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The Apelo™ Pedicle Screw System is intended for noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: 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; pseudarthrosis; and failed previous fusion.

The subject of this submission is the design of Fixed Length Cross Connectors for the Apelo" Pedicle Screw System and additional smaller sizes, 20mm through and including 42mm. The Atlas Spine Fixed Length Cross Connectors will provide surgeons additional smaller sizes from which to choose based on the patients' anatomies. The Atlas Spine Fixed Length Cross Connectors will be manufactured from medical grade titanium alloy, Ti-6AI-4V (ELI), in accordance with ASTM F-136.

The provided text is a 510(k) Premarket Notification for the Atlas Spine Pedicle Screw System. This document is a regulatory submission for a medical device that demonstrates substantial equivalence to a legally marketed predicate device. The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is typically associated with studies evaluating the performance of AI/ML-driven diagnostic or prognostic devices, or software as a medical device (SaMD).

This 510(k) submission, however, is for a physical orthopedic implant (pedicle screw system), not a diagnostic or AI-enabled device. Therefore, the detailed performance metrics and study design elements requested in the prompt are not applicable to this type of submission.

Here's why the information cannot be provided from this document:

• Device Type: This is a physical orthopedic implant (pedicle screw system), not a diagnostic device or a software product requiring AI performance evaluation.
• Regulatory Pathway: A 510(k) for such devices primarily focuses on demonstrating "substantial equivalence" to a predicate device in terms of intended use, design, materials, and functional characteristics (e.g., mechanical testing, biocompatibility). It does not typically involve clinical performance studies in the way an AI/ML device would, especially not with "acceptance criteria" related to sensitivity, specificity, or other diagnostic performance metrics.
• Missing Information: The document does not contain any information regarding:
  • Acceptance criteria for diagnostic or prognostic performance.
  • Reported device performance in terms of diagnostic accuracy.
  • Sample sizes for test sets (as there isn't a "test set" in the context of AI performance).
  • Data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types (pathology, outcomes data, expert consensus).
  • Training set size or how ground truth for a training set would be established, as these terms are irrelevant to a physical implant's 510(k).

The document explicitly states the basis for substantial equivalence:

• Same indications for use
• Same operating principle
• Same raw materials
• Similar manufacturing environments
• Same packaging configurations
• Same sterilization process
• Implanted using the same surgical techniques and similar equipment types

The conclusion explicitly states "This conclusion is based on the devices' similarities in indications for use, design, function, materials and mechanical function." This indicates the focus is on engineering and material equivalence, not clinical diagnostic performance.

Therefore, I cannot provide the requested table and study details as they are not relevant to or present in the provided 510(k) document for the Atlas Spine Pedicle Screw System.

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The Apelo™ Pedicle Screw System is intended for noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: 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; pseudarthrosis; and failed previous fusion.

Being proposed in this Special 510(k) is the introduction of line extensions to the existing Apelo™ Pedicle Screw System. The proposed line extensions consist of new sizes of solid monoaxial and polyaxial pedicle screws and cannulated monoaxial and polyaxial pedicle screws without fenestrations. The new design and sizes of pedicle screws will be offered in order to provide surgeons a variety of screws from which to choose for open and minimally invasive procedures based on patients' anatomies.

The provided text describes a Special 510(k) Premarket Notification for the Apelo™ Pedicle Screw System, which is a medical device. This document does NOT contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/machine learning application.

Instead, this document describes a traditional medical device submission to the FDA, focusing on:

• Substantial Equivalence: The primary objective of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and either the same technological characteristics or different technological characteristics that do not raise new questions of safety and effectiveness.
• Device Modification (Line Extension): The specific purpose of this Special 510(k) is to introduce new sizes of solid and cannulated pedicle screws as line extensions to an existing system.
• Mechanical Testing: The document mentions "Dynamic compression bending testing according to ASTM F1717" was conducted to show that the proposed screws do not create a new worst-case construct. This is a standard engineering test for spinal fixation devices to assess their mechanical performance and safety, not a clinical study involving human or AI performance.

Therefore, I cannot extract the requested information (acceptance criteria, device performance tables, sample sizes for test/training sets, ground truth details, expert qualifications, MRMC studies, standalone studies, etc.) because this document pertains to a mechanical device submission, not an AI-powered device or software as a medical device (SaMD). The concepts of "acceptance criteria" and "study" in this context refer to engineering specifications and mechanical tests, not statistical performance metrics for an algorithm.

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The Atlas Spine Pivoting System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Atlas Spine Pivoting System is to be used with a supplemental fixation system and autogenous bone graft.

The Atlas Spine Pivoting System is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion. The Atlas Spine Pivoting System consists of an implant manufactured from PEEK-Optima and insertion tools. The PEEK-Optima implant is crescent-shaped and radiolucent. The implant design includes three (3) radiopaque, tantalum markers, which allow postoperative radiographic confirmation of the device position and orientation. The design also includes two (2) titanium alloy pins which secure the implant to an insertion tool for placement and deployment. The Atlas Spine Pivoting System is provided in various configurations and heights; containing hollow core to receive bone autograft.

The provided text describes the Atlas Spine Pivoting System, an intervertebral body fusion device. The document primarily focuses on its substantial equivalence to predicate devices for 510(k) clearance, rather than a detailed performance study with acceptance criteria and results.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it mentions that "Pre-clinical, mechanical testing was performed… in accordance with ASTM F-2077 and ASTM F-2267." The conclusion states that "Provided documentation demonstrates that the Atlas Spine Pivoting System is substantially equivalent to the aforementioned predicate devices. This conclusion is based on the devices' similarities in indications for use, design, function, materials and mechanical function." This implies that the device met performance standards rather than specific, pre-defined acceptance criteria with quantified results within this document.

If we were to infer the "acceptance criteria" from the statement about substantial equivalence, it would be that the mechanical performance (static axial compression, expulsion, subsidence, dynamic axial compression) of the Atlas Spine Pivoting System is comparable to that of legally marketed predicate devices, as assessed by complying with ASTM F-2077 and ASTM F-2267. However, the specific numerical targets and results are not provided in this summary.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for the mechanical testing. The document states "Testing consisted of static testing..." and "dynamic axial compression testing," implying multiple tests were run, but the number of devices or test iterations is not provided.
• Data Provenance: The testing was "Pre-clinical, mechanical testing" performed by the manufacturer, Atlas Spine, Inc. The location of the test facility is not specified beyond the manufacturer's address in Jupiter, FL, USA. This is retrospective data collected for the purpose of a 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to the pre-clinical mechanical testing described. The "ground truth" here is compliance with engineering standards (ASTM F-2077 and ASTM F-2267), not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

Not applicable. This was mechanical testing against engineering standards.

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 a medical device (intervertebral body fusion device), not an AI diagnostic tool.

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

Not applicable. This is a medical device, not an AI algorithm.

7. The type of ground truth used:

• For Mechanical Testing: Compliance with established engineering standards (ASTM F-2077 and ASTM F-2267) regarding mechanical properties and performance (e.g., load to failure, expulsion resistance, subsidence resistance, run-out load). The "ground truth" is adherence to these validated test methods and achieving results comparable to predicate devices.
• For Substantial Equivalence: Comparison to the design, materials, indications for use, and mechanical function of previously cleared predicate devices (Novel® Spinal Spacer System, Atlas Spine Spacer, Pivotec Lumbar Interbody Fusion Device).

8. The sample size for the training set:

Not applicable. This is a medical device, not a machine learning model. There is no concept of a "training set" for the type of testing described here.

9. How the ground truth for the training set was established:

Not applicable. There is no training set mentioned or implied.

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Intervertebral Body Fusion Device: The Atlas Spine Spacer is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is to be used with autogenous bone graft. The Atlas Spine Spacer is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Atlas Spinc Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). This device is to be used with autogenous bone graft. The Atlas Spine Spacer is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Vertebral Body Replacement: When used as a vertebral body replacement, the Atlas Spine Spacer is intended for use in the thoracolumbar spine (TI-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine Spacer is also indicated for treating fractures of the thoracic and lumbar spine.

The Atlas Spine Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine Spacer can be packed with bone. This device is intended to be used with supplemental spinal fixation systems that have been cleared 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 Atlas Spine Spacer is a rectangular, radiolucent device in various sizes. The device design includes four radiopaque markers, two on the superior surface and two on the inferior surface, in opposing corners, that allow postoperative radiographic confirmation of the device position and orientation.

This 510(k) summary describes a medical device, the Atlas Spine Spacer, which is an intervertebral body fusion device and a vertebral body replacement. It is a traditional medical device, not an AI/ML software device. Therefore, the questions related to AI/ML software performance criteria, ground truth establishment, sample sizes for training/test sets, and expert involvement are not applicable here.

The document indicates that the device's acceptance criteria and performance were established through pre-clinical data per ASTM F2077, demonstrating substantial equivalence to previously cleared devices.

Here's a breakdown of the provided information, focusing on the relevant parts for a non-AI/ML device:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable (N/A) for an AI/ML device. The performance data cited is pre-clinical (likely mechanical and material testing), not related to clinical or imaging test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable (N/A) for an AI/ML device. Ground truth for device performance is established through engineering and material testing standards (ASTM F2077), not expert consensus on diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable (N/A) for an AI/ML device. Adjudication methods are typically for clinical diagnostic outcomes or image interpretation, not for mechanical device performance.

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 (N/A). This refers to AI/ML software studies. The Atlas Spine Spacer is a physical implant.

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

• Not Applicable (N/A). This refers to AI/ML software studies.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the physical device, the "ground truth" for demonstrating performance is derived from engineering and material testing standards (ASTM F2077), ensuring the device meets predefined mechanical and material properties necessary for its intended use and is comparable to predicate devices. This is not a clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

• Not Applicable (N/A). This refers to AI/ML software development.

9. How the ground truth for the training set was established

• Not Applicable (N/A). This refers to AI/ML software development.

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The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.

The Atlas Spine VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine VBR can be packed with bone. This device is intended to be used with supplemental spinal fixation systems that have been cleared 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 Atlas Spine VBR is generally rectangular in shape with anterior and posterior walls that are concentric arcs. The device is available in various sizes with an anterior height ranging from 10mm to 18mm and anterior width of 28mm while providing 0 or 5 degrees of lordosis. The posterior aspect is tapered, or bulleted, for ease of insertion. All devices are 20.0mm in length. The device design includes four radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.

This document describes a 510(k) premarket notification for the Atlas Spine Vertebral Body Replacement (VBR) device. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials or detailed performance studies to establish acceptance criteria for novel device performance.

Therefore, many of the requested elements for a study proving device performance (such as acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not typically present or required in a 510(k) submission for a device demonstrating substantial equivalence. The primary "study" is often a comparison of the new device's design, materials, and intended use against a legally marketed predicate device.

Based on the provided text, here's what can be extracted and what cannot:

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

This information is not provided in the document. A 510(k) for substantial equivalence usually doesn't specify new, quantifiable acceptance criteria for device performance beyond meeting the characteristics of the predicate device. The "performance" demonstrated is that the device is substantially equivalent to the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided because a specific "test set" in the context of a new performance study (e.g., clinical trial) is not described. The submission relies on a comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided. Ground truth established by experts is not relevant in this 510(k) context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided.

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:

This information is not provided. An MRMC study is not relevant to this type of device and submission. The device is a physical spinal implant, not an AI diagnostic tool.

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

This information is not provided. This refers to AI algorithms, which is not applicable here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided.

8. The sample size for the training set:

This information is not provided. Training sets are generally associated with machine learning models, which are not applicable to this physical device submission.

9. How the ground truth for the training set was established:

This information is not provided.

Summary of what is present in the document relevant to how the device meets "acceptance criteria" (understood here as "criteria for substantial equivalence"):

The document argues that the Atlas Spine VBR meets the acceptance criteria for substantial equivalence through a comparison to its predicate device, Atlas Spine Vertebral Body Replacement (K063464).

Here's how the "study" (the 510(k) submission) proves the device meets these criteria:

• Intended Use: The intended use of the Atlas Spine VBR is directly compared and found to be "substantially the same" as the predicate device. Both are for use in the thoracolumbar spine (T1-L5) for partial or complete replacement of a diseased vertebral body (tumors, fractures) to achieve decompression, restore height, and maintain biomechanical integrity. Both are intended to be used with supplemental spinal fixation systems and packed with bone.
• Design: The device's design (generally rectangular, anterior and posterior walls with concentric arcs, various sizes: 10mm-18mm anterior height, 28mm anterior width, 0 or 5 degrees lordosis, 20.0mm length, tapered posterior aspect, four radiopaque markers) is presented and compared against the predicate as being "substantially the same" in design principles.
• Materials: Both the subject device and the predicate devices are made from implantable PEEK (polyetheretherketone) polymer, establishing material equivalence.
• Functional Characteristics: It is stated that the "functional characteristics... are substantially the same." Both systems provide support after resection/removal of a damaged/collapsed/unstable vertebral body and are complemented by supplemental internal fixation.

Conclusion from the document:

The FDA reviewed the 510(k) submission (K071497) and determined that the Atlas Spine Vertebral Body Replacement is substantially equivalent to legally marketed predicate devices, thereby allowing it to be marketed. This determination implies that the device "meets the acceptance criteria" as defined by the 510(k) process for substantial equivalence.

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The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.

The Atlas Spine VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine VBR can be packed with bone. This device is intended to be used with supplemental spinal fixation systems that have been cleared 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 Atlas Spine VBR is a rectangular, radiolucent vertebral body replacement device designed to replace, in whole or in part, a thoracic or lumbar vertebral body after complete or partial vertebrectomy.

The device design includes four radiopaque markers, two on the superior surface and two on the inferior surface, in opposing corners, that allow postoperative radiographic confirmation of the device position and orientation.

This 510(k) premarket notification for the Atlas Spine Vertebral Body Replacement (VBR) does not describe a study involving acceptance criteria and device performance in the way typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices. This is a common pathway for medical devices that are similar in design, materials, and intended use to products already on the market.

Therefore, many of the requested categories (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, there are no explicit "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for an AI algorithm. The primary "acceptance criterion" for this 510(k) was that the device demonstrates substantial equivalence to predicate devices, meaning it has similar intended use, design, materials, and functional characteristics.

The "reported device performance" is framed in terms of its similarity to predicates:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission did not involve a "test set" of data for performance evaluation in the context of an AI algorithm. Substantial equivalence is determined through a comparison of the device's characteristics to those of predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "ground truth" was established by experts in the context of a dataset for performance evaluation. The FDA reviewed the company's detailed comparison of its device to predicates to determine substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No "test set" or adjudication method was used for performance evaluation.

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 a physical implantable device, not an AI/software device. There were no "human readers" interpreting data with or without AI assistance.

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

Not applicable. This is a physical implantable device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this type of submission is essentially the legally marketed predicate devices and their known characteristics, safety, and effectiveness. The FDA's determination of substantial equivalence relies on comparing the new device's features, materials, and intended use against these established predicates.

8. The sample size for the training set

Not applicable. This is a physical implantable device; it does not involve a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable. See point 8.

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