(210 days)
The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following:
- ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by . patient history and radiographic studies)
- Spondylolisthesis .
- Spinal stenosis •
- Fracture/dislocation •
- Revision of previous cervical spine surgery .
- . Tumors
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the system only. They are not intended to be placed in the cervical spine.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4–T12), or lumbar spine. Pedicle screws are intended for placement only in T1-T3 as a means of anchoring the system.
The Reliance Posterior Cervical-Thoracic System is comprised of implant and instrument components. The implant component, the Reliance Posterior Cervical-Thoracic device, consists of posterior attachment elements with a set screw and rod. The Posterior Cervical-Thoracic pedicle screw component is offered in a mono-axial configuration. In addition to this components, there are also ancillary components such as hooks, connectors, cross-links, and lateral offset connectors. There are also thoracic poly-axial screw components. Furthermore, the Reliance Posterior Cervical-Thoracic System has a variety of configurations to meet specific patients' needs.
The Reliance Posterior Cervical-Thoracic instrument components include screw drivers, drill guides, plate holders, and drill bits. These instruments are manufactured from stainless steel, high grade plastic, and silicone rubber. There are also instrument trays that house these components.
The provided document describes a medical device called the "Reliance Posterior Cervical-Thoracic System," for which the FDA is confirming substantial equivalence to a predicate device. This document does not describe the acceptance criteria and a study proving a device meets the acceptance criteria in the way a clinical trial or AI/ML performance study would.
Instead, this document focuses on demonstrating substantial equivalence for a medical implant device, which involves showing that the new device is as safe and effective as a legally marketed predicate device. For this type of device, the "acceptance criteria" are typically met through non-clinical testing and comparison to predicate devices, rather than through studies involving human readers or expert consensus on observations.
Here's an analysis based on the information provided, framed as closely as possible to your request, but acknowledging the different nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Static Compressive Strength (ASTM F1717) | Tested and found substantially equivalent to predicate devices. |
| Static Torsion Strength (ASTM F1717) | Tested and found substantially equivalent to predicate devices. |
| Dynamic Compressive Strength (ASTM F1717) | Tested and found substantially equivalent to predicate devices. |
| Dynamic Torsion Strength (ASTM F1717) | Tested and found substantially equivalent to predicate devices. |
| Sterilization Compatibility (ISO standards implied) | Found substantially equivalent to predicate devices. |
| Biocompatibility (ISO standards implied) | Found substantially equivalent to predicate devices. |
| Material equivalence | Found substantially equivalent to and itself (K122292), primary predicate device and the secondary predicate device, Synthes System & OC Fusion System (K141897). |
| Intended Use equivalence | Found substantially equivalent to and itself (K122292), primary predicate device and the secondary predicate device, Synthes System & OC Fusion System (K141897). |
| Levels of attachment equivalence | Found substantially equivalent to and itself (K122292), primary predicate device and the secondary predicate device, Synthes System & OC Fusion System (K141897). |
| Size range equivalence | Found substantially equivalent to and itself (K122292), primary predicate device and the secondary predicate device, Synthes System & OC Fusion System (K141897). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as "sample size" in the context of clinical data for a test set. Instead, it refers to multiple test configurations for the mechanical testing of the device components. The number of samples tested for each mechanical property (e.g., number of constructs for static compressive testing) is not specified but would follow ASTM F1717 guidelines.
- Data Provenance: The data is generated from non-clinical laboratory testing of the device prototypes. No human data (e.g., country of origin, retrospective/prospective) is involved in this described performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable in the context of this submission. The "ground truth" for the mechanical testing is based on the physical testing results against established international standards (ASTM F1717). No human experts are used to interpret clinical images or establish ground truth in a diagnostic sense for this type of submission.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method for a test set of clinical cases is described as this is not a study assessing diagnostic performance or human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.
- Not applicable. This submission does not include an MRMC study. It is a premarket notification for a spinal fixation device, focusing on mechanical properties and substantial equivalence to existing devices, not on human diagnostic performance with or without AI assistance.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm or AI software. There is no standalone algorithm performance to evaluate.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical performance evaluation is based on established engineering and biomechanical standards (ASTM F1717) and the performance characteristics of the identified predicate devices. This includes material properties, mechanical strength under various loads, sterilization, and biocompatibility.
8. The Sample Size for the Training Set
- Not applicable. This submission describes a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
In summary: The provided text details a 510(k) premarket notification for a spinal implant. The "acceptance criteria" discussed are related to the mechanical performance, materials, and intended use of the device, demonstrated through non-clinical testing and comparison to legally marketed predicate devices by showing "substantial equivalence." This is a different type of evaluation than those typically performed for AI-driven diagnostic devices.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.