(25 days)
Solstice CCI 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 (C1to 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 CCI 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 CCI may be connected to the titanium Life Spine NAUTILUS Spine System using the 3.5mm/5.5mm titanium parallel connectors.
The Solstice CCI 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, hooks, connectors, rods, and locking caps.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Solstice CCI components with components from any other system or manufacturer. The components should never be reused under any circumstances.
The provided FDA 510(k) clearance letter and summary for the Solstice CCI device primarily focus on mechanical and material equivalency to predicate devices, rather than an AI/ML-driven diagnostic or assistive technology. Therefore, the typical acceptance criteria and study designs associated with AI performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by expert consensus) are not applicable to this device submission.
The "Performance Data" section explicitly states:
"The Solstice CCI was tested according to ASTM F2706 which included Static & Dynamic Axial Compression Bending and Torsion."
This indicates that the performance evaluation was primarily mechanical testing to ensure the device's structural integrity and ability to function as intended, rather than its diagnostic accuracy or impact on human reading performance.
Given this, I cannot extract the information requested in your prompt regarding acceptance criteria and study design for an AI/ML medical device.
If this were an AI/ML device submission, the requested information would typically look like this (illustrative example based on common AI/ML diagnostic device submissions):
Hypothetical Example for an AI/ML Device (NOT based on the provided document)
Let's imagine, for the sake of demonstrating the requested output, that the Solstice CCI was an AI-driven system designed to detect spinal fractures from medical images.
1. A table of acceptance criteria and the reported device performance
| Metric | Acceptance Criteria (e.g., Lower Bound of 95% CI) | Reported Device Performance |
|---|---|---|
| Sensitivity | ≥ 90% | 92.5% (95% CI: 90.1-94.4) |
| Specificity | ≥ 80% | 85.0% (95% CI: 82.1-87.5) |
| Positive Predictive Value (PPV) | ≥ 75% | 78.2% (95% CI: 75.0-81.0) |
| Negative Predictive Value (NPV) | ≥ 95% | 96.1% (95% CI: 94.8-97.1) |
| AUROC | ≥ 0.90 | 0.93 |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 1500 medical images (e.g., CT scans of the spine).
- Data Provenance: Retrospective data collected from multiple institutions across the United States (e.g., university hospitals, large medical centers). Data diversity included varying scanner types, patient demographics, and image acquisition protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: 3 board-certified radiologists.
- Qualifications: Each radiologist had at least 10 years of experience specializing in musculoskeletal or neuroradiology and had previously participated in consensus reading studies.
4. Adjudication method for the test set
- Adjudication Method: 2+1; All cases were independently reviewed by two primary radiologists. In cases of disagreement between the two primary readers, a third, senior radiologist acted as an arbiter to establish the final ground truth.
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
- MRMC Study: Yes, an observer performance study was conducted.
- Effect Size: Human readers demonstrated a statistically significant improvement in fracture detection accuracy (measured by AUROC) when assisted by the AI algorithm compared to reading without AI assistance. The average AUROC for human readers increased from 0.85 (without AI) to 0.91 (with AI assistance), representing an improvement of 0.06 AUROC points (p
§ 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.