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When used with the integrated fixation and as a standalone system:

The Genesys Spine AIS-C II Cervical Interbody Fusion System is a standalone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine AIS-C II Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach.

When used without the integrated fixation:

The Genesys Spine AIS-C II Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e., cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine AIS-C II Cervical Interbody Fusion will be offered in various device configurations based on surgical approach and patient anatomy. The AIS-C II System has two interbody options: Regular or Standalone.

The Regular Cervical Interbody System does not require the use of Anchors but is designed for use with supplemental fixation (i.e., cleared cervical plating system).

The Standalone Cervical Interbody System requires the use of Anchors for integrated fixation. This version includes an integrated cam lock mechanism and various sizes of anchors. The cam lock mechanism may be used as a secondary aid in keeping the anchors from backing out of the interbody and vertebral bodies. After anchor deployment, a cam lock key is used to turn the lockwise) to engage the cam lock and secure the anchors. When engaged (closed), the wings of the cam lock cover the anchor channels and provide a backing plate for the anchors.

The subject and predicate devices are based on the same technological characteristics: Integrated fixation anchors provide additional biomechanical support to the interbody. lmplant materials are identical: PEEK, Titanium 6AL-4V ELI alloy, and tantalum. A single inserter can be used to position the interbody and deploy the anchors.

The provided text is a 510(k) summary for the Genesys Spine AIS-C II Cervical Interbody Fusion System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on technological characteristics and mechanical testing. However, the document does not contain information related to software, artificial intelligence (AI), or clinical studies involving human readers or expert ground truth adjudication.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI or software.
• Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for test sets.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Details on standalone algorithm performance.
• Type of ground truth used for AI/software evaluation.
• Sample size for the training set or how ground truth was established for a training set.

The document focuses on the mechanical performance of a physical medical implant (intervertebral body fusion device) and demonstrates substantial equivalence to predicate devices through non-clinical mechanical testing.

Here's the relevant information that is present in the document regarding the device's acceptance criteria and the study proving it:

1. Acceptance Criteria and Reported Device Performance (Mechanical Testing)

The acceptance criteria are implicitly defined by the guidance documents and consensus standards listed, aiming to demonstrate the mechanical performance of the device is equivalent or superior to predicate devices and generally accepted standards for intervertebral body fusion devices.

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

• Sample size: Not specified in the provided text. Mechanical testing typically involves a number of devices or components to establish statistical significance for properties like strength, fatigue, and subsidence, but the exact number is not detailed here.
• Data provenance: Not applicable in the context of human data or AI. The "data" refers to the results of in vitro mechanical tests conducted on the device itself.

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

• Not applicable. This is a physical device; its mechanical performance is measured directly by adherence to engineering standards and comparison to established benchmarks from other devices, not by expert consensus on clinical cases.

4. Adjudication method for the test set:

• Not applicable. Mechanical testing results are objective measurements against defined parameters.

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. The document explicitly states: "Clinical testing is not required." This device is not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is a physical surgical implant, not a standalone algorithm.

7. The type of ground truth used:

• Not applicable in the AI/software sense. The "ground truth" for this device's performance is established through internationally recognized engineering standards (ASTM, ISO) for static and dynamic mechanical properties, and comparative data from previously cleared devices, as measured in a laboratory setting.

8. The sample size for the training set:

• Not applicable. This device is not an AI/software product, so there is no training set.

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

• Not applicable. This device is not an AI/software product, so there is no training set or ground truth establishment relevant to AI.

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The Genesys Spine Sacroiliac Joint Fusion System with Navigation is intended to be used with the Genesys Spine Sacroiliac Joint Fusion System to assist the surgeon in precisely locating anatomical structures in SIros and SIros O procedures, in which the use of stereotactic surgery may be appropriate, and where reference to anatomical structures, such as the pelvis or vertebra, can be identified relative to acquired imaging (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or image data based models of the anatomy. Navigation instruments are intended to be used with the Medtronic O-arm® Imaging System and StealthStation® Navigation System.

The Genesys Spine Sacrolliac Joint Fusion with Navigation consist of instruments compatible with the Medtronic O-arm® Imaging System and StealthStation™ Navigation System to assist the surqeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Medtronic O-arm® Imaging System and StealthStation™ Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.

The Genesys Spine Sacrolliac Joint Fusion System consists of implants designed to secure the sacroiliac joint and minimize micromotion to enable bony fusion. All Implants are cannulated and self-tapping; they are offered with different diameters and lengths to accommodate variations in patient anatomy and surgeon preference. The Slros OTM Sacrolliac Joint Fusion System implants are manufactured from implant grade titanium (Ti-6AL-4V ELI).

This document, K233595, describes a 510(k) premarket notification for the "Genesys Spine Sacroiliac Joint Fusion System with Navigation". This device is an orthopedic stereotaxic instrument intended to assist surgeons in precisely locating anatomical structures during sacroiliac joint fusion procedures using navigation systems. The information provided heavily emphasizes the substantial equivalence of the device to legally marketed predicate devices, rather than presenting a detailed independent study with specific acceptance criteria and performance metrics typically found for AI-based or novel diagnostic devices.

Therefore, many of the requested details about acceptance criteria, study design for proving performance, and expert involvement are not explicitly present in this 510(k) summary, as the submission focuses on demonstrating equivalence through non-clinical testing rather than complex clinical performance studies.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not provide a table of precise quantitative acceptance criteria in the format of thresholds for specific metrics (e.g., accuracy percentages, sensitivity, specificity). Instead, the performance testing focuses on functional and compatibility aspects:

1. Acceptance Criteria (Implied from Testing Objectives):

• Registration: The instruments must be able to successfully register with the Medtronic StealthStation®.
• Accuracy: The accuracy of the subject instruments must be comparable to the reference instruments (predicates).
• Rigidity: The connection between the Medtronic NavLock and the subject instruments must demonstrate sufficient rigidity.
• Compatibility: The subject instruments must be compatible with the Genesys Spine Sacroiliac Fusion System Implants.

2. Reported Device Performance:

The document states, "The performance testing completed:

1. Registration - Registration testing was performed to ensure that the instruments can be registered to the StealthStation®.
2. Accuracy - Accuracy testing was completed for comparison to the reference instruments.
3. Rigidity - Rigidity testing evaluated the connection between the Medtronic NavLock and the subject instruments.
4. Compatibility with Genesys Spine Sacroiliac Fusion System Implants - Compatibility with the Implant System has been evaluated to ensure that the isubject instruments are compatible with the Implant System."

It then concludes: "The verification and validation results support substantial equivalence of the subject instruments compared to the predicate devices."

Summary Table (Derived/Inferred):

Study Details:

Many of the requested details are not applicable or not provided, as the study described is a non-clinical performance testing study focused on demonstrating functional compatibility and equivalence, rather than a clinical trial or performance study comparing a new algorithm's diagnostic performance against human experts.

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

   • Sample Size: Not specified in the provided text. The testing focuses on mechanical/functional aspects of the instruments, not data samples like images for an AI.
   • Data Provenance: Not applicable in the context of this device. The testing is described as "performance testing" of the physical instruments with the navigation system.

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

   • Not applicable. Ground truth for an AI/diagnostic device is typically established by medical experts reviewing data. This device is a surgical instrument system, and its "ground truth" relates to its mechanical and functional performance, verified through engineering tests.

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

   • Not applicable. This is not a study requiring adjudication of expert interpretations.

4. 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. It's a stereotaxic instrument for surgical guidance.

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

   • Not applicable. This is not a standalone algorithm. It's a system with a human surgeon in the loop, intended to assist the surgeon.

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

   • The "ground truth" for this device's performance would be engineering specifications, established physical properties, and the known performance baseline of the predicate devices and compatible navigation systems (Medtronic O-arm® and StealthStation™). It's based on engineering and functional validation, not medical expert consensus on patient data.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

   • Not applicable. As there's no training set for an AI model, this question is irrelevant to the described device and its testing.

In summary, this 510(k) submission demonstrates the device's substantial equivalence through non-clinical performance testing focused on its functional compatibility and mechanical properties when used with specified predicate navigation systems, rather than through clinical or AI performance studies against diagnostic criteria.

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When used with the integrated fixation and as a stand-alone system:

The Genesys Spine 3D Printed AIS-C II Cervical Interbody Fusion System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine 3D Printed AIS-C II Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach.

When used without the integrated fixation:

The Genesys Spine 3D Printed AIS-C II Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenc pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e., cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine 3DP Als-C II Cervical Interbody System includes 3D-Printed (3DP) titanium interbody System offers a stand-alone version as well as a traditional (Regular) interbody that requires supplemental fixation.

The interbody that utilizes supplemental fixation may be used as a stand-alone that is implanted with two (2) titanium alloy anchors. This version includes an integrated cam lock mechanism and various The cam lock mechanism may be used as a secondary aid in keeping the anchors from backing out of the interbody and vertebral bodies after anchor deployment. After anchor deployment, in order to engage the cam lock key instrument is used to turn the lock (counterclockwise direction) from an open to closed position. When closed, the wings of the cam lock slide over the anchor channels and provide a backing cover for the anchor and anchor channels.

Al interbodies and anchors are made from Ti-6Al-4V ELI titanium alloy. The cam lock is made out Ti-6Al-4V ELI titanium alloy with a PEEK washer.

The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., anterior cervical screws) may be needed.

This FDA 510(k) summary for the Genesys Spine 3DP AIS-C II Cervical Interbody System does not contain information about acceptance criteria or a study proving the device meets those criteria. My analysis of the provided text is as follows:

The document is a 510(k) premarket notification letter and summary for a medical device. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (K191489, Genesys Spine 3DP Cervical Interbody System), rather than detailing specific acceptance criteria and a study to prove meeting them.

The sections that might typically contain such information (Non-Clinical and/or Clinical Tests Summary & Conclusions) are explicitly marked as "N/A" or describe comparative testing against the predicate (e.g., "results proved superior to predicates"). This indicates that the regulatory pathway for this device did not require a standalone study to establish de novo performance against specified acceptance criteria. Instead, it leveraged the established safety and effectiveness of a predicate device.

Therefore, I cannot provide the requested information from the provided text.

Here's why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the new device to a predicate, not on defining and meeting specific performance acceptance criteria for a novel device.
2. Sample size used for the test set and the data provenance: Not applicable as a standalone performance study against acceptance criteria is not described. The document mentions "Anchor Push-Out testing," "Biocompatibility analysis," "Sterilization/Cleaning analysis," "Design Validation testing," "mechanical performance... in accordance with ASTM F2077," and "Finite Element Analysis (FEA)." However, these are presented as comparative tests to the predicate or as engineering analyses, not as a study against a specific set of acceptance criteria with defined sample sizes for that purpose. No data provenance (country, retrospective/prospective) is stated for these tests beyond their comparative nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The document refers to "user feedback" for design validation but does not detail a process for establishing ground truth by experts in the context of a clinical performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an interbody fusion system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable given the nature of the device and the lack of a clinical performance study described. The document discusses mechanical testing and design validation.
8. The sample size for the training set: Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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The Genesys Spine 3DP Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Genesys Spine 3DP Lumbar Interbody System is comprised of additively manufactured lumbar intervertebral body fusion devices. Numerous styles, footprints, and sizes of interbodies are offered including PLIFs, TLIFs, ALIFs, and LLIFs. The 3DP Lumbar Interbody System implants are manufactured from titanium Ti-6AL-4V ELI alloy.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "Genesys Spine 3DP Lumbar Interbody System." It discusses the regulatory approval process for this device and its indications for use.

Crucially, the document states "PERFORMANCE DATA Not Required." It explains that "Engineering analyses were performed on the Subject Devices and it was determined that a new worst-case was not created, therefore additional testing was not required. The instrument additions mimic previously cleared instruments with minor alterations."

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria based on performance data. The approval is based on a determination of substantial equivalence to a predicate device (Genesys Spine 3DP Lumbar Interbody System - K182987) and engineering analyses, rather than new clinical or performance testing.

Given this, I cannot provide the requested information as it does not exist within the provided document. The sections you asked for, such as acceptance criteria, specific performance data, sample sizes, expert involvement, and ground truth establishment, are not detailed because new performance data was not required for this specific 510(k) submission.

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When used with the internal fixation and as a stand-alone system:

The Genesys Spine 3DP Cervical Interbody Fusion System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine 3DP Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach.

When used without the internal fixation:

The Genesys Spine 3DP Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine 3DP Cervical Interbody System includes 3D-Printed (3DP) titanium interbodies. The 3DP Cervical Interbody System offers a stand-alone version as well as a traditional (Regular) interbody that requires supplemental fixation. The version that utilizes integrated fixation may be used as a stand-alone cervical device that is implanted with two (2) titanium alloy anchors. All interbodies are made from Ti-6Al-4V ELI titanium alloy. The standalone version includes an integrated locking mechanism and various sizes of anchors which are all manufactured from Ti-6Al-4V ELI titanium alloy.

The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g. anterior plate, posterior cervical screws) may be needed.

The provided text describes a 510(k) premarket notification for a medical device, the Genesys Spine 3DP Cervical Interbody System. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance evaluations, rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in the provided text, as this type of information is typically part of clinical trials or specific performance studies, which are not detailed in a 510(k) summary focused on non-clinical equivalence.

Here's an assessment based on the available information:

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

The document describes performance evaluations conducted on constructs against mechanical testing standards. It does not list quantitative acceptance criteria or specific reported numerical performance values in a table format. Instead, it makes a general statement of equivalency.

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

• Sample Size: Not specified. The document mentions "constructs representing the worst-case components" for the non-clinical tests. Medical device mechanical testing typically uses a certain number of samples, but the exact count is not provided here.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. No country of origin for clinical retrospective or prospective data is applicable or mentioned.

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

• Not applicable. For mechanical and cadaveric testing of medical implants, "ground truth" as typically defined for AI/diagnostic studies (e.g., expert consensus on clinical images) does not apply. The "ground truth" in this context would be the objective measurements obtained during the mechanical tests themselves, compared against established industry standards (e.g., ASTM).

4. Adjudication method for the test set:

• Not applicable. An adjudication method, common in clinical studies involving human interpretation or subjective assessments, is not relevant for the described non-clinical mechanical performance evaluations.

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. The provided document details a 510(k) submission for an interbody fusion device, which is a physical implant, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed or mentioned.

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

• Not applicable. This question pertains to AI algorithms. The device is a physical cervical interbody fusion system.

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

• For the non-clinical performance evaluation, the "ground truth" is implied to be adherence to scientifically established mechanical testing standards (e.g., ASTM F2077, ASTM F2267) and engineering principles. The document states "The Genesys Spine 3DP Cervical Interbody System was found to be substantially the same as predicate devices" based on these evaluations.

8. The sample size for the training set:

• Not applicable. There is no "training set" mentioned or implied, as this document describes the evaluation of a physical medical device, not an AI algorithm.

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

• Not applicable. As there is no training set mentioned, the establishment of its ground truth is also not applicable.

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The Genesys Spine 3DP Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Genesys Spine 3DP Lumbar Interbody System is comprised of additively manufactured lumbar intervertebral body fusion devices. They are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. Numerous styles, footprints, and sizes of interbodies are offered including PLIFs, TLIFs, ALIFs, and LLIFs. The 3DP Lumbar Interbody System implants are manufactured from titanium Ti-6AL-4V ELI alloy.

This document, K182987, is an FDA 510(k) Premarket Notification for the Genesys Spine 3DP Lumbar Interbody System. It details the device's indications for use and a comparison to predicate devices, but it does not contain information about a study that proves the device meets specific acceptance criteria in terms of performance measures such as sensitivity, specificity, or accuracy, as would be relevant for an AI/ML-based medical device.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices based on design, materials, technological characteristics, and non-clinical performance evaluations (mechanical testing), not on clinical performance or diagnostic accuracy.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study to prove they are met, as this document does not describe such a study for this type of medical device (physical implant).

Specifically, the information you requested that is NOT present in this document includes:

1. A table of acceptance criteria and the reported device performance: This document reports mechanical test results for "worst-case components" (static compression, static torsion, etc.) but does not list performance metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set for AI performance is described.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
7. The type of ground truth used: Not applicable (no ground truth for diagnostic performance).
8. The sample size for the training set: Not applicable (no AI/ML training set is mentioned).
9. How the ground truth for the training set was established: Not applicable.

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The Genesys Spine Binary Lumbar Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor. degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The Genesys Spine Binary Lumbar Plate System consists of an assortment of plates and screws. The Binary Lumbar Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions. The Genesys Spine Binary Lumbar Plate System implants are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F136.

The provided text describes a 510(k) premarket notification for a medical device, the Genesys Spine Binary® Lumbar Plate System. It details the device's purpose, components, indications for use, and a comparison to a predicate device.

However, the document does not contain information about an Artificial Intelligence (AI) / Machine Learning (ML) enabled device, nor does it discuss clinical studies with acceptance criteria, human reader performance, ground truth establishment, or training/test set details related to AI/ML device performance.

This document pertains to a physical medical device (spinal plates and screws) and its regulatory clearance based on substantial equivalence to an existing predicate device, primarily through engineering analysis, not through the performance or evaluation of an AI algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and study data for an AI/ML device, as such information is not present in the provided text.

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The Genesys Spine Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.

Genesys Spine's Sacroiliac Joint Fusion System consists of partially threaded and fully threaded implants designed to secure the sacroiliac joint and minimize micromotion in order to enable bony fusion. All screws and anchors are cannulated and self-tapping; they are offered with different diameters (up to 13.5mm), lengths (up to 70mm), and styles to accommodate variations in patient anatomy and surgeon preference. Fusion across the graft space can be aided by the addition of bone graft material to the lumen of each screw; fenestration in each screw allow for direct allograft apposition across the sacroiliac joint. Dual thread screws and fully threaded screws provide joint compression by utilizing a compressive thread pattern. Optional Washers are included to aid in conforming to patient anatomy and to help distribute the load onto a larger area. All implants are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI). The delivery system uses guide pins for accurate surgical placement into pre-drilled bone. All implants will be provided non-sterile and are intended for single use only.

This document, K191748, is a 510(k) Premarket Notification from Genesys Spine for their Sacroiliac Joint Fusion System. As such, it does not contain details of clinical studies, acceptance criteria, or ground truth establishment typically associated with AI/ML-driven medical devices.

Medical devices cleared through the 510(k) pathway, especially those like bone fixation fasteners, are primarily evaluated based on equivalence to legally marketed predicate devices through non-clinical performance evaluations (mechanical testing), rather than human clinical trials or complex algorithms requiring extensive performance studies with acceptance criteria for sensitivity, specificity, etc.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance: This document does not present such a table. The acceptance criteria for this device are implied by its substantial equivalence to predicate devices, meaning it must meet similar mechanical and material properties.
• Sample size used for the test set and data provenance: Non-clinical mechanical testing does not involve human subjects or "data provenance" in the clinical sense. Test "samples" would refer to the number of devices tested, but specific numbers are not provided, only the standards used (e.g., ASTM F2193-18a).
• Number of experts used to establish ground truth: Not applicable for a mechanical device.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an image-based diagnostic or AI-assisted device.
• Standalone (algorithm only) performance: There is no algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable, as there's no machine learning model.
• How the ground truth for the training set was established: Not applicable.

What the document does provide in terms of performance evaluation:

The document states that non-clinical testing was performed on "worst-case devices" and "demonstrated substantially equivalent performance to the predicate systems." The mechanical tests performed are listed:

• Static Bending Strength (ASTM F2193-18a)
• Fatigue Bending Strength (ASTM F2193-18a)
• Torsional strength/breaking angle (ASTM F543-17)
• Insertion/removal torque (ASTM F543-17)
• Pullout force (ASTM F543-17)

The acceptance criteria for these tests would be defined by the specified ASTM standards and the performance of the predicate devices. The "reported device performance" is summarized by the statement that it "demonstrated substantially equivalent performance to the predicate systems," meaning it met or exceeded the performance benchmarks set by the predicates under these test conditions. However, specific numerical results or detailed pass/fail thresholds are not included in this summary.

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The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.

The Genesys Spine Binary® Anterior Cervical Plate System components are temporary implants used to stabilize the cervical spine during the development of a solid spinal fusion in patients with degenerative disease, trauma (including fractures), and tumor pathology.

The Genesys Spine Binary® Anterior Cervical Plate System consists of multi-segmented titanium/nitinol bone plates of various sizes and lengths, titanium bone screws in various diameters and lengths, and associated instrumentation. Fixation is provided by the insertion of bone screws into the anterior surface of adjacent cervical vertebrae. Fixation of the screws to the plate is accomplished by seating into the screw securement mechanism.

This document is a 510(k) premarket notification from the FDA, granting clearance for the Genesys Spine Binary® Anterior Cervical Plate System. This type of document is for medical devices and does not typically include detailed performance studies with acceptance criteria as would be found for software or AI medical devices. It focuses on demonstrating "substantial equivalence" to a legally marketed predicate device.

Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not present in this document.

The document states:

"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

And under "CONCLUSION":

"The overall technological characteristics have led to the conclusion that the additional implantable devices in the subject submission do not create a new worst case. As a result, the modified Genesys Spine Binary® Anterior Cervical Plate System is considered substantially equivalent to the previously cleared Genesys Spine Anterior Cervical Plate II System (Genesys Spine - K133245)."

This means the acceptance criterion is substantial equivalence to a predicate device, not performance against a set of statistical metrics from a clinical study for a new device. The "study" proving this is the 510(k) submission itself, where the manufacturer provides information comparing their device to the predicate device in terms of indications for use, technological characteristics, and safety and effectiveness.

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The Genesys Spine Cervical Stand-Alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine Cervical Stand-Alone System is to be used with autogenous bone graft and implanted via an anterior approach.

The Genesys Spine AIS-C Cervical Stand-Alone System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium alloy bone anchors. The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g. anterior plate, posterior cervical screws) may be needed. The PEEK interbody devices are made of polyether-ether-ketone (Invibio's PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the PEEK implants contain tantalum markers per ASTM F560 to assist the surgeon with proper placement of the device in the disk space. The titanium alloy interbody devices, anchor locking mechanism, and the bone anchor components are manufactured from medical grade Ti6Al-4V ELI titanium alloy per ASTM F136.

The provided text describes the Genesys Spine AIS-C Cervical Stand-Alone System, a medical device, and its equivalency to predicate devices based on non-clinical performance data.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of devices or specimens) used for each mechanical test (axial compression, compressive-shear, torsion, subsidence, expulsion, cadaver testing, locking mechanism force). It only mentions that "all possible configurations of the AIS-C Cervical Stand-Alone System constructs were analyzed in order to determine the worst case to be used for testing."

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the nature of mechanical testing of devices, it is inherently prospective in the sense that new samples of the device are manufactured and specifically tested for the purpose of the study.

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

This information is not applicable as this study involves non-clinical mechanical testing of a medical device, not a study evaluating human performance or diagnostic accuracy where expert ground truth would be established. The "ground truth" here is adherence to mechanical standards (ASTM F2077-11, ASTM F2267-04) and comparison to predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Mechanical testing results are objective measurements against defined standards and comparisons, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the mechanical performance of the device itself, not on the effectiveness of human readers (e.g., radiologists) with or without AI assistance.

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

This question is not applicable because the Genesys Spine AIS-C Cervical Stand-Alone System is a physical medical implant, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to assess.

7. The Type of Ground Truth Used

The "ground truth" in this context is defined by:

• Established ASTM standards: Specifically, ASTM F2077-11 for static and dynamic axial compression, compressive-shear, and torsion; and ASTM F2267-04 for static subsidence.
• Performance of legally marketed predicate devices: The study's acceptance criterion was that the new device's mechanical test results should be "equivalent to (or greater than) previously cleared interbody fusion systems."

8. The Sample Size for the Training Set

This information is not applicable. This is a study of a physical medical device's mechanical properties, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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