Search Results

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 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 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) spondylolisthesis.

Solstice OCT System:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The hooks, rods, and connectors are also intended to provide stabilization to promote fusion of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Solstice OCT system can also be linked to the Conquest, Pilot, and Nautilus Spinal Systems through the use of transitional rods and rod connectors.

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.

The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, locking caps, connectors and breakaways.

The purpose of this submission is to add transition connectors to both the Nautilus and Solstice Systems.

This document pertains to a 510(k) premarket notification for the Nautilus Spinal System and the Solstice OCT System, both spinal fixation devices. The submission focuses on adding transition connectors to these systems. The FDA letter confirms the substantial equivalence of the devices to legally marketed predicates.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" for performance in a table format with corresponding reported device performance values against those criteria. Instead, it relies on the concept of substantial equivalence to predicate devices. This means that the new device (Nautilus Spinal System and Solstice OCT System with added transition connectors) performs comparably to devices already cleared by the FDA.

The "Performance Data" section states:

• "Mechanical testing was included to demonstrate the substantial equivalency of the Nautilus Spinal System and the Solstice OCT System."
• "The testing included static and dynamic compression and static torsion testing per ASTM F1717, static axial and torsional grip per ASTM F1798."

This implies that the acceptance criteria for these tests were that the performance of the Nautilus and Solstice systems (with the new connectors) had to be equivalent or superior to that of the predicate devices or meet the general requirements of the ASTM standards for spinal implant systems. However, specific numerical thresholds for these criteria are not provided in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Mechanical testing." This typically refers to laboratory testing of physical samples of the devices, not clinical data from human subjects. Therefore, the concept of "sample size for the test set" in the context of human data or "data provenance" (country of origin, retrospective/prospective) is not applicable here. For mechanical testing, the "samples" would be the physical devices tested according to the ASTM standards. The exact number of device samples tested is not specified in this document.

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)

This question is not applicable to this document. The device in question is a spinal implant system, and the "study" described is mechanical testing in a laboratory setting, not a study involving human interpretation of medical images or clinical outcomes that would require expert consensus for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable to this document. Adjudication methods like 2+1 or 3+1 refer to processes used in clinical studies, particularly for interpreting ambiguous findings, typically by multiple experts. The study mentioned here is 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

This question is not applicable to this document. The device is a spinal implant system, not a diagnostic or AI-powered imaging device that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to this document. This question relates to AI algorithms operating independently, which is not relevant to a physical spinal implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This question is not applicable in the traditional sense for a medical device that undergoes mechanical testing. For mechanical testing, the "ground truth" is defined by the physical properties and performance characteristics measured by standardized test methods (ASTM F1717, ASTM F1798). The goal is to demonstrate that the device meets the performance requirements (e.g., strength, durability) as defined by these standards and is comparable to predicate devices.

8. The sample size for the training set

This question is not applicable to this document. "Training set" refers to data used to train machine learning models. This document describes mechanical testing of a physical medical device, not an AI or software device.

9. How the ground truth for the training set was established

This question is not applicable to this document for the same reasons as #8.

Ask a specific question about this device