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Sydney IVF Embryo Biopsy Medium is intended for use in assisted reproduction technologies to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis.

Sydney IVF Embryo Biopsy Medium is bicarbonate based, free of calcium and magnesium to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis of the embryo. Embryos are placed in this medium for approximately five minutes to break down gap junctions between blastomeres. One or two blastomeres are removed, and the embryo is then returned to Cleavage Medium or Blastocyst Medium for further culture.

Sydney IVF Embryo Biopsy Medium contains Human Serum Albumin (5 mg/mL) and Gentamicin (0.01 mg/mL). The device is available as a 20 mL fill only.

The Sydney IVF Embryo Biopsy Medium is provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sydney IVF Embryo Biopsy Medium, incorporating the requested information where available:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on the comparison to a predicate device and stability studies. Specific, quantified acceptance criteria for clinical performance are not explicitly stated in a typical format (e.g., sensitivity, specificity). Instead, the performance is demonstrated through meeting established specifications and validating shelf-life.

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

The document describes stability studies as the primary performance validation.

• Sample Size for Test Set: Not explicitly stated for each specific test (e.g., number of vials tested for endotoxin, number of MEAs performed). However, stability studies typically involve multiple samples tested at various time points.
• Data Provenance: Not explicitly stated. The manufacturer is William A. Cook Australia Pty Ltd, so the testing likely occurred in Australia or through their designated testing facilities. The study appears to be prospective with regard to the shelf-life validation, as the product's performance was evaluated over time to determine its stability.

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

• This information is not provided in the document. The device is a culture medium, and its performance is assessed against physical, chemical, and biological specifications rather than through expert interpretation of clinical outcomes directly from the medium's use. The "ground truth" for the tests (e.g., what constitutes an acceptable osmolality reading) would be based on established scientific and regulatory standards for reproductive media.

4. Adjudication Method for the Test Set

• This information is not provided and is generally not applicable to this type of device and testing. Performance appears to be assessed against predefined quantitative specifications (e.g., numerical ranges for pH, osmolality, endotoxin).

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive devices that assist human readers. The Sydney IVF Embryo Biopsy Medium is a laboratory reagent, not an AI or diagnostic tool.

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

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

7. The Type of Ground Truth Used

• The "ground truth" for the performance validation relies on:
  • Validated laboratory methods and established specifications: For chemical (pH, osmolality, proline, pyruvate, ammonia), physical (sterility), and biological (endotoxin, Mouse Embryo Assay for embryo toxicity) tests.
  • Predicate device characteristics: The similar chemical formulation and performance specifications (osmolality, endotoxin, MEA) of the previously cleared predicate device K023850 served as a benchmark for comparison.

8. The Sample Size for the Training Set

• Not applicable. As this is a biological/chemical product evaluated through laboratory testing and stability studies, there is no "training set" in the context of machine learning or AI models. The testing involved samples of the manufactured medium.

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

• Not applicable. (See point 8).

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Sydney IVF Embryo Biopsy Medium is intended for use in assisted reproduction technologies to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis.

Sydney IVF Embryo Biopsy Medium is an aqueous solution containing electrolytes and buffering agents, and is provided in glass vials with silicone rubber stoppers. Sydney IVF Embryo Biopsy Medium will be available in 20 mL fill volumes.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document describes a traditional medical device (culture medium), not an AI/ML powered device. As such, many of the typical AI/ML study components (like expert consensus, ROC curves, multi-reader studies, etc.) are not applicable here.

Device Name: Sydney IVF Embryo Biopsy Medium

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly list numerical acceptance criteria or performance metrics because it's a traditional device submission focused on "substantial equivalence" to a predicate, rather than an AI/ML device with performance benchmarks.

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

This information is not provided in the document. For a traditional medical device like a culture medium, the "test set" would likely refer to batches of the product manufactured and subjected to quality control and performance testing (e.g., pH, osmolarity, sterility, and potentially cell culture performance). The document only states that the device was "subjected to testing." Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of device.

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

This information is not applicable and not provided. For a culture medium, ground truth isn't established by human experts in the same way it would be for diagnostic imaging. Performance is typically assessed through laboratory tests and functional assays.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication typically refers to resolving disagreements among multiple human readers or experts, which is not relevant for testing a laboratory medium.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving interpretation by human readers. It is not applicable to a culture medium.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical culture medium, not an algorithm. Therefore, a standalone algorithm performance study was not done.

7. Type of Ground Truth Used

The concept of "ground truth" as it applies to AI/ML or diagnostic performance is not directly applicable here. For this type of device, the "ground truth" or standard of comparison relies on established scientific and manufacturing standards for culture media, and comparison to the predicate device's expected performance in supporting IVF procedures. This would likely involve:

• Physicochemical standards: pH, osmolarity, endotoxin levels, sterility, etc.
• Functional assays: Ability to support cell viability, growth, and development (e.g., embryo development in vitro).

8. Sample Size for the Training Set

This information is not applicable and not provided. "Training set" is a term used in machine learning. This device is a physical product, not an AI model, and therefore does not have a training set.

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

This information is not applicable and not provided. As there is no training set for a physical culture medium, the concept of establishing ground truth for it is irrelevant.

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