(94 days)
The YUKON OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies. and degenerative disease of the facets with instability.
The YUKON OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tu mors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation. the YUKON OCT Spinal System may be connected to EVEREST, MESA and DENALI Spinal System components via the rod to rod connectors or transition rods.
The YUKON OCT Spinal System is a top-loading, multiple component, posterior (occipitalcervical-thoracic) spinal fixation system consisting of screws, hooks, rods, rod connectors, and occipital components. The purpose of this submission is to add connectors to the system.
Function: The system functions as an adjunct to provide stabilization of the posterior cervical and thoracic spine.
The provided document is a 510(k) summary for the YUKON OCT Spinal System, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
It is critical to understand that this document describes a mechanical medical device (a spinal fixation system) and not an AI/ML algorithm or software device. Therefore, the questions related to AI/ML performance, such as acceptance criteria for AI algorithms, AI-assisted reader performance, ground truth for AI training and testing, and standalone algorithm performance, are not applicable to this submission.
The acceptance criteria and study information provided in this document pertain to the mechanical and physical performance of the spinal fixation system.
Here's an analysis of the provided information, focusing on what is relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
For a mechanical device like the YUKON OCT Spinal System, acceptance criteria typically involve demonstrating mechanical strength and durability. The document states:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Static Compression Testing (ASTM F1717) | Performed equivalent to or better than the predicates. |
| Static Torsion Testing (ASTM F1717) | Performed equivalent to or better than the predicates. |
| Dynamic Compression Testing (ASTM F1717) | Performed equivalent to or better than the predicates. |
| Overall substantial equivalence performance | "There are no significant differences between the YUKON OCT Spinal System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material, intended use and performance." |
2. Sample size used for the test set and the data provenance
For mechanical testing, the "test set" refers to the number of physical samples of the device components tested. The document does not specify the exact number of samples tested for each type of mechanical test (static compression, static torsion, dynamic compression).
- Data Provenance: The testing appears to be conducted by the manufacturer as part of the regulatory submission process, implying internal laboratory testing. There is no mention of country of origin of data in terms of patient data, as this is not a clinical study based on patient outcomes but rather a mechanical performance study. It is a prospective test in the sense that new samples of the device were manufactured and then tested to demonstrate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. For mechanical performance testing of a spinal fixation system, "experts" in the sense of clinicians establishing a "ground truth" for a diagnostic task are not involved. The ground truth is defined by engineering standards (e.g., ASTM F1717) and the physical properties of the materials and design. The interpretation of test results would be performed by qualified engineers.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or AI performance evaluations to reconcile discrepancies between expert opinions on a specific outcome (e.g., diagnosis). For mechanical testing, there isn't typically an "adjudication" of results in this sense, but rather adherence to standardized testing protocols and interpretation by engineers.
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. This is a mechanical device, not an AI or software device. The concept of "human readers" and "AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a mechanical device, not an AI or software device.
7. The type of ground truth used
The "ground truth" for this device's performance evaluation is established by engineering standards and specifications. Specifically, the document references ASTM F1717, which is a standard specification for spinal implant constructs in a corpectomy model. The performance of the device is assessed against the requirements and methodologies outlined in this standard, and in comparison to legally marketed predicate devices.
8. The sample size for the training set
This question is not applicable. This is a premarket notification for a mechanical device; there is no "training set" in the context of machine learning or AI. The design of the device is based on engineering principles and prior experience with similar devices, not a 'training set'.
9. How the ground truth for the training set was established
This question is not applicable. As there is no training set for an AI/ML algorithm for this mechanical device, there is no ground truth established for a training set in that context.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.