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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."

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.

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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.

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