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The ATEC Universal Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.

Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.

Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies

The ATEC Universal Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with allograft (e.g., Allogenic bone graft composed of cancellous and/or corticocancellous bone graft) and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

ATEC Universal Spacer System includes the Battalion Universal Spacer System and Porous Ti Spacer System.

The Battalion Universal Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants come in three material varieties: polyetheretherketone with tantalum markers, commercially pure titanium coated polyetheretherketone with tantalum markers, and titanium alloy (Ti-6Al-4V ELI). The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device.

The Porous Ti Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are made of a commercially pure porous titanium (PTi). The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally, the PTi implant is offered with a microstructure due to the layering of material that forms the porous geometry. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation.

All materials are of surgical grade; polyetheretherketone (PEEK Optima LT1) conforms to ASTM F2026, tantalum conforms to ASTM F560, titanium coating conforms to ASTM F1580, the titanium alloy (Ti-6Al-4V ELI) conforms to ASTM F136, and the commercially pure titanium conforms to ASTM F67. All implants will be provided sterile.

The provided text is a 510(k) Summary for the ATEC Universal Spacer System, a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It's crucial to understand that this document describes the device itself and its substantial equivalence to other legally marketed devices, not an AI/ML algorithm or software device. Therefore, the requested information pertaining to acceptance criteria for an AI device, sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, training sets, or how ground truth was established for a training set, is not applicable to this document.

The document focuses on the mechanical and material performance of the ATEC Universal Spacer System.

Here's the relevant information that can be extracted:

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

The document lists performance data and engineering analyses that support the substantial equivalence of the ATEC Universal Spacer System. While specific acceptance criteria values are not explicitly stated in this summary, the types of tests conducted imply that the device met the standards defined within the referenced ASTM specifications.

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, and the testing involves mechanical and material properties, not an AI test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical device's mechanical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device's mechanical testing.

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. The document explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

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 (expert concensus, pathology, outcomes data, etc): Not applicable for the mechanical and material tests performed on a physical device. The "ground truth" for these tests would be the established scientific and engineering principles and the specifications within the referenced ASTM standards themselves.

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

9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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The Battalion Universal Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.

Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.

Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies

The Battalion Universal Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with allograft or autograft (e.g., Allogenic bone graft composed of cancellous and/or corticocancellous bone graft) and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

The Battalion Universal Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are available in the following two material varieties:

• Polyetheretherketone (PEEK) with tantalum markers
• Commercially pure titanium coated polyetheretherketone (PEEK) with tantalum markers. .

All materials are of surgical grade; polyetheretherketone (PEEK Optima LT1) conforms to ASTM F2026, tantalum conforms to ASTM F560, titanium coating conforms to ASTM F1580. All implants are provided sterile.

This system includes inserter instruments used to set the implants between the vertebrae. The patient contacting portions of these instruments are made of surgical grade stainless steel (17Cr-4Ni) per ASTM A564/A564M. These instruments are provided non-sterile and are intended to be cleaned and steam sterilized before each use.

This document is a 510(k) premarket notification for a medical device called the "Battalion Universal Spacer System." It's a submission to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance data (mechanical testing and a cadaver study) rather than specific acceptance criteria for a diagnostic/AI device. Therefore, a table for "acceptance criteria and reported device performance" as typically seen for AI devices (e.g., sensitivity, specificity, AUC) is not directly applicable.

However, the "acceptance criteria" here relate to the device's mechanical integrity and biological safety, as demonstrated through adherence to specific ASTM standards and FDA guidance. The "device performance" refers to the results of these tests.

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

• Test Set Sample Size: Not applicable in the context of this device's non-clinical testing. The "test set" here refers to the samples used for mechanical and biological testing (e.g., individual implants for mechanical tests, cadavers for the cadaver study). Specific numbers are not provided in the summary.
• Data Provenance: Not explicitly stated for the cadaver study or the materials used in mechanical testing. The document is for a medical device (spinal spacer system), not a diagnostic or AI product, so traditional "data provenance" like country of origin for patient data is not relevant here. The studies are non-clinical.

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

Not applicable. This device is a physical implant, and its performance is evaluated through mechanical and cadaveric studies, not through expert-labeled ground truth like in an AI diagnostic study. The "ground truth" for mechanical testing is established by the defined ASTM standards and measurements, and for biological safety by the BET standard. The cadaver study would involve surgeons, but their role is for surgical technique validation, not "ground truth establishment" in the sense of a diagnostic interpretation.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study requiring adjudication of expert opinions (like 2+1, 3+1 for imaging reads). The evaluations are based on objective physical measurements and established biological safety protocols.

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 device is a physical implant, not an AI diagnostic tool that assists human readers.

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

No, a standalone algorithm performance study was not done. This is a physical medical device.

7. The Type of Ground Truth Used:

For this type of device, the "ground truth" is established by:

• Engineering Standards: For mechanical performance, the ground truth is defined by the requirements and measurement methods outlined in the cited ASTM standards (e.g., F2077, F-04.25.02.02, F2267). The device performs as expected if it meets these quantifiable engineering criteria.
• Biological Safety Standards: For bacterial endotoxin, the ground truth is defined by the acceptable limits specified in ANSI/AAMI ST72.
• Surgical Feasibility/Technique Validation: For the cadaver study, the ground truth relates to the successful and appropriate implantation of the device according to surgical principles and the company's intended technique.

8. The Sample Size for the Training Set:

Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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The NuVasive® CoRoent Thoracolumbar Implants are devices indicated for the following:

Intervertebral Body Fusion

The NuVasive CoRoent Thoracolumbar Implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

Thoracic Spine:

The CoRoent Thoracolumbar Implants are intended for use for thoracic interbody fusions at one or two contiguous levels in the thoracic spine, from T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

Lumbar Spine:

The CoRoent Thoracolumbar Implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Partial Vertebral Body Replacement

The NuVasive CoRoent Thoracolumbar Implants may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (TI to LS) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The implants are intended to be used with supplemental internal spinal fixation systems (e.g., pedicle screw system) that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.

The CoRoent Thoracolumbar Implants are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The PEEK device contains radiographic markers manufactured from titanium alloy conforming to ASTM F136 or ASTM F1472. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The hollow aperture allows for packing of autogenous bone graft. Teeth on the superior and inferior surface of the implants provide resistance to expulsion. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine. This Special 510(k) is for additional implant offerings for use in the thoracic spine.

The provided document is a 510(k) summary for the NuVasive® CoRoent® Thoracolumbar Implants. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study or performance data against a predefined benchmark.

Therefore, the document explicitly states:

• "No performance data was provided to demonstrate that the subject NuVasive CoRoent Thoracolumbar Implants are substantially equivalent to the predicate devices." (Page 5, "G. Performance Data")
• "Based on the technological characteristics and comparison to predicate devices, the subject NuVasive CoRoent Thoracolumbar Implants has been shown to be substantially equivalent to legally marketed predicate devices." (Page 6, "H. Conclusions")

Given this information, it is not possible to provide the details requested in "1. A table of acceptance criteria and the reported device performance" or any other points related to a study proving the device meets acceptance criteria, as such a study and performance data were not part of this 510(k) submission.

The document focuses on demonstrating substantial equivalence through:

• Device Description: Material composition (PEEK-Optima® LT-1 or titanium alloy), design features (hollow aperture for bone graft, teeth for expulsion resistance), and variations in shapes and sizes.
• Intended Use: Intervertebral body fusion for thoracic and lumbar spine, and partial vertebral body replacement in the thoracolumbar spine.
• Technological Characteristics: Comparison to predicate devices in areas including design, labeling/intended use, material composition, and function.

In summary, this document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or ground truth establishment methods.
• Number of experts, their qualifications, or adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Ground truth types or training set sample sizes for AI/algorithmic performance, as this is a medical implant, not an AI device.

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