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The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical, posterior spine in order 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.

The previously cleared Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws. The standard (one level) Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivoting-slide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the nuts on the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise. To allow for multiple level fusions, four additional components were added to the system (K160216): 1) Transition Bone Screws, 2) Transition Connectors, 3) Two-Post Connectors, and 4) Two-Post Bone Screws. These components provide two connector attachment posts with a single bone screw, which allows the attachment of two connectors (one superior, one inferior) to a single level of the spine. In the case of the Transition Connector, the Transition Bone Screw includes a connector attachment post. This 510(k) submission adds two types of components to the system: 1) Two-Level Connectors, and 2) Two-Level Bone Screws. These components, when utilized with the previously cleared, standard Revolution™ connectors and standard bone screws, allow stabilization of two levels of the spine. These new Two-Level components allow fusion of two spinal levels when the patient's inter-pedicular distances are very short, by allowing attachment of two connector interfaces to a single bone screw. Like the previously cleared Revolution™ bone screws, the Two-Level Bone Screws are available in diameters of 4.5 mm - 7.5 mm, and in lengths from 25 mm to 55 mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire. The Two-Level Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage a standard (one level) connector and a Two-Level Connector. The Two-Level Connector uses the same technology (the pivoting-slide and the spherical bearing), and has a stepped central plate. The step in the plate allows two connectors to stack on top of each other, thus requiring less horizontal space to attach two connectors. All implant components of the Revolution™ Spinal Fixation System, including the additional components, are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

This document refers to the Revolution™ Spinal Fixation System which is a medical device, and therefore the "device performance" mentioned in the request refers to the structural and mechanical performance of the system rather than diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text, focusing on the mechanical performance as that's what was evaluated for this device:

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 (number of devices tested) for the mechanical performance tests. It mentions "testing was conducted" but no specific count of components or systems tested.

• Data Provenance: Retrospective, as the testing was conducted on samples of the device to demonstrate their properties. The origin of the data is from the manufacturer's internal testing.

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

Not applicable for this type of device and study. The ground truth for mechanical testing is established by recognized international standards (ASTM F1798-13 and ASTM F1717-15), not human expert consensus on images or outcomes.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements against defined standard criteria, 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 type of study is for evaluating observer performance, typically in diagnostic imaging, which is not relevant for this spinal fixation system, whose performance is determined by mechanical properties.

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

Not applicable. This device is a physical implant, not an algorithm or software. Its performance is entirely standalone in terms of its mechanical function without human interpretation.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance was the established criteria and methodologies outlined in the ASTM F1798-13 and ASTM F1717-15 standards, along with pyrogenicity requirements. These standards define the expected static and dynamic mechanical properties (e.g., strength, bending, torsional resistance) for spinal implants.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical, posterior spine in order 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.

The Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws. This 510(k) submission adds four types of components to the system: 1) Transition Connector, 2) Transition Bone Screws, 3) Two-Post Connector, and 4) Two-Post Bone Screws. These components, when utilized with the existing standard Revolution™ connectors and standard bone screws, allow stabilization of multiple levels of the spine. Like the existing bone screws, the Transition and Two-Post bone screws are available in diameters of 4.5 mm - 7.5 mm, and in lengths from 25 mm to 55 mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire. The Transition Bone Screws and Two-Post Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage the Revolution™ Connectors. The Transition Connector and Two-Post Connector effectively create two threaded posts from a single bone screw. These threaded posts are utilized to connect to the Revolution™ Connectors. The standard Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivoting-slide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory and eliminating the need to cut spinal rods. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise. All implant components of the Revolution™ Spinal Fixation System. including the new multi-level components, are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

This document is a 510(k) premarket notification for the Revolution™ Spinal Fixation System, which is a medical device and not an AI/ML regulated device. Thus, the provided information does not contain the requested details on acceptance criteria and a study that proves a device meets them in the context of AI/ML performance.

Therefore, I cannot provide the requested information.

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The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical posterior spine in order 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.

The Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws. The Revolution™ Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage the Revolution™ Connectors. Screws are available in 4.5mm major diameter and lengths from 25mm to 50mm and 5.5mm, 6.5mm, and 7.5mm major diameters and lengths from 25mm to 55mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire. To allow the surgeon to determine the height of the connector relative to the bone, screws with extended non-threaded collars are provided. These extended collars effectively provide built in spacers that prevent the bone screw from being driven too deep and control the overall height of the completed assembly. The Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivoting-slide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory and eliminating the need to cut spinal rods. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the nuts on the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise. All implant components of the Revolution™ Spinal Fixation System are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

This FDA 510(k) summary describes a spinal fixation system, not a device with AI components. Therefore, the questions related to AI performance, ground truth, experts, and training/test sets are not applicable.

The document focuses on the Revolution™ Spinal Fixation System, a mechanical implant. For such a device, acceptance criteria and testing revolve around its physical properties, material compatibility, and structural integrity under simulated physiological conditions.

Here's an analysis of the provided information, addressing the applicable questions and indicating when a question is not relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the testing was conducted "according to methods defined in ASTM F 1798-13, 'Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants', and ASTM F 1717-14, 'Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model'."

Since specific numerical acceptance criteria (e.g., minimum strength in Newtons) are not explicitly stated in this summary, the table below will reflect the type of tests performed and the general conclusion given in the document. The implicit acceptance criterion is that the device meets the requirements of these ASTM standards and performs comparably to predicate devices.

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

The document does not specify a "sample size used for the test set" in terms of patient data, as this is a mechanical device. Instead, it refers to mechanical testing. The sample size for mechanical testing (i.e., the number of devices or components tested) is not explicitly stated in this summary. The data provenance is mechanical testing conducted in a laboratory setting to validate the device's physical properties.

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

Not applicable. This device is not an AI/diagnostic system. Ground truth in this context refers to the physical properties measured against established engineering standards (ASTM).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for clinical studies or AI algorithm outputs where multiple human reviewers assess data. Here, the "truth" is determined by standardized mechanical testing procedures.

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 is a mechanical spinal fixation system, not an AI or diagnostic device that would involve human readers.

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

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

For this mechanical device, the "ground truth" is defined by established engineering and material standards, specifically:

• ASTM F 1798-13: "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants"
• ASTM F 1717-14: "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model"
• ASTM F-136: Standard for the Ti-6Al-4V ELI material.

The device's performance is compared against the requirements and typical performance values for devices conforming to these standards.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. This device does not have a "training set" in the context of AI.

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The Spinal Innovations REVOLUTION ™ Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a pedicle screw system 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the Spinal Innovations REVOLUTION ™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degencration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations REVOLUTION ™ Spinal Fixation System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are TI to the sacrum.

The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes fixed and polyaxial screws of varying diameters and lengths, and hooks in varying designs and lengths, curved and straight rods and transverse connectors.

Here's a breakdown of the acceptance criteria and study information for the Spinal Innovations REVOLUTION™ Spinal Fixation System, 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

• Sample Size for Test Set: Not explicitly stated. The document refers to "various system components" being tested, implying a range of components were subjected to the biomechanical tests.
• Data Provenance: Not explicitly stated. However, given that it's a 510(k) submission for a spinal fixation system, the testing would be conducted in a laboratory setting, likely in the country of origin of the manufacturer (Tennessee, USA). The study is prospective in the sense that the device was manufactured and then tested to demonstrate its performance.

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

• This is not applicable to this type of study. The ground truth for this device's acceptance is established through objective, quantitative biomechanical testing against established ASTM standards and comparison to predicate devices, not through expert consensus on qualitative data.

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Biomechanical testing results are objective measurements and do not require adjudication in the same way clinical or imaging studies might.

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, an MRMC comparative effectiveness study was not done. This document describes a biomechanical performance study of a physical medical device (spinal fixation 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 a physical implant, not a software algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The ground truth used for this device's acceptance is based on objective biomechanical measurements and established engineering standards (ASTM F 1798-97). The device's performance is compared directly against the performance of legally marketed predicate devices, implying that their established performance serves as the "ground truth" for what is considered safe and effective in this context.

8. The Sample Size for the Training Set

• Not applicable. This is a biomechanical study, not a machine learning study. There is no "training set" in the context of device performance testing through physical measurements.

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

• Not applicable. See point 8.

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