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BlastAssist® and BlastAssist® with Phenol Red are used for culture of embryos from the 4-8 cell stage through to blastocyst stage. Can also be used for transfer.

BlastAssist® and BlastAssist® with Phenol Red are defined sterile media, used by assisted reproduction professionals and intended for culture of embryos from the 4-8 cell stage to blastocyst stage and for embryo transfer.

The design of BlastAssist® and BlastAssist® with Phenol Red is based on BlastAssist® System Medium 2 ( K003156). The BlastAssist® medium is a salt solution added SSR (Synthetic Serum Replacement), HSA, ethanolamine, amino acids, a stable form of L-glutamine, vitamins and antibiotics.

BlastAssist® is supplied in 10 ml polyethylene plastic vials with screw top closures

The provided document (K080172) is a 510(k) Summary for a reproductive media device (BlastAssist®), not an AI/ML medical device. Therefore, many of the requested details regarding AI/ML device acceptance criteria and performance studies (such as MRMC studies, effect size of human reader improvement with AI, ground truth establishment for training sets, etc.) are not applicable to this submission.

However, I can extract the relevant information regarding the performance data and product testing controls mentioned for this specific device.

Here's the information based on the provided text, tailored to what is applicable for a medical device like BlastAssist®:

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

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document states "BlastAssist® has been tested in a human study." However, the specific sample size (number of embryos, patients, or study participants) for this human study is not provided in the summary.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "human study," implying prospective clinical assessment, but further details are not given.

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

• This information is not applicable and not provided. The performance assessment was based on the effectiveness and safety of the media in embryo culture, likely evaluated by assisted reproduction professionals (e.g., embryologists), but no details on expert panels for 'ground truth' in the AI sense are relevant here.

4. Adjudication method for the test set

• Not applicable and not provided. This is relevant for AI/ML studies where multiple human readers might disagree; for a media product, effectiveness is typically measured by biological outcomes.

5. 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

• No. An MRMC study is not relevant for this type of medical device (embryo culture media) and was not performed. This is an AI/ML-specific study design.

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

• Not applicable. This device is an embryo culture media, not an algorithm.

7. The type of ground truth used

• The "ground truth" for the device's performance was its demonstrated effectiveness in supporting embryo development to the blastocyst stage and safety (absence of complaints/adverse events) in a human study, and its ability to pass various biochemical and biological quality control tests (sterility, osmolality, pH, endotoxin, MEA, stability).

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The "design" (formulation) was based on the predicate device and modified with new ingredients (vitamins, ethanolamine, stable L-glutamine).

9. How the ground truth for the training set was established

• Not applicable. As above, there is no 'training set' in the AI/ML sense for this product. The development of the media was based on scientific formulation and empirical testing (performance data, product testing controls).

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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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EmbryoAssist™ and EmbryoAssist™ with Phenol Red are for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3.

EmbryoAssist™ and EmbryoAssist™ with Phenol Red are each a defined sterile media used by professionals within assisted reproduction and intended for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3. The composition of EmbryoAssist™ and EmbryoAssist™ with Phenol Red are almost identical to The predicate device Embryo Assist™ (K061309), but with an extension of the intended use including a transfer indication. The EmbryoAssist" medium is a salt solution containing SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml and 60 ml polyethylene plastic vials with screw top closures.

The provided 510(k) summary for EmbryoAssist™ and EmbryoAssist™ with Phenol Red describes a medical device, a cell culture medium, rather than a diagnostic AI device. Therefore, many of the requested categories related to AI specific performance, such as sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable to this submission.

However, I can extract the information that is present and relevant to the "acceptance criteria" (implied functional and safety requirements) and the "study that proves the device meets the acceptance criteria" from the provided text.

Acceptance Criteria and Device Performance

The core acceptance criteria for this type of device (reproductive media) revolve around its safety and effectiveness for its intended use, which is fertilization, culture until the 2-8 cell stage, and embryo transfer. The primary way this is demonstrated for a 510(k) submission is through substantial equivalence to a legally marketed predicate device.

Study Information

As this is a 510(k) for an in vitro diagnostic/culture medium, the "study" is a human clinical study aimed at demonstrating safety and effectiveness, leveraging the concept of substantial equivalence.

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

   • Sample Size: Not explicitly stated in the provided text. It mentions "a human study" but does not give the number of participants or embryos.
   • Data Provenance: The study was "a human study." The sponsoring company, MediCult a/s, is located in Denmark, suggesting the study may have been conducted there or in a similar regulatory environment, but this is not explicitly stated. It is a prospective study as it states "During our studies there have been no registered complaints," implying current data collection.

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

   • Not Applicable. This is a cell culture medium, not an AI diagnostic device where expert ground truth is typically assigned to images or patient data. The "ground truth" here is the biological outcome of the cultures and transfers.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable. See point 2.

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:

   • No. This is not an AI device.

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

   • Not Applicable. This is not an AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For this type of device, the "ground truth" would be the observed biological outcomes (e.g., successful fertilization, embryo development to the 2-8 cell stage, successful transfer leading to pregnancy/live birth outcomes – although the latter is often not required for 510(k) for culture media, usually focusing on early embryological development and safety). The text specifically states: "The results showed that the product is effective and safe for its intended use." This efficacy is based on the biological performance observed in the human study.

7. The sample size for the training set:

   • Not Applicable. This is not an AI device, so there is no training set in the AI sense.

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

   • Not Applicable. See point 7.

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EmbryoAssist™ is used for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes.

EmbryoAssist™ is a defined sterile medium, used by assisted reproduction professionals and intended for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes. The design of EmbryoAssist™ is based on BlastAssist Medium 1 (MediCult's BlastAssist®System K003156). The EmbryoAssist™ medium is a salt solution added SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml polyethylene plastic vials with screw top closures

Here's an analysis of the provided text regarding the acceptance criteria and study for the EmbryoAssist™ device:

Important Note: The provided document is a 510(k) summary for a medical device (EmbryoAssist™), which is a reproductive medium. The information available in these types of summaries focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results for a diagnostic AI device. Therefore, many of the requested points, especially those related to AI algorithm performance (e.g., sample sizes for training/test sets, expert consensus for ground truth, MRMC studies, standalone performance), are not applicable to this type of device and submission.

This document describes a culture medium and its performance is assessed in terms of its ability to support embryo development, which is a biological outcome.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Inferred Criteria: The document directly states the conclusion that the product is "effective and safe for its intended use." The product testing controls listed (sterility, osmolality, pH, endotoxin, MEA, stability) are inherent quality and performance checks for such a biological medium, and the successful completion of these tests implies they met pre-defined acceptance criteria for release. The core acceptance criterion for the 510(k) submission itself is demonstrating substantial equivalence to existing, legally marketed predicate devices.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document states, "EmbryoAssist™ has been tested in a human study." It does not specify the sample size of this human study.
• Data Provenance: The study was a "human study," implying prospective collection since it involved testing the new device. The country of origin is not explicitly stated, but the submission came from MediCult a/s in Denmark.

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

• This question is not applicable as the device is a culture medium, not an AI diagnostic tool. "Ground truth" for this product would be the successful development of embryos or lack thereof, observed by embryologists/clinicians, rather than expert interpretation of images or data. No "experts" were used in the sense of adjudicating diagnostic decisions.

4. Adjudication Method for the Test Set

• Not applicable for this type of device (culture medium). Adjudication methods like 2+1 or 3+1 are used in diagnostic studies (e.g., radiology) where multiple readers assess cases and discrepancies are resolved. This is not relevant to a cell culture medium.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No, an MRMC study was not done. This type of study is specifically for evaluating the performance of human readers, often with and without AI assistance, in interpreting medical images or data. It is not relevant to a cell culture medium.

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

• No, this is not an AI algorithm. This question is not applicable as EmbryoAssist™ is a physical culture medium, not an algorithm.

7. The Type of Ground Truth Used

• For the human study, the "ground truth" would be the biological outcome of embryo culture, such as:
  • Successful fertilization of oocytes.
  • Progression of embryos to the 4-8 cell stage (Day 2 or Day 3).
  • Absence of adverse effects on embryo morphology or viability.
  • Essentially, it's based on observing the biological performance of the medium as intended.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm requiring a training set.

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

• Not applicable. This device is not an AI algorithm and does not have a training set or associated ground truth in that context.

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SpermSlow™ is used to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI).

SpermSlow™ is a defined medium used by professionals within assisted reproduction designed to slow down the movement and to select the most mature, viable sperm as required for Intracytoplasmatic sperm injection (ICSI). SpermSlow wis principally composed of hyaluronate (HA), the main component of the extracellular matrix, which appears in large amounts between the cumulus cells of the matured oocyte-cumulus complex.

SpermSlow™ is based on a sodium bicarbonate buffered solution containing hyaluronate, HSA (US licensed source), pyruvate, glucose, amino acids, nucleotides, vitamins and antibiotics.

SpermSlow™ is supplied in polypropylene plastic vials with screw top closures in a volume of 0.5ML. Each unit is labelled and the product is presented in four pack containers which also include a package insert.

The provided 510(k) summary for K061145 (SpermSlow™) is very limited in its details regarding performance data and acceptance criteria, typical for a device of this classification and submission year. It primarily focuses on demonstrating substantial equivalence to a predicate device. Therefore, much of the requested information cannot be directly extracted from the provided text.

Here is a summary of what can be extracted and what is not available based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It makes a general claim:

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

• Sample Size for Test Set: Not specified. The document only states "a human study."
• Data Provenance: The document mentions that the product "has been marketed in Europe since May 2004" and that safety data (absence of serious adverse events) is derived from this European marketing experience. It is not explicitly stated where the "human study" was conducted, but given the European marketing history, it is plausible it was also European data. It is not specified if the human study was retrospective or prospective.

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

This information is not provided in the document. The document describes a "human study" but does not detail how effectiveness (sperm slowing, selection, or ICSI outcomes) was assessed or by whom. The "ground truth" for a device that assists in sperm selection would logically be the successful use in ICSI, potentially assessed by embryologists or reproductive specialists, but the document does not elaborate.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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

This information is not applicable/not provided. The device is a medium used to assist in a biological process (sperm selection), not an AI algorithm or an imaging device that would typically undergo an MRMC study. Therefore, there is no mention of improvement with AI vs. without AI assistance or an effect size.

6. Standalone (Algorithm Only) Performance:

This information is not applicable/not provided. This is a biological medium, not an algorithm.

7. Type of Ground Truth Used:

The document vaguely implies that the "results" of the human study demonstrated the product's effectiveness for its intended use, which is "to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI)." The specific "ground truth" (e.g., successful fertilization rates, embryo development, live birth rates subsequent to ICSI using SpermSlow™-selected sperm) is not specified.

8. Sample Size for the Training Set:

This information is not applicable/not provided. As this is a biological medium and not an AI/machine learning device, there would not be a "training set" in the computational sense. If "training set" refers to developmental or preliminary studies, the size is not mentioned.

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

This information is not applicable/not provided for the same reasons as point 8.

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Biopsy Medium is intended for blastomere biopsy of cleavage stage embryos for PGD (preimplantation genetic diagnosis)

MediCult Biopsy Medium is a defined sterile media used by professionals within assisted reproduction and designed for blastomere biopsy of cleavage stage embryos for pre-implantation genetic diagnosis (PGD). The formulation is based on a HEPES-buffered HTF solution added SSR (Synthetic Serum Replacement: ART supplement), human serum albumin (HSA) and amino acid but without calcium and magnesium ions to facilitate the process of biopsy. The absence of calcium and magnesium ions reversibly reduces the cellular connection between the blastomeres making it easy to excise a blastomere from the embryo without fatal trauma.
Biopsy Medium is supplied in 10 ml polyethylene plastic vials with screw top closures.

The provided text describes a 510(k) submission for the MediCult Biopsy Medium. It includes details about the device's intended use, technological characteristics, and performance data. However, the document is a regulatory submission and approval letter, not a detailed study report. Therefore, it lacks specific information typically found in a scientific study.

Based on the provided information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the device as meeting its intended use but does not present a table with explicit acceptance criteria or quantitative performance metrics that would typically be found in a study for medical devices requiring specific performance measurements.

Note: The acceptance criteria are largely implied by the statements that the product is "effective," "safe," and has "no serious adverse events" or "registered complaints." Specific numerical thresholds or pass/fail criteria are not detailed in this document.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions a "human study" but does not provide the number of participants or embryos involved in this study.
• Data Provenance: The human study was conducted in a European context, as it states the device "has been marketed in Europe since 2002." It is implied to be retrospective reporting of clinical experience rather than a prospective trial designed to specifically test the device's performance in a controlled manner, though the exact study design is not detailed.

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

N/A. This information is not provided in the document. For a product like a biopsy medium, "ground truth" would likely relate to embryo viability, successful biopsy, or genetic diagnosis outcomes, which would be assessed by embryologists, geneticists, or other ART professionals. However, the document does not specify how these outcomes were assessed or by whom.

4. Adjudication Method for the Test Set

N/A. The document does not describe any specific adjudication method.

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

No. An MRMC comparative effectiveness study is typically relevant for diagnostic imaging devices where human readers interpret results with and without AI assistance. This device is a culture medium used in a laboratory procedure, not an imaging device with human interpretation.

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

N/A. This question is not applicable as the device is a biopsy medium, not an AI algorithm. Its performance is intrinsically tied to its use by human embryologists/technicians in a laboratory setting.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the efficacy of the biopsy medium would indirectly relate to:

• Successful blastomere excision without fatal trauma to the embryo.
• Viability and further development of the biopsied embryo.
• Accuracy of subsequent PGD results (though the medium itself doesn't directly perform diagnosis, it facilitates the sample collection).

The document states, "The results showed that the product is effective for its intended use." This implies that the human study observed positive outcomes related to these aspects, but the specific metrics and how ground truth was established (e.g., through embryo development rates, successful genetic diagnosis, etc.) are not detailed.

8. The Sample Size for the Training Set

N/A. The concept of a "training set" is typically associated with machine learning or AI models. This device is a chemical medium, not a software algorithm that would require a training set.

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

N/A. As there's no training set for this type of device, this question is not applicable.

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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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The LAG medium is for pre-incubation of immature oocytes and the IVM Medium is a basal medium for maturing immature oocytes of infertile women undergoing in vitro fertilization who for medical reasons can not undergo conventional ovarian stimulation using drugs.

MediCult IVM® System including Vial 1, LAG Medium and Vial 2 , IVM®Medium. The MediCult IVM® System is a sequential media system including LAG Medium and IVM®Medium which has been developed specifically to support maturation in-vitro of immature oocytes. The composition of the LAG medium is similar to the composition of Universal IVF Medium. Like the Universal IVF Medium the IVM®Medium contains physiological salts and nutritients but differs from this medium by also containing vitamins, amino acids and nucleotides and by being free from human serum albumin.

The provided document describes the MediCult IVM® System, a medical device used for in vitro maturation of immature oocytes. The information focuses on establishing substantial equivalence to a predicate device rather than a standalone study proving specific performance metrics against pre-defined acceptance criteria for a diagnostic AI device.

Therefore, many of the requested categories are not applicable to this type of regulatory submission. However, I will extract the available information.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to two "studies" but these appear to be clinical observations or comparisons rather than formal, controlled trials with a defined "test set" sample size for evaluating a diagnostic AI device.

• Sample Size: Not explicitly stated as a number of cases or patients for a test set. The document refers to "the pregnancy rates obtained after retrieval of immature oocytes" and compares them to "the pregnancy rates obtained after retrieval of mature oocytes." This suggests aggregate data from patient cohorts.
• Data Provenance:
  • Country of Origin: Denmark (Herlev University Hospital) and Finland (Väestöliitio, the Infertility Clinic of the Family Federation of Finland in Helsinki).
  • Retrospective or Prospective: Not explicitly stated, but the description of comparing "pregnancy rates obtained" suggests data collected over time rather than a single prospective, controlled study designed for regulatory submission with a fixed test set.

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

N/A. This information is typically relevant for diagnostic AI devices where human experts establish ground truth for image or data interpretation. For a media system, the "ground truth" would be the biological outcomes (e.g., successful maturation, fertilization, pregnancy rates), which are reported directly from clinical data, not "established" by experts in the same way.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among experts when establishing ground truth for diagnostic AI. This is not applicable here.

5. 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

N/A. This device is not an AI-powered diagnostic tool, so an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

N/A. This is a cell culture medium, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to clinical outcomes data, specifically:

• Successful maturation of oocytes (implied by subsequent processes)
• Pregnancy rates per embryo transfer
• Absence of serious adverse events

8. The Sample Size for the Training Set

N/A. There is no concept of a "training set" as this is not an AI/machine learning device. The studies mentioned essentially served as general clinical experience or observational data rather than a structured training phase for an algorithm.

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

N/A. Not applicable for this type of device.

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ISM1+: For culture of embryos. To be used in culture after fertilization in Universal IVF Medium (K 991279) up to Day3 to 6- to8-cell stage, followed by extended culture in ISM2+ or by transfer in UTM+.
ISM2+: For culture of embryos. To be used in culture from 6- to 8-cell stage on Day3 to blastocyst stage on day 5, followed by transfer in UTM+. ISM2+ shall be used after ISM1+.
UTM+: For transfer of embryos cultured in ISM1+ or ISM2+.

ISM1+, ISM2+, and UTM+ are sequential media for the culture and transfer of embryos. Their composition includes physiological salts, sodium bicarbonate, Penicillin/Streptomycin, HSA, Glucose and derived metabolites, Nucleosides, Non-essential amino acids, Essential amino acids, Phenol Red, and Vitamins. UTM+ also contains Hyaluronate.

Here's a breakdown of the acceptance criteria and the study information for the ISM1+, ISM2+, and UTM+ media, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set (Clinical Data for Original ISM):
  • Sample Size: 466 cycles.
  • Data Provenance: France, prospective multicenter trial.
• Test Set (Clinical Data for ISM1+/ISM2+ vs. Original ISM):
  • Sample Size: Not specified (referred to as "a clinical study").
  • Data Provenance: Not specified (implied to be clinical, likely related to the sponsor's efforts).
• Test Set (Clinical Data for ISM+ series vs. G1.2/G2.2):
  • Sample Size: Not specified (referred to as "two prospective studies").
  • Data Provenance: Not specified (implied to be clinical).
• Batch Release Testing (Mouse Embryo Assay):
  • Sample Size: Not specified per batch, but it's a routine quality control test.
  • Data Provenance: Laboratory testing by the manufacturer.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. The studies are clinical trials involving patients and their outcomes, which serve as the "ground truth" for effectiveness in supporting embryo development and transfer. The assessment of embryo viability and success is performed by clinicians (e.g., embryologists, IVF specialists), but their specific qualifications and number are not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Clinical outcomes (pregnancies, embryo development) were likely assessed by the involved clinical centers and compiled. There's no mention of a specific adjudication panel or method beyond what's inherent in clinical practice.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The studies described are clinical trials comparing the culture media's efficacy in achieving desired embryo development and pregnancy outcomes, not studies involving human readers interpreting outputs or effects of an AI system.

6. Standalone (Algorithm Only) Performance

• No, a standalone performance study was not done. The device is a culture medium, not an algorithm or AI system. Its performance is directly observed through biological outcomes in embryos.

7. Type of Ground Truth Used

• Clinical Outcomes: For the clinical studies, the ground truth was based on:
  • Embryo development (cleavage, blastocyst formation).
  • Pregnancy rates.
  • Singleton vs. twin pregnancies.
  • Absence of serious adverse events.
• Biological/Laboratory Standards: For the product testing controls (sterility, pH, osmolality, endotoxin, Mouse Embryo Assay), the ground truth was established against predefined acceptable ranges and biological performance thresholds (e.g., blastocyst rate > 70%).

8. Sample Size for the Training Set

• Not Applicable. This is a medical device (culture medium), not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

• Not Applicable. As there is no AI training set, this question does not apply.

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For freezing and thawing human blastocysts.

BlastFreeze™: For freezing of human blastocysts.

BlastThaw™: For thawing of human blastocysts.

BlastFreeze™ and BlastThawTM, Cat.No. 10532010 and 10542010. BlastFreeze and BlastThaw are based on Earle's Balanced Salts Solution and differing concentrations of sucrose. BlastFreeze contains glycerol as the cryprotectant.

Here's a breakdown of the acceptance criteria and study information for the BlastFreeze™ and BlastThaw™ devices, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a clinical documentation approach supported by a substantially equivalent argument to a predicate device (K991471). It does not outline a formal, prospective clinical trial in the traditional sense with specific statistical endpoints to meet acceptance criteria. Instead, it relies on accumulated clinical experience and comparison to existing products.

Here's what can be inferred and what is not explicitly stated:

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

   • Sample Size: Not explicitly stated. The document refers to "clinical documentation" and "daily clinical practice" but does not give a specific number of cases or patients included in the reported survival, implantation, and abortion rates.
   • Data Provenance: The document states, "BlastFreeze and BlastThaw were marketed in Europe in April 2002. There has been no registered complaints and no evidence that the product has been the cause of any serious adverse events in connection with its intended use." This suggests the clinical data is retrospective and derived from real-world usage in Europe.

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

   • This information is not provided. Given that the data is presented as aggregated clinical outcomes from "daily clinical practice," it's highly unlikely that a formal ground truth establishment process with a defined number of experts was conducted for this submission. The outcomes (survival, implantation, abortion) are typically documented by treating clinicians in a standard IVF clinic setting.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. There is no indication of an adjudication method as would be used in a blinded, prospective study. The clinical outcomes are likely recorded as part of routine patient care.

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:

   • No. This is a medical device for freezing/thawing blastocysts, not an AI-powered diagnostic device. Therefore, an MRMC study and AI-related effectiveness are not applicable.

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

   • No. This device is a cryopreservation solution used by human embryologists/clinicians with human intervention. It is not an algorithm that performs tasks independently.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the clinical performance metrics (survival rate, implantation rate, abortion rate) is based on patient outcomes data collected during routine clinical practice (IVF/ICSI cycles).

7. The sample size for the training set:

   • Not applicable. The "study" here is not an algorithm a's training. It's a submission for a medical device (cryopreservation media) that relies on clinical performance data and substantial equivalence to a predicate device.

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

   • Not applicable. As stated above, there is no "training set" in the context of an algorithm. The clinical data supports the observed performance of the product in human embryology procedures. The document does reference "Ménézo. Y and Veiga.A. 1997" for similar results, suggesting a comparison to published literature or internal data used to inform the observed performance.

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