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The BEACON® Stabilization System, when used as a posterior pedicle screw system, 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 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, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

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, ML connectors, other 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, commercially pure titanium or cobalt chromium-molybdenum, as specified in ASTM F136, F1295, F67 and F1537. All other BEACON® implants are composed of titanium alloy, as specified in ASTM F136 and F1295. The screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy or cobalt chromium-molybdenum alloy implants.

This 510(k) submission (K121922) for the BEACON® Stabilization System Additional Implants describes a medical device, not a software algorithm or diagnostic test. Therefore, many of the requested criteria, such as "acceptance criteria and reported device performance" in the context of diagnostic accuracy, "sample size for the test set," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established," are not applicable to this type of submission.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, performance specifications (engineering tests), and intended use. The "study" that proves the device meets acceptance criteria for a spinal fixation system typically involves mechanical and material testing to ensure safety and performance, rather than diagnostic accuracy studies.

Here's a breakdown of what information is provided or can be inferred, and why other categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present a table in the format of diagnostic accuracy metrics (e.g., sensitivity, specificity). For a medical implant like a spinal fixation system, "acceptance criteria" and "reported device performance" are based on mechanical testing to established standards and material compatibility.

• Acceptance Criteria (Inferred from regulatory context): New implants (specialty rods and HA coated screws) must meet the performance and safety standards demonstrated by the predicate BEACON® Stabilization System and other similar predicate devices. This includes:

  • Material Composition: Conformance to ASTM standards (F136, F1295, F67, F1537 for rods; F136, F1295, F1185 for screws).
  • Mechanical Integrity/Strength: The new implants must withstand physiological loads without failure. This involves tests like fatigue strength, static strength, and pull-out strength, typically benchmarked against predicate devices and relevant ASTM standards (e.g., F1717 for Spinal Implant Constructs, F1798 for Spinal Intervertebral Body Fusion Devices, F1839 for Metallic Spinal Wire Specification). These specific test results are not detailed in this summary but would be part of the full 510(k) submission.
  • Biocompatibility: Materials must be biocompatible (implicitly covered by ASTM standards and prior predicate device clearances).
  • Surgical Functionality: The new components must integrate correctly with the existing BEACON® system.

• Reported Device Performance: The document states:
  "The BEACON® Stabilization System additional implants are similar to the predicate devices with respect to technical characteristics, material, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices."

  This statement indicates that the performance of the new implants (specialty rods and HA coated screws) has been shown to be substantially equivalent to the cleared predicate devices, implying they meet the same mechanical and material performance criteria.

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

• Not applicable for "test set" in the diagnostic sense. For mechanical testing of implants, "sample size" refers to the number of individual implants tested according to engineering protocols (e.g., 5-10 samples per test type, per variant). This information is not provided in the 510(k) summary, as it would be in the detailed engineering test reports.
• Data Provenance: The data would be from in vitro (laboratory) mechanical and material testing, performed by the manufacturer or contracted labs, following international and national standards (ASTM, ISO). There is no "country of origin of data" in the sense of patient data, nor is it retrospective or prospective clinical data.

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

• Not applicable. "Ground truth" in this context refers to established mechanical and material properties or regulatory standards, not expert clinical interpretations of diagnostic images or outcomes. Engineers and material scientists define and verify these properties.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "adjudication method" in the sense of resolving differences in expert opinions. Performance is determined by objective physical measurements against predefined engineering specifications.

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

• No. This type of study is for evaluating the impact of AI algorithms on human reader performance, typically in diagnostic imaging. It is completely irrelevant for a spinal implant.

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

• No. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used:

• For this device, "ground truth" would be:
  • Established ASTM Standards: Material specifications (e.g., ASTM F136 for Titanium Alloy).
  • Benchmarking to Predicate Devices: Mechanical performance (e.g., fatigue life, static strength) demonstrated by the previously cleared BEACON® Stabilization System and other listed predicate devices (K073172, K092610, K100788, K113395, K061202, K111449, K082572).
  • Engineering Specifications: Internal design requirements for the new components.

8. The Sample Size for the Training Set:

• Not applicable. This device does not involve machine learning or a "training set" in the AI sense.

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

• Not applicable.

In summary, this 510(k) submission is for an expansion of a physical medical device (spinal implant), and the "study" demonstrating it meets acceptance criteria consists of engineering bench testing and material characterization to prove substantial equivalence to predicate devices, rather than clinical studies or AI performance evaluations.

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The BEACON® Stabilization System, when used as a posterior pedicle screw system, 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 ilium 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, spondvlolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

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, ML connectors, other 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BEACON® ML Connectors, extracted from the 510(k) summary:

Based on the provided 510(k) summary for the BEACON® ML Connectors, the device's acceptance criteria and the study proving it meets these criteria are not related to an AI/ML powered medical device but rather to a traditional mechanical spinal implant system.

Therefore, I cannot provide information on items such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set size, or how ground truth was established, as these concepts are specific to AI/ML device studies and are not applicable to the information given in this document.

The acceptance criteria for this device are established through mechanical testing and comparison to a predicate device, focusing on substantial equivalence in terms of technical characteristics, performance, and intended use.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria Met:

The study that proves the BEACON® ML Connectors meet the acceptance criteria is mechanical testing in comparison to a predicate device.

Regarding AI/ML specific information:

• 2. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI/ML device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device is based on established engineering standards for medical implants and direct mechanical performance, not expert review of diagnostic data.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: For this type of device, the "ground truth" is typically defined by established engineering standards and performance specifications for spinal implants, as outlined in the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s." The mechanical testing demonstrates that the device performs within these acceptable limits and is substantially equivalent to the predicate.
• 8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

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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