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The Xenix Medical RIVA Posterior Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine:

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

Xenix Medical fenestrated screws are intended to be used with saline or radiopaque dye.

Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Posterior Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation™ S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Xenix Medical RIVA Posterior Fixation System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur.

The Xenix Medical RIVA Posterior Fixation System includes a variety of single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of polyaxial pedicle screws, as well as connecting spinal rods, connectors, crossbars, and a separate set screw locking element. The instruments included in the Xenix Medical RIVA Posterior Fixation System facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants, and accessories to the system include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

This document, a 510(k) Clearance Letter for the RIVA Posterior Fixation System, is a submission for a physical medical device (pedicle screw system and navigation instruments), not a software or AI-driven medical device. Therefore, the specific information requested in your prompt regarding acceptance criteria and study proving performance for AI/software-based devices (such as statistical metrics, test/training sets, expert consensus, MRMC studies) cannot be directly derived from this document.

The document focuses on proving substantial equivalence to existing predicate devices, primarily through mechanical performance testing for the physical implants and accuracy testing for the navigation instruments. It does not describe a clinical study in the way an AI/software device would.

However, I can extract and interpret the available information to best fit your requested structure, making assumptions where necessary based on typical 510(k) submissions for physical devices:

Analysis of Acceptance Criteria and Performance for RIVA Posterior Fixation System

Given that the RIVA Posterior Fixation System is a physical medical device (spinal implant and surgical instruments), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" differ significantly from those for an AI/software device. For physical devices like this, acceptance is primarily based on meeting mechanical performance standards and demonstrating substantial equivalence to existing legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Static and dynamic compression bending
• Static torsion
• Axial and torsional grip
• Tulip shank dissociation
• Flexion-extension | These are industry-standard tests for spinal implants to ensure strength, durability, and resistance to common stresses. "Substantially equivalent" means the performance is comparable to and not worse than the predicate devices, not necessarily meeting a specific numerical threshold beyond that. |
  | Mechanical Performance | Adherence to ASTM F1798 standards | Demonstrated substantially equivalent mechanical performance. | ASTM F1798 covers resistance to unscrewing for spinal implants. |
  | Navigation Instrument Accuracy | Instruments register and function properly with Medtronic® StealthStation™ S8 System | Accuracy testing confirmed instruments register and function properly. | This implies that the instruments provide sufficiently accurate anatomical location data when used with the specified navigation system. |
  | Navigation Instrument Dimensional Analysis | Dimensions are comparable to predicate instruments. | Dimensional analysis performed against predicate instruments. | This ensures compatibility and similar performance characteristics to established navigation instruments. |
  | Biocompatibility | Use of Biocompatible Materials | Implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562). | These are well-established, biocompatible materials commonly used in medical implants, conforming to relevant ASTM standards. Although not explicitly stated as "acceptance criteria," material conformity is a fundamental requirement. |
  | Sterilization | Compatibility with Steam Sterilization | Accessories include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process. | Confirms the device/accessories are designed for appropriate sterilization. |

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

• Sample Size: The document does not specify the exact number of devices or components tested for mechanical or accuracy performance. For mechanical testing, samples typically involve multiple units of each component type (e.g., screws, rods, connectors) to ensure statistical validity across batches. For navigation instrument accuracy, it would involve a certain number of instrument uses with the navigation system.
• Data Provenance: The data provenance is from laboratory testing (mechanical and accuracy testing) performed by the manufacturer, HT Medical d.b.a. Xenix Medical. This is not patient data; it's engineering test data.
  • Country of Origin: Not specified, but generally performed at the manufacturer's R&D facilities or contracted testing labs, typically in the country of manufacture or where submission is being sought (implied US, given FDA 510(k)).
  • Retrospective or Prospective: This is not applicable in the context of laboratory mechanical/accuracy testing.

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

This section is not applicable in the context of this device and submission type. "Ground truth" as defined for AI/software (e.g., expert consensus on medical images) is not relevant here. The "truth" is established by the physical and mechanical properties of the device and its ability to function as intended in a controlled laboratory environment according to established engineering standards (ASTM). The "experts" involved would be engineers, material scientists, and quality assurance personnel conducting the tests and interpreting the results against the ASTM standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements in labeling or classifying data, typically by human experts reviewing complex medical images or clinical cases. For mechanical testing, the "adjudication" is against the pre-defined ASTM standards and the performance of the predicate device. Test results are quantitative and either meet or do not meet the criteria.

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 performed or described in this 510(k) submission. MRMC studies are typically done for diagnostic imaging devices or AI tools that assist human readers in making clinical decisions. This device is a surgical implant and navigation system, not a diagnostic tool requiring MRMC.

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

Not Applicable. This concept applies to AI algorithms. The "RIVA Posterior Fixation System" is a physical implant and surgical navigation instrumentation. There is no standalone "algorithm" to evaluate in this context. The navigation instruments are designed for "human-in-the-loop" use with a surgeon and the Medtronic StealthStation system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment is based on accepted engineering standards (ASTM F1717, ASTM F1798) and the established performance of the predicate devices. This means:

• Mechanical Integrity: The ability to withstand specified static and dynamic forces as defined by ASTM standards.
• Functional Accuracy: For the navigation instruments, the ability to register and provide accurate location information within the Medtronic StealthStation system, demonstrated through bench testing.
• Material Conformity: Conformance to specified biocompatible material standards.

It is not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be validated. Clinical outcomes data would typically be gathered in post-market surveillance or specific clinical trials for PMA devices, which this is not.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning. There is no algorithm being trained.

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one. The "truth" for the design and manufacturing of this physical device is based on engineering principles, material science, and established manufacturing processes.

Summary Caveat:

It is crucial to understand that the provided document is a 510(k) clearance letter for a traditional physical medical device (implant and instruments). The questions in your prompt are specifically tailored towards the validation of Artificial Intelligence (AI) or software as a medical device (SaMD). Therefore, many of the requested details (like ground truth establishment from experts, MRMC studies, training/test sets for algorithms) are not relevant to this type of device and are consequently not found in the 510(k) clearance letter. The FDA's assessment for this device focuses on substantial equivalence in terms of intended use, indications for use, design, materials, function, manufacturing, and most importantly, mechanical performance as demonstrated through rigorous engineering bench testing.

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The neoWave LS Porous Titanium Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine 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. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). neoWave LS Porous Titanium Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The neoWave LS Porous Titanium Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The neoWave C Porous Titanium Cage is intended for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

When used as a Cervical Interbody Fusion device, Ti3D Cervical is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

Xenix Medical neoWave LS Lumbar Straight Cages are intervertebral body fusion devices intended for use in the lumbar spine and made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in 6-17mm heights and various footprints to accommodate patient anatomy. The implants are provided sterile. Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (10°) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

Xenix Medical neoWave C Cervical Cage is intervertebral body fusion device intended for use in the cervical spine and made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in 4-12mm heights and various footprints to accommodate patient anatomy. The implants are provided sterile. Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (100) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

Xenix Medical Ti3D Cervical Cages are intervertebral body fusion devices intended for use in the cervical spine and made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in 4-12mm heights and various footprints to accommodate patient anatomy. The implants are provided sterile. Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (100) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

This document describes the premarket notification (510(k)) for new Wave LS Lumbar Straight, newWave C Cervical, and Ti3D Cervical intervertebral body fusion devices. This submission aims to add a nanotechnology claim and a change in the additive manufacturing (AM) supplier.

Here's a breakdown of the requested 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 explicitly state the sample size for the "test set" in terms of patient data. The performance testing described focuses on in vitro and mechanical evaluations.

• For in vitro evaluations and imaging studies: The sample size isn't specified, but it refers to "human mesenchymal stem cells in vitro." The provenance is in vitro (laboratory setting).
• For mechanical testing (ASTM F2077): The number of devices tested isn't specified, but it was performed on "cervical (dynamic axial compression, dynamic torsion) and lumbar (dynamic axial compression, dynamic compression shear) versions of the devices." This is laboratory-based testing, not human data.

The data provenance is limited to laboratory studies (in vitro and mechanical testing) and does not involve human subjects or clinical data in the context of this 510(k) submission. Therefore, it is retrospective in the sense that no new clinical patient data was collected for this specific submission for performance evaluation.

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

This information is not provided in the document. The performance testing described (in vitro and mechanical) does not involve expert review or establishment of "ground truth" in the clinical sense with patient data. The "ground truth" for the in vitro study would be the observable cellular and biochemical responses, which are quantitative and not subject to expert consensus in the same way clinical diagnoses would be.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human-read test set or clinical outcome data that would require an adjudication method. The evaluations are objective laboratory tests.

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. The document describes laboratory-based in vitro and mechanical testing, not clinical studies involving human readers or patient cases. Therefore, no effect size of human readers improving with or without AI assistance is mentioned.

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

This question is not applicable to this device. The devices are intervertebral body fusion cages, which are physical implants, not AI algorithms. The "nanotechnology claim" refers to the surface features of the physical implant, not a software algorithm.

7. The Type of Ground Truth Used

• For Biocompatibility/Surface Characteristics (in vitro studies): The ground truth is established by observable cellular and biochemical responses (e.g., mineralization in human mesenchymal stem cells) as measured and quantified in a laboratory setting.
• For Mechanical Performance (ASTM F2077): The ground truth is defined by objective measurements of mechanical properties according to the ASTM F2077 standard.

8. The Sample Size for the Training Set

This information is not applicable. The described device is a physical medical implant, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by prior research and engineering principles, but not a dataset used to train an algorithm.

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

This information is not applicable as there is no training set for an AI algorithm.

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The Xenix Medical Sacroiliac Fixation System is indicated for sacroiliac joint fusion for:

• Sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint ● disruptions
• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature ● patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion

The Xenix Medical Sacroiliac Fixation System is also indicated for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The Xenix Medical Sacroiliac Fixation System Navigation Instruments are intended to be used with the Xenix Medical Sacroiliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Xenix Medical Sacroiliac Fixation System consists of 3D printed medical grade Titanium Alloy Implants (Ti-6Al-4V ELI per ASTM F-3001) and surgical instrumentation for implantation. Implants are provided sterile in various lengths and diameters. The reusable instrumentation is provided non-sterile in a steam sterilization instrument tray.

The provided text is a 510(k) summary for the Xenix Medical Sacroiliac Fixation System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence.

However, the document does not describe the acceptance criteria and the study that proves the device meets those acceptance criteria in the context of an AI/ML medical device. The information requested in the prompt, such as acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy), sample size for test sets (along with data provenance), expert ground truth establishment, MRMC studies, or standalone algorithm performance, is completely absent from this document.

The performance testing described here is for mechanical properties, sterilization, bacterial endotoxin, and navigation instrument accuracy, which are typical for traditional hardware medical devices like orthopedic fixation systems, not AI/ML algorithms.

Therefore, I cannot provide the requested information based on the given input. The device referred to in the document is a physical implant and surgical instrumentation system, not an AI/ML-driven diagnostic or therapeutic device.

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