Search Results

To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to three days (72 hr) covering the time from post-fertilization to day 3 of development.

The EmbryoScope™ - (Version D) is an embryo incubator, which performs a series of unattended measurements including time-lapse microscopy at multiple planes and logging of incubation conditions on individual embryos during their development. The device has a build-in microscope within a red light source. Separate processing units control the incubation environment and the data acquisition to ensure safe and reliable operation. The Device allows incubation of up to 72 individual embryos in six sterile disposable EmbryoSlides™ each with capacity for 12 embryos.

Here's a breakdown of the acceptance criteria and study information for the EmbryoScope™ (Version D) and EmbryoSlide™ devices, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents describe the EmbryoScope™ (Version D) as an IVF incubator and the EmbryoSlide™ (FT-S-ES-D) as an IVF incubator accessory. The acceptance criteria primarily revolve around demonstrating substantial equivalence to predicate devices. This means the new devices perform as safely and effectively as existing legally marketed devices.

The "acceptance criteria" are not explicitly stated in numerical thresholds but are implied by the comparison to predicate devices and the clinical testing outcome. The "reported device performance" is the statement of equivalence and the finding of comparable outcomes.

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

The document mentions "Clinical data showed that the EmbryoScope TM - (Version D) performs according to the intended use of the device. No significant difference was found between the rates of ongoing pregnancies in a standard incubator and the EmbryoScope™ - (Version D)."

• Sample Size for Test Set: The exact sample size for the clinical study is not specified in the provided text.
• Data Provenance: The provenance (country of origin, retrospective/prospective) is not specified. It refers to "Clinical data," implying a human clinical study. Given the company's address in Denmark, it's possible the study was conducted there or in another European country. The context of a 510(k) submission to the FDA suggests the data must meet FDA's requirements for demonstrating safety and effectiveness.

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

The document does not specify the number of experts used to establish ground truth or their qualifications for the clinical study. The "ground truth" for the clinical study appears to be the "rates of ongoing pregnancies," which would typically be determined by medical professionals in an IVF setting.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the clinical study results. It simply states the finding of "no significant difference" in ongoing pregnancy rates.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed or described in the provided text.
• Effect Size (Human Readers with/without AI): Not applicable, as this device (EmbryoScope) is an incubator and imaging system, not an AI-assisted diagnostic tool that aids human readers in interpretation. The "imaging system" is for embryo viewing, not AI-driven analysis for human interpretation.

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

• Standalone Performance: Not applicable in the context of the primary function of these devices. The EmbryoScope™ is an incubator with an integrated imaging system for embryo viewing, and the EmbryoSlide™ is an accessory. There isn't an "algorithm" performing a diagnostic or interpretive function in a standalone capacity described in the documentation. The device's performance relates to maintaining a suitable environment for embryo development and enabling imaging, not making automated diagnoses.

7. The Type of Ground Truth Used

For the clinical study of the EmbryoScope™ (Version D), the type of ground truth used was outcomes data, specifically "rates of ongoing pregnancies."

For the EmbryoSlide™ (FT-S-ES-D), the ground truth for its biological compatibility was established through:

• Sterility testing (SAL 10-6)
• Non-pyrogenic testing by Limulus Amebocyte Lysate (LAL)
• Non-embryotoxic testing by the 1-cell mouse embryo assay (MEA)
• "Embryo survival rate" comparable to the predicate device.

8. The Sample Size for the Training Set

The document does not mention or imply any training set, as these devices are not described as employing machine learning or AI models that would require a dedicated training set. The "testing" referred to is for device performance, safety, and clinical outcomes.

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

Not applicable, as no training set is described for these devices.

Ask a specific question about this device