(92 days)
The ESTECH Clearview™ MV Atrial Depressor is intended to remove excess fluids from the surgical field for filtering and return to the patient during cardiopulmonary bypass of up to 6 hours. It can also be used to retract tissue to increase visibility.
The Estech Clearview™ MV Atrial Depressor is a sterile, single use, surgical instruments intended for the collection of blood and other fluids from the surgical field for return through the cardiotomy system during open heart surgery. The a molded polymer proximal connector is intended to connect into cardiopulmonary bypass system to return blood and fluids into the extracorporeal circulation circuit, most typically during stoppedheart surgical procedures. The Estech Clearview™ MV Atrial Depressor has an integrated shaft designed to connect to the Estech Small Incision Retractor. The retractor creates access to the surgical field via thoracotomy or mini-sternotomy. When mounted to the retractor, the Estech Clearview™ MV Atrial Depressor can also be used to retract tissues while collecting fluids.
The provided text describes a medical device, the ESTECH Clearview™ MV Atrial Depressor, and its regulatory submission. It does not contain information about acceptance criteria for device performance, nor details of a study (clinical or otherwise) proving it meets such criteria. The document is primarily a 510(k) summary for regulatory approval, focusing on substantial equivalence to predicate devices, biocompatibility, and preclinical performance data.
Therefore, I cannot provide the requested information. The text explicitly states "Preclinical performance data was supplied to demonstrate that the Estech Clearview™M MV Atrial Depressor can meet its labeled performance claims, and to demonstrate substantial equivalence with the predicate device," but it does not provide the details of this data or the specific acceptance criteria.
The questions you've asked (about sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, etc.) are typical for studies assessing the diagnostic accuracy or effectiveness of AI/imaging devices. The device described here is a surgical instrument for fluid collection and tissue retraction, and its performance evaluation would likely focus on different metrics (e.g., fluid collection rate, suction integrity, material strength, biocompatibility, ease of use in a surgical setting) rather than accuracy against a ground truth in an AI context.
§ 870.4420 Cardiopulmonary bypass cardiotomy return sucker.
(a)
Identification. A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.