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Cumulase™ is indicated for use in removing the cumulus matrix surrounding oocytes in preparation for assisted reproduction technology (ART) procedures.

Recombinant Human Hyaluronidase Solution

Cumulase™ is a hyaluronidase enzyme in a HEPES buffered salt solution. The hyaluronidase enzyme raw material is a highly characterized biotechnology developed recombinant human hyaluronidase (rHuPH20). Cumulase™ is not preserved.

The provided document describes the Cumulase™ device, a recombinant human hyaluronidase solution intended for use in assisted reproduction technology (ART) procedures. The document focuses on the device's technical specifications and regulatory clearance, rather than a clinical study evaluating its performance against specific acceptance criteria.

Therefore, I cannot directly extract details about a study demonstrating the device meets acceptance criteria in the format requested, as the information is not present in the provided text. The document is a 510(k) premarket notification summary, which primarily establishes substantial equivalence to a predicate device and outlines manufacturing and characterization rather than a clinical performance study with predefined acceptance criteria.

However, I can infer some aspects based on the available information:

1. A table of acceptance criteria and the reported device performance:

The document lists "Product Control Testing" which can be interpreted as internal quality control acceptance criteria. However, it does not provide performance results against these criteria in a comparative table for a specific study.

The document states: "rHuPH20 Hyaluronidase has been extensively characterized to International Committee on Harmonization regulatory requirements." and "Cumulase™ has been qualified to ISO 10993 standards for biocompatibility." This indicates that these criteria were met, but specific data is not provided.

The "study that proves the device meets the acceptance criteria" is not described in detail as a standalone clinical performance study with statistical results. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device (Medi-Cult Hyaluronidase, 510(k) # K991334) through characterization and quality control, rather than a prospective clinical trial.

Based on the provided information, the following questions cannot be answered as the relevant data is not present:

• Sample sized used for the test set and the data provenance: Not applicable as a clinical "test set" for performance evaluation is not described in this document.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• 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: Not applicable. This device is a biological solution, not an AI or imaging device requiring human reader interpretation.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For the quality control tests listed, the ground truth would be the established USP standards and ISO 10993 requirements for each parameter.
• The sample size for the training set: Not applicable as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

Summary of available information related to the device's characteristics and "demonstration of meeting criteria":

• Technological Characteristics: Cumulase™ uses a recombinant human biotechnology-developed source of hyaluronidase enzymatic activity, distinguishing it from the bovine testicular derived source of the predicate device.
• Product Formulation: Hyaluronidase enzyme in a HEPES buffered salt solution, unpreserved. The raw material is rHuPH20, extensively characterized to ICH regulatory requirements.
• Manufacturing Process: Chemically defined and free of animal-derived components or materials.
• Biocompatibility: Qualified to ISO 10993 standards.
• Product Control Testing (Acceptance Criteria): Enzymatic Activity (USP Assay), pH (USP ), Endotoxin (USP ), Osmolality (USP ), Sterility (USP ), Mouse Embryo Assay (One Cell). The implication is that the product consistently meets these internal specifications.
• Predicated Device: Medi-Cult Hyaluronidase (510(k) # K991334). The 510(k) process for Cumulase™ is based on demonstrating substantial equivalence to this device.

The provided text serves as a regulatory submission document for market clearance, highlighting the safety and effectiveness of the device through characterization and comparison to a legally marketed predicate, rather than a detailed report of a clinical performance study against quantified acceptance criteria.

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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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