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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.

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The intended use of this incubator is to provide an environment with controlled temperature, CO2 elevated humidity, an automatic decontamination mode, and O2 at suppressed levels, for the development of ova or embryos at or near body temperature.

The Kendro HERAcell 240 incubators are bench top or floor standing units. The devices control CO2, temperature, provide elevated humidity, feature a decontamination mode, and control O- at suppressed levels to ensure the proper development of ova or embryos at or near body temperature. The conditions produced by the subject device are an exact simulation of physiological conditions. Controlled parameters and alarin functions are microprocessor controlled. The basic model includes the auto-zero self-balancing CO2 control system, which ensures long term stability of CO2 levels. Each unit is equipped with a water level alarm to remind the user to refill the water reservoir. As with the predicate device the user has the choice of a stainless steel or solid copper inner chamber. Additionally, the user can choose from additional options such as Oxygen control, Infra-Red Sensor, and the roller bottle system. The basic model includes the TC (thermal conductivity) sensor, however the user can choose the Infra-Red Sensor option.

The provided text describes a 510(k) premarket notification for the Kendro Laboratory Products HERAcell 240 incubator, an assisted reproduction accessory. This submission focuses on demonstrating substantial equivalence to a predicate device (Kendro HERAcell CO2 Incubator - K002805) rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria, specific performance studies, sample sizes, expert involvement, and ground truth are not available in the provided document. The submission relies on the concept of substantial equivalence to a previously cleared device.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The submission asserts substantial equivalence based on the device's technical characteristics and intended use being similar to a predicate device. Performance is generally implied to be acceptable because it's equivalent to the predicate, which already met regulatory requirements.

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

This information is not provided. The submission does not describe a clinical performance study with a test set. This is a premarket notification for a device that relies on demonstrating substantial equivalence, not a new clinical trial.

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

This information is not provided. As no specific clinical test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

This information is not provided. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

No. An MRMC comparative effectiveness study was not done or described in this 510(k) submission. This type of study is typically for evaluating diagnostic algorithms with human readers, which is not applicable to an incubator. The submission focuses on device function for an intended environment for biological samples.

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

This information is not applicable to this device. The HERAcell 240 is an incubator, not an algorithm or AI system for diagnostic or interpretive purposes. Its performance is based on its ability to maintain environmental conditions.

7. The Type of Ground Truth Used:

This information is not explicitly stated as part of a formal study with "ground truth." For a device like an incubator, "ground truth" would generally refer to the accurate measurement and maintenance of physical parameters like temperature, CO2, O2, and humidity. Performance is implied to be acceptable based on the device's design, compliance with electrical safety standards, and its similarity to the predicate device. The statement "The subject device complies with internationally accepted electrical safety standards as well as other requirements such as CE marking" is the closest to a performance claim, suggesting compliance with established standards defines successful device operation.

8. The Sample Size for the Training Set:

This information is not provided and is not applicable. This is not an AI/ML device that requires a training set.

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

This information is not provided and is not applicable. This is not an AI/ML device.

Summary of Device Performance and Acceptance (based on available information):

The submission for the Kendro HERAcell 240 incubator sought to establish substantial equivalence to its predicate device (Kendro HERAcell CO2 Incubator - K002805).

• Intended Use: To provide an environment with controlled temperature, CO2, elevated humidity, an automatic decontamination mode, and O2 at suppressed levels, for the development of ova or embryos at or near body temperature.
• Key "Performance" Claims/Characteristics:
  • Direct control of Carbon Dioxide and Oxygen levels (the predicate only directly controlled CO2).
  • New options: Oxygen O2 control ranges (1-21% or 5-90%), Infra-red CO2 Sensor, Roller Bottle System, Water Level Alarm.
  • Complies with internationally accepted electrical safety standards and CE marking.
  • "The conditions produced by the subject device are an exact simulation of physiological conditions."
• Acceptance Criteria (Implicit via Substantial Equivalence): The device is considered to meet acceptance criteria because its technological characteristics and performance are "as safe and effective as the predicate devices" (Kendro HERAcell CO2 Incubator - K002805, and citing Forma Scientific Incubator - K991408 for oxygen control). This means it is expected to maintain the specified environmental conditions (temperature, CO2, O2, humidity) within levels suitable for ova or embryo development, akin to the predicate device.
• Study: The submission relies on a comparison to a predicate device (Kendro HERAcell CO2 Incubator - K002805) and general compliance with electrical safety standards, rather than a specific clinical performance study with predefined acceptance criteria for the new features. The argument is that the key operational principles and safety are essentially the same, with minor additions that have also been demonstrated in other cleared devices (e.g., oxygen control in K991408).

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