(133 days)
The OLYMPIC Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities of thoracic, lumbar, and sacral spine (T1-S2/ilium): degenerative spondylolisthesis with objective evidence of neuroment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior System is intended to be used with autograft/allograft.
In addition, the OLYMPIC Posterior System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the LS-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 the attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pediatic patients, the OLYMPIC Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idionathic scoliosis. The OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system implanted from the posterior approach and designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, crosslinks, and rod connectors. The system is supported by a comprehensive set of instruments to install the implants within the system.
This document is a 510(k) Summary for the OLYMPIC Posterior Spinal Fixation System. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices primarily based on non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance values. Instead, it lists the types of non-clinical tests performed and states a general conclusion of equivalence to predicate devices. The "acceptance criteria" are implied by the standards cited for each test.
| Test Type | Standard | Reported Device Performance / Outcome |
|---|---|---|
| Finite Element Analysis | (Not a specific ASTM standard listed for FEA) | Determined worst case for testing |
| Static Compression Bending | ASTM F1717 | "Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices." |
| Dynamic Compression Bending | ASTM F1717 | "Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices." |
| Static Torsion | ASTM F1717 | "Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices." |
| Axial grip | ASTM F1798 | "Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices." |
| Torsional grip | ASTM F1798 | "Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices." |
| Corrosion testing | ASTM F2129 | "Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable as the study involved non-clinical bench testing rather than human or animal subjects. The "test set" here refers to the physical device components and constructs subjected to mechanical testing. The specific number of samples for each test (e.g., how many constructs were tested for static bending) is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed on actual device components. The location where these tests were conducted is not specified, but the applicant (Astura Medical, LLC) is based in Carlsbad, CA, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This study is a non-clinical, mechanical performance evaluation of a spinal fixation system. "Ground truth" in the sense of expert clinical consensus or pathology is not relevant for this type of testing. The performance is measured against engineering standards (ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is a non-clinical, mechanical testing study, there is no adjudication of findings by experts. The results are objective measurements against defined engineering standards.
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 document explicitly states: "No clinical studies were performed." Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a physical spinal implant, not a software algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests are the established mechanical performance requirements and limits defined by the cited ASTM standards. The device's performance is compared against the performance of predicate devices and the requirements of these standards to demonstrate substantial equivalence, not against clinical expert consensus or pathology data.
8. The sample size for the training set
Not applicable. There is no training set for this device, as it is a physical medical implant and not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 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.