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Sydney IVF Culture Oil is intended for use as an oil overlay for culture of gametes, zygotes, or embryos in assisted reproduction technology (ART) and micro-manipulation procedures.

Sydney IVF Culture Oil is designed to protect gametes and embryos during ART processing by providing a barrier between the embryo culture media and the air, thereby minimizing evaporation, and reducing fluctuations in osmolality. Sydney IVF Culture Oil consists of pharmaceutical grade mineral oil.

Sydney IVF Culture Oil is provided in glass vials (50 ml). This product is a single use, aseptically-filtered device.

The Sydney IVF Culture Oil is intended for use as an oil overlay for the culture of gametes, zygotes, or embryos in assisted reproduction technology (ART) and micromanipulation procedures. The study was conducted to expand the shelf-life of the device from 90 days to 20 weeks when stored at 2-8℃.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the exact number of units of Sydney IVF Culture Oil tested for the shelf-life study. It refers to a "real-time shelf-life study."
• Data Provenance: The study was conducted by William A. Cook Australia Pty Ltd in Australia. It is a prospective, real-time shelf-life study.

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

Not applicable. This device is not an AI/imaging diagnostic device requiring expert interpretation for ground truth. The acceptance criteria are based on standardized laboratory assays (MEA, LAL, Sterility).

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established by objective laboratory assays, not expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a culture oil, not an AI diagnostic tool, and therefore human reader performance is not relevant.

6. Standalone Performance

Yes, a standalone performance study was done in the form of a real-time shelf-life study. This study evaluated the performance of the device (Sydney IVF Culture Oil) itself against pre-defined specifications without human intervention or interpretation as part of the primary outcome.

7. Type of Ground Truth Used

The ground truth used for the acceptance criteria are:

• Mouse Embryo Assay (MEA): A biological assay, an established standard for assessing the suitability of materials for embryo culture, providing an objective measure of embryo development.
• Endotoxin (LAL): A chemical assay (Limulus Amebocyte Lysate assay), a standard method for detecting bacterial endotoxins.
• Sterility: A microbiological test, an established standard for confirming the absence of viable microorganisms.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning device that requires a training set. The study pertains to the physical and biological stability of a manufactured product over time.

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

Not applicable, as there is no training set for this type of device.

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The Sydney IVF Culture Oil is intended for use as an oil overlay for culture of gametes, zygotes, or embryos in assisted reproduction technology (ART) and micromanipulation procedures.

Sydney IVF Culture Oil consists of colorless mineral oil, and is provided in glass vials with silicone rubber stoppers. The Sydney IVF Culture Oil will be available in 200 mL fill volumes.

The provided text describes a 510(k) premarket notification for the "Sydney IVF Culture Oil" device. However, it does not include detailed information regarding specific acceptance criteria, a formal study design, or quantitative performance data typically associated with studies demonstrating a device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device. It states, "The Sydney IVF Culture Oil was subjected to testing to assure satisfactory operating performance. The Sydney IVF Culture Oil passed the requirements of all tests." This is a general statement and lacks the specificity required to answer most of your detailed questions.

Therefore, for many of your points, the answer will be that the information is not provided in the given text.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not provided.
• Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). While the device name includes "Sydney IVF," the document does not specify where the testing data originated or its nature (e.g., in-vitro studies, animal studies, human clinical data).

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

• This type of information is not applicable to the submission for this device. The submission does not describe a study involving expert assessment of a test set to establish ground truth. The device is a culture oil, not an diagnostic imaging device or an AI algorithm requiring human interpretation.

4. Adjudication Method for the Test Set

• Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, often with or without AI assistance. This device is a culture oil for IVF procedures.

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

• Not applicable. This device is a culture oil, not an algorithm.

7. The Type of Ground Truth Used

• Not explicitly stated in terms of "ground truth" as typically understood in diagnostic studies. The "tests" mentioned likely refer to quality control tests relevant to a culture medium, such as sterility, pH, osmolality, and possibly performance in culturing gametes/embryos, but the specific metrics are not detailed. The "ground truth" would be objective measurements against predefined specifications for these quality parameters.

8. The Sample Size for the Training Set

• Not applicable. This device is a culture oil, not a machine learning model that requires a training set.

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

• Not applicable. See point 8.

Summary of Device and Approval:

The submission K022002 for "Sydney IVF Culture Oil" is a 510(k) premarket notification. The core of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (63 FR 48428, September 10, 1998, a reproductive media and supplement). The review process determined that the device is substantially equivalent based on intended use and technological characteristics. The document mentions that testing was conducted and the device "passed the requirements of all tests" to assure satisfactory operating performance, but it does not provide specifics about these tests, the acceptance criteria, or the study design and results in detail. This type of submission generally relies more on comparing the new device's specifications and performance to known characteristics of the predicate rather than presenting extensive, detailed clinical trials or performance studies with defined acceptance criteria in the way you've outlined.

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