Search Results

Medium for culture of embryos from fertilization to blastocyst stage

G-TL™ is an aseptically filtered and manufactured bicarbonate-buffered physiological medium ready to use after warming to 37°C and equilibration in a CO2 environment. It is designed to be used by professionals within assisted reproduction. G-TL™ is intended for the culture of human embryos from fertilization to the time of embryo transfer. G-TL™ is contained within a 30ml transparent polyethyleneterephthalate glycol (PETG) bottle with high density polyethylene (HDPE) closures. Both the bottle and box are individually labeled and each box contains a package insert.

The G-TL™ device is a medium for the culture of human embryos. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with acceptance criteria for device performance in human subjects.

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document mentions a "one-cell mouse embryo assay (MEA)" as the test method. However, it does not specify the sample size (i.e., the number of mouse embryos or experiments) used in this assay.
• Data Provenance: The study was an "animal study during product development." It can be inferred that the data is prospective as it was conducted to validate the new device. The country of origin for the data is not explicitly stated, but the submitting company is Vitrolife, Inc. based in Englewood, CO, USA.

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

• Ground truth in this context typically refers to the confirmed outcome against which the device's performance is measured.
• For the technical specifications (pH, osmolality, SAL, endotoxin), the "ground truth" is established by standard laboratory measurement techniques, not human experts.
• For the Mouse Embryo Assay (MEA), the assessment of "expanded blastocyst on Day 5" would involve expert observation and scoring, likely by trained embryologists or laboratory technicians. However, the document does not specify the number or qualifications of experts involved in establishing this ground truth.

4. Adjudication Method for the Test Set

• Given that the MEA involves standardized biological endpoints (percentage of expanded blastocysts), it's unlikely that a formal adjudication method like "2+1" or "3+1" (common in image-based diagnostic studies) would be used.
• The results are likely based on objective counts and percentages validated by direct observation. The document does not describe any specific adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is not relevant for an IVF culture medium. The study performed compared the device to a predicate device using a mouse embryo assay.

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

• The G-TL™ is an IVF culture medium, not an algorithm or an AI device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. Its performance is evaluated through its biological effect on embryos.

7. The Type of Ground Truth Used

• For the technical specifications (pH, osmolality, etc.), the ground truth is based on standard analytical measurements (e.g., pH meters, osmometers, bacterial culture for SAL, LAL assay for endotoxin).
• For the mouse embryo assay, the ground truth is based on biological outcomes (percentage of expanded blastocysts) observed in a controlled in-vitro environment, which in itself serves as an indicator of embryo viability and developmental competence.

8. The Sample Size for the Training Set

• The document does not mention a training set. This is expected as the G-TL™ is a physical culture medium, not an AI model that requires training data. The "animal studies during product development" mentioned could be considered development/optimization studies, but not a "training set" in the machine learning sense.

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

• As there is no training set in the context of an AI device, this question is not applicable to the G-TL™ culture medium.

Ask a specific question about this device

ORIGIO® Sequential Blast™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. ORIGIO® Sequential Blast™ can also be used for embryo transfer.

ORIGIO® Sequential Blast™ (with and without phenol red) is intended for the culture of human embryos from the 4-8 cell stage through to the blastocyst stage and for embryo transfer.

Two versions of ORIGIO® Sequential Blast™ are available:

• Catalogue no. 8305: ORIGIO® Sequential Blast™ .
• . Catalogue no. 8306: ORIGIO® Sequential Blast™ with phenol red

Both versions of ORIGIO® Sequential Blast™ are aseptically filtered, non viscous solutions, light pink or colorless solutions, which are ready to use by professionals within assisted reproduction.

The ORIGIO® Sequential Blast™ media are contained in 10 mL or 60 mL transparent polyethylene terephthalate glycol (PETG) bottles with high density polyethylene (HDPE) closures, available in card board boxes of 1 x 10 mL and 1 x 60 mL bottles. The bottles and boxes are individually labeled. The boxes also contain instruction for use provided as package insert.

The provided document is a 510(k) summary for ORIGIO® Sequential Blast™ and ORIGIO® Sequential Blast™ with phenol red, a reproductive media for culturing human embryos. It focuses on demonstrating substantial equivalence to a predicate device, BlastAssist® (K080172), rather than presenting a study to prove acceptance criteria for a device involving AI or human-in-the-loop performance. Therefore, many of the requested elements are not applicable to this type of submission.

However, I can extract the relevant information regarding acceptance criteria and performance data for this specific medical device (embryo culture media):

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

The document provides a comparison of product specifications between the proposed device (ORIGIO® Sequential Blast™) and the predicate device (BlastAssist®), which serve as the de-facto acceptance criteria for demonstrating substantial equivalence. The reported device performance is indicated by its ability to meet these comparable specifications.

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

The document describes "stability studies" and "Mouse Embryo Assay (MEA) test" as part of the performance data. However, it does not explicitly state the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not applicable as the device is an embryo culture medium, not an AI or diagnostic device requiring expert interpretation of results for ground truth establishment.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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 as the device is not an AI or diagnostic device that would involve human readers.

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

This information is not applicable as the device is not an algorithm or AI system.

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

For this type of device, the "ground truth" or validation is based on:

• Physicochemical properties: Meeting specified pH, osmolality, and endotoxin limits.
• Sterility: Absence of microbial growth.
• Biological performance: Mouse Embryo Assay (MEA) demonstrating proper embryonic development (≥80% 1-cell MEA).
• Stability studies: Showing the product maintains its specifications over its shelf life.

8. The sample size for the training set

This information is not applicable as the device is not an AI or machine learning system that requires a "training set."

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device

These products are intended for the in vitro fertilization and culture of human gametes and embryos from fertilization until Day 5/6 of development. The media can also be used for transfer.

The SAGE 1-Step 11 medium is intended for in vitro fertilization and culture of human gametes and embryos from fertilization until Day 5/6 of development. The medium can also be used for transfer. Two versions of the SAGE 1-Step™ medium are available: Catalogue no. 6701: SAGE 1-Step™ supplemented with Human Serum Albumin. Catalogue no. 6702: SAGE 1-Step™ supplemented with Serum Protein Supplement. Both versions of SAGE 1-Step™ are aseptically filtered, light pink, non viscous solutions, which are ready to use by professionals within assisted reproduction. The SAGE 1-Step™ media products are contained in 10 ml or 60 ml transparent Polyethylene Terephthalate Glvcol (PETG) bottles with high density polyethylene (HDPE) cap, available in a card boxes of 1 x 10 ml and 1 x 60 ml bottles. The bottles are individually labeled. The boxes also contain instruction for use provided as package insert.

The provided document describes the SAGE 1-Step™ culture medium for in vitro fertilization and embryo culture, comparing it to a predicate device, Global® Total®. The focus of the document is on establishing substantial equivalence to the predicate device, not on presenting a standalone study or a comparative effectiveness study with human readers and AI. Therefore, I can only address aspects related to the product specifications and how they compare to acceptance criteria, which are derived from the predicate device's performance.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" for clinical performance, but rather compares the SAGE 1-Step™ to a predicate device's specifications. The implicit acceptance criterion for SAGE 1-Step™ is that its performance and specifications should be "comparable" or "similar" to the predicate, or that any differences do not raise new safety or effectiveness concerns.

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

The document does not specify a "test set" in the context of a clinical performance study using patient data. The performance data presented are primarily based on product specifications and laboratory tests (like Mouse Embryo Assay - MEA). Therefore, information regarding sample size used for a test set, its country of origin, or whether it was retrospective or prospective, is not provided.

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

This information is not applicable as there is no human-involved "test set" or clinical study described where ground truth would need to be established by experts.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human-involved "test set" or clinical study described that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes the technical comparison of a culture medium with a predicate device, not the comparison of human readers with and without AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone study in the context of an algorithm's performance was not done. This document concerns a medical device (culture medium), not a diagnostic algorithm or AI. The product specifications mentioned (pH, osmolality, endotoxin, sterility, MEA) can be considered a type of "standalone" performance assessment for the medium itself, but not in the context of an AI algorithm.

7. The Type of Ground Truth Used

For the product specifications (pH, osmolality, endotoxin, sterility, 1-cell MEA), the "ground truth" is established through laboratory testing and validated analytical methods as per industry standards and regulatory requirements. For the Mouse Embryo Assay (MEA), the typical ground truth involves observing successful embryo development (e.g., to blastocyst stage) in a controlled environment, indicating the medium's suitability for supporting growth.

8. The Sample Size for the Training Set

There is no training set in the context of an AI algorithm described in this document. The development of SAGE 1-Step™ is based on established scientific principles of embryo culture and comparison with existing, cleared devices.

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

This is not applicable as there is no training set for an AI algorithm. The "ground truth" for the development and validation of the SAGE 1-Step™ medium itself would be based on fundamental biological and chemical principles, experimental data from studies on embryo culture, and the historical performance data of the predicate device and other similar media.

Ask a specific question about this device