(30 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (REVERE™ Stabilization System K061202) in technical characteristics, performance, and intended use. | "The BEACON™ Stabilization System implants are similar to the predicate REVERE™ Stabilization System (K061202) implants system with respect to technical characteristics, performance, and intended use." |
| "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." (The results of this mechanical testing are not detailed in the provided summary, but its presentation implies successful demonstration of equivalence). | |
| The FDA's letter (K073172) confirms "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". |
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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.