(81 days)
The Spinal USA RCS Anterior Buttress Plate System is intended to stabilize the allograft or autograft at one level (TI-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 Spinal USA RCS Anterior Buttress Plate System is a temporary implant used to prevent allograft or autograft extrusion. The Spinal USA RCS Anterior Buttress Plate System consists of plates and bone screws. The Spinal USA RCS Anterior Buttress Plate System is also intended to provide stabilization and augment development of a solid spinal fusion. The Spinal USA RCS Anterior Buttress Plate System fixates to the anterior portion of the thoracolumbar vertebral body. The construct may be employed alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. The components will be provided non-sterile.
This document is a 510(k) summary for a medical device (Spinal USA RCS Anterior Buttress Plate System) focusing on its intended use and equivalence to previously cleared devices. It does not contain information about explicit acceptance criteria or a study that rigorously proves the device meets specific performance criteria in terms of quantitative metrics or clinical outcomes.
Instead, the document asserts "substantial equivalence" to predicate devices based on "equivalence in intended use, indications, anatomic sites, performance and material of manufacture." This is a regulatory pathway for lower-risk devices, not a detailed performance study.
Therefore, most of the requested information cannot be extracted from this document as it doesn't describe such a study.
Here's what can be stated based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not specify quantitative acceptance criteria or report device performance against such criteria. The basis for clearance is "substantial equivalence" to predicate devices, implying similar performance is expected, but no specific performance metrics are provided for the Spinal USA RCS Anterior Buttress Plate System itself.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No "test set" in the context of a performance study is described. The document relies on substantial equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No ground truth establishment by experts is described as there is no performance study.
4. Adjudication Method for the Test Set
Not applicable. No test set or associated adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC comparative effectiveness study was not done.
6. If a Standalone Performance Study (algorithm only without human-in-the-loop performance) was done
No. This device is a physical implant, not an algorithm. Therefore, a "standalone algorithm performance" study is not relevant or described.
7. The Type of Ground Truth Used
Not applicable. No specific ground truth is mentioned. The clearance is based on substantial equivalence rather than a study validating performance against a definitive ground truth.
8. The Sample Size for the Training Set
Not applicable. No training set is mentioned as this is a physical medical device clearance, not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set or ground truth establishment is mentioned.
Summary of what the document does state regarding "acceptance criteria" and "study":
- Acceptance Criteria: The primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to legally marketed predicate devices. This means that the device must be shown to have the same intended use, indications, anatomic sites, performance, and material of manufacture as already cleared devices.
- Study/Proof: The "study" or proof provided is a documentation effort demonstrating substantial equivalence. The document states: "Documentation was provided which demonstrated the Spinal USA RCS Anterior Buttress Plate System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture." This is a regulatory submission process, not a clinical trial or performance study with quantitative results against predefined acceptance criteria for the new device.
§ 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.