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The Lifetek Medical Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for use and intended to be used for obtaining female gametes/oocytes from the body.

The Oocyte Retrieval Needle Set is used in In-Vitro Fertilization (IVF) procedures to obtain female gametes/oocytes from the body. It is a single-lumen needle of the proper length and diameter. Some physicians experienced in this procedure prefer a 17 ga x 35 cm needle which complies to the government specification GG-N-196. For convenience the needle is provided with PTFE connecting tubes and a silicone stopper.

This 510(k) summary describes a medical device, not a software algorithm, therefore, some of the requested information regarding AI/ML device performance and testing is not applicable.

Here's the analysis of the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the "Oocyte Retrieval Needle Set" does not explicitly state quantitative acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity, which are common for AI/ML devices. Instead, it focuses on biocompatibility and sterility/endotoxin levels for the physical device.

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

Not applicable. The testing described is for the physical device's biocompatibility and endotoxin levels, not for a software algorithm that would typically involve a "test set" of data. The "tests" here refer to laboratory assays performed on the device materials.

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

Not applicable. Ground truth, in the context of expert consensus, is typically established for diagnostic or prognostic AI/ML applications where human experts interpret medical images or data. For a physical medical device, "ground truth" is typically defined by standardized laboratory methods and regulatory guidelines.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies among expert interpretations in diagnostic studies, which is not relevant for the biocompatibility and endotoxin testing of a physical device.

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

No. This study is for a physical medical device (an oocyte retrieval needle), not an AI/ML device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

No. This study is for a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's assessment is based on:

• Standardized Biocompatibility Testing: Per ISO 10993, Part 1, for "external communicating device" for tissue contact.
• Mouse Embryo Assay (MEA): A specific biological assay required for devices coming into contact with gametes/embryos.
• Bacterial Endotoxin Assay: A standardized test to quantify endotoxin levels.

These are established laboratory and biological testing standards, rather than expert consensus on medical cases or pathology review.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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