(90 days)
These instruments are intended for use by qualified surgeons and provide aspiration of fluid and tissue from the surgical site during laparoscopic surgical procedures, and general and endoscopic plastic, reconstructive and aesthetic surgical procedures.
The Karl Storz Unimat 45 and accessories are a aspiration pump with user adjustable aspiration suction underpressure.
This 510(k) submission for the Karl Storz Unimat 45 suction pump does not include a study describing acceptance criteria or device performance in the manner you've requested.
The document is a "510(k) Summary of Safety and Effectiveness" which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies against specific acceptance criteria.
Here's why the requested information cannot be extracted from the provided text:
- No Acceptance Criteria or Performance Data: The document explicitly states: "The Karl Storz Unimat 45 system is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Unimat 45 and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This indicates that the claim for safety and effectiveness is based on similarity to already approved devices, not on new performance testing with defined acceptance criteria.
- Focus on Substantial Equivalence: The core of a 510(k) submission is to argue that a new device is "substantially equivalent" to one or more legally marketed devices (predicates). This often means demonstrating that the device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. This is distinct from conducting a clinical or performance study to prove specific acceptance criteria.
- Device Type: This is a suction pump. For such devices, "performance" is often assessed through bench testing (e.g., flow rate, vacuum pressure) and mechanical safety, which would typically be compared to predicate device specifications or recognized standards, not necessarily through a clinical study with human readers or AI.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth for training data because this information is not present in the provided 510(k) summary. The document is essentially a regulatory declaration of equivalence based on known predicate devices.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.