(221 days)
DOLPHIN Inflation Device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.
DOLPHIN is a single-use, sterile, and ergonomically designed inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc).
The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device.
Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device.
All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.
The provided document is a 510(k) summary for the "DOLPHIN Inflation Device". It is a premarket notification for a medical device and describes its indications for use, technological characteristics, and how its substantial equivalence to predicate devices was demonstrated. However, this document does not contain acceptance criteria or detailed study data to prove device performance against such criteria in the way typically expected for an AI/ML device or a device requiring specific performance metrics like sensitivity/specificity for a diagnostic tool.
Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device (Indeflator 20/30) based on intended use, conditions of use, design, materials, packaging, sterilization, and location. The "Performance Data" section briefly states that "The safety and efficacy of DOLPHIN has been demonstrated through a variety of preclinical tests and analyses, as well as non-clinical comparisons to the Indeflator 20/30." It does not provide specific numerical acceptance criteria or detailed results of these tests.
Therefore, I cannot populate the requested table and answer the study-specific questions as the detailed information on acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/ML device are not present in this 510(k) summary.
The questions you've asked are typical for the evaluation of AI/ML-based diagnostic or prognostic devices, which often require extensive clinical performance studies with specific statistical endpoints. The "DOLPHIN Inflation Device" is a manual, mechanical device (an angiographic injector and syringe) used to inflate and deflate balloon catheters during cardiovascular procedures. Its evaluation for 510(k) clearance primarily focuses on demonstrating its functional equivalence and safety compared to existing devices, rather than establishing diagnostic accuracy metrics.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.