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The COOK® Ultra Quiet Vacuum Pump & Regulator is intended for the aspiration of eggs (ova), during assisted reproduction procedures using low flow, intermittent vacuum.

The COOK® Ultra Quiet Vacuum Pump & Regulator provides high vacuum, ranging from -30 to -300 ± 5 mmHg, low flow aspiration.

The provided 510(k) Premarket Notification for the COOK® Ultra Quiet Vacuum Pump & Regulator does not contain a study that establishes performance against acceptance criteria in the manner typically found for novel diagnostic devices or algorithms.

Instead, this submission is for a medical device (a vacuum pump and regulator) that is demonstrating substantial equivalence to a predicate device. The "Discussion of Tests and Test Results" section primarily focuses on technical safety and performance, rather than clinical efficacy measured by metrics like sensitivity, specificity, or accuracy.

Here's an analysis based on the provided text, addressing the requested information where applicable, and noting where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a "test set" in the context of clinical data or patient samples. The testing mentioned refers to electromagnetic compatibility (EMC) and device specifications. Therefore, sample size, data provenance (country of origin, retrospective/prospective), and related details are not applicable as these types of clinical studies were not performed or reported.

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

Not applicable. As noted above, this submission focuses on device design and technical safety/performance, not clinical diagnostic accuracy requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or ground truth adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. An MRMC study is not mentioned or implied in the submission. This type of study is more relevant for diagnostic imaging or interpretation algorithms where human readers' performance is being evaluated or augmented by AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This device is a physical medical device (vacuum pump), not a software algorithm or AI, so the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device relates to its electrical and mechanical performance specifications and safety standards (e.g., electromagnetic compatibility). The ground truth for these tests would be the established engineering/safety standards themselves, not clinical outcomes or pathology.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this device is a physical product and not an AI/machine learning algorithm that requires a training phase.

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

Not applicable, as there is no training set mentioned.

Summary of the 510(k) Submission's Approach:

The 510(k) for the COOK® Ultra Quiet Vacuum Pump & Regulator primarily demonstrates substantial equivalence to a predicate device. The "Discussion of Tests and Test Results" focuses on:

• Technical Specifications: The device provides high vacuum ranging from -30 to -300 ± 5 mmHg and low flow aspiration.
• Safety Testing: Specifically, electromagnetic compatibility (EMC) testing was performed, and the device passed all requirements.

The conclusion is that the device is "similar, with respect to intended use and technological characteristics, to the FDA published predicate device description." This type of submission relies on demonstrating that the new device shares fundamental technological characteristics and performs within established safety and functional parameters, similar to an already cleared device, rather than requiring extensive new clinical efficacy studies with ground truth establishment in the way AI or diagnostic algorithms would.

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