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

ICSI Cumulase is a defined sterile, ready to use media used by professionals within assisted reproduction and intended for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI. ICSI Cumulase is a modified version of SynVitro® Cumulase ( K060699) and is based on a salt solution containing a recombinant hyaluronidase and HSA (US license No 1716). ICSI Cumulase is supplied in transparent polypropylene plastic vials with screw top closures in a volume of 0.5 ml.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a distinct "test set" sample size in the traditional sense of a clinical trial. Instead, the evaluation relies on a literature review of existing data for the Cumulase® enzyme.
• Data Provenance: The data provenance is described as "an evaluation of all relevant preclinical and clinical literature regarding the use of the Cumulase® enzyme." This indicates the data is retrospective, drawn from already published or available studies concerning the active enzyme. The country of origin for this literature is not specified, but the device manufacturer is Danish.

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

• This information is not provided in the document. The evaluation was based on a literature review, not a new study with expert-labeled ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable/not provided. There was no new test set requiring expert adjudication in the context of this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a medical media intended for laboratory use, not an AI-assisted diagnostic tool that would typically involve human readers.

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

• Not applicable. This device is a biochemical solution (enzyme) used in a laboratory procedure, not an algorithm. The assessment focused on the safety and effectiveness of the media itself.

7. The Type of Ground Truth Used

• The "ground truth" for the safety and effectiveness determination was established through a review of existing preclinical and clinical literature on the Cumulase® enzyme. This literature would contain outcomes data from previous studies where the enzyme was used. The claim of "effective and safe" is based on the findings within this body of literature.

8. The Sample Size for the Training Set

• This information is not applicable/not provided. There is no "training set" in the context of this device, as it is not an AI/machine learning product. The evaluation relies on existing scientific literature, not a newly trained model.

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

• Not applicable. As above, there is no training set for this type of device. The ground truth for the overall safety and effectiveness claim was established via a literature review of existing studies on the Cumulase® enzyme.

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SynVitro Cumulase™ is used by professionals within assisted reproduction for the removal of the cell complex (cumulus and corona radiata) surrounding the oocyte in the preparation for intracytoplasmatic sperm injection (ICSI).
SynVitro Cumulase™ is indicated for the removal of the cell complex (cumulus and corona radiate) surrounding the oocyte in preparation for the ICSI procedure.

SynVitro®Cumulase™ is a sterile non preserved solution containing 80 U/mL of recombinant Synther Camandase (rHuPH20) in a HEPES buffered salt solution with SSR (Synthetic serum replacement) added.

The provided document describes the acceptance criteria and the study for the SynVitro®Cumulase™ device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states "The efficiency of removing the cumulus from the oocytes have been compared to the predicated device in a prospective, randomised clinical study."

• Sample Size for Test Set: The specific sample size (number of patients or oocytes) for this clinical study is not explicitly mentioned in the provided text.
• Data Provenance: The study was a "prospective, randomised clinical study," indicating that data was collected specifically for this study in a prospective manner. The country of origin is not specified.

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

The document does not explicitly state the number of experts used or their qualifications to establish ground truth for the clinical study. The assessment of "efficiency of removing the cumulus from the oocytes" would typically involve embryologists or fertility specialists, but this is not detailed.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for evaluating the results of the clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This device is a medical product (a solution/reagent) used in assisted reproduction, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this submission and was not performed.

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

This device is a chemical reagent, not a standalone algorithm. Therefore, a standalone performance study as described is not applicable and was not performed.

7. The Type of Ground Truth Used:

For the primary efficacy endpoint (efficiency of cumulus removal), the ground truth was likely established through direct observation and evaluation by trained professionals (e.g., embryologists) in the context of the prospective clinical study. This would fall under expert observation/assessment based on established laboratory protocols in assisted reproduction.

8. The Sample Size for the Training Set:

This device is a chemical reagent, not a machine learning algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable.

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

As explained above, a "training set" is not applicable for this type of device.

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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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