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The TigerPaw® System II is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).

The TigerPaw® System II consists of an implantable Fastener and Delivery Tool designed for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. The Fastener is composed of linearly spaced connectors overmolded with a soft silicone. The spacing between the connectors along with the silicone gives the Fastener an ability to conform to the anatomy and exclude the LAA. The TigerPaw System II also includes a hand-held disposable Delivery Tool. The Delivery Tool consists of a pistol grip handle with two triggers that when separately actuated, close opposing jaws thus mating the two sides of the permanently implanted Fastener, and, then allowing release of the Fastener and opening of the jaws for Delivery Tool removal.

The provided text describes a 510(k) premarket notification for the TigerPaw® System II, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical or AI-driven study.

Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established) are not applicable to this type of submission. This 510(k) is for a modification to an existing device, and the evaluation focuses on bench testing and biocompatibility to show that the modifications do not alter the safety or effectiveness of the device compared to its predicate.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of acceptance criteria with specific quantitative thresholds and corresponding device performance data in a clinical context. Instead, it relies on a comparison to the predicate device and in vitro bench testing for verification.

Evaluation of Sections Not Applicable to a 510(k) for Device Modification:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This submission details in vitro bench testing and biocompatibility assessments, not a clinical study involving human patient data.

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)

• Not Applicable. No human-interpreted "ground truth" was established as there was no clinical study or diagnostic imaging component. The evaluation relied on engineering and biocompatibility testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No clinical test set or subjective interpretation requiring adjudication was involved.

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

• Not Applicable. This is a hardware medical device (implantable fastener and delivery tool), not an AI-based diagnostic tool. No human reader or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. The "ground truth" for the engineering tests would be derived from physical measurements against defined engineering specifications, not clinical outcomes or expert consensus. For biocompatibility, it's adherence to relevant standards.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The testing involved a limited number of devices for bench evaluations.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set.

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The TigerPaw® System is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).

The TigerPaw System consists of an implantable Fastener and Delivery Tool designed for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. The Fastener is composed of linearly spaced connectors overmolded with a soft silicone. The spacing between the connectors along with the silicone gives the Fastener an ability to conform to the anatomy and completely exclude the LAA. The TigerPaw® System also includes a hand-held disposable Delivery Tool. The Delivery Tool consists of a pistol grip handle with triggers that when actuated close jaws that in turn mate the two sides of the permanently implanted Fastener together.

Here's a summary of the acceptance criteria and the study used to demonstrate the device meets those criteria, as extracted from the provided 510(k) summary:

Acceptance Criteria and Device Performance

Note: The document does not explicitly present a table of "acceptance criteria" against which a "device performance" is measured. Instead, it describes "primary effectiveness outcomes" and "secondary effectiveness endpoints" which serve as de facto acceptance criteria. The device's performance is then reported against these.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: 60 patients.
   • Data Provenance: Clinical study, conducted prospectively (implies data collected during the study). The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting it might be a U.S.-based or international multi-center study for U.S. market approval.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document implies that the ground truth for LAA occlusion was primarily established through visual confirmation by the surgeon (peri-operatively) and Transesophageal Echocardiography (TEE). TEE interpretation would typically be performed by a qualified cardiologist or echocardiographer. The specific number of experts or their exact qualifications are not detailed in this summary.

3. Adjudication method for the test set:

   • The document does not explicitly state an adjudication method (like 2+1 or 3+1) for the clinical study's effectiveness outcomes. The TEE assessments and visual confirmations would inherently involve expert interpretation but no multi-reader adjudication process is described.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical implant/tool, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No, a standalone algorithm-only performance study was not done. This is a medical device for surgical intervention, not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Effectiveness Ground Truth:
     • Visual confirmation by the operating surgeon (peri-operative).
     • Transesophageal Echocardiography (TEE) by qualified personnel (peri-operative and at 90 days).
   • Safety Ground Truth:
     • Observation/reporting of adverse events by clinical staff and investigators.
     • Clinical outcomes data (e.g., absence of bleeding/leakage, absence of late AEs).

7. The sample size for the training set:

   • This device is an implantable fastener system, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's development would have involved pre-clinical testing (bench, animal, cadaver) which could be considered a "training/development" phase for the physical device, but no separate "training set" as understood for AI is mentioned.

8. How the ground truth for the training set was established:

   • As this is not an AI/ML device, there isn't a "training set" in that sense. The "ground truth" for the device's design and functionality would have been established through a combination of:
     • Engineering principles and biomechanical testing (bench testing).
     • Physiological responses and surgical observations (acute and chronic animal studies, cadaver evaluations).
     • Clinical experience and medical knowledge of LAA occlusion requirements.

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