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EmbryoGen® is for culture of human embryos until the 2-8 cell stage. EmbryoGen® can also be used for embryo transfer at day 2 or 3.

EmbryoGen® (1204) is a modification of EmbryoGen® (1203) (K120136), where the base medium has been changed from EmbryoAssist® (K080473) to the new ORIGIO Sequential Cleav™ (K133912) medium. EmbryoGen® (1204) contains GM-CSF (Granulocyte macrophage- colony stimulating factor), in the same concentration as EmbryoGen® (1203). EmbryoGen® (1204) is an aseptically filtered, colorless, non viscous solution, which is ready to use by professionals within assisted reproduction. EmbryoGen® (1204) is contained in 3 ml transparent glass bottles with white polypropylene caps, available in a single piece card board box, individually labeled and with instruction for use provided as a package insert.

The provided document is a 510(k) Summary for a medical device called EmbryoGen® (Cat. No. 1204). This device is a reproductive culture medium used for human embryos. The document focuses on demonstrating substantial equivalence to a predicate device, EmbryoGen® (Cat. No. 1203).

The 510(k) summary does not contain acceptance criteria or details of a study designed to prove the device meets specific performance acceptance criteria in the typical sense of a clinical trial for diagnostic or interventional devices with quantifiable outcomes like sensitivity, specificity, accuracy, etc.

Instead, the submission for EmbryoGen® (1204) relies on demonstrating substantial equivalence to a legally marketed predicate device (EmbryoGen® (1203)). This means the "acceptance criteria" are effectively the characteristics and performance of the predicate device. The "study" proving the device meets these criteria is a comparison of technological characteristics and performance data between the new device and the predicate device, as well as another cleared device (ORIGIO® Sequential Cleav™).

Here's an breakdown based on the provided text, addressing your questions where possible:

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

Since this is a submission for substantial equivalence of a culture medium, the "acceptance criteria" are the established specifications and comparable performance parameters of the predicate device and other similar cleared devices. The "reported device performance" are the specifications of the new device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" sample size for a typical clinical performance study. The "performance data" section primarily discusses laboratory tests and stability studies, which would involve samples of the culture medium itself, not biological samples from human patients in a clinical trial.

• 1-cell MEA (Mouse Embryo Assay): This is a biological assay using mouse embryos. The document states a performance criterion (≥80%) but does not specify the sample size (e.g., number of mouse embryos, number of batches tested) used to demonstrate this for EmbryoGen® (1204).
• Stability studies: These tests involved multiple batches of the product over time. The sample size (number of batches) is not explicitly stated.
• Data Provenance: Not specified as a clinical trial. The manufacturing company, ORIGIO a/s, is based in Denmark.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device submission. There is no concept of "ground truth" established by human experts in the context of this culture medium's substantial equivalence demonstration. The "ground truth" is essentially the established specifications and safety profile of the predicate device and the general scientific understanding of IVF media components.

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

Not applicable. There is no clinical read by human readers that would require an adjudication method.

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

Not applicable. This device is a culture medium, not an AI-powered diagnostic or decision support system that would involve human readers or AI assistance.

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

Not applicable. This device is a culture medium, not an algorithm.

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

The "ground truth" in this context is based on:

• Established scientific understanding and regulatory requirements for reproductive media.
• Performance specifications of the predicate device (EmbryoGen® (1203)) and another cleared device (ORIGIO® Sequential Cleav™).
• Standardized laboratory tests for pH, osmolality, endotoxin, specific protein concentrations, and biological assays like MEA (Mouse Embryo Assay), GM-CSF ELISA, and GM-CSF potency (TF-1 cell assay).
• Biocompatibility testing (cytotoxicity, sensitization, irritation) against ISO 10993-1:2009 standards.

There is no "expert consensus" or "pathology" in the sense of interpreting images or clinical findings.

8. The sample size for the training set

Not applicable. This device is a culture medium, not an AI/machine learning model that requires a training set.

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

Not applicable. As stated above, this device does not involve a training set.

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EmbryoGen® is for fertilization and culture until the 2-8 cell stage. EmbryoGen® can also be used for embryo transfer at day 2 or 3.

EmbryoGen® is designed to provide physiological conditions for the embryo from fertilization to Day 3 at the time when the embryo under in vivo conditions would be transported through the oviduct. EmbryoGen® is based on the FDA-cleared culture media EmbryoAssist™(K080473) supplemented with Leukine (sargramostim) GM-CSF. EmbryoGen is supplied in sterilized transparent glass bottles with polypropylene screw top closure in a volume of either 3 mL or 5 mL. The media is colorless, sterile and ready to use by professionals for assisted reproduction. EmbryoGen is quality control tested before release for pH, sterility, Mouse Embryo Assay, endotoxin, osmolality, GM-CSF concentration (by ELISA), GM-CSF potency (TF-1 cell assay) and HSA concentration (by ELISA).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria with pre-defined thresholds for performance metrics. The primary "acceptance criteria" here are implicitly tied to proving that EmbryoGen® is as safe and effective as the predicate device, EmbryoAssist™ (K080473), with the added benefit of GM-CSF.

The study aimed to demonstrate a 25% relative increase in ongoing implantation rate at gestational week 7 as its primary hypothesis. While this was the initial goal, the overall study results did not meet this specific statistical significance for the general population. However, the device's performance within a specific subgroup did show a significant improvement.

Here's a table summarizing the implicit acceptance criteria and the device's reported performance within the context of substantial equivalence:

Study Details

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

   • Test Set Sample Size:
     • Enrolled/Randomized (ITT): 1,332 subjects
     • Per-Protocol (PP) Population: 1,149 subjects
     • Interim Analysis (PP population with embryo transfer & Day 7 data): 301 women
     • Final PP population (Primary Endpoint): The 23.5% vs 20.0% is based on the PP population, which was 1,149 subjects.
     • Subgroup (Previous Miscarriage): 289 patients with embryo transfer.
     • Total Babies Born: 369
   • Data Provenance: Multicenter, randomized, parallel group, double-blind, placebo-controlled clinical study. Follow-up data was retrieved from the Danish National Board of Health Register (93%) and supplemented by patient/couple questionnaires (7% for birth data). This indicates a prospective study primarily conducted in Denmark (given the mention of the Danish National Board of Health Register) across 14 study centers.

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

   • The document does not specify the number or qualifications of experts used to establish "ground truth" for the test set.
   • The primary endpoint (ongoing implantation rate at gestational week 7) was evaluated by ultrasound scan. Secondary endpoints (embryo quantity/quality) were judged against predefined classification. Follow-up for live birth and health characteristics relied on national registries and questionnaires.
   • While medical professionals (e.g., sonographers, clinicians, embryologists) would have been involved in data collection, their specific roles in establishing a "ground truth" for the study endpoints (beyond standard medical practice) are not detailed.

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

   • The document does not explicitly describe an adjudication method (like 2+1 or 3+1).
   • The double-blind, placebo-controlled, multicenter design suggests efforts to minimize bias. The use of national registries for a large portion of follow-up data implies a standardized, albeit external, source of truth rather than a specific internal adjudication process for every case.

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, a MRMC comparative effectiveness study was not done. This study is evaluating a medical device (culture medium), not an AI or imaging diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

   • No, this is not an AI-driven device. It's a culture medium. The concept of "standalone algorithm" is not applicable.

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

   • The "ground truth" for the primary and secondary endpoints consisted of clinical outcomes data and standard clinical assessments:
     • Ongoing implantation rate: Evaluated by ultrasound scan.
     • Live Birth: Confirmed through the Danish National Board of Health Register and patient/couple questionnaires.
     • Abnormalities/Malfunctions: Retrieved from the Danish National Board of Health Register and questionnaires.
     • Embryo quantity and quality parameters: Judged against predefined classifications, likely by embryologists.

7. The sample size for the training set:

   • Not applicable. This study is a clinical trial for a medical culture medium, not a machine learning model. There is no concept of a "training set" in this context.

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

   • Not applicable. As a clinical trial for a culture medium, there is no training set or ground truth establishment method for such a set.

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