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The Rexious Spinal Fixation 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 disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Rexious Spinal Fixation System is intended for use as a posterior, non-pedicle system indicated for 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; pseudoarthrosis; and failed previous fusion.

The Rexious Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and transverse (cross) linking mechanisms.

The Rexious Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Rexious implant components are supplied non-sterile, single use and fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. Various sizes of these implants are available.

This document is a 510(k) summary for the Rexious Spinal Fixation System. It explicitly states that no performance testing was required for this submission. The basis for clearance is that the device is identical to previously cleared predicate devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be provided from the given text because such studies were not conducted for this specific submission.

The relevant section from the document is:

• Performance Data: "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 K100765, K113324, K111362, and K173131. No testing is required."

This means the device's acceptance was based on its substantial equivalence to a previously cleared device, not on new performance data demonstrating it meets specific acceptance criteria through a new study.

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The FORTIS and HANA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include:

degenerative disc disease (DDD) (defined as neck pain of discogenic origin 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, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The REX Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

degenerative disc disease (DDD) (defined as neck pain of discogenic origin 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 failed previous fusion.

The BALTEUM™ and BALTEUM-ONE™ Lumbar Plate Systems are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1 - L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1 - S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The FORTIS and HANA Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for HANA and one, two, three, and four level procedures for FORTIS. Main plate is available from 13mm to 46mm for HANA and 10mm to 112mm for FORTIS. Screws are available in lengths from 12mm to 20mm for HANA and 10mm to 20mm in 2mm increments for FORTIS. The screws have either a 4.5mm or 5.1mm diameter for HANA and 4.0mm or 4.5mm diameter for FORTIS. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The FORTIS and HANA Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

Rex Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and the associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion. The rivets are also preassembled to the main plate and designed to assemble the subplate to the main plate firmly. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are fixed self-tapping, Variable self-tapping screw, fixed selfdrilling screw, Variable self-drilling and are available in lengths ranging from 10mm to 20mm in 2mm increments. The Rex Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136.

The BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the thoracolumbar spine (T1-L5) either through an anterolateral, or lateral approach and to the lumbar/lumbosacral spine (L1-S1) through an anterior approach. The system includes instrumentation which assists in the surgical implantation of the device.

The provided document is a 510(k) summary for the FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System. It explicitly states that the subject and predicate devices are identical, and therefore, no performance testing was required.

Because no performance testing was conducted, there are no acceptance criteria or studies to describe as per your request related to device performance. The submission is solely for transferring the name of a system that has already been cleared under previous 510(k) numbers (K121862, K173099, K200846, and K213820).

Therefore, answering your specific questions:

1. A table of acceptance criteria and the reported device performance: Not applicable, as no performance testing was done.
2. Sample sized used for the test set and the data provenance: Not applicable, as no performance testing was done.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance testing was done.
4. Adjudication method for the test set: Not applicable, as no performance testing was done.
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 spinal implant system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a spinal implant system, not an algorithm.
7. The type of ground truth used: Not applicable, as no performance testing was done.
8. The sample size for the training set: Not applicable. This device is a spinal implant system, not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This device is a spinal implant system, not an AI/ML device.

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The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

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. 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)

This appears to be an FDA 510(k) clearance letter and a 510(k) summary for the UNITY Sacroiliac Joint Fixation System. This type of documentation permits a device to be legally marketed, but it typically does not contain detailed information about the acceptance criteria and study results in the way you've requested for proving a device meets acceptance criteria, especially regarding AI or diagnostic performance studies.

The document states: "The UNITY Sacroiliac Joint Fixation does not create a new worst case for device performance; additional testing is not needed." This is a key statement indicating that the device is cleared based on substantial equivalence to an existing predicate device, not on new clinical performance data demonstrating its effectiveness in a traditional clinical trial or AI performance study.

Therefore, I cannot provide the requested information from this document. The questions you've asked (sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) are common for AI/diagnostic device clearances, but this particular device is a fixation system (essentially, screws for the sacroiliac joint), which falls under a different regulatory pathway.

To directly answer your points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The device is cleared based on equivalence to a predicate, not performance against specific criteria.
2. Sample sized used for the test set and the data provenance: Not applicable. No new test set data for performance was generated as per the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
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.

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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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