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SAGE Vitrification Kit: These products are intended for ultra-rapid freezing and containment of human blastocysts in assisted reproductive technology procedures. This kit is designed to be used in conjunction with the SAGE Virtification Warming Kit (ART-8031) for optimal recovery of specimens.

SAGE Vitrification Warming Kit: These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using SAGE Vitrification Kit (ART-8026) for assisted reproductive technology procedures.

SAGE Vitrification Kit: This kit includes two solutions (Equilibration Solution and Vitrification Solution). Both solutions in the kit consist of a MOPS-buffered media containing non-essential amino acids, gentamicin suffate, and human serum albumin. These solutions also contain the cryoprotectants ethylene glycol, dimethyl sulfoxide (DMSO) and sucrose as described below:

Equilibration Solution: 7.5% (v/v) each of DMSO and ethylene glycol.

Vitrification Solution: 15% (v/v) each of DMSO and ethylene glycol, and 0.6 M sucrose

SAGE Vitrification Warming Kit: This kit includes three solutions (1.0 M Sucrose Warming Solution, 0.5 M Warming Solution, and MOPS Solution). All solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids, gentamicin sulfate, and human serum albumin. These solutions contain the cryoprotectant sucrose at the level described in their names (i.e., 1.0 M, 0.5 M, or no sucrose).

Solutions in the SAGE Vitrification Kit and SAGE Vitrification Warming Kit are aseptically-filtered and are provided to users in 2 ml polypropylene vials. The solutions in these kits are considered single-use devices.

This document describes the SAGE Vitrification Kit and SAGE Vitrification Warming Kit, which are used in assisted reproductive technology (ART) for the ultra-rapid freezing and warming of human blastocysts.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary includes a comparison table between the subject device (K170560) and its predicate device (K073522), which also serves to outline the acceptance criteria for various parameters. The "reported device performance" is implicitly stated as meeting these criteria for the subject device.

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

The document does not explicitly state the specific sample sizes used for each test (e.g., MEA, endotoxin, osmolality, pH, sterility, stability). It refers to "All devices tested" in the context of stability and "Samples tested" for transportation testing.

The data provenance is not specified regarding country of origin or explicit retrospective/prospective design. However, the tests (MEA, endotoxin, etc.) are standard laboratory tests for reproductive media, usually conducted under controlled laboratory conditions rather than with human patient data.

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

This information is not applicable to this type of device and study. The "ground truth" here relates to the chemical, physical, and biological properties of the media, which are measured against established scientific and regulatory standards (e.g., USP for sterility, MEA for toxicity). Expert consensus in the clinical sense (e.g., radiologists interpreting images) is not relevant for proving the performance of vitrification media.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used for studies involving human interpretation (e.g., medical image reading) where there might be disagreement among experts. This is not applicable to the type of performance testing described for this device, which relies on objective, quantifiable laboratory measurements.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This type of study assesses how human readers' diagnostic performance changes with or without AI assistance, which is for devices involving diagnostic or interpretive tasks. The SAGE Vitrification Kit and Warming Kit are chemical media, not a diagnostic AI device.

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

No. A standalone algorithm performance study is not applicable as this is not an algorithm-based device. The "performance" refers to the chemical and biological integrity of the media.

7. The Type of Ground Truth Used

The ground truth used for performance assessment consists of:

• Established scientific and regulatory specifications: These are the predefined ranges and limits for parameters like pH, osmolality, endotoxin levels, sterility assurance level (SAL), and acceptable MEA blastocyst development rates (e.g., ≥80% at 96h).
• Predicate device characteristics: The predicate device K073522's established specifications also served as a benchmark for comparison and "ground truth" equivalence.

8. The Sample Size for the Training Set

This concept is not applicable. This device is not an AI/ML algorithm that requires training data. The "training set" for physical devices could loosely refer to the initial development and optimization batches, but the document does not provide details on this. The studies mentioned are primarily for validation and verification.

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

As per point 8, this is not applicable for a chemical media product.

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