(111 days)
The HEARTSTRING III Proximal Seal System is intended for use by Physicians during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis to the aorta without application of an aortic clamp.
The HEARTSTRING III Proximal Seal System is a device designed to enable the creation of a proximal anastomosis of a vessel graft to the aorta without the need for an aortic clamp during coronary artery bypass graft (CABG) surgery. The HEARTSTRING III Proximal Seal System is comprised of the Proximal Seal, Delivery Device, Loading device and Aortic Cutter. The HEARTSTRING III Seal is a device that is delivered into the aorta via an aortotomy created by the Aortic Cutter and provides a sealed region to facilitate the proximal anastomosis. The Delivery Device is a syringe-like tube with plunger that is used to deploy the HEARTSTRING III Seal inside of the aorta. The Loading Device is a mechanism that rolls the HEARTSTRING III Seal and loads the HEARTSTRING III Seal into the Delivery Device. The Aortic Cutter is a single use (one aortotomy) device that consists of a Grip, a Cutter, Aortic Stop, a Cap, a Needle, a Safety Lock and an Actuation Button. It is used to create the aortotomy for the anastomosis.
The provided text does not contain detailed acceptance criteria and a study to prove its performance in the format requested. This document is a 510(k) summary for the HEARTSTRING III Proximal Seal System, which focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it states:
- Acceptance Criteria (Implied): Functionality and performance characteristics of the proposed device are comparable to the currently marketed HEARTSTRING III Proximal Seal System (predicate device).
- Reported Device Performance: "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed HEARTSTRING III Proximal Seal System."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality comparable to predicate device | Functionality demonstrated to be comparable to predicate device |
| Performance characteristics comparable to predicate device | Performance characteristics demonstrated to be comparable to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "in-vitro tests" but provides no details on the number of samples or tests conducted.
- Data Provenance: Not specified. The tests were "in-vitro," meaning conducted in a lab environment, but the location or whether the data was retrospective/prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of testing described (in-vitro performance tests for a medical device). "Ground truth" in this context would typically refer to objective measurements of the device's physical and functional properties, not expert consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is usually relevant for human-read evaluations or clinical trials, not for in-vitro performance testing of a device's mechanical or functional properties.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was mentioned. The device described is a surgical tool, not an AI-assisted diagnostic or interpretive system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical instrument and does not involve an algorithm or AI. The performance discussed is the device's own functionality.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "in-vitro tests," the "ground truth" would be the objective measurements of the device's physical and functional properties, as compared to established specifications for the predicate device. Details of these specific measurements are not provided in this summary.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 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).