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Provide Low flow regulated negative pressure for general suction and aspiration.

The Craft™ Suction Pumps have been developed to provide a smooth low volume vacuum at variable negative pressure. The device has the same technological characteristics as the predicate device. vacuum being activated by a foot operatual switch controlled by the surgeon. The range of vacuyum being variable from 0-4.50mmHg and adjustable over this range by a pre-set control. Vacuum is provided by a quiet diaphringm pump, working from a mains voltage supply (USA I IOV 60Hz). An overflow bottle provides a mensure of safety to prevent aspirated fluids being drawn into the vacuum power unit. The tran also acting us a reservoir to provide an even vacuum pressure during procedures, The foot control has an air-operated solennid, switching the main purnp unit. No electrical connections are made to the sealed foot operated control.

The provided text is a 510(k) summary for a medical device submitted to the FDA in 1997. It describes a "Craft™ Suction Pump" and "Craft™ Duo-Vac Suction Pump" by Rocket Medical plc.

Based on the provided text, a detailed answer to your request regarding acceptance criteria and study information is not available. The document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a performance study with detailed acceptance criteria and results.

Here's a breakdown of what can and cannot be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not available in the provided text. The document states, "The device is indicated for use to provide low flow regulated negative pressure for general suction and aspiration. These devices are safe and effective for the above application and have been tested to confirm there safety and effectiveness in this format for over 12 years, without incident in the UK." This is a general statement about safety and effectiveness, but it doesn't specify quantitative acceptance criteria (e.g., specific vacuum levels, flow rates with tolerances) or provide measured performance data from a formal study.

2. Sample Size Used for the Test Set and Data Provenance:

• Not available. The document mentions "tested to confirm there safety and effectiveness in this format for over 12 years, without incident in the UK." This implies historical data or market experience, but not a specific test set with a defined sample size or detailed provenance. It's likely referencing post-market surveillance or general clinical use over time.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not applicable/Not available. There is no mention of a test set with an established ground truth using experts in this document. Substantial equivalence claims typically rely on comparing device specifications and indications for use to a legally marketed predicate device, rather than on expert-adjudicated test sets for performance.

4. Adjudication Method for the Test Set:

• Not applicable/Not available. As there's no mention of a test set requiring ground truth establishment, no adjudication method is discussed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, not performed according to the document. This type of study would compare human reader performance with and without AI assistance, which is not relevant for a suction pump device or the regulatory pathway taken (510(k) for substantial equivalence based on existing predicate).

6. Standalone (Algorithm Only) Performance Study:

• No, not applicable. This device is a physical medical device (suction pump), not an algorithm or AI system. Therefore, a standalone algorithm performance study would not be relevant.

7. Type of Ground Truth Used:

• Not applicable in the context of a formal performance study for this submission. The "ground truth" for this 510(k) submission is the demonstration of substantial equivalence to predicate devices, supported by the device's design, materials, and intended use being similar to those already on the market. The claim of "tested to confirm their safety and effectiveness... for over 12 years, without incident in the UK" suggests real-world performance as an anecdotal "ground truth" for safety and effectiveness, but not a formally established ground truth for a specific test set.

8. Sample Size for the Training Set:

• Not applicable/Not available. As this is a physical medical device and not an AI/ML product, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

In summary, the provided document is a regulatory submission for a physical medical device (suction pump) aiming for 510(k) clearance based on substantial equivalence. It does not provide the detailed study results, acceptance criteria, or ground truth information typically associated with performance studies for certain types of medical devices (e.g., diagnostic imaging, AI/ML products). The "testing" mentioned refers to general safety and effectiveness observed over years in the UK, rather than a specific, controlled study with defined metrics.

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