(76 days)
The Reliance Buttress Washer System is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
The Reliance Buttress Washer System is a temporary implant used to prevent bone graft extrusion. The Reliance Buttress Washer Systems consists of washers and bone screws. The Buttress Washer is also intended to provide stabilization and augment development of a solid spinal fusion. The Buttress Washer fixates to the anterior portion of the thoracolumbar vertebral body, The construct may be employed alone device or with other anterior, anterolateral, or posterior spinal systems made of compatible materials.
The provided text is a 510(k) summary for the Reliance Buttress Washer System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than robust clinical trial data with acceptance criteria, sample sizes, and detailed ground truth establishment as would be found in a PMA (Premarket Approval) application.
Therefore, the information requested in your prompt regarding acceptance criteria, specific study details (test set size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not present in this 510(k) summary.
Here's why and what can be extracted:
- Acceptance Criteria & Device Performance: A 510(k) relies on demonstrating that the new device is "substantially equivalent" to existing, legally marketed devices. It doesn't typically involve new clinical studies with predefined acceptance criteria and performance metrics in the same way a PMA does. Instead, it compares features, materials, and intended use.
- Study Details (Sample Size, Ground Truth, Adjudication, MRMC, Standalone): These are standard components of clinical trials or rigorous performance studies. A 510(k) summary for a device like this, which is a temporary implant for spinal fusion, primarily uses engineering performance testing (e.g., mechanical tests, biocompatibility) and comparison to predicate devices, not clinical studies involving human readers or extensive ground truth establishment in the way AI/ML devices might.
- Training Set Information: This is entirely irrelevant for a traditional medical device like the Reliance Buttress Washer System, which is a physical implant, not an AI/ML algorithm.
What can be extracted from the text relevant to the spirit of your request (substituting "substantial equivalence" for "acceptance criteria"):
Substantial Equivalence and Supporting Information
The "study" proving the device meets its "acceptance criteria" (in this context, substantial equivalence) is documented through a comparison to legally marketed predicate devices.
1. Table of "Acceptance Criteria" (Substantial Equivalence Factors) and Reported Device Performance (Comparison to Predicates)
| Substantial Equivalence Factor | Predicate Devices | Reliance Buttress Washer System (Reported Performance/Claims) | Met? |
|---|---|---|---|
| Intended Use/Indications | Synthes Titanium Locking Plate System (K970048), Medtronic Sofamor Danek Bone Graft Washer (K994122, K041217), DePuy BowTi Anterior Buttress Staple System (K021039), SeaSpine Anterior Lumbar Buttress System (K040130), Altiva ALTES™Anterior Buttress Plating System (K061482) | Stabilize bone graft at one level (T1-S1) as an aid to spinal fusion, temporary stabilization, augment solid spinal fusion. May be used alone or with other compatible spinal systems. Not for load-bearing. | Yes |
| Material | Same predicate devices | Materials are equivalent to predicate devices. | Yes |
| Levels of Attachment | Same predicate devices | Equivalent to predicate devices. | Yes |
| Size Range | Same predicate devices | Equivalent to predicate devices. | Yes |
| Use with Supplemental Fixation | Same predicate devices | Equivalent to predicate devices in its use with supplemental fixation. | Yes |
2. Sample Size for Test Set and Data Provenance:
* This document does not describe a "test set" in the context of a clinical study or AI/ML validation with human data. The assessment is based on design specifications, material properties, and comparison to existing devices. Therefore, no specific sample size or data provenance is provided. The evaluation is largely based on engineering and design principles.
3. Number of Experts and Qualifications for Ground Truth:
* Not applicable. Ground truth as typically defined for AI/ML or complex diagnostic devices, involving expert consensus on patient data, is not part of this 510(k) submission. Regulatory experts at the FDA (Office of Device Evaluation) review the submission for substantial equivalence based on the provided engineering and comparative data.
4. Adjudication Method:
* Not applicable. There was no specific "test set" requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No. This type of study is for evaluating diagnostic medical imaging devices or AI-assisted diagnostic tools, not for a physical implant like the Reliance Buttress Washer System.
6. Standalone Performance Study:
* A "standalone performance" study in the context of an algorithm's performance is not applicable to this device. However, the device's mechanical and material properties would have been evaluated to ensure safety and function, likely through bench testing, but specific details of those tests are not in the summary.
7. Type of Ground Truth Used:
* Not applicable in the conventional sense of patient data. The "ground truth" for substantial equivalence is the well-established safety and effectiveness profile of the legally marketed predicate devices, as proven through their prior regulatory clearances and post-market experience.
8. Sample Size for the Training Set:
* Not applicable as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
* Not applicable.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.