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The BEACON™ Stabilization System, when used as posterior pedicle screw systems, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment. fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the BEACON™ Stabilization System is intended for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or illum with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system (using REVERE™ hooks), the BEACON™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/illium.

When used as an anterolateral thoracolumbar system. the BEACON™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

The BEACON™ Stabilization System consists of rods, posted screws, reduction screws, clamps, connectors and associated manual surgical instruments. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Screws, clamps, and rods may be used anteriorly or posteriorly. Connectors are intended for posterior use only. Preassembled clamps are used to connect screws to the rod.

The most common use of this screw and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws. The most common use of this screw and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via screws through an appropriate size staple.

The rods are composed of titanium alloy, or commercially pure titanium, as specified in ASTM F136, F1295, and F67. All other BEACON™ implants are composed of titanium alloy, as specified in ASTM F136, and F1295. Due to the risk of galvanic corrosion following implantation, titanium or titanium alloy implants should not be connected to stainless steel implants.

The provided document is a 510(k) Summary for a medical device called the BEACON™ Stabilization System. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It does not describe a study involving an AI device or a device that has performance criteria typically associated with AI/software-based medical devices (e.g., sensitivity, specificity, accuracy). Instead, it focuses on the mechanical properties and intended use of a physical implant system.

Therefore, many of the requested criteria cannot be answered from the provided text, as they are specific to studies evaluating the performance of AI/software devices. The document explicitly states: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." This indicates the evaluation methodology was focused on physical, mechanical aspects of the device, not diagnostic or predictive performance.

However, I can provide information based on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable for this type of device submission. The evaluation is based on mechanical testing of the physical device components, not a "test set" of patient data or images. The "data" are results from mechanical tests.

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

• Not applicable. Ground truth for mechanical testing would be established by validated engineering standards and testing protocols, not human experts interpreting data.

4. Adjudication method for the test set

• Not applicable. This concept pertains to resolving discrepancies among expert readers, which is irrelevant for 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

• No, this was not done. This type of study is specifically designed for evaluating the impact of AI on human performance in diagnostic tasks and is not relevant for a spinal implant system.

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

• No, this was not done. This device is a physical implant, not an algorithm.

7. The type of ground truth used

• For a 510(k) submission for a spinal implant, the "ground truth" for demonstrating substantial equivalence is adherence to established mechanical testing standards and comparison to the predicate device's characteristics. The document mentions "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004". This guidance document specifies the mechanical performance standards and methodologies that serve as the "ground truth" for evaluating the safety and effectiveness of such devices.

8. The sample size for the training set

• Not applicable. This device is a spinal implant, not an AI model requiring a training set.

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

• Not applicable. As above, this pertains to AI model development, not a physical medical device.

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