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The Swemed Follicle Aspiration Sets are intended to be used to obtain gametes from the body. The Swemed Follicle Aspiration Sets are indicated for use in flushing and/or aspiration of oocytes from ovarian follicles.

The Swemed Follicle Aspiration Sets are designed with either a single lumen which is capable for aspiration from the follicle or a double lumen which is capable of aspiration and flushing of sterile medium through the outer lumen up to the follicle. The needle has a beveled tip provided with shallow grooves to improve ultrasound image enhancement. The needle are supplied with a protective tube on the tip, which must be removed before use. The needles have inner diameters of 0.8 - 1.2 mm and outer diameters of 1.47 - 1.65 mm, which approximates a 16 and 17 gauge needle, respectively. The needle length ranges from 25 to 35 cm. The set is packed in an inner and outer wrapping, and steam sterilized.

The provided text focuses on the 510(k) summary for the Swemed Follicle Aspiration Set, demonstrating its substantial equivalence to a predicate device. This type of submission relies on comparisons to existing legally marketed devices rather than extensive new clinical studies with detailed acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, specific studies, ground truth establishment, and expert involvement are not present in this document.

Here's a breakdown of the information that can be extracted and a clear indication of what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) submission for the Swemed Follicle Aspiration Set is based on demonstrating substantial equivalence to a predicate device (Cook OB/GYN Ovum Pick-Up Aspiration Needles). Substantial equivalence means the device is as safe and effective as a legally marketed predicate device, not that it met specific quantitative performance criteria in a de novo study with acceptance thresholds. The document states:

"The Swemed Follicle Aspiration Sets and the Cook Ovum Pick-Up Needles share the exact same intended use: to obtain oocytes from the body and the exact same indication for use: flushing and/or aspiration oocytes from ovarian follicles. Except for four minor features, the Swemed Follicle Aspiration Sets and the Cook Ovum Pick-Up Needles are nearly identical. ... These minor differences do not affect the safety or effectiveness of the device."

This implies that the "acceptance criteria" were met by demonstrating that the device's technological characteristics and intended/indications for use are sufficiently similar to a device already deemed safe and effective, and that the minor differences do not negatively impact safety or effectiveness. No specific performance metrics (e.g., aspiration efficiency, follicle retrieval rate) are provided or compared.

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

This information is not provided. The document describes the device's features and its proposed equivalence to a predicate device, but it does not detail any specific clinical testing or studies with a "test set" in the context of typical AI/diagnostic device validation. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided. As no specific test set or study is detailed, there's no mention of experts establishing a ground truth.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study and, crucially, this device is a medical instrument (needles), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as the device is a medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

This information is not provided. Since the submission relies on substantial equivalence and not a de novo performance study, there's no detailed discussion of ground truth. The "ground truth" implicitly references the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

This information is not provided. As this is not an AI/algorithmic device, there would be no "training set."

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

This information is not provided and is not applicable for this type of device and submission.

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