(29 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 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-6Al-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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NAUTILUS Spinal System:
The provided text does not contain information about acceptance criteria or a study with performance metrics in the way one would typically find for an AI/ML medical device. This document is a 510(k) summary for a traditional medical device (spinal implant system).
Therefore, I cannot populate most of the requested fields as they pertain to the performance evaluation of an AI/ML device. I will indicate where the information is not applicable (N/A) or not found (N/F) based on the context of this traditional device submission.
Acceptance Criteria and Study for NAUTILUS Spinal System
This 510(k) submission for the NAUTILUS Spinal System demonstrates substantial equivalence to a predicate device (NAUTILUS Spinal System K133564) primarily through performance testing based on established industry standards and engineering analysis. It is for a physical medical implant, not an AI/ML diagnostic or prognostic device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Mechanical Performance | Substantial Equivalence to Predicate Device (K133564) demonstrated through testing in accordance with ASTM F1717. | "Testing in accordance with ASTM F1717 in addition to engineering analysis was presented to demonstrate the substantial equivalency of the NAUTILUS Spinal System." (Implies the device met the performance requirements of ASTM F1717 to establish equivalency to the predicate, though specific numerical results or pass/fail thresholds are not detailed in this summary.) |
| Material Composition | Adherence to specified material standards: Titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and cobalt chrome per ASTM 1537. | "The NAUTILUS Spinal System is 6AL-4V-ELI titanium manufactured according to ASTM F136 and cobalt chrome per ASTM 1537." (This is a statement of material composition meeting the specified standard.) |
| Design Characteristics | Substantial Equivalence to Predicate Device (K133564) in terms of design, materials, indications for use and sizing. | "The NAUTILUS Spinal System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing." (This is a conclusion based on the overall assessment, including the mechanical testing.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a "sample size" in the context of test subjects or data points for an algorithm. For a physical device like this, testing typically involves a set number of implants or components subjected to mechanical tests. The exact number of test articles is not provided in this summary.
- Data Provenance: N/A for AI/ML context. For mechanical testing, the "data" is generated in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a physical device, and "ground truth" for its performance is established by objective mechanical testing according to recognized standards (ASTM F1717), not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or expert review of images/data, which is not the nature of this device's performance evaluation.
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:
- N/A. This is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, "ground truth" for performance relates to objective mechanical properties and structural integrity as measured by standardized engineering tests (e.g., fatigue strength, static load capacity, pull-out strength). The "truth" is whether the device meets the physical requirements outlined in the ASTM standard, demonstrating equivalence to the predicate.
8. The sample size for the training set:
- N/A. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A. 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.