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Sperm Freezing Medium is intended for the cryopreservation of human semen samples to sperm samples during cryopreservation and thawing prior to use in assisted reproductive technology procedures.

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I am sorry, but based on the provided text, there is no information available about the acceptance criteria or a study proving that a device meets such criteria.

The document is an FDA 510(k) clearance letter for a device named "Sperm Freezing Medium." This letter confirms that the device is substantially equivalent to a legally marketed predicate device. It discusses regulatory requirements, such as general controls, quality systems, and UDI, but it does not include any details about performance criteria or studies conducted by the manufacturer to demonstrate the device's performance.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set size.

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Giftlife Single-Step Medium Plus is used for culture of embryos from fertilization to the blastocyst stage.

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The provided FDA 510(k) clearance letter for the "Giftlife® Single-Step Medium Plus" does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.

This document is a clearance letter for a medical device (Reproductive media and supplements, specifically for embryo culture), not an AI/ML software as a medical device (SaMD). Therefore, the typical acceptance criteria and study data associated with AI/ML performance metrics (such as sensitivity, specificity, AUC, human reader improvement, etc.) are not present in this type of regulatory submission.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has been determined to be as safe and effective as a previously cleared device. This determination is based on various factors, including design, materials, chemical composition, intended use, and performance characteristics, but these are assessed through methods appropriate to the device type (e.g., chemical analysis, biological assays, sterility testing, stability studies for culture media), rather than AI/ML performance studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone AI performance.
7. Type of ground truth (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

These elements are specific to the evaluation of AI/ML devices and are not relevant to the clearance of a reproductive culture medium as described in this document.

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The G-Vitri™ Vitrification Straw is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.

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The provided document is an FDA 510(k) clearance letter for the G-Vitri™ Vitrification Straw, a medical device used in assisted reproduction. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment typically found in a clinical study report or a detailed validation study.

The letter primarily focuses on:

• Stating that the device is substantially equivalent to legally marketed predicate devices.
• Outlining regulatory requirements and general controls for the device.
• Defining the Indications for Use for the G-Vitri™ Vitrification Straw.

Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design validation report, or a clinical study report submitted as part of the 510(k) application.

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Giftlife Fertilization Medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) procedures and culture to the two pronuclei (zygote) stage of development.

Giftlife Cleavage Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from pronucleate stage to day 2 or day 3. This medium is not intended for transferring embryos to the uterine cavity.

Giftlife Blastocyst Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from day 3 to the blastocyst stage. This medium is not intended for transferring embryos to the uterine cavity.

Giftlife Single Step Medium is used for culture of embryos from fertilization to the blastocyst stage.

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This FDA clearance letter for the Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium does not contain the detailed information necessary to answer your request regarding acceptance criteria and the study that proves the device meets those criteria.

The provided document is a standard 510(k) clearance letter, which confirms that the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance, outlining the general controls provisions, potential additional controls, and responsibilities of the manufacturer.

Specifically, the letter does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample size, data provenance, or details of a test set.
• The number or qualifications of experts, or any adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
• Details of a standalone (algorithm-only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• The sample size for the training set or how its ground truth was established.

These types of details would typically be found in the 510(k) summary or the full 510(k) submission, neither of which is contained within the provided document. The clearance letter acknowledges the submission, but does not reiterate its technical content in this level of detail.

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Oocyte Flushing & Retrieval Medium is intended for use during and oocyte collection procedures for use in in vitro fertilization procedures.

Gamete Buffer is indicated for use in short-term handling gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).

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I am sorry, but the provided FDA letter for Gimbo Medical Technology Shenzhen Co., Ltd. regarding K234023 does not contain the information needed to answer your request. The document is a 510(k) clearance letter for "Oocyte Flushing & Retrieval Medium; Gamete Buffer" and outlines regulatory information and indications for use. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies, which are typically found in a full submission or study report.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done and any effect size
6. If a standalone performance (algorithm only) study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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The G-Vitri™ Vitrification Freeze Media is indicated for use in the vitrification of occytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

The G-Vitri™ Vitrification Thawing Media is indicated for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

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This is a 510(k) clearance letter for G-Vitri™ Vitrification Freeze Media and G-Vitri™ Vitrification Thawing Media. The document focuses on regulatory approval and does not contain information about the device's technical acceptance criteria or a study proving those criteria.

Therefore, I cannot provide the requested information, which typically pertains to performance studies for medical devices with algorithmic components or diagnostic functions. The G-Vitri™ products are reproductive media and supplements, and their clearance is based on substantial equivalence to predicate devices, rather than a quantifiable performance study against specific acceptance criteria as detailed in your request.

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