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Sydney IVF Hyaluronidase is intended for use to facilitate removal of the cumulus cells surrounding oocytes in assisted reproduction technology (ART) procedures.

Sydney IVF Hyaluronidase is an enzymatic preparation containing 80 IU/mL Hyaluronidase (of ovine origin) in a Bicarbonate buffered media supplemented with 5 mg/mL Human Serum Albumin (HSA) and 10 ug/mL Gentamicin.

Sydney IVF Hyaluronidase is provided sterile (aseptically filtered) and is packaged in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. It is available in a 5 pack carton box with each vial containing 1 mL of Sydney IVF Hvaluronidase.

The provided text describes the Sydney IVF Hyaluronidase device and its substantial equivalence to a predicate device, focusing on its formulation, shelf-life, and performance. However, it does not contain the kind of detailed information typically found in a study demonstrating the device meets specific acceptance criteria with reported device performance against those criteria in a tabular format, nor does it provide information about the methodology of such a study (sample sizes, expert involvement, adjudication, etc.).

The document is a 510(k) summary for regulatory clearance, which primarily focuses on demonstrating substantial equivalence to a previously cleared device. It mentions "performance data" and "stability & shelf life" but doesn't present a formal study report with acceptance criteria and results in the requested format.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance.
• Sample sizes used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study effect size.
• Standalone performance.
• Type of ground truth used (beyond "MEA data").
• Sample size for the training set.
• How ground truth for the training set was established.

However, I can extract the relevant information known about the device's performance based on the document:

The document states that the Sydney IVF Hyaluronidase (the proposed device) and the predicate device (K023353 - Sydney IVF Hyaluronidase) share similar performance specifications and that the proposed device has been validated in stability studies.

Here's what can be pieced together from your request and the provided text:

1. A table of acceptance criteria and the reported device performance:

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Sydney IVF Hyaluronidase is intended for use as to facilitate removal of the cumulus cells surrounding oocvtes in assisted reproduction technology (ART) procedures.

Sydney IVF Hyaluronidase is an aqueous solution containing electrolytes and buffering agents, and is provided in glass vials with silicone rubber stoppers. Sydney IVF Hyaluronidase will be available in 1 mL fill volumes.

The provided documents are a 510(k) Premarket Notification for the Sydney IVF Hyaluronidase. This notification focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way one might find for an AI/ML powered device.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not provided in these documents for the Sydney IVF Hyaluronidase.

The submission confirms that the device was subjected to testing to assure satisfactory operating parameters. However, the specific acceptance criteria for these tests and the detailed results are not disclosed in these public summaries. The overall conclusion is that the device passed the requirements of all tests and is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. The document states "Sydney IVF Hyaluronidase was subjected to testing," but does not specify the sample size of any biological or non-biological test sets, nor their provenance. This is typical for a 510(k) summary, which focuses on demonstrating equivalence rather than presenting raw study data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/Not provided. The nature of the testing described (operating parameters) for this type of medical device generally involves laboratory bench testing and characterization. It would not typically involve expert review in the way an AI diagnostic algorithm would for establishing ground truth in a clinical image dataset.

4. Adjudication Method for the Test Set
Not applicable/Not provided. Adjudication methods are relevant for studies where multiple human readers assess data to establish a consensus ground truth, typically in the context of diagnostic performance. This is not described for the testing performed on Sydney IVF Hyaluronidase.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported. This type of study is specifically relevant for evaluating the impact of AI on human reader performance, which is not pertinent to a product like Hyaluronidase.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. Sydney IVF Hyaluronidase is a medical solution, not a standalone algorithm.

7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI/ML device studies (e.g., expert consensus, pathology, outcome data) is not entirely applicable here. For this device, "ground truth" would refer to established physical, chemical, and biological specifications and performance characteristics demonstrating the solution's ability to facilitate cumulus cell removal safely and effectively, consistent with its intended use and the predicate device. The document states it "passed the requirements of all tests," implying a comparison against predefined quality and performance standards.

8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established
Not applicable. This device is not an AI/ML algorithm.

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