(24 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 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.
§ 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.