(393 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, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
The NAUTILUS Spinal System consists of an assortment of rods, screws, and cross connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Spinal System screw assembly component. The cross connectors are also assembled during manufacturing. Do not use any of the NAUTILUS Spinal System components with the components from any other system or manufacturer.
The NAUTILUS Spinal System is a medical device and its "acceptance criteria" and "study that proves the device meets the acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, rather than clinical performance metrics typical of AI/software devices. Therefore, the questions related to AI/software performance metrics (like sample size for test set, experts for ground truth, MRMC study, standalone performance) are not applicable in this context.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Substantial Equivalence) | Reported Device Performance (Means of Demonstration) |
|---|---|
| Design Substantial Equivalence | Same basic design principle (pedicle screw system for posterior spinal fixation). |
| Material Substantial Equivalence | Manufactured from 6AL-4V-ELI titanium according to ASTM F136; variety of non-sterile, single-use components. |
| Indications for Use Substantial Equivalence | Intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients as an adjunct to fusion, for conditions like degenerative disc disease, trauma, curvatures, spinal tumor, failed previous fusion, pseudarthrosis, spinal stenosis, and spondylolisthesis. This perfectly matches the predicate devices. |
| Sizing Substantial Equivalence | Not explicitly detailed, but stated as being substantially equivalent in sizing to predicate systems. Implies similar range and types of components. |
| Performance (Mechanical) Substantial Equivalence | Static compression, static torsion, and dynamic compression testing per ASTM F1717 presented. These tests demonstrate substantial equivalency to the mechanical performance of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable: This is a mechanical device, not an AI/software device. There is no "test set" in the context of image analysis or algorithm performance. The data provenance would relate to the mechanical testing, which is performed in a laboratory setting. The document only states "Static compression, static torsion, and dynamic compression testing per ASTM F1717 was presented". The specific number of samples for each test type is not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable: There is no "ground truth" in the clinical or image analysis sense for this type of device submission. Substantial equivalence is established through comparison of design, materials, indications, and mechanical testing against recognized standards (ASTM F1717) and predicate devices.
4. Adjudication Method for the Test Set
- Not Applicable: See point 3.
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 spinal system, not an AI or software device that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is a physical spinal system; there is no algorithm or standalone performance in the context of AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable (in the conventional sense): The "ground truth" for this device's acceptance is its compliance with recognized mechanical testing standards (ASTM F1717) and its similarity in design, materials, and indications for use to already legally marketed predicate devices (CONQUEST Spinal System K080767, Pilot Spinal System K063601, ARX Spinal System K061600). The "truth" is established by showing it performs comparably and is structurally similar to devices already deemed safe and effective.
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" for this type of medical device submission.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: See point 8.
§ 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.