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VitriBlast is intended for ultra-rapid freezing (vitrification) of human blastocysts. This kit is designed for use with Nidacon's ThermoBlast kit for optimal recovery of specimens. This product is used for assisted reproduction-technology procedures.

ThermoBlast is intended for the recovery of human blastocysts that have undergone ultra-rapid freezing (vitrification) using Nidacon's VitriBlast kit. It is designed for optimal thawing and recovery of the specimens. This product is used for assisted reproduction-technology procedures.

VitriBlast consists of 5 separate vials as described hereunder:

• VitriBlast 1: 10mL based on PureSperm Wash (K002630), with additional hSA.
• VitriBlast 2: 10mL same as solution 1, plus Ethylene glycol (7.5%) and DMSO (7.5%) both provided for separate addition.
• VitriBlast 3: 10mL same as solution 1, including Sucrose (0.67 M) and Ficoll (0.14 mM), plus Ethylene glycol (15%) and DMSO (15%), both provided for separate addition just prior to use.

ThermoBlast consists of 4 separate, 10 mL vials as follows:

• ThermoBlast 4: based on VitriBlast I with additional sucrose (0.33 M).
• ThermoBlast 5: based on VitriBlast I with additional sucrose (0.21 M).
• ThermoBlast 6: the same as VitriBlast | (2 vials).

Here's a breakdown of the acceptance criteria and the study details for the Nidacon VitriBlast™ and ThermoBlast™ devices, based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for performance metrics. Instead, the "acceptance" appears to be based on demonstrating safety, effectiveness, and substantial equivalence to predicate devices, primarily through the clinical outcomes observed. The key metrics reported from the clinical study are:

Study Information

1. Sample Size and Data Provenance:

   • Test Set Sample Size:
     • Number of thawed blastocysts: 424
     • Number of transferred blastocysts: 391
     • Number of transfers: 385
   • Data Provenance: Clinical data from The Fertility Centre at Carlanderska Hospital in Gothenburg, Sweden. The data is retrospective, as the products were used routinely at the clinic for two years before Nidacon became the manufacturer, and the data reflects all results from 2007 onwards.

2. Number of Experts and Qualifications for Ground Truth:

   • The document does not explicitly state the "number of experts" used to establish ground truth in the context of adjudication. Instead, the ground truth is derived from the routine clinical practice and outcomes data from The Fertility Centre, which has been described as one of the world's leading clinics in ART. The clinic's founder, Dr. Matts Wikland, started it in 1987, and it was the first European laboratory to be accredited according to ISO/IEC 17025 in 1998. This implies that the clinical staff (embryologists, doctors) involved in the procedures and data collection are highly qualified ART professionals.

3. Adjudication Method for the Test Set:

   • No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The clinical outcomes (survival, implantation, pregnancy, birth) are direct results of the procedures and are presumably recorded as per standard clinical practice at a leading fertility clinic.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a clinical outcome study of the media itself, not an AI or imaging device with human readers.

5. Standalone (Algorithm Only) Performance Study:

   • No, a standalone (algorithm only) performance study was not done. This is a medical device (vitrification and thawing media), not an algorithm or AI.

6. Type of Ground Truth Used:

   • The ground truth is based on clinical outcomes data from actual human patient treatments (e.g., blastocyst survival, implantation confirmation, clinical pregnancy diagnosis, live births, observed malformations).

7. Training Set Sample Size:

   • No explicit "training set" sample size is mentioned in the context of an algorithm. The clinical data presented is the primary evidence for effectiveness. However, it's mentioned that the products were "developed during scientific collaboration between Nidacon International AB and The Fertility Centre," implying an iterative development process that would have involved extensive testing and refinement of the media formulations. The clinical use at the center prior to Nidacon becoming the manufacturer could be seen as an extensive "real-world" testing phase.

8. How Ground Truth for Training Set was Established:

   • As this is not an AI/algorithm-based device, there isn't a "training set" in the traditional sense for an algorithm. The development of the media (VitriBlast™ and ThermoBlast™) relied on:
     • Bench testing: pH, Osmolality, One cell MEA, MEA according to intended use, Endotoxin level measurements.
     • Animal Non-Clinical Trials: Two types of Mouse Embryo Assay (MEA) testing (FDA recommended 2-cell MEA %blast 96h and performance evaluation according to intended use).
     • Clinical experience and collaboration: The products were developed in scientific collaboration with The Fertility Centre, which had been using vitrification methodology since 2005 and whose "same recipe" Nidacon later became the manufacturer for. This indicates that the formulation was refined and validated through significant clinical experience and observation of outcomes over time by ART specialists at a leading clinic.

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