(63 days)
The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach.
The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.
The CBx screws are to be included in the currently marketed Arsenal Spinal Fixation System which is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of screws, rods, and connectors that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The CBx screws are made of Titanium Alloy (Ti 6Al 4V ELI) and are designed for placement in the cortical areas of the pedicle where the bone is typically harder, stronger and stiffer than the cancellous portion of the pedicle/vertebra. The threadform of the CBx screws allows the surgeon to use the screw that best suits the patient's anatomy where either cortical bone or both cortical bone and cancellous bone are present.
The provided text describes a 510(k) premarket notification for the "Arsenal Spinal Fixation System," specifically introducing CBx screws as part of this system. This document is focused on demonstrating substantial equivalence to predicate devices for a medical device (pedicle screw system), not an AI or software device.
Therefore, the information typically requested in an acceptance criteria and study section for an AI/software device (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance, ground truth establishment methods) is not applicable to this document. The document describes mechanical performance testing to prove substantial equivalence for a physical medical implant.
However, I can extract the relevant performance data and acceptance criteria as presented in the document concerning the mechanical aspects of the device.
Acceptance Criteria and Device Performance for the Arsenal™ Spinal Fixation System (CBx screws)
The document focuses on demonstrating substantial equivalence of the CBx screws to existing predicate devices (Zodiac Spinal Fixation System, K100685, and Arsenal Spinal Fixation System, K133221) based on mechanical performance. The "acceptance criteria" are implied by the performance of the predicate devices and the relevant ASTM standards, where the CBx screws must perform equivalently.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Required Performance | Reported Device Performance (CBx screws) |
|---|---|---|
| ASTM F1717 |
- Static Compression Bending Test | Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems). | Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws. |
| ASTM F1717 - Dynamic Compression Bending Test | Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems). | Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws. |
| ASTM F1717 - Static Torsional Test | Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems). | Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws. |
| ASTM F1798 - Flexion extension moment (My) | Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems). | Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws. |
| ASTM F1798 - Flexion extension moment fatigue run out (My) | Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems). | Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws. |
Study Description:
The study conducted was a mechanical performance testing program, rather than a clinical or AI performance study.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of physical screws tested. The document generally refers to "the CBx screw" undergoing testing. Typically, mechanical tests for medical devices involve a statistically significant number of samples, but the exact count is not provided here.
- Data Provenance: The tests were conducted to specific ASTM standards (ASTM F1717 and ASTM F1798). The data originates from laboratory mechanical testing of the physical device components. Country of origin for the data is not specified, but it would have been generated in a testing facility. The nature of the testing is by definition prospective for the device being evaluated, as the tests are performed on newly manufactured devices to assess their properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This relates to mechanical performance, not diagnostic interpretations or clinical outcomes requiring human expert "ground truth." The "ground truth" is defined by the objective physical properties and performance metrics measured according to established engineering standards.
4. Adjudication method for the test set:
- Not applicable. This refers to methods for resolving discrepancies in expert opinions, which is not relevant 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:
- Not applicable. This is a physical medical device, not an AI system or diagnostic tool used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an independent algorithm.
7. The type of ground truth used:
- For mechanical performance, the "ground truth" is defined by the measured physical properties and performance characteristics of the device under controlled laboratory conditions, as outlined by the specified ASTM standards. The performance of the predicate devices under the same tests serves as the benchmark for "substantial equivalence."
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning 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.