(165 days)
The Spinal Elements Cerclage System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternum following sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion.
The Spinal Elements Cerclage System consists of a strap manufactured from PEEK-Optima®. The leading tip of the device is tapered and smooth to help lead the cerclage through or around the bony structures to be secured. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop, created by feeding the strap though the latch, to be made consecutively shorter or taught by continuing to pull the strap through the latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the structures intended to be fixed. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded.
The provided document describes the Spinal Elements Cerclage System, a medical device intended for use in cardiovascular surgery for sternum closure after sternotomy. The submission focuses on substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for the device. Instead, it refers to non-clinical mechanical testing and a comparison to predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical Performance | All test results indicate the cerclage will perform as intended. This is based on a comparison to devices cleared for similar or identical indications for use. |
| Static Tensile Strength | Performed (specific values not provided, but deemed acceptable compared to predicates). |
| Dynamic Tensile Strength | Performed (specific values not provided, but deemed acceptable compared to predicates). |
| Relative Abrasion | Performed (results not detailed, but deemed acceptable compared to predicates). |
| Creep Tensile Strength | Performed (specific values not provided, but deemed acceptable compared to predicates). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document states "Non-clinical, mechanical testing was performed," but does not detail the number of samples or trials for each test.
- Data Provenance: Not specified, but implied to be laboratory-generated mechanical test data, not patient-derived data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. The "ground truth" here refers to the physical properties measured in mechanical tests, not expert interpretation of clinical data. The tests themselves are designed to measure inherent material and structural performance.
4. Adjudication Method for the Test Set:
- Not applicable. As mechanical tests are objective measurements, there is no need for expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a MRMC comparative effectiveness study was not done. The submission focuses on mechanical performance and substantial equivalence, not human reader performance with or without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI/software device.
7. The Type of Ground Truth Used:
- For the mechanical testing, the "ground truth" would be the objectively measured physical properties of the device (tensile strength, abrasion resistance, creep resistance) according to established testing standards or methods.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable (see point 8).
Summary of Device Performance Study:
The primary study type conducted for the Spinal Elements Cerclage System was non-clinical, mechanical testing. The purpose was to demonstrate that the device performs as intended and is substantially equivalent to predicate devices already cleared for market. The performance was assessed by comparing the results of static tensile testing, dynamic tensile testing, relative abrasion testing, and creep tensile testing against the expected performance of predicate devices with similar or identical indications for use. No clinical studies, human reader studies, or AI-specific studies were performed or described in this 510(k) summary.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.