(15 days)
The Proximal Seal System is intended for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
The HEARTSTRING® III Proximal Seal System delivers a hemostatic seal device designed to enable the proximal anastomosis of an aortic graft without the need for an aortic clamp during coronary artery bypass graft (CABG) surgery. The Proximal Seal System is comprised of the Proximal Seal, Delivery Device, Loader and the Aortic Cutter. The proximal Seal is a semi-spherical shaped device that is delivered into the aorta via the punch hole site and provides a sealed region to facilitate the proximal anastomosis. The Loader is a mechanism that rolls the Proximal Seal and loads the Seal into the Delivery Device. The Delivery Device is a plastic injected molded device that is used to deploy the Seal inside of the aorta. The HEARTSTRING® Aortic Cutter creates the aortotomy and hole opening in the aorta for the anastomosis.
This 510(k) summary for the HEARTSTRING® III Proximal Seal System does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a definitive study proving the device meets those criteria. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's description and intended use.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The results of the verification testing demonstrate that the Guidant HEARTSTRING® III Proximal Seal System meet the established acceptance criteria and performs in a manner equivalent to the predicate devices."
However, the actual specific acceptance criteria (e.g., maximum allowable blood leakage, deployment success rate, seal integrity under specific pressures, etc.) and the quantifiable reported device performance against those criteria are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided text. The summary mentions "verification testing" but does not detail the sample size (number of tests, number of devices/simulations, patients, etc.) or the provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not available in the provided text. The nature of this device (a surgical tool for hemostasis) suggests that "ground truth" would likely be established through physical performance testing rather than expert review of data like images.
4. Adjudication Method for the Test Set
This information is not available in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC study is typically performed for devices that involve human interpretation of medical images or data where the AI assists in that interpretation. The HEARTSTRING® III Proximal Seal System is a physical surgical device. Therefore, a MRMC study is not applicable and was not performed.
6. Standalone (Algorithm Only) Performance Study
The HEARTSTRING® III Proximal Seal System is a physical medical device, not an algorithm or AI. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The performance data mentioned refers to the physical device's performance through "verification testing."
7. Type of Ground Truth Used
Based on the nature of the device (a surgical tool for hemostasis), the ground truth for performance testing would likely be based on objective physical measurements and observations during simulations, bench testing, and potentially animal or cadaveric studies. For example, ground truth could involve:
- Absence of bleeding/hemostasis.
- Integrity of the seal under specified pressure.
- Successful deployment.
- Ease of use or deployment time.
- Mechanical strength and durability.
However, the specific methods for establishing ground truth are not detailed in this summary.
8. Sample Size for the Training Set
This information is not applicable as the HEARTSTRING® III Proximal Seal System is a physical device and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).