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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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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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Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.

Single Step Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to be used during fertilization and culture of zygote/embryo through the desired development stage (up to 5/6 days) in vitro.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Irvine Scientific Single Step Medium (K072609):

Overall Assessment:

The provided document is a 510(k) summary for a reproductive media device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a comprehensive clinical study with detailed acceptance criteria and performance metrics typically seen for high-risk devices or AI/software. The "performance data" section primarily describes a quality control assay and makes a general statement about the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For this type of device (in vitro embryo culture medium), the "acceptance criteria" are predominantly related to manufacturing quality control (sterility, endotoxin), general functionality as demonstrated by a biological assay (mouse embryo assay), and comparison to legally marketed predicate devices for substantial equivalence. The document does not provide specific numerical performance targets (e.g., embryo blastocyst rates, live birth rates) from a clinical study for K072609, but rather references a quality control test and general concordance with regulatory requirements.

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

• Sample Size for Test Set: Not specified for a discrete "test set" in the context of a clinical study. The performance data section refers to a "mouse embryo assay," which is a quality control test. The number of mouse embryos used in this assay is not provided.
• Data Provenance: The mouse embryo assay is an internal quality control measure. No information is given about the country of origin for any human clinical data because clinical studies, in the typical sense for a new device's primary efficacy, are not presented for K072609. The document mentions that the predicate device (MultiBlast Medium) "has been used in a variety of clinical settings." This implies real-world usage, but no specific study details are provided for K072609 itself.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. The document does not describe a study involving expert review for establishing ground truth, as it is not a diagnostic device or an AI/software product requiring human interpretation. The "ground truth" for this product is its biological efficacy in supporting embryo development, which is assessed via an in vitro mouse embryo assay, not expert consensus.

4. Adjudication Method

• Not Applicable. As no expert review or human interpretation study is described, there is no need for an adjudication method like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is not mentioned. This type of study is typically relevant for diagnostic imaging devices or AI systems that assist human readers in making diagnoses. This device is a culture medium.

6. Standalone Performance Study (Algorithm Only)

• Not Applicable. This is a physical biological medium, not an algorithm or AI product.

7. Type of Ground Truth Used

• The primary "ground truth" or performance assessment method described is the mouse embryo assay. This is an in vitro biological assay designed to assess the product's ability to support embryonic growth and its lack of toxicity. It's a form of biological assay outcome data.
• The overall "ground truth" for K072609's market clearance is substantial equivalence to legally marketed predicate devices, meaning it performs as expected for its intended use based on comparison rather than entirely novel clinical trial data.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML product, so there is no concept of a "training set" in the conventional sense for algorithm development.

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

• Not Applicable. (See point 8).

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