(91 days)
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The NAUTILUS Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.
When used as a posterior spine thoracic/lumbar system, the NAUTILUS Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.
This document describes a spinal system called the NAUTILUS Spinal System and details its substantial equivalence to predicate devices, which is the basis for its 510(k) clearance. Because this is a spinal implant and not an AI/ML device, the typical AI/ML-focused acceptance criteria and study components requested in the prompt (e.g., sample size for test set, expert ground truth, MRMC study, training set details) are not applicable.
Here's a breakdown of the information provided in the context of the prompt:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate device comparison) | Reported Device Performance (NAUTILUS Spinal System) |
|---|---|
| Design Equivalence | Substantially equivalent to predicate systems. |
| Material Equivalence | Composed of 6AL-4V-ELI titanium (ASTM F136) and cobalt chrome (ASTM 1537), same as predicates. |
| Indications for Use Equivalence | Identical indications for use as predicate systems. |
| Sizing Equivalence | Substantially equivalent to predicate systems. |
| Static Compression Testing (ASTM F1717) | Performance data presented to demonstrate substantial equivalency. |
| Static Torsion Testing (ASTM F1717) | Performance data presented to demonstrate substantial equivalency. |
| Dynamic Compression Testing (ASTM F1717) | Performance data presented to demonstrate substantial equivalency. |
| Axial Grip Testing (ASTM F1798) | Performance data presented to demonstrate substantial equivalency. |
| Torsional Grip Testing (ASTM F1798) | Performance data presented to demonstrate substantial equivalency. |
| Moment Bending Testing (ASTM F1798) | Performance data presented to demonstrate substantial equivalency. |
- Study that proves the device meets the acceptance criteria: The device's compliance with acceptance criteria is established through a substantial equivalence determination to predicate devices (NAUTILUS Spinal System K132760 and CD Horizon Spinal System K132471). This is supported by performance data from static, torsional, and dynamic compression testing per ASTM F1717, as well as axial grip, torsional grip, and moment bending testing per ASTM F1798. These tests demonstrate that the NAUTILUS Spinal System performs comparably to the predicate devices in terms of mechanical properties.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A). This is a submission for a medical device (spinal implant) based on substantial equivalence, not an AI/ML diagnostic or predictive device. There is no "test set" in the context of medical images or patient data to evaluate an algorithm. The "test set" here refers to the mechanical tests performed on the physical device components. The document does not specify sample sizes for the mechanical tests, nor does it provide details on data provenance beyond stating the tests performed to demonstrate substantial equivalency.
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 (N/A). As this is a mechanical device, ground truth is established by engineering standards and test results, not by expert medical review of images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (N/A). Adjudication methods are relevant for subjective interpretations (e.g., image reading) by multiple experts. For mechanical testing, the results are objectively measured against established 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
- Not Applicable (N/A). This study is irrelevant for a spinal implant device. MRMC studies are used to evaluate the diagnostic accuracy of imaging or AI systems with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A). This study is irrelevant for a spinal implant device. "Standalone" performance refers to the accuracy of an AI algorithm without human input, which does not apply here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on established engineering standards and material specifications (e.g., ASTM F136, ASTM 1537, ASTM F1717, ASTM F1798) and the performance characteristics of legally marketed predicate devices. The goal is to demonstrate that the new device's mechanical properties and safety are equivalent to those already accepted.
8. The sample size for the training set
- Not Applicable (N/A). This concept applies to AI/ML algorithms, not to the mechanical testing of a medical implant.
9. How the ground truth for the training set was established
- Not Applicable (N/A). This concept applies to AI/ML algorithms.
§ 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.