(266 days)
The TigerPaw Pro 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, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
The TigerPaw Pro is a flexible, implantable occlusion fastener to be placed on the ostium of the left atrial appendage (LAA) during open cardiac surgical procedures. TigerPaw Pro consists of a Fastener implant that is pre-loaded onto a Delivery Tool and is for single use only. It is designed to provide an alternative to conventional suture and surgical staplers for occlusion of the ostium of the LAA. The TigerPaw Pro implantable fastener comes in two lengths; 35mm and 45mm. Surgeon judgment based on patient anatomy should determine what length fastener to apply.
The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary for the TigerPaw Pro Left Atrial Appendage Occlusion Fastener and Delivery Tool, which outlines the device's indications for use, technological characteristics, and safety and performance testing conducted to demonstrate substantial equivalence to a predicate device.
While it mentions various performance tests and an animal study, it does not provide:
- A table of acceptance criteria and reported device performance: The document lists several performance tests (e.g., ability to completely close the fastener, tensile strength of barbs, force required to actuate, corrosion testing) but does not present specific quantitative acceptance criteria or their corresponding results in a table format.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, or how ground truth was established for these specific criteria. The animal study details the sample size (7 canines) and that a board-certified pathologist performed the necropsy, indicating the ground truth assessment method. However, these details are for the animal study, not explicitly linked to acceptance criteria in the tabular form or for a human-in-the-loop or standalone AI performance study.
Information that is present regarding studies and their findings:
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GLP Animal Study:
- Sample size: 7 canines.
- Data provenance: Acute Good Laboratory Practices (GLP) animal study.
- Ground truth experts: Board-certified pathologist for full necropsy examination of local tissues post device implantation.
- Ground truth type: Pathology and visual assessment of the device's usability, safety, and performance during and after deployment.
- Results: "All acceptance criteria were met for this animal study performed using the market version of this device."
- Purpose: To evaluate the usability of the device and the risk of tissue injury on the LAA during deployment and securement of the fastener.
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Performance Testing (In-vitro):
- Included tests such as:
- Ability to completely close the fastener after deployment and prevent leakage from a mock LAA.
- Tensile strength of individual fastener barbs after closure.
- Assessment of Delivery Tool jaw component characteristics (e.g., angle measurements).
- Force required to actuate the Delivery Tool trigger, unlock button, and torque for shaft rotation.
- Corrosion testing (ISO 10555-1 Annex A).
- Comparison of TigerPaw II and TigerPaw Pro's tool jaw resistance to flexure on a worst-case thickness mock LAA ostium.
- Comparison of TigerPaw II and TigerPaw Pro's ability to deploy and secure fasteners under different worst-case rotational forces on a mock ostium.
- Results: "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the previously cleared TigerPaw System II."
- Included tests such as:
The document concludes that "The performance and other testing established that the TigerPaw Pro is substantially equivalent to the predicate device," but it does not provide the specific acceptance criteria and detailed quantitative results for each test in a format that directly addresses all parts of your request.
§ 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.