(109 days)
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.
| Acceptance Criteria (Effectiveness Outcome/Endpoint) | Reported Device Performance |
|---|---|
| Primary Effectiveness Outcome: | |
| Percentage of patients with complete occlusion of the LAA assessed peri-operatively (visually). | Visually confirmed in 60/60 treated patients (100%). |
| Percentage of patients with complete occlusion of the LAA assessed peri-operatively via Transesophageal Echocardiography (TEE). | Confirmed in 56/60 patients. (One patient required adjunctive suture to achieve closure). |
| Percentage of patients with complete occlusion of the LAA assessed at 90 days post-procedure via TEE. | Confirmed in 54/54 evaluable patients followed up (100% of those evaluated at 90 days). |
| Absence of leaks or communication between the LAA and LA at 90 days post-procedure. | Zero leaks or communication observed. |
| Secondary Effectiveness Endpoint: | |
| Assessment of the size of residual LAA cavity remaining after application of the TigerPaw® System compared with a pre-defined target (≤ 6 mm). | Not explicitly reported in this summary, other than 100% complete occlusion at 90 days, which implies meeting this criterion. |
| Primary Safety Outcome: | |
| Rate of device-related adverse (AE) and serious adverse events (SAE) assessed peri-operatively and at 30 days post-procedure. | No unanticipated adverse events. One minor device-related tissue tear, repaired with suture. Zero incidences of bleeding or leakage from the device footprint area. |
| Secondary Safety Endpoints: | |
| Major Adverse Cardiac Event (MACE) rates. | Not explicitly reported in this summary, but implies acceptable rates given overall safety findings. |
| Absence of late device-related AEs at 90 days. | Zero late device-related AEs. |
Study Details
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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.
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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.
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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.
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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.
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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.
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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).
- Effectiveness Ground Truth:
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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.
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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.
- 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:
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.