(238 days)
The STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion.
The STERN FIX is a long-term implantable postoperative sternal stabilization system that closes and stabilizes the sternum after a sternotomy. The STERN FIX is a clamping device consisting of two parts, male and female, which match telescopically with one another to form the sternal stabilization system. Both male and female parts have a curved arm that catches one of the two halves of the sternum laterally and approximates them until the sternum is securely fixed. Five sizes of the STERN FIX are available for use with different sternum thicknesses. The STERN FIX can be cut and removed for emergent, and long-term, re-entry through the sternum.
Here's an analysis of the provided text regarding the Stern Fix Sternal Stabilization System, focusing on acceptance criteria and study details.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally framed as the device meeting "specifications" and demonstrating "adequate performance." The document does not provide a specific table of quantitative acceptance criteria with numerical targets. Instead, it offers qualitative conclusions based on performance testing.
| Test | Acceptance Criteria (Qualitative) | Reported Device Performance |
|---|---|---|
| Functional Testing | ||
| Breaking strength | Meet specifications; Functionality demonstrated | All tested samples meet specifications. Functionality of the devices is demonstrated. |
| Fatigue test | Meet specifications; Functionality demonstrated | All tested samples meet specifications. Functionality of the devices is demonstrated. |
| Biomechanical Testing | ||
| Breaking strength | Meet specifications; Adequate biomechanical behavior when subjected to relevant efforts | All tested samples meet specifications. The STERN FIX system has an adequate biomechanical behavior when subject to relevant efforts. |
| Lateral distraction test | Meet specifications; Adequate biomechanical behavior when subjected to relevant efforts | All tested samples meet specifications. The STERN FIX system has an adequate biomechanical behavior when subject to relevant efforts. |
| Cadaver testing | Correct device implantation verified; Adequate performance and safety demonstrated | Correct devices implantation is verified in a simulated real-life situation. The devices show adequate performance and safety. |
2. Sample Sizes and Data Provenance
The document does not specify the exact sample sizes used for the functional, biomechanical, or cadaveric testing. It consistently refers to "All tested samples," but the number of samples is not provided.
- Test Set Sample Size: Not specified.
- Data Provenance: The studies appear to be in-house or contracted laboratory testing based on the context. No country of origin is mentioned, nor is it specified if the data is retrospective or prospective. Given the nature of the testing (functional, biomechanical, cadaveric), it's inherently prospective data generation for this submission.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
For the cadaver testing, it mentions "Correct devices implantation is verified in a simulated real-life situation," which implies assessment by individuals with expertise in surgical procedures or device implantation, but their specific qualifications or number are not detailed. For the other tests (breaking strength, fatigue, lateral distraction), "ground truth" refers to the measured physical properties against established engineering specifications, rather than expert interpretation of medical images or observations.
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective measurements of physical properties (e.g., breaking strength, fatigue resistance) or direct observation of device implantation in cadavers, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed to support this submission." The studies were limited to performance testing (functional, biomechanical, cadaveric) in a non-clinical setting.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Stern Fix Sternal Stabilization System is a physical medical device (an implant for sternal closure), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not relevant to this device.
7. Type of Ground Truth Used
- Functional and Biomechanical Testing: The ground truth is based on engineering specifications and physical measurements (e.g., in a material testing machine) which determine if the device meets required strength, durability, and resistance parameters.
- Cadaver Testing: The ground truth is the successful and correct implantation of the device in a simulated real-life situation, likely assessed by observing the implementation and stability of the device during and after placement. This would be observed performance against an expected surgical/mechanical outcome.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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.