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SynVitro® Hyadase is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.

SynVitro® Hyadase is a modified version of the prior cleared SynVitro® Hyadase device and is used for removal of cumulus and corona radiata cells surrounding the oocytes (denudation) prior to intracytoplasmic sperm injection (ICSI).

SynVitro® Hyadase is a clear non-viscous hyaluronidase enzyme solution contained in a 2 ml transparent plastic bottles (containing 1 ml solution) with caps and provided in cardboard boxes containing five bottles. This product has a one-year shelf-life when stored as recommended and can be used for up to seven days after opening.

This document describes the acceptance criteria and the study that demonstrates the performance of the SynVitro® Hyadase device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample size" for each test in terms of number of units or replicates. For the Mouse Embryo Assay (MEA), the acceptance criterion mentions "at least 80% of the one-cell stage control embryos" which implies a set of embryos were used, but the exact number is not provided.

The data provenance is not specified. It is likely internal testing conducted by ORIGIO a/s, a CooperSurgical Company, given they are the manufacturer and submitter of the 510(k). The document does not indicate country of origin for data or if it was retrospective or prospective.

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

This document describes the testing of a medical device (reproductive media) against established physical, chemical, and biological performance specifications, not an AI or diagnostic device that requires expert adjudication of images or clinical data. Therefore, the concept of "experts used to establish the ground truth" in the context of image interpretation or clinical diagnosis does not apply here. The "ground truth" for each test is the established scientific/regulatory standard or a biological outcome (e.g., embryo development to blastocyst stage).

4. Adjudication Method for the Test Set

Not applicable. As explained in point 3, this is not a study requiring expert adjudication of data or images. The tests described are laboratory analyses with objective endpoints.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a reproductive media (hyaluronidase enzyme solution) and not a diagnostic or AI-assisted interpretation device that would involve human readers.

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

No, this is not an algorithm or AI-based device. The device itself is a chemical solution. The performance testing is a standalone evaluation of the solution's properties and efficacy as intended.

7. The Type of Ground Truth Used

The ground truth used for the tests is based on:

• Established scientific/regulatory standards: For pH (USP ), Osmolality (USP ), Sterility (USP ), and Endotoxin (USP ). Aseptic processing validation adheres to ISO standards.
• Biological efficacy defined by a specific outcome: For the Mouse Embryo Assay (MEA), the ground truth is the development of one-cell mouse embryos to the blastocyst stage within 96 hours.
• Quantitative measurement of active ingredient: For Hyaluronidase enzyme activity, the ground truth is the measured activity falling within a specified range (40-120 IU/ml), with the device specified at 80 IU/ml.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device that requires a "training set." The performance testing described evaluates the chemical and biological properties of the manufactured product.

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

Not applicable. Same as point 8.

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For the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.

SynVitro® Hyadase is a ready-to-use hyaluronidase product designed for denudation of the oocyte and is based on raw material from a non-bovine source. SynVitro®Hyadase does not contain human serum albumin (HSA) or antibiotics.

Here's an analysis of the provided text regarding the SynVitro® Hyadase device, focusing on acceptance criteria and supporting studies:

This document describes a 510(k) submission for a medical device, SynVitro® Hyadase, which is a hyaluronidase product used for denuding oocytes (removing surrounding cells) prior to Intracytoplasmic Sperm Injection (ICSI). The submission focuses on demonstrating substantial equivalence to a predicate device.

Key takeaway: The provided text describes a comparative effectiveness study to demonstrate substantial equivalence to a predicate device, rather than a study defining and meeting de novo acceptance criteria for a novel device. The acceptance criteria are implicitly based on the predicate device's performance regarding morphological quality of embryos, fertilization rate, and cleavage rate.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated. The text mentions "Two comparable groups of oocytes were inseminated." and "a randomised clinical study has been performed comparing SynVitro® Hyadase... to Medi-Cult's Hyaluronidase product." Without specific numbers, the exact sample size cannot be determined from this document.
• Data Provenance: Not explicitly stated (e.g., country of origin). Both studies are described as "clinical studies." It is implied to be prospective since it's a comparative study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned. Given the nature of assessing embryo morphology, fertilization, and cleavage rates, it would typically involve embryologists or fertility specialists, but this is not specified.

3. Adjudication method for the test set:

• Adjudication Method: Not mentioned.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No, this does not appear to be an MRMC study. This device is a biochemical product (hyaluronidase), not an AI algorithm or an imaging device requiring human reader interpretation in the context of an MRMC study.
• Effect Size: Not applicable.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable. This is not an algorithm.

6. The type of ground truth used:

• The "ground truth" for the comparative studies was based on clinical outcomes relevant to assisted reproductive technology:
  • Morphological quality of the embryos
  • Fertilization rate
  • Cleavage rate

7. The sample size for the training set:

• Training Set Sample Size: Not applicable. This submission describes a clinical study to compare a new product to a predicate, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable.

Summary of Device Performance and Equivalence:

The provided clinical documentation indicates that two comparative studies were conducted:

1. Comparison of Hyaluronidase Sources: This study compared hyaluronidase from two different sources (one being SynVitro® Hyadase's non-bovine source) and found no significant difference in morphological quality of embryos, fertilization rate, and cleavage rate.
2. Comparison to Predicate Device (Medi-Cult's Hyaluronidase): This randomized clinical study compared SynVitro® Hyadase (without HSA) to the predicate Medi-Cult Hyaluronidase (with HSA). The results indicated that both products were "equally effective" regarding morphological quality of the embryos, fertilization rate, and cleavage rate.

Based on these studies, the manufacturer concluded that SynVitro® Hyadase is substantially equivalent to the predicate device K991334 (Medi-Cult Hyaluronidase) and effective for its intended use. The FDA concurred with this determination.

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