(30 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance Equivalent to Predicate Device: The device must demonstrate similar mechanical properties and performance characteristics to the predicate BEACON® Stabilization System (K073172). This includes demonstrating adequate strength, fatigue resistance, and stability for its intended use in spinal fixation. | Mechanical testing was performed in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. This testing likely involved various static and dynamic tests to assess the structural integrity and performance of the BEACON® ML Connectors. The successful completion of this testing, demonstrating equivalence or superior performance to the predicate device, is considered compliance with this criterion. The 510(k) cleared the device for market, indicating that FDA found sufficient evidence of substantial equivalence based on the provided mechanical test data. |
| Intended Use Compatibility: The device must be suitable for the same intended uses as the predicate device, specifically in providing immobilization and stabilization of spinal segments for various conditions in skeletally mature patients (degenerative disc disease, spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, failed previous fusion, and severe spondylolisthesis). | The BEACON® ML Connectors are additions to the BEACON® Stabilization System. The Indications for Use Statement for the overall BEACON® Stabilization System (which the ML Connectors are a part of) is virtually identical to the intended uses of the predicate device (K073172). The 510(k) application states that the BEACON® ML connectors are "similar to the predicate BEACON® Stabilization System (K073172) with respect to technical characteristics, performance, and intended use." This statement confirms compatibility with the established intended uses. |
| Material Compatibility and Safety: The materials used must be biocompatible and safe for implantation, consistent with established standards (e.g., ASTM F136, F1295, F67). Compatibility with other components of the BEACON™ Stabilization System is also implied. | The rods are composed of titanium alloy, or commercially pure titanium, as specified in ASTM F136, F1295, and F67. All other BEACON™ implants (including the ML Connectors) are composed of titanium alloy, as specified in ASTM F136, and F1295. The document also notes a safety precaution: "Due to the risk of galvanic corrosion following implantation, titanium or titanium alloy implants should not be connected to stainless steel implants." This indicates compliance with material standards and proper safety considerations. |
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.
§ 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.