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The EVOS Lumbar Interbody System is an intervertebral body device in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The EVOS Lumbar Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.

The EVOS Lumbar Interbody System is comprised of a variety of Implants manufactured from PEEK (Polyetheretherketone) -Optima LT1 (per ASTM F-2026) and PEEK Optima LT120HA, with Tantalum bead markers per ASTM F-560. There are three main configurations; STRAIGHT, CURVED, and ROTATE. The different configurations allow for multiple surgical technique options. The EVOS STRAIGHT and the EVOS ROTATE are generally rectangular in shape while the EVOS CURVED is curved. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs.

The EVOS device(s) are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. The angle of lordosis on each lordotic EVOS device is oriented in a way that will provide a true anterior/posterior lordotic orientation once the device has been implanted in its final intervertebral location. For example, the True Oblique Lordotic (TOL) devices have a lordotic orientation to the device that will provide a correct anterior/posterior lordotic orientation once they have been inserted at 30 degrees from the anterior/posterior midline.

Implant heights range from 6mm to 16mm in maximum height (minus the height of the teeth). Widths range from 8mm to 12mm and lengths range from 22mm to 30mm. The variety of implant shapes and sizes accommodate various surgical technique options. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. Teeth on top and bottom of the spacers improve fixation. The EVOS Lumbar Interbody System includes the instrumentation to facilitate the implantation of the implants.

The approach and the discectomy are conducted using standard instruments while subsequent steps are conducted using standard and/or custom instruments. The system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel and/or polymeric materials.

The EVOS rotate and non-rotate Inserter(s) are instruments intended for use with the EVOS Lumbar Interbody System. The inserter(s) are designed specifically to implant the EVOS device into a prepared disc space. The EVOS non-rotate inserters are designed to work with the EVOS straight and curved devices while the EVOS rotate inserter is designed to work with the EVOS rotate devices.

The provided text is an FDA 510(k) premarket notification for the EVOS Lumbar Interbody System. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about the acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop performance study.

Therefore, I cannot provide the requested information based on the provided text. The document states:

"No design changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed." (Page 6, Section VII)

This indicates that the submission relies on the prior clearance of the predicate device and does not include new performance studies or acceptance criteria beyond those relevant for establishing substantial equivalence for a medical device (material properties, dimensions, mechanical performance, etc.), rather than the type of AI-driven performance testing implied by the detailed questions.

To answer your request, a document detailing the clinical or technical performance study of an AI-enabled medical device would be needed.

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The EVOL® Spinal Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The EVOL® Spinal Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal, retroperitoneal or anterior approach. The CES-PLIF and CES-LIF are implanted in pairs, while the CES-TLIF and CES-RLIF devices may be implanted singly or in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation.

The EVOS Lumbar Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The EVOS Lumbar Interbody System is intended to be used with autograft comprised of cancellous and or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.

The EVOL® Spinal Interbody System is a family of PEEK-OPTIMA or PEEK-OPTIMA HA spacers offered in a variety of widths and lengths. There are five main configurations: CES-PLIF, CES-LIF, CES-TLIF, CES-CLIF and CES-RLIF. The different configurations allow for multiple surgical technique options. The CES-PLIF, CES-LIF, CES-CLIF and CES-RLIF are generally rectangular in shape while the CES-TLIF is curved. The CES-PLIF and CES-LIF are used in pairs while the other options are used singly or in pairs.

The EVOL® Spinal Interbody System implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the spacers as an option to help allow for radiographic visualization. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. The implants themselves are made of biocompatible PEEK-Optima Natural (LT1) or [PEEK-Optima HA Enhanced (LT120) - CES-LIF only] polymer material (per ASTM F2026).

Teeth on top and bottom of the implants improve fixation. They are symmetrical so that the implant will resist motion equally in either direction (anterior or posterior).

The EVOS Lumbar Interbody System is comprised of a variety of Implants manufactured from PEEK (Polyetheretherketone) -Optima LT1 and PEEK Optima LT120HA per ASTM F-2026, with Tantalum bead markers per ASTM F-560. There are three main configurations; STRAIGHT, CURVED, and ROTATE. The different configurations allow for multiple surgical technique options. The EVOS STRAIGHT and the EVOS ROTATE are generally rectangular in shape while the EVOS CURVED is curved. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs.

The EVOS device(s) are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. The angle of lordosis on each lordotic EVOS device is oriented in a way that will provide a true anterior/posterior lordotic orientation once the device has been implanted in its final intervertebral location. For example, the True Oblique Lordotic (TOL) devices have a lordotic orientation to the device that will provide a correct anterior/posterior lordotic orientation once they have been inserted at 30 degrees from the anterior/posterior midline.

Implant heights range from 6mm to 16mm in maximum height (minus the height of the teeth). Widths range from 8mm to 12mm and lengths range from 22mm to 30mm. The variety of implant shapes and sizes accommodate various surgical technique options. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. Teeth on top and bottom of the spacers improve fixation. The EVOS Lumbar Interbody System includes the instrumentation to facilitate the implantation of the implants.

The approach and the discectomy are conducted using standard instruments while subsequent steps are conducted using standard and/or custom instruments. The system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel and/or polymeric materials.

The EVOS rotate and non-rotate Inserter(s) are instruments intended for use with the EVOS Lumbar Interbody System. The inserter(s) are designed specifically to implant the EVOS device into a prepared disc space. The EVOS non-rotate inserters are designed to work with the EVOS straight and curved devices while the EVOS rotate inserter is designed to work with the EVOS rotate devices.

The provided text is a 510(k) summary for the EVOL® Spinal Interbody System and EVOS Lumbar Interbody System. It does not describe acceptance criteria, a specific study proving the device meets acceptance criteria, or any details related to AI/algorithm performance.

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, intended use, design features, and mechanical performance. It mentions non-clinical performance testing for the EVOL® Spinal Interbody System, specifically:

• Static Compression
• Static Compression Shear
• Dynamic Compression
• Expulsion testing

These tests were performed per ASTM F2026, and the conclusion states that the "Testing performed showed substantial equivalence to the predicate." However, specific acceptance criteria values and the reported device performance values are not provided within this summary for these tests.

For the EVOS Lumbar Interbody System, the document states, "No design changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed." This implies that prior testing for the original EVOS system would have satisfied the substantial equivalence requirements, but those details are not in this document.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details because these particulars are not present in the provided text. The document is a regulatory submission focused on substantial equivalence based on mechanical and material properties, not an AI or diagnostic device study.

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The EVOS Lumbar Interbody System (EVOS device) is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The EVOS Lumbar Interbody System is intended to be used with autologous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.

The EVOS Lumbar Interbody System is an Intervertebral Body Fusion System for the lumbar spine. The EVOS Lumbar Interbody System includes surgical instruments to deliver the EVOS devices via a Posterior or Transforaminal approach. The generally rectangular design of the EVOS device incorporates an internal cavity for insertion of biological bone growth material through the top and bottom openings, as well as four small transverse holes (two on each side) that are designed to enhance bony ingrowth. Each device has a series of ridges or "teeth" on the top and bottom surfaces that are designed to ensure strong anchoring on the vertebral body endplates and resist backing out of the implant. The EVOS devices are provided sterile (gamma irradiated) for single use.

The EVOS device is made of radiolucent PEEK-OPTIMA® LT1 or PEEK-OPTIMA® HA Enhanced material. In addition, tantalum beads are embedded in the spacers to allow for radiographic visualization. The geometric shape of the EVOS devices are categorized as either STRAIGHT, CURVED, or ROTATE. All are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. Most of the EVOS STRAIGHT devices are offered with an option of a Standard nose, Wide nose, or Narrow nose. The devices are available in various heights, widths, and lengths to accommodate various surgical technique options.

The provided text describes the EVOS Lumbar Interbody System, an intervertebral body fusion device, and its substantial equivalence to predicate devices, but does not contain information about studies related to acceptance criteria for a device that relies on artificial intelligence (AI) or machine learning.

The document is a 510(k) summary for a medical device approval. It focuses on:

• Device Description: The physical characteristics, material, and types of the EVOS Lumbar Interbody System.
• Indications for Use: The medical conditions and patient population for which the device is intended.
• Comparison to Predicate Devices: How the EVOS system is similar to other legally marketed devices, primarily regarding technological characteristics and indications for use.
• Performance Data: Lists mechanical testing performed on the device to demonstrate its structural integrity and safety. These are standard tests for spinal implants.

Therefore, I cannot provide the requested information regarding AI acceptance criteria or studies proving performance based on this document. The questions you posed (sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth, etc.) are highly relevant to AI/ML medical devices, which this document does not cover.

Ask a specific question about this device