Search Results

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

LifeGlobal ® Human Serum Albumin (HSA) is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth and embryo cryopreservation.

Not Found

The provided text is a clearance letter from the FDA for a medical device called "LifeGlobal® Human Serum Albumin LG HSA." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot extract the requested information from this document. This document is a regulatory approval, not a technical report or study summary.

Ask a specific question about this device

HSA is intended as a protein supplement for in-vitro mammalian-cell culture media. These procedures include in vitro fertilization, gamete washing, embryo culture, micromanipulation and embryo cryopreservation.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document is a 510(k) premarket notification letter from the FDA regarding a device named "Enhance-HSA." It states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must comply with. The "Indications for Use Statement" indicates that "HSA is intended as a protein supplement for in-vitro mammalian-cell culture media," listing procedures like in vitro fertilization, gamete washing, embryo culture, micromanipulation, and embryo cryopreservation.

This type of document confirms regulatory clearance but does not typically include detailed performance study results or acceptance criteria.

Ask a specific question about this device

Ask a specific question about this device

Human Serum Albumin is a macromolecular supplement used in media for IVF, ART, GIFT, ICSI, embryo culture, embryo transfer, cryopreservation and sperm washing for IUI.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Human Serum Albumin in Normal Saline," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The document mentions the "Indications For Use" for Human Serum Albumin, which is a macromolecular supplement used in various assisted reproductive technology (ART) procedures. However, it does not contain the detailed study information, acceptance criteria table, or ground truth establishment methods requested in your prompt.

Ask a specific question about this device

Human Serum Albumin (HSA) is intended for those assisted reproductive procedures that require the use of a protein supplement. In particular. HSA is intended for use during in vitro fertilization, during in vitro embryo culture to the desired stage of embryo development, and for the cryopreservation of human embryos.

Human Serum Albumin consists of human serum albumin from therapeutic-grade source material (10mg/mL) in a sterile saline solution.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified directly for the mouse embryo assay. The description mentions "HSA is assayed by mouse embryo assay prior to release to market," implying a continuous testing process rather than a single, fixed test set.
• Data Provenance: The mouse embryo assay is performed in-house by Irvine Scientific as a pre-market release condition. It is a prospective test for each lot produced. The document also mentions "Human Serum Albumin has been used in a variety of clinical settings, for their intended use, for a number of years," suggesting retrospective clinical experience contributes to the overall understanding of its performance, though this isn't a controlled test set in the traditional sense for regulatory submission. The specific country of origin for the mouse embryo assay is not explicitly stated beyond Irvine Scientific's location in Santa Ana, CA, USA.

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

• Number of Experts: Not applicable. The "ground truth" for the mouse embryo assay is established by the biological outcome of the embryos (growth, absence of toxicity), as evaluated by laboratory personnel following established protocols. No panel of human expert readers is described.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The mouse embryo assay relies on direct biological observation of embryo development. There is no mention of human expert adjudication or resolution of discordant interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No. This device (Human Serum Albumin) is a biological reagent, not an AI or imaging device. Therefore, MRMC studies and the concept of AI assistance for human readers are not relevant.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI-driven device. Its performance is assessed through biological assays and clinical usage.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Ground Truth: The primary ground truth for the mouse embryo assay is biological outcome/observation (embryo growth and the absence of toxic effects). Additionally, general outcomes data from "a variety of clinical settings" over "a number of years" contributes to the understanding of its real-world performance as a protein supplement. The "Notice of Final Rule" referenced likely provides a regulatory definition or standard for what constitutes acceptable performance in this context.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The "historical information contained in professional literature" and "variety of clinical settings" could be considered analogous to a broad historical "training" or experience base for the product's efficacy, but not a formally defined training set for an algorithm.

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

• Ground Truth Establishment: Not applicable, as there is no formal training set for an algorithm. The understanding of the product's effectiveness and safety has been established through years of clinical use and scientific research in the field of assisted reproductive technologies, summarized as "historical information in professional literature" and "clinical settings."

Ask a specific question about this device