, the T-FIX™ 3DSI Joint Fusion System, is a physical medical device (implants and instruments) for sacroiliac joint fusion, not a software-based diagnostic or therapeutic tool.

The "Non-Clinical and Clinical Performance Testing" section (VIII) refers to "Additional testing was performed to determine that Steam as a sterilization method will not impact the safety or efficacy of this implant," but it does not provide details on specific acceptance criteria or study results for this testing, beyond concluding that it "does not raise any new concerns of safety or efficacy."

Therefore, I cannot provide a table of acceptance criteria and reported device performance (Point 1) or any of the detailed information related to studies proving device performance, as requested in points 2 through 9, because this information is not present in the provided text for this specific device.

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The T-FIX® 3DSI Joint Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including;

• sacroiliac joint disruptions
• degenerative sacroiliitis
• to augment immobilization and stabilization of the sacrolliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar of thoracolumbar fusion and
• acute, non-acute and non-traumatic fractures involving the sacroiliac joint

The T-FIX® 3DSI Joint Fusion System, a line extension of the EVOL® -SI Fusion System (K190025), is intended to treat dysfunctions of the sacroiliac joint. The subject T-FIX® 3DSI Joint Fusion System includes cannulated, 3D printed, titanium alloy bone screws as well as a full complement of instruments to place them in the body. The subject T-FIX® screw is headless so that it may be implanted with a zero profile. The distal portion of the screw has a single lead thread and the proximal end has a double lead thread. The subject T-FIX® is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis thereby preventing motion of the sacroiliac joint. The subject T-FIX® screws are made from a titanium alloy Ti-6A1-4V Grade 23 per ASTM 3001 and offered with a HA nano surface treatment.

This document is a 510(k) summary for a medical device called the T-FIX® 3DSI Joint Fusion System. It details the device's indications for use and compares its technological characteristics and performance to predicate devices to establish substantial equivalence.

Based on the provided text, the device is a smooth or threaded metallic bone fixation fastener (product code OUR) and the approval process is for a Class II device. The device is intended for fixation of sacroiliac joint disruptions and fusion for conditions including degenerative sacroiliitis, augmentation of sacropelvic fixation in lumbar/thoracolumbar fusion, and acute/non-acute/non-traumatic fractures involving the sacroiliac joint.

The provided text does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance, nor does it define such acceptance criteria. The "performance testing" described is mechanical testing of the physical device and non-pyrogenicity endotoxin testing.

Therefore, I cannot provide a response fulfilling the request for acceptance criteria and study details related to AI/ML device performance. This document pertains to the regulatory clearance of a physical implantable medical device, not a software or AI/ML-driven diagnostic or assistive device.

To directly address the specific points of your request based on the available document:

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

   • Acceptance Criteria (Mechanical): The device must demonstrate "substantial equivalent performance" to identified predicates based on specific mechanical tests.
     • ASTM F543 (Static cantilever bending, Axial Pullout, Torque to Failure, and Dynamic cantilever bending)
     • ASTM F2193
   • Reported Performance (Mechanical): "In all, the biomechanical testing results demonstrate that the T-FIX® 3DSI Joint Fusion System is substantially equivalent to the predicate device."
   • Acceptance Criteria (Non-Pyrogenicity): The implants must meet the 20 endotoxin units (EU)/device pyrogen limit specification.
     • ANSI/AAMI ST72
     • USP
   • Reported Performance (Non-Pyrogenicity): "the worst case subject EVOL® -SI Joint Fusion System implants verify that the subject implants (line extension T-FIX® 3DSI) meet the 20 endotoxin units (EU)/device pyrogen limit specification..."

2. Sample size used for the test set and the data provenance: Not applicable/not stated. The performance evaluation is based on mechanical properties of the device, not a data-driven test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and test results.

4. Adjudication method for the test set: Not applicable.

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, as this is not an AI/ML device.

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

7. The type of ground truth used: Not applicable in the context of diagnostic performance. For mechanical testing, the ground truth is the specified performance thresholds per ASTM and ANSI/AAMI standards.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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The EVOL® Spinal Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The EVOL® Spinal Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal or anterior approach. The CES-LIF is implanted in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation.

The EVOL® Spinal Interbody System is a family of PEEK-OPTIMA® HA Enhanced spacers offered in a variety of widths and lengths. The CES-LIF are generally rectangular in shape. The CES-LIF is used in pairs.

The EVOL® Spinal Interbody System implants are available in a range of sizes to accommodate variations in patients' anatomy. In addition, tantalum beads are embedded in the spacers to help allow for radiographic visualization. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. The CES-LIF HA implants themselves are made of biocompatible PEEK-Optima® HA Enhanced (LT120) polymer material and provided non-sterile for single-use.

Teeth on top and bottom of the implants improve fixation. They are symmetrical so that the implant will resist motion equally in either direction (anterior or posterior).

The purpose of this submission is to add a new sterilization method.

This document is a 510(k) premarket notification for a medical device called the "EVOL® Spinal Interbody System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria that a new, novel device would require.

Therefore, the document does not contain the kind of information you are asking for regarding acceptance criteria and a study that proves the device meets those criteria, as typically seen for AI/ML-driven medical devices or devices requiring clinical performance studies to establish performance claims.

Here's why the requested information cannot be extracted from this document:

• Device Type: The EVOL® Spinal Interbody System is a spinal implant (a physical medical device), not an independent diagnostic or AI/ML-driven device that would output performance metrics like sensitivity, specificity, or image analysis results.
• Regulatory Pathway (510(k)): A 510(k) simply requires demonstrating that the new device is "substantially equivalent" to an already legally marketed device (predicate device). This is primarily done through a comparison of technological characteristics, materials, intended use, and sometimes non-clinical performance (e.g., mechanical testing, biocompatibility). It generally doesn't involve clinical performance studies with pre-defined acceptance criteria, expert ground truth establishment, or MRMC studies for quantifying human-AI collaboration.
• Purpose of Submission: The specific purpose of this K200991 submission is to add a new sterilization method (steam sterilization) for an already cleared device line (EVOL® Spinal Interbody System). It explicitly states: "No additional testing is required to determine if Steam as a sterilization method will impact the safety or efficacy of this implant."

In summary, this document does not describe a study that proves the device meets specific acceptance criteria related to its diagnostic or performance accuracy, as it is a physical implant and the submission focuses on a change in sterilization method.

If this were an AI/ML device, the detailed information requested would be crucial for its 510(k) clearance or de novo authorization.

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The EVOS Lumbar Interbody System is an intervertebral body device in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The EVOS Lumbar Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.

The EVOS Lumbar Interbody System is comprised of a variety of Implants manufactured from PEEK (Polyetheretherketone) -Optima LT1 (per ASTM F-2026) and PEEK Optima LT120HA, with Tantalum bead markers per ASTM F-560. There are three main configurations; STRAIGHT, CURVED, and ROTATE. The different configurations allow for multiple surgical technique options. The EVOS STRAIGHT and the EVOS ROTATE are generally rectangular in shape while the EVOS CURVED is curved. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs.

The EVOS device(s) are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. The angle of lordosis on each lordotic EVOS device is oriented in a way that will provide a true anterior/posterior lordotic orientation once the device has been implanted in its final intervertebral location. For example, the True Oblique Lordotic (TOL) devices have a lordotic orientation to the device that will provide a correct anterior/posterior lordotic orientation once they have been inserted at 30 degrees from the anterior/posterior midline.

Implant heights range from 6mm to 16mm in maximum height (minus the height of the teeth). Widths range from 8mm to 12mm and lengths range from 22mm to 30mm. The variety of implant shapes and sizes accommodate various surgical technique options. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. Teeth on top and bottom of the spacers improve fixation. The EVOS Lumbar Interbody System includes the instrumentation to facilitate the implantation of the implants.

The approach and the discectomy are conducted using standard instruments while subsequent steps are conducted using standard and/or custom instruments. The system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel and/or polymeric materials.

The EVOS rotate and non-rotate Inserter(s) are instruments intended for use with the EVOS Lumbar Interbody System. The inserter(s) are designed specifically to implant the EVOS device into a prepared disc space. The EVOS non-rotate inserters are designed to work with the EVOS straight and curved devices while the EVOS rotate inserter is designed to work with the EVOS rotate devices.

The provided text is an FDA 510(k) premarket notification for the EVOS Lumbar Interbody System. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about the acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop performance study.

Therefore, I cannot provide the requested information based on the provided text. The document states:

"No design changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed." (Page 6, Section VII)

This indicates that the submission relies on the prior clearance of the predicate device and does not include new performance studies or acceptance criteria beyond those relevant for establishing substantial equivalence for a medical device (material properties, dimensions, mechanical performance, etc.), rather than the type of AI-driven performance testing implied by the detailed questions.

To answer your request, a document detailing the clinical or technical performance study of an AI-enabled medical device would be needed.

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The EVOL® ha – D Lateral Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. EVOL® ha - D Lateral Interbody Fusion System is indicated for use at either one level or two contiguous levels in the lumbar spine (L2-S1) 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 EVOL® ha - D Lateral Interbody Fusion System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The EVOL® ha -D Lateral Interbody Fusion System is designed for use as a lumbar interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and depth), height, and lordotic angle. All sizes have two central windows for bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.

The provided text is a 510(k) summary for a medical device called the EVOL® ha - D Lateral Interbody Fusion System. It describes the device, its intended use, and its comparison to predicate devices, including performance testing. However, it does not contain the specific information required to complete the detailed table about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study specifics (like MRMC studies, expert qualifications, or adjudication methods).

This document focuses on demonstrating substantial equivalence for regulatory approval, primarily through mechanical performance testing to established standards, rather than establishing clinical effectiveness or diagnostic accuracy.

Therefore, most of the requested information cannot be extracted from this document.

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

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

• Acceptance Criteria: The document states that "Testing was performed for the EVOL® ha – D Lateral Interbody Fusion System and demonstrated substantial equivalent performance to the identified predicate" and "In all, the biomechanical testing results demonstrate the EVOL® ha – D Lateral Interbody Fusion System is substantially equivalent to the predicate device." It also mentions testing in accordance with ASTM F2077 and ASTM F2267 standards (static & dynamic tests for compression and compression shear, subsidence, and expulsion tests).
  • However, the specific numerical acceptance criteria (e.g., "must withstand X N of compression for Y cycles") and the numerical reported device performance (e.g., "device withstood Z N for W cycles") are NOT provided in this summary. The summary only states that the device "demonstrated substantial equivalent performance" to the predicate.

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

• Sample Size for Test Set: Not specified. This refers to the number of physical devices or constructs tested, which is not detailed in this summary.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. This type of information is typically for clinical data, which is not the focus here.

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

• Not Applicable. This device is an interbody fusion system (an implant), not a diagnostic algorithm. The "ground truth" for mechanical testing is based on the physical properties and performance of the device under stress, compared against established standards and predicate devices, not expert human interpretation of medical images or diagnostic outcomes.

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

• Not Applicable. As above, this is for diagnostic algorithms assessing human interpretation, not mechanical device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is a mechanical orthopedic implant, not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.

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

• No. This is a mechanical orthopedic implant, not an algorithm.

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

• The "ground truth" for this type of submission is the mechanical performance standards (ASTM F2077, ASTM F2267) and the established performance of the predicate devices. The device is deemed "substantially equivalent" if it meets or exceeds these mechanical benchmarks.

8. The sample size for the training set:

• Not Applicable. This is a mechanical device, not an AI/ML model that requires a training set.

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

• Not Applicable. As above, this is for AI/ML models.

In summary, the provided document focuses on the mechanical equivalence for regulatory clearance of an orthopedic implant. It is not an evaluation of a diagnostic AI device, which would require the kinds of detailed clinical study information requested in your prompt.

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The EVOL® -SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The EVOL® -SI Joint Fusion System is designed to treat dysfunctions of the sacroiliac joint. It includes titanium alloy (Ti-6Al-4V ELI per ASTM F136-13) screws and optional washers as well as instruments to place them in the body. It is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis. Each screw is treated with a hydroxyapatite (HA) surface treatment that is approximately 20 nanometers thick.

Here's an analysis of the provided FDA 510(k) summary, specifically focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the mechanical and endotoxin tests. It refers to "the worst-case subject EVOL® -SI Joint Fusion System implants" for endotoxin testing, implying a limited number. The data provenance is not specified, but these are typically laboratory-based tests performed by the manufacturer or a contract research organization.

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

This information is not applicable. The device's performance is objectively measured against engineering standards (ASTM) and biological contamination limits (ANSI/AAMI, USP), not against expert interpretations of data.

4. Adjudication Method for the Test Set

This information is not applicable, as there is no human interpretation or adjudication involved in the mechanical or endotoxin testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes a medical device (surgical implant) and not an AI/imaging diagnostic tool. Therefore, an MRMC study is not relevant.

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

No. This document describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth is established through:

• Established engineering standards: ASTM F543 and ASTM F1264 for mechanical properties.
• Established biological safety standards: ANSI/AAMI ST72 and USP for endotoxin limits.
• Comparison to predicate devices: The "substantial equivalence" is based on the new device's performance meeting or exceeding that of legally marketed predicate devices, which serve as a benchmark for safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable. This is a 510(k) submission for a physical medical device, not an AI/machine learning model. There is no concept of a "training set" in this context.

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

This information is not applicable (see point 8).

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The EVOL® ha - C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha - C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with degenerative disc disease (DDD) at up to two contiguous levels from C2 - T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha – C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha – C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of nonoperative treatment.

The EVOL® ha - C Cervical Interbody Fusion System is designed for use as a cervical interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and depth), height, and lordotic angle. All sizes have a central window for autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.

The provided text is a 510(k) Summary for the EVOL® ha - C Cervical Interbody Fusion System. It describes a medical device, its intended use, and its equivalence to predicate devices, primarily through non-clinical performance testing and a clinical literature review.

Crucially, there is no mention of a study involving AI, machine learning, or software performance in this document. The acceptance criteria and study details requested in the prompt (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are relevant to studies validating AI/ML-based medical devices.

Since this 510(k) is for a physical intervertebral body fusion device and does not involve AI or software, it does not contain the information required to answer the specific questions about AI/ML device acceptance criteria and study proof.

The document states:

• "Testing was performed for the EVOL® ha – C Cervical Interbody Fusion System and demonstrated substantial equivalent performance to the identified predicates. The mechanical tests were performed in accordance to these test methods: ASTM F2077, ASTM F2267, Expulsion Testing. The tests performed include: static & dynamic tests for compression, torsion, and compression shear. Subsidence and expulsion tests were also performed." This refers to bench testing of the physical implant related to its biomechanical properties.
• "Comprehensive, clinical literature review of published data for cervical interbody fusion devices, similar to the EVOL® ha - C Cervical Interbody Fusion System, was performed to support the Indications for Use at two levels." This refers to a review of existing scientific literature on similar devices, not a new clinical study conducted for this specific device.

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study proof from this document.

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The EVOL® Spinal Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The EVOL® Spinal Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal, retroperitoneal or anterior approach. The CES-PLIF and CES-LIF are implanted in pairs, while the CES-TLIF and CES-RLIF devices may be implanted singly or in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation.

The EVOS Lumbar Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The EVOS Lumbar Interbody System is intended to be used with autograft comprised of cancellous and or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.

The EVOL® Spinal Interbody System is a family of PEEK-OPTIMA or PEEK-OPTIMA HA spacers offered in a variety of widths and lengths. There are five main configurations: CES-PLIF, CES-LIF, CES-TLIF, CES-CLIF and CES-RLIF. The different configurations allow for multiple surgical technique options. The CES-PLIF, CES-LIF, CES-CLIF and CES-RLIF are generally rectangular in shape while the CES-TLIF is curved. The CES-PLIF and CES-LIF are used in pairs while the other options are used singly or in pairs.

The EVOL® Spinal Interbody System implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the spacers as an option to help allow for radiographic visualization. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. The implants themselves are made of biocompatible PEEK-Optima Natural (LT1) or [PEEK-Optima HA Enhanced (LT120) - CES-LIF only] polymer material (per ASTM F2026).

Teeth on top and bottom of the implants improve fixation. They are symmetrical so that the implant will resist motion equally in either direction (anterior or posterior).

The EVOS Lumbar Interbody System is comprised of a variety of Implants manufactured from PEEK (Polyetheretherketone) -Optima LT1 and PEEK Optima LT120HA per ASTM F-2026, with Tantalum bead markers per ASTM F-560. There are three main configurations; STRAIGHT, CURVED, and ROTATE. The different configurations allow for multiple surgical technique options. The EVOS STRAIGHT and the EVOS ROTATE are generally rectangular in shape while the EVOS CURVED is curved. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs.

The EVOS device(s) are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. The angle of lordosis on each lordotic EVOS device is oriented in a way that will provide a true anterior/posterior lordotic orientation once the device has been implanted in its final intervertebral location. For example, the True Oblique Lordotic (TOL) devices have a lordotic orientation to the device that will provide a correct anterior/posterior lordotic orientation once they have been inserted at 30 degrees from the anterior/posterior midline.

Implant heights range from 6mm to 16mm in maximum height (minus the height of the teeth). Widths range from 8mm to 12mm and lengths range from 22mm to 30mm. The variety of implant shapes and sizes accommodate various surgical technique options. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. Teeth on top and bottom of the spacers improve fixation. The EVOS Lumbar Interbody System includes the instrumentation to facilitate the implantation of the implants.

The approach and the discectomy are conducted using standard instruments while subsequent steps are conducted using standard and/or custom instruments. The system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel and/or polymeric materials.

The EVOS rotate and non-rotate Inserter(s) are instruments intended for use with the EVOS Lumbar Interbody System. The inserter(s) are designed specifically to implant the EVOS device into a prepared disc space. The EVOS non-rotate inserters are designed to work with the EVOS straight and curved devices while the EVOS rotate inserter is designed to work with the EVOS rotate devices.

The provided text is a 510(k) summary for the EVOL® Spinal Interbody System and EVOS Lumbar Interbody System. It does not describe acceptance criteria, a specific study proving the device meets acceptance criteria, or any details related to AI/algorithm performance.

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, intended use, design features, and mechanical performance. It mentions non-clinical performance testing for the EVOL® Spinal Interbody System, specifically:

• Static Compression
• Static Compression Shear
• Dynamic Compression
• Expulsion testing

These tests were performed per ASTM F2026, and the conclusion states that the "Testing performed showed substantial equivalence to the predicate." However, specific acceptance criteria values and the reported device performance values are not provided within this summary for these tests.

For the EVOS Lumbar Interbody System, the document states, "No design changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed." This implies that prior testing for the original EVOS system would have satisfied the substantial equivalence requirements, but those details are not in this document.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details because these particulars are not present in the provided text. The document is a regulatory submission focused on substantial equivalence based on mechanical and material properties, not an AI or diagnostic device study.

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The EVOS Lumbar Interbody System (EVOS device) is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The EVOS Lumbar Interbody System is intended to be used with autologous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.

The EVOS Lumbar Interbody System is an Intervertebral Body Fusion System for the lumbar spine. The EVOS Lumbar Interbody System includes surgical instruments to deliver the EVOS devices via a Posterior or Transforaminal approach. The generally rectangular design of the EVOS device incorporates an internal cavity for insertion of biological bone growth material through the top and bottom openings, as well as four small transverse holes (two on each side) that are designed to enhance bony ingrowth. Each device has a series of ridges or "teeth" on the top and bottom surfaces that are designed to ensure strong anchoring on the vertebral body endplates and resist backing out of the implant. The EVOS devices are provided sterile (gamma irradiated) for single use.

The EVOS device is made of radiolucent PEEK-OPTIMA® LT1 or PEEK-OPTIMA® HA Enhanced material. In addition, tantalum beads are embedded in the spacers to allow for radiographic visualization. The geometric shape of the EVOS devices are categorized as either STRAIGHT, CURVED, or ROTATE. All are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. Most of the EVOS STRAIGHT devices are offered with an option of a Standard nose, Wide nose, or Narrow nose. The devices are available in various heights, widths, and lengths to accommodate various surgical technique options.

The provided text describes the EVOS Lumbar Interbody System, an intervertebral body fusion device, and its substantial equivalence to predicate devices, but does not contain information about studies related to acceptance criteria for a device that relies on artificial intelligence (AI) or machine learning.

The document is a 510(k) summary for a medical device approval. It focuses on:

• Device Description: The physical characteristics, material, and types of the EVOS Lumbar Interbody System.
• Indications for Use: The medical conditions and patient population for which the device is intended.
• Comparison to Predicate Devices: How the EVOS system is similar to other legally marketed devices, primarily regarding technological characteristics and indications for use.
• Performance Data: Lists mechanical testing performed on the device to demonstrate its structural integrity and safety. These are standard tests for spinal implants.

Therefore, I cannot provide the requested information regarding AI acceptance criteria or studies proving performance based on this document. The questions you posed (sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth, etc.) are highly relevant to AI/ML medical devices, which this document does not cover.

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