(62 days)
The SOLSTICE OCT 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 (T1 to T3): Traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic 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 SOLSTICE OCT 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 tumors 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 SOLSTICE OCT System may be connected to the titanium Life Spine NAUTILUS Spine System using the 3.5mm/5.5mm titanium parallel connectors.
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, connectors, rods, and locking caps.
The provided document states that the Solstice OCT System is "substantially equivalent" to predicate devices based on technological characteristics and performance data. Specific acceptance criteria and a study proving the device meets those criteria, as typically understood in a clinical efficacy or accuracy study for AI/software, are not explicitly present in this 510(k) summary.
This document describes a premarket notification for a medical device (spinal system) which, under Section 510(k) of the Food, Drug, and Cosmetic Act, aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. The focus here is on mechanical and material equivalence, not clinical performance as evaluated by diagnostic accuracy or outcomes.
Therefore, many of the requested information points, particularly those related to AI/software performance studies (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details), are not applicable or not provided in this type of submission.
Here's a breakdown of what can be extracted and what is not available:
Acceptance Criteria and Reported Device Performance:
The document states equivalence to predicate devices based on mechanical testing. The "acceptance criteria" are implied by meeting the performance of the predicate device as described in the ASTM standards.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Equivalent to predicate Synapse Occipital-Cervical-Thoracic (OCT) System ([K142838](https://510k.innolitics.com/search/K142838)) based on ASTM F1717 and ASTM F1798. | "Static compression, dynamic compression, static dissociation and static tension testing according to ASTM F1717 along with static axial grip, static torsional grip, and static moment bending testing according to ASTM F1798 was presented to demonstrate the substantial equivalency of The SOLSTICE OCT System." |
| Design | Equivalent to predicate | "substantially equivalent ... in terms of design" |
| Materials | Equivalent to predicate (Titanium alloy 6AL-4V-ELI per ASTM F 136) | "substantially equivalent ... in terms of ... materials" |
| Indications for Use | Equivalent to predicate | "substantially equivalent ... in terms of ... indications for use" |
| Sizing | Equivalent to predicate | "substantially equivalent ... in terms of ... sizing" |
Information Not Applicable or Not Provided for this Device Type and Submission:
This submission is for a physical implantable device, not an AI/software device. Therefore, the following are not relevant or described:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical testing of physical samples, not a dataset for algorithm evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is typically based on physical measurements and engineering specifications, not expert consensus on medical images or diagnoses.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 type of study relates to software/AI performance in a diagnostic context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the ground truth is often defined by physical properties and engineering standards. Clinical outcomes data would be part of a larger clinical trial, which is generally not required for 510(k) unless substantial equivalence cannot be established through other means.
- The sample size for the training set: Not applicable. This document does not describe an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
In summary: The document establishes "substantial equivalence" of the Solstice OCT System to a predicate device primarily through mechanical testing and comparison of design, materials, and indications for use. It does not provide information about clinical performance studies, diagnostic accuracy, or AI/software validation, as those are not the focus of this particular 510(k) submission for this type of device.
§ 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.