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When used as vertebral body replacement, the ATLAS Intervertebral Body Cage is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma. The ATLAS Intervertebral Body Cage is intended to be used with supplemental fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) the interior spacer may be packed with bone grafting material. The ATLAS Intervertebral Body Cage has been designed to provide anterior column support even in the absence of fusion for a prolonged period of time.

When used as a lumbar intervertebral body fusion device the ATLAS Intervertebral Body Cage is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 to S1. DDD is defined and discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have six months of non-operative treatment. These DDD patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The ATLAS Intervertebral Body Cage is implanted via an anterior or posterior approach and is combined with supplemental fixation.

For either intended use, the ATLAS Intervertebral Body Cage must be used with supplemental internal fixation.

This submission is intended to seek clearance for a product line extension to the ATLAS Spinal Cage VBR. The extension includes the addition of 8mm, 10mm, 12mm, 14mm, and 16mm cages to the current offering. Additionally adding the product code MAX for Intervertebral body fusion devices CFR 21 888.3080.

The Spinal Edge ATLAS Intervertebral Body Cage is an Intervertebral Body Cage device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each cage has an axial hole to allow grafting material to be packed inside. Protrusions on the superior and inferior surfaces of the device will grip the cortical endplates of the adjacent vertebrae and resist expulsion. The Spinal Edge ATLAS Intervertebral Body Cage components are available in titanium alloy conforming to ASTM F-136 specifications.

This document describes the ATLAS Intervertebral Body Cage, a medical device, and its regulatory clearance. The information provided is primarily for a 510(k) submission, which demonstrates substantial equivalence to predicate devices, rather than a clinical study proving device performance against specific acceptance criteria in the manner one might expect for a diagnostic AI device.

Therefore, the requested details regarding acceptance criteria for device performance, sample size for test sets, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission for a spinal implant. This submission focuses on mechanical and material equivalence to existing devices, not on the diagnostic accuracy or interpretive performance often associated with AI algorithms.

However, I can extract the relevant information concerning the performance testing that was conducted to support the substantial equivalence claim.

Description of the Acceptance Criteria and Study Proving Device Meets Criteria

The ATLAS Intervertebral Body Cage is a spinal implant whose clearance was sought through a 510(k) submission, demonstrating substantial equivalence to predicate devices. The "acceptance criteria" here refer to meeting established mechanical performance standards for intervertebral body fusion devices, rather than criteria for diagnostic accuracy or clinical outcomes as might be seen with AI.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Representative samples of the ATLAS Intervertebral Body Cage device" were used for testing, specifically the largest size (17mm). The exact number of samples is not specified, but typically this would involve a small set for mechanical testing.
• Data Provenance: The testing was conducted as part of a regulatory submission in the United States (FDA 510(k)). This is a prospective test in the sense that it was performed specifically for this submission, using manufactured devices.

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

• Not Applicable. For a mechanical device, "ground truth" relates to physical properties and performance under stress, which are measured objectively by engineering tests, not subjectively by experts or interpreted from medical images.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods are typically used for assessing subjective interpretations or diagnostic accuracy. Mechanical testing results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. This is a mechanical device, not an AI or diagnostic tool where MRMC studies would be relevant.

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

• Not Applicable. This is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

• Engineering Measurements/Physical Properties: The "ground truth" for this device's performance is derived from standardized mechanical testing (axial compression, vertebrectomy model simulation) that measures physical characteristics like load-induced subsidence, strength, and stability.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of mechanical device testing for a 510(k) submission. Design and manufacturing processes are based on engineering principles and material specifications, not machine learning training.

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

• Not Applicable. As there is no training set, this question is not applicable.

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The Spinal Edge TITAN Pedicle Screw Systems is intended for posterior, noncervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The Spinal Edge TITAN Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. The Spinal Edge TITAN Pedicle Screw System components are available in titanium alloy conforming to ASTM F-136 specifications.

The provided text describes the regulatory clearance of the Spinal Edge TITAN Pedicle Screw System. Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a table format. Instead, it relies on demonstrating comparable function and performance characteristics to the predicate device as the primary acceptance criterion. The performance is reported in relation to relevant industry standards.

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

• Sample Size: The document mentions "Representative samples of the device" were tested. However, the exact sample size (e.g., number of screws, number of constructs) used for the mechanical testing is not specified.
• Data Provenance: The testing methodology ("ASTM F1717 'Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model'") describes a laboratory-based, ex-vivo (or simulated in-vitro) test. Therefore, it's not applicable to "country of origin of the data" or "retrospective/prospective" in the clinical sense, as it's a mechanical performance study.

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

This information is not applicable to this type of device and study. The "ground truth" here is objective mechanical performance measured against a standard, not expert interpretation of clinical data. The ASTM F1717 standard itself defines the "ground truth" in terms of physical properties and behaviors under specified loads.

4. Adjudication Method for the Test Set:

This information is not applicable. Mechanical testing against a standard does not involve an adjudication method in the way clinical studies or image interpretations do. The results are typically quantitative measurements compared directly to specified limits or benchmarks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is involved. The TITAN Pedicle Screw System is a physical implant, and its performance is assessed through mechanical testing, not through human reading of cases.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable. The device is a surgical implant, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used:

The ground truth used for this study is based on engineering standards and established material science properties. Specifically, the ASTM F1717 standard defines the appropriate testing methodology and expected performance characteristics for spinal implant constructs in a vertebrectomy model. The "ground truth" is therefore objective mechanical strength, stiffness, and fatigue resistance as measured against the parameters defined by this engineering standard.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical implant, not a machine learning model. Therefore, there is no "training set."

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

This information is not applicable as there is no training set for this type of device.

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The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damage or unstable vertebral body due to tumor or trauma. The Spinal Edge ATLAS Spinal Cage is intended to be used with supplemental spinal fixation system(s) that have been labeled for use in the thoracic and/or lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer may if indicated be packed with bone grafting material. The Spinal Edge ATLAS Spinal Cage is designed to provide anterior spinal column support for a prolonged period of time even in the absence of fusion.

The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow optional grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the cortical endplates of the adjacent vertebrae to resist expulsion

The provided text describes a medical device, the "Spinal Edge ATLAS Spinal Cage," and its premarket notification (510(k)) to the FDA. The document outlines the device's description, intended use, and substantial equivalence to predicate devices. It briefly mentions performance testing but does not provide specific acceptance criteria or detailed study results directly comparable to such criteria.

Therefore, I cannot fully answer your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance. The document focuses on regulatory compliance through substantial equivalence, primarily through material and functional similarity to existing devices and general performance testing against a standard.

Here's what can be extracted based on the provided text, while highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that testing was completed and demonstrated compliance with a specific FDA guidance and an ASTM standard. However, it does not detail the specific acceptance criteria (e.g., "device must withstand X Newtons of compression for Y cycles") or the actual test results (e.g., "device withstood Z Newtons for W cycles") that would allow for a direct comparison as typically presented in such a table for software or diagnostic devices. This is common for predicate device submissions where the focus is often on demonstrating comparable mechanical properties to legally marketed devices rather than establishing new performance benchmarks.

Missing Information from the Provided Text for all other points:

The provided document does not contain any information regarding:

• Sample sized used for the test set and the data provenance: This information is not present. The testing described is physical, mechanical testing of the device, not a study involving patient data or a "test set" in the context of AI/diagnostic device evaluation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as the testing described is mechanical, not involving expert interpretation of data.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the type of device and testing described.
• 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 physical implant, not an AI or diagnostic software.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" would be the measured physical properties against the specified standard requirements. The document only states compliance with ASTM F2077-03 and FDA guidance.
• The sample size for the training set: Not applicable. There is no "training set" for physical device testing in this context.
• How the ground truth for the training set was established: Not applicable.

Summary of Device-Related Information:

• Device Name: ATLAS Spinal Cage
• Sponsor: Spinal Edge, LLC
• Intended Use: Thoracolumbar spine (T1-L5) vertebral body replacement due to tumor or trauma. To be used with supplemental spinal fixation systems. Provides anterior spinal column support for a prolonged period, even without fusion.
• Materials: Same as predicate devices (specific material not detailed, but implies biocompatibility and appropriate mechanical properties).
• Performance Testing Standard: MTI Protocol PR465-0001 and ASTM F2077-03, "Test Methods for Intervertebral Body Fusion Devices."
• FDA Determination: Substantially equivalent to predicate devices K990148 (Stackable Cage System - DePuy AcroMed, Inc.) and K040284 (Sustain Radiolucent Spacer - Globus Medical, Inc.).

The provided text focuses on the regulatory submission process for a physical medical implant based on substantial equivalence, rather than a detailed performance study with explicit acceptance criteria and corresponding results for a diagnostic or AI-driven device.

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