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The JAZZ Spinal System is intended for posterior, non - cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. In addition, when used as a pedicle screw fixation system, the JAZZ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The JAZZ Spinal System consists of a variety of shapes and sizes of screws and rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy, unalloyed titanium, or cobalt chrome alloy. Implant components of the system include straight and pre-bent rods, monoaxial and polyaxial screws, reduction screws, domino connectors, crosslinks, dual headed screws and connectors, transverse and sagittal uniplanar screws, favored angle screws, modular screws, iliac screws, along with associated set screws.

The provided FDA 510(k) clearance letter for the JAZZ Spinal System does not describe a study related to AI/algorithm performance for a diagnostic or imaging device. Instead, it details a clearance for a medical implant device (Thoracolumbosacral Pedicle Screw System).

Therefore, I cannot extract the information requested about acceptance criteria, study design, ground truth establishment, or human-in-the-loop performance related to an AI/algorithm. The document focuses on the mechanical performance and material safety of the spinal implant.

Specifically:

• Acceptance Criteria & Reported Performance (Table): Not applicable for an AI/algorithm study based on this document. The document mentions "Performance testing" for the spinal implant, including "static compression bending, static torsion, and dynamic compression bending per ASTM F1717-21, as well as static neutral angle dissociation and static maximum angle dissociation per ASTM F1798-13." However, these are mechanical tests for the implant itself, not metrics for an AI's diagnostic performance.
• Sample size and data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set size and ground truth: None of this information is present in the document because it pertains to the validation of a software algorithm or AI, not a spinal implant. The "ground truth" for a spinal implant would be its material properties and mechanical integrity, tested in a lab setting, not clinical annotation by experts.

In summary, the provided document is irrelevant to the prompt's request for details on an AI/algorithm performance study.

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KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, KHEIRON® Spinal Fixation System including patient specific K-ROD is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft and/or allograft.

Pediatric pedicle screw fixation is limited to a posterior approach.

Patient specific K-ROD devices are compatible with NuVasive Reline System components and Seaspine Mariner System components that are compatible with ø5.5mm and/or ø6.0mm rods as well as screws ø4.5mm or larger and at least 25mm in length.

S.M.A.I.O.'s patient specific K-ROD is part of the 510(k) cleared KHEIRON® Spinal Fixation system (K211981, K232650) designed for stabilization and correction of chronic instability or deformity of the thoracic, lumbar, and sacral spine. The patient specific K-ROD is manufactured from Ti-6Al-4V ELI per ASTM F136 and is available in diameters of 5.5 and 6.0 mm.

The Seaspine Mariner System is a 510(k) cleared pedicle screw system (K222110) that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors, and general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The Seaspine Mariner System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. The Seaspine Mariner System is also used to treat severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft.

The purpose of this Special 510(k) Device Modification is to extend indication of S.M.A.I.O.'s patient specific K-ROD (K211981, K232650) for use with the Seaspine Mariner System (K222110).

This FDA 510(k) clearance letter pertains to a spinal fixation system, which is a medical device, not an AI/software device. Therefore, the provided text does not contain the information needed to answer the questions about AI/software device acceptance criteria and study details (such as sample size, ground truth expert qualifications, MRMC studies, standalone performance, training set details, etc.).

The letter explicitly 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...".
It refers to the device as "KHEIRON® Spinal Fixation System, including patient specific K-ROD".

The performance data mentioned (Dynamic compression bending – ASTM F1717, Static torsion – ASTM F1717, Static axial gripping capacity – ASTM F1798, Static torsional gripping capacity – ASTM F1798) are mechanical tests performed to verify the physical properties and compatibility of the spinal fixation system components. These are not related to AI model performance or clinical accuracy studies typically seen with software as a medical device (SaMD).

Therefore, I cannot fulfill the request as the provided document does not contain the type of information required for an AI/software device.

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The Momentum Posterior Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum™ Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.

In order to achieve additional levels of fixation, the Momentum Posterior Spinal Fixation System can also be connected to the Cortium® Universal OCT Spinal Fixation System or neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the Cortium or neon3 Instructions for Use for a list of indications for use.

The Momentum® Posterior Spinal Fixation System is a standard pedicle screw and rod systems designed for fixation and correction in the thoracolumbar and sacroiliac spine. This 510(k) submission adds hooks, various connectors, and monoaxial screws to the previously cleared system from K231809 and K191932.

The subject hooks are intended to provide deformity correction according to patient anatomical needs. The subject connectors are intended to provide additional options to improve stability. The subject monoaxial fenestrated screws are identical below the tulip to the previously cleared fenestrated screws with the addition of the option to use G21 V-Steady bone cement. The Momentum® Posterior Spinal Fixation System is manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3 and cobalt chromium Co-Cr-28Mo per ASTM F1537 and ISO 5832-12.

This document is a 510(k) premarket notification decision letter for a medical device called the "Momentum® Posterior Spinal Fixation System." It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The letter simply states that the FDA has reviewed the submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison of the device's indications for use, technological characteristics, and performance data (mechanical strength testing results) to existing predicate devices.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study data for an AI/ML powered device based solely on the provided text. The document concerns a traditional implantable medical device, not an AI/ML product.

To reiterate, the provided text does not contain any of the following information:

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is not an AI/ML device with performance metrics like sensitivity, specificity, etc.
2. Sample sizes used for the test set and the data provenance: Not applicable for an AI/ML model. The "test set" here refers to mechanical testing of physical components, not a data-driven model.
3. Number of experts used to establish the ground truth...: Not applicable, as ground truth is not established in the context of an AI/ML model for this device.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The performance data mentioned (ASTM F1717 Dynamic Compression Bending) refers to mechanical testing of the spinal fixation system components to ensure their structural integrity and durability, not the performance of an AI/ML algorithm.

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The intended use of the Virata Spinal Fixation System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis,
• trauma (i.e., fracture or dislocation),
• spinal stenosis,
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• spinal tumor,
• pseudarthrosis, and/or
• failed previous fusion.

When used for posterior non-cervical screw fixation in pediatric patients, the Virata Spinal Fixation System is also indicated as adjunct to fusion to treat:

• Adolescent Idiopathic Scoliosis (AIS)
• Neuromuscular scoliosis
• Congenital scoliosis

The Virata Spinal Fixation System can be used with components of the Mariner and Malibu Systems such as rods and connectors. The Virata Spinal Fixation System is intended to be used with autograft or allograft.

Virata Spinal Fixation Navigated Instruments:
The Virata Spinal Fixation Navigated Instruments are intended to be used in the preparation and placement of Virata screws during spinal 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, which 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Virata Spinal Fixation System is a pedicle screw-based system that utilizes modular and preassembled screws. The modular screw shanks and the shanks of the preassembled screws are available in solid and cannulated configurations, in a variety of length and diameter size options. The rods are provided in a variety of lengths, diameters, and material options in both straight and pre-contoured configurations that can also be bent with instrumentation to more optimally accommodate the anatomy.

The Virata Spinal Fixation System consists of single-use implants intended to build constructs within the body to act as a temporary or permanent posterior, non-cervical pedicle fixation system, or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

Screws are placed in the pedicles of the vertebral body using a posterior approach. The construct is connected using rods to span across screws implanted at various levels. The construct is secured using a set screw tightened to a predetermined torque value which is threaded into the top of the screw to secure the rod. All modular tulips and the tulips of preassembled screws of the system are designed to accept a rod through the opening in the top of the tulip, except the closed polyaxial modular tulip and the tulip of closed preassembled screws for which the rod is passed through an opening on the side of the tulip. The Virata Spinal Fixation System implants are manufactured from titanium alloy Ti-6Al-4V ELI (per ASTM F136), and cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537).

The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. Non-sterile instruments also include instrumentation compatible with navigation arrays to allow for navigated implant placement.

The provided document, an FDA 510(k) clearance letter for the Virata Spinal Fixation System, is for a medical device (spinal implant) and not an AI/software-as-a-medical-device (SaMD). Therefore, the information typically required for describing acceptance criteria and a study proving a digital device meets those criteria (such as analysis of test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training data) is not applicable or present in this document.

Instead, the document focuses on the mechanical performance and substantial equivalence of the physical spinal fixation system to existing predicate devices.

Here's the relevant information that can be extracted from the provided text, adapted to the context of a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For the Virata Spinal Fixation System, acceptance criteria are generally implied by demonstrating safe and effective mechanical performance as compared to predicate devices, typically by meeting or exceeding standards outlined in ASTM (American Society for Testing and Materials) standards. The document doesn't explicitly list numerical acceptance criteria values or specific reported device performance metrics beyond stating that testing was conducted and the device was found substantially equivalent.

However, the types of tests performed indicate the areas where mechanical performance was evaluated:

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

• Sample Size: The document does not specify the exact number of test samples (e.g., screws, rods, constructs) used for each mechanical test. Mechanical testing typically involves a sufficient number of samples to ensure statistical validity for the properties being evaluated, as per the ASTM standards.
• Data Provenance: Not applicable in the context of mechanical testing of a physical implant. The "test set" here refers to the physical devices manufactured for testing. The testing was conducted by SeaSpine Orthopedics Corporation as part of their 510(k) submission.

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

Not applicable. For mechanical testing of a physical device, "ground truth" is established by the physical properties and performance characteristics measured according to standardized test methods (e.g., ASTM standards), not by human expert opinion or interpretation in the way it is for digital health technologies.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for reconciling differing expert opinions in clinical or diagnostic assessments, not for objective mechanical performance tests.

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

No. An MRMC study is relevant for evaluating the impact of an assist device (like AI) on human diagnostic performance. The Virata Spinal Fixation System is a physical implant, not a diagnostic or AI-assisted device. While it includes "Navigated Instruments," these are physical tools designed for use with a separate "Medtronic StealthStation® System" (a stereotactic surgery system), and the testing presented here focuses on the mechanical performance of the fixation system itself, not a comparative effectiveness study involving human readers' diagnostic accuracy.

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

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" is defined by the objective physical measurements and adherence to the specified performance parameters and failure modes outlined within the respective ASTM standards (F1717 and F1798). Compatibility and substantial equivalence to existing predicate devices (SeaSpine Mariner Pedicle Screw System, NuVasive GSB Global Spinal Balance System) also serve as a form of "ground truth" benchmark.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical testing for a physical implant.

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

Not applicable. There is no "training set" or "ground truth" establishment in this context.

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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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When used with pedicle screw fixation systems, the Annex® 2 Adjacent Level System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Annex® 2 Adjacent Level System can be linked to 4.75 mm, 5.5 mm, and/or 6.0 mm diameter rods of the following systems: CapSure®, Sniper® or Salvo® Spine Systems.

The Annex® 2 Adjacent Level System consists of a selection of non-sterile, single-use locking screws, adjacent level devices, and connectors for attachment to an existing pedicle spinal fixation construct to extend a rigid spinal construct. The Annex® 2 Adjacent Level System components are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing between existing screw and rod hardware. The implant components of this system are manufactured from titanium (ASTM F67)), titanium alloy (Ti-6Al-4V ELI (ASTM F136)), and cobalt-chromium (CoCr (ASTM F1537)).

The provided FDA 510(k) clearance letter pertains to a medical device, the Annex® 2 Adjacent Level System, which is a physical implant, not an AI/ML-driven software device. Therefore, the information requested regarding acceptance criteria and study design for AI/ML performance metrics (such as test set size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document.

The document discusses non-clinical testing to support substantial equivalence for a physical medical implant. Here's a summary of the relevant information from the provided document:

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

The document mentions that non-clinical testing was performed, but it does not explicitly state specific pass/fail acceptance criteria or quantitative performance results in the provided text. It generally concludes that the device is "substantially equivalent" based on these tests.

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

• Sample size: Not specified in the document.
• Data provenance: Not applicable in the context of clinical data for a physical implant. The testing described is non-clinical mechanical testing.

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

This information is not applicable as the study involved non-clinical mechanical testing of a physical device, not expert interpretation of AI/ML output.

4. Adjudication method for the test set:

Not applicable as the study involved non-clinical mechanical testing of a physical device, not subjective interpretation requiring adjudication.

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 a physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable, as this is a physical medical device, not an AI algorithm.

7. The type of ground truth used:

For mechanical testing, the "ground truth" would be established by standardized testing methods and material properties, rather than expert consensus, pathology, or outcomes data. The document states testing was performed "per ASTM F1717," indicating adherence to a recognized standard for spinal implant testing.

8. The sample size for the training set:

Not applicable, as this is a physical medical device, not an AI/ML system requiring a training set.

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

Not applicable, as this is a physical medical device, not an AI/ML system.

In summary, the provided document is a 510(k) clearance letter for a physical orthopedic implant system. The study mentioned (non-clinical testing per ASTM F1717) focuses on establishing mechanical and material equivalence to predicate devices, not on AI/ML performance metrics.

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The COLONNADE Posterior Screw Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation): spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Fenestrated screws are not intended for use with cement.

The COLONNADE Posterior Screw Fixation System pedicle screw is an internal fixation device for spinal surgery. Various forms and sizes of these implants are available so that constructions can be utilized to account for the unique pathology and anatomy of each patient. The subject pedicle screws and set screw of COLONNADE Posterior Screw Fixation System are manufactured from Ti-6Al-4V ELI as per ASTM F136, and are anodized The subject rods are manufactured from Ti-6Al-4V ELI as per ASTM F136 and Co-28Cr-6Mo as per ASTM F1537.

This document, an FDA 510(k) clearance letter for the "COLONNADE Posterior Screw Fixation System," details the regulatory approval of a medical device intended for spinal surgery. However, it does not contain information about a study proving that an AI/software device meets acceptance criteria.

The 510(k) letter explicitly states, "Clinical Testing: Not Applicable" in the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 6. This indicates that no human clinical study was performed to assess the device's performance in a clinical setting against acceptance criteria for diagnostic or AI-driven tasks.

Instead, the provided text emphasizes the substantial equivalence of the "COLONNADE Posterior Screw Fixation System" to predicate devices based on:

• Identical Indications for Use: The intended applications of the new device are the same as previously cleared devices.
• Similar Technological Characteristics: The design, materials (Ti-6Al-4V ELI, Co-28Cr-6Mo), function, and fundamental technologies are comparable to predicates, with only "slight differences between the length and diameter of screws, and rod length."
• Non-Clinical Testing: Performance was evaluated through mechanical testing standards (ASTM F1717) related to spinal implant constructs (Static Compression Bending, Static Torsion, Dynamic Compression Bending).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/software device meets them, as this information is not present in the provided FDA 510(k) clearance letter.

The letter pertains to a hardware device (a spinal fixation system), not a software or AI device for which performance metrics like those typically associated with diagnostic AI (e.g., sensitivity, specificity, AUC, human reader improvement) would be established and tested in a clinical trial.

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The Eminent Spine 3D Titanium Pedicle Screw System is designed to provide immobilization and stabilization to the thoracic, lumbar and sacral spinal segments as an adjunct to fusion. The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: severe spondylolisthesis (grades 3 or 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis and failed previous fusion.

The Eminent Spine 3D Titanium Pedicle Screw System consists of rods, polyaxial screws with set caps, and cross connectors with lock screws. Rods are 5.5mm in diameter and are available either straight or pre-contoured. Straight and pre-contoured rods are each offered in lengths ranging from 40mm to 600mm in various increments. The radius of curvature of the pre-contoured rods is 154mm throughout the entire series. Cannulated polyaxial screws are available in 6.0mm, 6.5mm, 7.0mm, 7.5mm, and 8.0mm diameters and in lengths ranging from 40mm to 60mm in 5mm increments. Set caps are used to fasten the rod and screw. Cross connectors are available in 3 length ranges: 32mm-42mm, 42mm-58mm, and 58mm-74mm. Cross connectors lock screws are used to fasten the cross connector together and fasten across the rods.

All components are manufactured from Ti6Al4V ELI. The screw is made specifically from Ti6Al4V ELI per ASTM F3001 and the tulip, set cap, rod, and cross link systems are made specifically from Ti6Al4V ELI per ASTM F136. The devices are sold non-sterile.

The provided document is an FDA 510(k) clearance letter for a medical device, the "Eminent Spine 3D Titanium Pedicle Screw System." This letter is a regulatory document, not a clinical study report.

Therefore, none of the information requested about acceptance criteria and study proving device performance (points 1-9) can be found in this document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. This equivalence is primarily demonstrated through mechanical testing (listed on page 6) and comparison of technological characteristics (page 6), rather than clinical performance studies involving human subjects or AI algorithms.

Specifically, the document mentions:

• Mechanical Testing:
  • Static torsion, static compression bending, and dynamic compression bending according to ASTM F1717
  • Torsional strength, driving torque, and axial pullout according to ASTM F543
  • Static cantilever bending according to ASTM F2193
  • Dynamic cantilever bending modified from ASTM F2193
• Conclusion: "The results support the substantial equivalence of the subject device compared to predicate devices."

This type of submission typically relies on non-clinical data (e.g., bench testing) to demonstrate that the new device performs as safely and effectively as a legally marketed predicate device, and does not usually include the detailed clinical study data points requested (such as sample size for test/training sets, expert adjudication, MRMC studies, or AI algorithm performance).

In summary, the provided text does not contain the information necessary to address the specific questions about acceptance criteria and clinical study performance for human readers or AI, as it pertains to a mechanical medical device cleared through substantial equivalence based on bench testing.

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The HC Biologics Osteopoint Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and 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, and/or
  -Failed previous fusion

HC Biologics Osteopoint Spinal Fixation System is top-loading, multiple components, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (straight and curved), connectors, hooks, and setscrews. It allows surgeons and functions to build a spinal implant construction to stabilize and promote spinal fusion. The System components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.Various sizes of these components are available to be used by a professional in a healthcare facility/ hospital.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to HC Biologics LLC for the "HC Biologics Osteopoint Spinal Fixation System." This type of document is part of the regulatory process for medical devices in the United States, where a manufacturer demonstrates that their new device is "substantially equivalent" to an already legally marketed device (a predicate device).

The document mainly covers:

• The FDA's determination of substantial equivalence.
• Regulatory requirements and guidelines for the device.
• The indicated uses of the device.
• A comparison of the new device to a predicate device (MSFX Mikron Spinal Fixation System) in terms of indications for use and technological characteristics.
• Mention of biomechanical tests performed according to ASTM standards for the Mikron System (which is stated to be identical to the HC Biologics Osteopoint Spinal Fixation System), but it does not provide the results of these tests or specific acceptance criteria met by those results.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, or other study-specific information because it is not present in the provided text.

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The VerteGlide Spinal Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome for the following subset of patients:

• · Patients who may require serial magnetic resonance imaging;
• · Patients with small stature:

· Patients with low body weight, compromised tissue coverage adjacent to spinal implants, or increased risk of implant associated wound healing adverse events;

• · Patients at risk for implant prominence following surgery;
• · Patients with hyperkykyphotic spinal deformities; OR.

· Patients at elevated risk of cardiac arrest/sudden death from anesthesia associated with additional spinal surgery.

The VerteGlide Spinal Growth Guidance System is intended to be removed after skeletal maturity.

The VerteGlide Navigation Compatible Instruments are intended to be used during the preparation and placement of the VerteGlide Spinal Growth Guidance System screws. The VerteGlide Navigation Compatible Instruments have the option to be used with or without Medtronic StealthStation® System. Use of VerteGlide Navigation Compatible Instruments with Medtronic StealthStation® System during spinal surgery can assist the surgeon in precisely locating anatomical structures in the VerteGlide Spinal Growth Guidance System procedures. The Medtronic StealthStation® 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The VerteGlide Spinal Growth Guidance System consists of longitudinal members (rods), anchors (screws), and interconnection components (cross connector and rod clamp) in a variety of sizes to accommodate differing anatomic requirements. The VerteGlide Spinal Growth Guidance System also include surgical instruments.

The VerteGlide Spinal Growth Guidance System offers a solution for early-onset scoliosis (EOS) patients with potential for additional spinal growth. Fusion screws are used at the apex of the curve to rigidly lock the rod in place, while sliding (non-fusion) screws are used above and below the apex to stabilize but allow for continued growth. A unique rod design is used to provide rigid fixation of the fusion screws and further promote sliding of the non-fusion screws. Fixation to the bone is provided using standard fusion and non-fusion pedicle screws. While the non-fusion pedicle screws are rigidly fixed to the bone, they also allow for sliding along the rod axis during normal growth without requiring separate rod lengthening procedures. The VerteGlide Spinal Growth Guidance System allows for deformity correction and minimizes repeat surgeries needed until skeletal maturity.

The components of the VerteGlide Spinal Growth Guidance System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.

The provided text describes the VerteGlide Spinal Growth Guidance System, a medical device. However, it does not detail a study that proves the device meets specific acceptance criteria in the manner requested (i.e., a clinical study with performance metrics like sensitivity, specificity, or accuracy in a diagnostic context).

The document is an FDA 510(k) clearance letter and a 510(k) Summary for a spinal growth guidance system. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria for a diagnostic or AI-driven system.

The "Performance Data" section primarily addresses biocompatibility, MR compatibility, and mechanical performance of the physical implant components. It states these aspects meet relevant ASTM and ISO standards, which serve as acceptance criteria for the hardware itself.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this type of device and submission.

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

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

2. Sample size used for the test set and the data provenance: Not applicable. This was a physical device testing, not an algorithmic performance evaluation on a patient dataset. The "test set" would refer to the physical samples tested for mechanical strength, biocompatibility, etc., the details of which are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be derived from physical measurements and standard testing protocols, not expert clinical interpretation of data.

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. This device is a physical spinal implant, not an AI or diagnostic imaging tool. The VerteGlide Navigation Compatible Instruments can be used with a Medtronic StealthStation® System, which is a navigation system, but the submission does not describe an MRMC study comparing human performance with and without this navigation assistance, nor is it the primary focus of the VerteGlide system's clearance.

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

7. The type of ground truth used:
* Biocompatibility: Conformance to ISO 10993-1 standards (chemical/biological assays).
* MR Compatibility: Physical measurements according to ASTM standards for heating, displacement, torque, and artifact generation.
* Mechanical Performance: Physical measurements (e.g., force, displacement, wear) against specified limits and comparison to predicate device performance.

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

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

Summary of the Study type:
The study described is a benchtop (in vitro) and material-based performance evaluation to demonstrate that the physical components of the VerteGlide Spinal Growth Guidance System are safe and perform as intended, and are substantially equivalent to a predicate device. This includes:

• Biocompatibility testing: To ensure the materials are not harmful to the body.
• MR Compatibility testing: To determine if the device is safe for use in an MRI environment.
• Mechanical performance testing: To ensure the device components have adequate strength, durability, and functional characteristics (like sliding mechanism) under simulated physiological loads and conditions.

The conclusion states that the data supports the differences between the subject and predicate devices and that the VerteGlide Spinal Growth Guidance System is substantially equivalent. A Post Market Surveillance Study (522 Order) will be issued to address potential safety concerns related to wear debris, indicating that some long-term clinical data will be collected after market entry.

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