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Sydney IVF Follicle Flush Buffer is intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection.

Sydney IVF Fertilization Medium is intended for use during in vitro procedures for insemination of oocytes.

Sydney IVF Cleavage Medium is intended for use during in vitro fertilization procedures for culture and transfer of cleavage stage embryos.

Sydney IVF Blastocyst Medium is intended for use during in vitro fertilization procedures for extended culture and transfer of embryos.

The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium are used for processing eggs and embryos during in vitro fertilization procedures.

Sydney IVF Follicle Flush Buffer is used to flush the follicles during oocyte recovery. It contains Gentamicin (0.01mg/mL) and is available in 100 mL vials.

Sydney IVF Fertilization Medium maintains oocytes in a 6% CO2 environment until insemination and fertilization is complete. Sydney IVF Fertilization Medium contains Humans Serum Albumin (HSA) (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20, 50 or 100 mL vials.

Sydney IVF Cleavage Medium facilitates the first two days of embryonic growth post fertilization. Sydney IVF Cleavage Medium contains HSA (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20, 50 or 100 mL vials.

Once an embryo has reached the Day 3 (eight-cell) stage, it is then transferred into Sydney IVF Blastocyst Medium. This medium has been metabolically balanced to maximize blastocyst development rates and is suitable for blastocyst transfer. Sydney IVF Blastocyst Medium contains HSA (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20 or 50 mL vials.

The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium are 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.

This document describes the FDA 510(k) clearance for Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, and Sydney IVF Blastocyst Medium. It is not a study proving a device meets acceptance criteria through clinical trials or performance metrics of an AI/software device. Instead, it demonstrates substantial equivalence to a predicate device based on similar technological characteristics and performance specifications for the storage and use of IVF media.

Therefore, many of the requested elements are not applicable in this context. Here's a breakdown of what can be extracted and what cannot:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify exact sample sizes for the stability tests. It mentions "stability studies" and "stability tests included endotoxin, MEA, pH, osmolality, sterility and the concentrations of pyruvate, amino acids (proline and lysine), and the HSA by-product ammonia." This implies various batches of the manufactured media were tested over time.
• Data Provenance: Not specified, but the manufacturing company is William A. Cook Australia Pty Ltd, so the testing data would likely originate from their facilities. The studies were likely internal validation studies conducted by the manufacturer. Whether retrospective or prospective is not explicitly stated, but stability studies are typically prospective, monitoring product characteristics over time.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable. This is a submission for in vitro fertilization media (a consumable medical device), not a diagnostic device or AI algorithm that requires expert interpretation to establish ground truth for performance. The "ground truth" here is adherence to chemical, biological, and physical specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters, which is not the case here.

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 is not applicable. This submission is for IVF media, not an AI/software device. No human readers or AI assistance are involved in performance evaluation.

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

• No. This is not applicable. This is IVF media, not an algorithm.

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

• The "ground truth" in this context is based on established scientific and regulatory standards for reproductive media, including:
  • Chemical specifications (pH, osmolality, constituent concentrations)
  • Biological specifications (MEA for embryo toxicity, sterility)
  • Physical specifications (shelf-life stability)
• These "ground truths" are not established by expert consensus in a clinical diagnostic sense, but rather by adherence to validated analytical methods and predefined acceptable ranges for critical quality attributes.

8. The sample size for the training set

• This information is not applicable. This is IVF media, not an AI/machine learning device that uses a "training set."

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

• This information is not applicable. No training set exists for this type of device.

In summary, this document is a regulatory submission for a traditional medical device (IVF media) seeking substantial equivalence to a predicate device. It demonstrates compliance through laboratory-based performance testing against predefined specifications, rather than clinical trials or AI algorithm validation studies.

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