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The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The FaSet Fixation System is indicated for treatment for any or all of the following:

• Spondylolisthesis
• Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity
• Spondylolysis
• Degenerative Disk Disease (DDD) as defined by back pain of discogenic origin with degeneration of disk confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
• Trauma including spinal fractures and/or dislocations.

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

The Huvex Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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), tumor, and/or lumbar spinal stenosis. The Huvex Interspinous Fixation System is intended for use, in conjunction with autogenous bone graft, and not intended for stand-alone use.

The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.

The FaSet Fixation System consist of permanent implant devices manufactured from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, and F136. Various sizes and lengths of these implants are available to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.

The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannulated form to accommodate patient anatomy and is manufactured from titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F136 and cobalt chrome alloy as specified in ASTM F1537. The three design types of the subject device are:

• 1. Standard Thread Screw (with and without slots)
• 2. Lag Screw (with and without slots) and
• 3. Washer Screw (with slots)

The Huvex Interspinous Fixation System consists of a left plate, a right plate, pin, bolt, inner cap, center bar, and set screw. Each of these components is provided in several sizes to allow for the construction of five different HUVEX Interspinous Fusion implant sizes. The left plate is provided assembled with the poly axial bar. The bar has a bone graft window to allow fusion between spinous process. Poly axial bar is also designed to fit the anatomical characteristics of the spinous process. The right plate is designed to be combined with left plate fixed to spinous process. Right plate contains a set screw to lock the right plate to the poly axial bar. The Huvex Interspinous Fixation System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.

In addition to the implants a set of reusable surgical instruments are provided. Both implant and instruments have trays that are used for handling and storage.

The AEON-C™ Stand Alone System includes PEEK interbodies and titanium interbodies, which utilize a titanium alloy locking mechanism that is either integrated in an anterior fixation plate or within the interbody. Both PEEK interbodies and titanium interbodies, with or without fixation plates, are to be anchored to patient anatomy via two (2) titanium alloy bone screws. The implant design includes multiple footprints, heights and lordosis options and the screw design includes multiple diameters and lengths, to fit a variety of patient anatomies. The interbodies can be used without the provided screws when supplemental fixation is used.

The provided document is a 510(k) summary for several medical devices: FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System.

This document describes that the subject devices are substantially equivalent to their predicate devices, which means they are considered as safe and effective as a legally marketed device that does not require premarket approval.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain specific quantitative acceptance criteria or reported device performance metrics in the way one would typically see for a novel diagnostic or AI-driven decision support system. Instead, the devices are cleared based on substantial equivalence to predicate devices.

The "Performance Data" section states:

• "The K&J Consulting - FaSet Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System devices are identical to predicate devices and therefore, no performance testing is required."
• "New components being added to the UNITY Sacroiliac Joint Fixation System, but the new components do not introduce a new mechanical worst-case, so no new testing is required."

Therefore, there is no table presenting acceptance criteria and reported device performance because the regulatory clearance is based on the devices being identical or having similar technological characteristics and not introducing new safety/effectiveness concerns compared to previously cleared devices.

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

Since no new performance testing was required due to substantial equivalence, there is no test set sample size or data provenance mentioned in this document for the subject devices.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Given that performance testing was not required for these devices (as they are identical or technologically similar to predicates), there is no mention of experts or ground truth establishment in this context.

4. Adjudication Method

No adjudication method is mentioned as there was no performance testing involving human review of a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or reported for these devices. The devices are hardware implants, not AI-driven systems where such studies are typically performed.

6. Standalone (Algorithm Only) Performance Study

Not applicable. These are physical implantable devices, not algorithms.

7. Type of Ground Truth Used

No ground truth data was used for the substantial equivalence determination beyond the specifications and established safety/effectiveness profiles of the predicate devices.

8. Sample Size for the Training Set

Not applicable. These are physical implantable devices, not AI/ML algorithms that require a training set.

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

Not applicable.

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The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. The FaSet Fixation System is indicated for treatment for any or all of the following:

• Spondylolisthesis
• Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity
• Spondylolysis
• Degenerative Disk Disease (DDD) as defined by back pain of discogenic origin with degeneration of disk confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
• Trauma including spinal fractures and/or dislocations.

The FaSet Fixation System consist of permanent implant devices manufactured from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, and F136. Various sizes and lengths of these implants are available to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.

This document is a 510(k) summary for the Dio Medical FaSet Fixation System, which is a medical device for spinal stabilization. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective.

Based on the provided text, no study was conducted to prove the device meets acceptance criteria. The key statement is found under "Performance Data" in the 510(k) Summary:

"The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K180729. No testing is required."

This means that instead of conducting new performance studies, Dio Medical Corporation is asserting that their "FaSet Fixation System" is identical to a previously cleared device (Huvexel Co. Ltd. - FaSet Fixation System, K180729). Therefore, the device's acceptance criteria and the study proving it meets them would be found in the documentation for the predicate device (K180729), not in this specific submission (K222515).

Since the document explicitly states "No testing is required," I cannot provide answers to the questions you posed regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment based on this FDA 510(k) summary for K222515. The information you're requesting would have been part of the original K180729 submission made by Huvexel Co. Ltd.

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The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The FaSet Screw Systems is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posterior through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the superior side of the facet, across the facet joint, and into the pedicle. The FaSet Fixation System is indicated for any or all of the following:
· Spondylolisthesis
· Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity
· Spondylolysis
· Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
· Trauma including spinal fractures and/or dislocations

The FaSet Fixation System consist of permanent implant devices manufactured from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, and F136. Various sizes and lengths of these implants are available to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.

This document is a 510(k) premarket notification from the FDA for the FaSet Fixation System, a medical device used for spinal fusion. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through mechanical testing and does not contain information about software or AI-based performance criteria, clinical study results with human readers, or ground truth establishment relevant to AI/ML device evaluations.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device. The provided text is solely about a physical implant device and its mechanical performance.

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