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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 VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:

Transfacet fixation: - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.

This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The screws and washers that are the subject components of this submission are modified DISCOVERY® System screws and washers that are available in various geometries and sizes. Manufactured from ASTM F 136 implant grade titanium alloy.

The provided text describes the 510(k) summary for the VIPER® F2 Facet Fixation System. It focuses on demonstrating substantial equivalence to predicate devices through nonclinical mechanical testing, rather than device performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from this document in the typical sense of AI/medical device performance evaluation.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the way a diagnostic AI device summary would. Instead, the "device performance" is demonstrated through nonclinical mechanical testing and comparison to predicate devices, implying that if the device performs comparably to legally marketed devices, it meets the unstated "acceptance criteria" for safety and effectiveness.

Nonclinical Test Summary and Implied Performance:

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 applicable as the study did not involve a test set of data points (e.g., medical images, patient records) for evaluation of the device's diagnostic or predictive performance. The "testing" involved mechanical benchmarks of the physical 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 applicable. The device is an implantable medical device, not an AI or diagnostic tool requiring ground truth established by medical experts for performance evaluation. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1798).

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

This information is not applicable. There was no clinical test set or human interpretation involved that would require an adjudication method.

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

There was no MRMC comparative effectiveness study done. This device is a surgical implant, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical implant, not an algorithm.

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

The "ground truth" for the nonclinical mechanical testing was based on engineering standards (ASTM F1798) for evaluating spinal arthrodesis implants.

8. The sample size for the training set

This information is not applicable. There was no training set involved as this is not an AI/machine learning device.

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

This information is not applicable. There was no training set.

Summary of the Study:

The study proving the device meets acceptance criteria was a nonclinical mechanical testing program involving static and dynamic compression bending, and static and dynamic three-point bending, all conducted in accordance with ASTM F1798. The intent was to demonstrate that the modified components of the VIPER® F2 Facet Fixation System perform mechanically comparably to its predicate devices. No clinical tests were performed. The FDA's substantial equivalence determination was based on this nonclinical testing and comparison of intended use, design, materials, manufacturing methods, performance, sterility, biocompatibility, safety, and packaging design to legally marketed predicate devices.

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The VIPER Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The VIPER Spine System is intended for noncervical pedicle fixation and nonpedicle fixation 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

This submission addresses additional rod components.

The provided document does not contain information regarding software or AI. It describes additions to a spinal implant system called VIPER™ Spine System. Therefore, I cannot extract information related to acceptance criteria, device performance, studies, sample sizes, ground truth, or expert involvement as these are not relevant to the content of this document.

The document discusses the regulatory approval (510(k) submission) of additional rod components for the VIPER™ Spine System, a medical device for spinal fixation. It details the device's intended use and materials, and mentions that "Performance data were submitted to characterize the subject VIPER™ Spine System components addressed in this notification." However, it does not provide the actual acceptance criteria, the results of the performance data, or details of any specific studies (e.g., sample sizes, ground truth establishment, expert involvement, or MRMC studies).

The FDA's letter states that they have reviewed the submission and find the device substantially equivalent to legally marketed predicate devices, allowing its marketing. This regulatory approval is based on the provided performance data, but the specifics of that data are not included in this extract.

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