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Sydney IVF PVP is intended for use as an aid in the immobilization of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

Sydney IVF PVP is a 10 % polyvinylpyrrolidine solution in a bicarbonate buffered media supplemented with 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. Sydney IVF PVP is ready to use after equilibration to 37℃ and 6% CO2. It is designed to be used by professionals within Assisted Reproduction. This solution is an aseptically filtered sperm medium containing 10% polyvinylpyrrolidone. The PVP increases the viscosity of the solution to facilitate the capture of motile sperm for intracytoplasmic sperm injection (ICSI) procedures during Assisted Reproduction Techniques (ART) procedures. Sydney IVF PVP is provided in glass vials with FluroTec coated rubber stoppers held in place with a tamper evident seal. It is available in a 5 pack carton box with each vial containing 200 µL Sydney IVF PVP.

This document is a 510(k) premarket notification for a medical device called Sydney IVF PVP, which is a sperm immobilization medium. The purpose of the submission is to demonstrate that the new Sydney IVF PVP is substantially equivalent to a previously cleared predicate device (also named Sydney IVF PVP, K031304).

Based on the provided text, a conventional "study" to rigorously prove device performance against acceptance criteria in the manner of a clinical trial or AI model validation has not been performed or described for this specific submission. Instead, the submission relies on demonstrating substantial equivalence by comparing the technological characteristics and performance specifications of the new device to its predicate.

Here's an analysis of the requested information, understanding that "device performance" in this context refers to manufacturing and quality control parameters rather than a clinical outcome measure, and that the "study" is a stability study:

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

2. Sample size used for the test set and the data provenance

The document does not explicitly state the "sample size" for the stability studies in terms of number of lots or individual units tested for each time point or parameter. It refers to "stability studies" in the plural, implying multiple tests. The provenance of the data is implied to be from the manufacturer, William A. Cook Australia Pty Ltd. The studies are prospective in the sense that they are assessing the stability of the manufactured product over time.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the "ground truth" for these tests (e.g., endotoxin levels, sterility, MEA results) would be based on validated laboratory reference methods and defined thresholds, not expert consensus or clinical interpretation.

4. Adjudication method for the test set

Not applicable. Laboratory results are typically objective and either pass or fail predefined specifications.

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

Not applicable. This is not an AI-powered diagnostic device, but a medical medium used in assisted reproduction.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance data (stability studies) is based on predefined analytical specifications and validated laboratory testing methods for parameters like endotoxin levels, sterility, and embryo toxicity (MEA).

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device submission, as it does not involve machine learning or diagnostic algorithms.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

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Sydney IVF™ PVP consists of a sperm medium containing 10% Polyvinylpyrrolidone (PVP) and is intended for use as an aid in the immobilization and isolation of indivudal sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

Sydney IVE™ PVP is an aqueous solution containing 10% polyvinylpyrrolidone (PVP), and is used to reduce the motility of sperm and make it easier to collect them with an ICSI Pipette. Sydney IVF™ PVP is provided in glass vials with FluroTech-coated stoppers available in 200 µL fill volumes.

The provided text is a 510(k) summary for a medical device called Sydney IVF™ PVP, which is a sperm immobilization medium. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance studies for the device itself against predefined metrics.

Therefore, many of the requested details about acceptance criteria, performance metrics, ground truth, and study design are not explicitly available in the provided text. The document primarily states that the device was "subjected to testing to assure biocompatibility and satisfactory operating performance" and "passed the requirements of all tests," but it does not specify what those tests were, what acceptance criteria were used, or the results.

Here's an attempt to answer your questions based on the limited information provided:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary does not include a detailed table of acceptance criteria and reported device performance in the way one would typically find for a diagnostic or AI-powered device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the device "passed the requirements of all tests." However, explicit numerical or qualitative acceptance criteria and the specific results achieved are not detailed in this summary.

2. Sample size used for the test set and the data provenance

This information is not provided in the 510(k) summary. The document does not describe specific clinical or in-vitro test sets with sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the 510(k) summary. The nature of the device (a sperm immobilization medium) suggests that validation would likely involve laboratory-based assays rather than expert interpretation of medical images or data.

4. Adjudication method for the test set

This information is not provided in the 510(k) summary.

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

This information is not applicable/provided. The device is a "sperm immobilization medium," not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This information is not applicable/provided. The device is a chemical medium, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The type of "ground truth" for a sperm immobilization medium would likely be established through laboratory-based assays and functional testing to confirm its ability to immobilize sperm and its biocompatibility. However, the specific methodology is not detailed in this summary.

8. The sample size for the training set

This information is not applicable/provided. The device is a chemical medium, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable/provided for the reasons stated in point 8.

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