Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Embryo Biopsy Medium is intended for use in assisted reproductive technology procedures that involve the manipulation of embryos. Specifically, Embryo Biopsy Medium is intended for use as a temporary culture medium during embryo biopsy blastomere removal procedures.

Embryo Biopsy Medium is a defined media intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in human fallopian tubes. Embryo Biopsy Medium uses a combination of HEPES/sodium bicarbonate buffering system and is appropriate for those procedures that do not require the use of a carbon dioxide incubator.

The provided text describes the 510(k) summary for "Embryo Biopsy Medium" and its predicate device. This document is a regulatory submission for a medical device and not a study report detailing acceptance criteria for an AI/ML powered device.

Therefore, most of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for AI models, training set details) is not applicable to this document as it pertains to a traditional medical device (a culture medium) and not an AI-powered diagnostic or predictive tool.

However, I can extract the acceptance criteria and the "performance data" as described for this non-AI device.

Acceptance Criteria and Device Performance for Embryo Biopsy Medium

The provided document describes a traditional medical device (a culture medium), not an AI-powered device. Therefore, the typical acceptance criteria and study methodologies for AI/ML devices (e.g., sensitivity, specificity, MRMC studies, training/test sets, expert ground truth) are not applicable.

Instead, the acceptance criteria for this medical device are based on its biological function and safety.

1. Table of Acceptance Criteria and Reported Device Performance

The following sections are Not Applicable (N/A) as this document describes a traditional medical device, not an AI/ML powered device.

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

• N/A. The performance data relies on Mouse Embryo Assays and historical clinical use, not a distinct "test set" in the context of an AI/ML study.

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

• N/A. Ground truth as understood for AI/ML models is not directly applicable here. The "ground truth" for this device's performance is its biological effect (non-toxicity, pH maintenance, support of embryonic growth/manipulation) demonstrated through laboratory assays and established clinical practice.

4. Adjudication method for the test set

• N/A. No adjudication method described as it's not a diagnostic reading task.

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

• N/A. This is not an AI-powered device.

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

• N/A. This is not an AI-powered device.

7. The type of ground truth used

• For the Mouse Embryo Assay (MEA), the ground truth is the observable outcome of embryonic development (e.g., toxicity, normal growth).
• For the pH maintenance, the ground truth is the measured pH value.
• For endotoxin and sterility, the ground truth is the absence or presence of contamination as determined by standard laboratory tests.
• For the intended use claims, the ground truth is established through "historical information contained in professional literature" and "clinical settings for the same intended use."

8. The sample size for the training set

• N/A. This is not an AI-powered device, so there is no training set.

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

• N/A. This is not an AI-powered device, so there is no training set.

Ask a specific question about this device