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The EmbryoScope® time-lapse incubator (version D) provides an environment with controlled temperature, CO2 (and other gasses) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.

The EmbryoViewer™ software is an optional accessory software package for use in displaying, comparing, storing, and transferring images generated by the EmbryoScope® time-lapse incubator (Version D). The software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The EmbryoViewer™ software does not control any hardware components in the EmbryoScope® time-lapse incubator (Version D).

The EmbryoScope® time-lapse incubator is a tri-gas incubator, which acquires a series of unattended measurements on individual embryos during their development. The measurements include: time-lapse microscopy at multiple focal planes and logging of incubation conditions. Separate processing units control the incubation environment and data acquisition to ensure safe and reliable operation. Up to 72 embryos (6 EmbryoSlide® culture dishes with 12 embryos in each culture dish) can be incubated simultaneously.

The purpose of the EmbryoViewer™ software is to assist the embryologist in selecting embryos for transfer or freezing. This is obtained by allowing the embryologist to inspect high-resolution time-lapse images of embryo development, to use detailed annotation tools and to inspect the running conditions of the EmbryoScope® time-lapse system. The EmbryoViewer™ software does not perform any diagnostics, but only shows data from the EmbryoScope® time-lapse system and data entered by the user.

The provided text describes the 510(k) summary for the "EmbryoScope time-lapse incubator (Version D) and EmbryoViewer software." However, it does not contain specific acceptance criteria, a detailed quantitative study proving the device meets acceptance criteria, or information on human reader performance with or without AI assistance, or details about the training set.

Instead, it states that the device is considered substantially equivalent to a predicate device (K113075) based on an evaluation of tests performed on previous versions, with additional tests for new features. The document explicitly states that "No clinical testing was performed" for the EmbryoViewer software and "No clinical testing was performed" for the EmbryoScope time-lapse incubator.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is an attempt to address the request based only on the information available:

1. A table of acceptance criteria and the reported device performance
   The document does not provide a table of acceptance criteria with specific quantitative targets. Instead, it relies on substantial equivalence to a predicate device (K113075). The reported "performance" for the EmbryoScope time-lapse incubator is that the "test results have been evaluated and it has been concluded to accept the test results; the EmbryoScope time-lapse incubator is substantially equivalent to the predicate device." For the EmbryoViewer software, "Test results have been evaluated and it has been concluded to accept the test results; the EmbryoViewer software is as safe, as effective and performs as well or better than the EmbryoViewer software included in the submission K113075."

   Acceptance Criteria	Reported Device Performance
   EmbryoScope time-lapse incubator (Version D):
   Substantial equivalence to predicate device (K113075) based on evaluation of tests performed on previous version (GB) and additional tests for new features (EGS).

Incubation conditions and image quality not adversely affected by changes.
New features do not raise new types of safety and effectiveness questions.
Underwent and passed electrical safety, electromagnetic compatibility, environmental, and operating performance testing in accordance with IEC 60601-1:2005. | Test results evaluated and accepted; device is substantially equivalent to the predicate device.
Incubation conditions and image quality are not adversely affected.
New features do not raise new types of safety and effectiveness questions.
Passed electrical safety, electromagnetic compatibility, environmental, and operating performance testing in accordance with IEC 60601-1:2005.
Tests with and without mouse embryos confirm gas system component (EGS) is equivalent to gas system component (GB) in predicate device. No adverse effects of image acquisition were observed. |
| EmbryoViewer™ software: | |
| Substantial equivalence to predicate device (K113075) based on evaluation of tests performed on previous version and additional tests for new features.
Fulfilling the requirements of the IEC 62304 standard according to software testing.
New features (models and Compare & Select) do not impact incubation conditions or require changes to the EmbryoScope time-lapse incubator and do not raise new types of safety and effectiveness questions. | Test results evaluated and accepted; software is as safe, as effective, and performs as well or better than the predicate device's software.
Fulfills the requirements of the IEC 62304 standard according to software testing.
New features have no impact on incubation conditions and do not raise new safety and effectiveness questions. |

2. Sample sized 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 distinct "test set" in terms of number of cases (e.g., embryos or patients). The testing for substantial equivalence for both the EmbryoScope incubator and EmbryoViewer software primarily refers to "an evaluation of tests performed on previous version" with "addition of tests related to new features." There's mention of "Tests with and without mouse embryos" for the incubator, but no sample size or specific provenance for these. No information is provided about data provenance or whether any data was retrospective or prospective.

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)
   Not applicable (N/A). The document states "No clinical testing was performed" for either device. Therefore, no ground truth was established by experts in a clinical study context for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable (N/A). As "No clinical testing was performed," there was no clinical test set requiring adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states "No clinical testing was performed." The EmbryoViewer software includes a "user-defined modeling function" to "aid in embryo selection," but no study on its effectiveness or the improvement of human readers is presented.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   The document describes the EmbryoViewer software's functionality, including "a user annotation function" and a "user-defined modeling function." It explicitly states that the "EmbryoViewer™ software does not perform any diagnostics, but only shows data from the EmbryoScope® time-lapse system and data entered by the user." This implies it's designed as an assistive tool for human-in-the-loop use, rather than a standalone diagnostic algorithm. No standalone performance metrics are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   Not applicable (N/A). As "No clinical testing was performed," there is no mention of ground truth types derived from studies for this submission. The EmbryoViewer software stores "patient details, treatment data and outcome data," but this refers to data input by the user and stored in the database, not ground truth used to evaluate the device itself for this submission.

8. The sample size for the training set
   Not applicable (N/A). No explicit training set is mentioned as part of the device's development or evaluation in this submission. The software's "user-defined modeling function" allows users to define models, which implies the models are user-trained or configured, but no internal training set used by the manufacturer is described.

9. How the ground truth for the training set was established
   Not applicable (N/A). As no training set is described for the manufacturer's algorithm development in this document, no information on how its ground truth was established is provided.

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The EmbryoScope (Version D) provides 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 five days (120 hr) covering the time from post-fertilization to day 5 of development.

EmbryoViewer is an optional accessory software package for use in displaying, comparing, storing, and transferring EmbryoScope (Version D) generated images. The software includes a user annotation function for capturing information on embryo development parameters, treatment data, and outcome data. The EmbryoViewer software does not control any hardware components in the EmbryoScope (Version D) device.

The EmbryoScope 1M - (Version D) is an embryo incubator, which performs timelapse microscopy at multiple planes and logging of incubation conditions on individual embryos during their development. The EmbryoScope (Version D) included in this submission is identical to that cleared in previous 510(k) submissions (K092183 and K111715).

The EmbryoViewer software is an accessory to the EmbryoScope (Version D). The Embryo Viewer™ software does not perform any diagnostics, but only shows data from the EmbryoScope™ (Version D) and data filled in by the user. The EmbryoViewer™ software assists the user by allowing for inspection of high resolution time-lapse images of embryo development, detailed annotation tools and inspection of EmbryoScope™ (version D) running conditions.

The provided document describes a 510(k) submission for the EmbryoScope (Version D) and EmbryoViewer software. The purpose of the submission is to add the optional accessory EmbryoViewer software to the existing EmbryoScope (Version D) device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (the EmbryoScope (Version D) without the EmbryoViewer software). It does not present a study with specific acceptance criteria and reported device performance metrics in the way one might expect for a new diagnostic or AI-driven decision support system. Instead, the "study" is a comparison to the predicate device and validation of the software's functionality.

Therefore, the requested information must be interpreted within the context of software validation and a demonstration of substantial equivalence rather than a traditional performance study against clinical endpoints.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or reported device performance metrics in terms of clinical accuracy, sensitivity, specificity, etc., for the EmbryoViewer software. The "performance" being validated is primarily related to the software's functionality and its non-interference with the predicate device.

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

• Test Set Sample Size: The document does not specify a quantitative "test set sample size" in terms of number of embryos or images used for software validation. The validation appears to be functional testing.
• Data Provenance: Not specified. The document outlines general software testing and validation rather than a clinical study involving patient data.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. The validation described is software functionality testing, not a clinical study with subjective interpretations requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not described. The EmbryoViewer software is an image display and annotation tool, not an AI-driven diagnostic or decision support system intended to improve human reader performance.

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

• Standalone Performance: Not applicable. The EmbryoViewer is an accessory software package for displaying data and enabling user annotation; it does not perform any diagnostic or analytical tasks autonomously.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For the software validation, the "ground truth" would be the expected behavior and output of the software based on its design specifications and user inputs. For annotations, the "ground truth" would be the intended user input being correctly recorded and associated. It does not involve "expert consensus, pathology, or outcomes data" in a clinical sense.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The EmbryoViewer software is not described as involving machine learning or AI that would require a "training set."

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no described training set.

Summary Conclusion from the Document:

The K113075 submission for the EmbryoViewer software focuses on demonstrating that this optional accessory solely provides features for displaying and annotating images generated by the predicate EmbryoScope device. The key argument for acceptance (substantial equivalence) is that the software does not control any hardware, does not affect the operation of the main device, and its functions (display, storage, annotation) have been validated through standard software testing (EN 62304) to ensure data integrity and correct functionality. The document explicitly states that the EmbryoViewer "does not perform any diagnostics." Therefore, the validation approach is centered on safety and functional performance rather than clinical efficacy or diagnostic accuracy studies.

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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 five days (120 hr) covering the time from post-fertilization to day 5 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.

The provided document describes a 510(k) submission for a change in the indication for use of the EmbryoScope™ - (Version D) device. Therefore, the "acceptance criteria" discussed are related to demonstrating that the device remains safe and effective for the extended use duration, rather than performance metrics of an AI model.

Here's an analysis based on the information provided, framed to address the requested categories for a device rather than an AI:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are implied by the need to demonstrate that extending the incubation period from 3 days to 5 days does not alter the safety and effectiveness of the device, specifically relating to ongoing pregnancies and adverse effects. The study aimed to show "non-inferiority" or "no significant difference" in relevant clinical outcomes.

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

The document states: "Clinical data showed that the EmbryoScope™ - (Version D) performs according to the intended use of the device. No significant difference was found between the rates of ongoing pregnancies in the EmbryoScope™ -- (Version D) with 5 days of incubation compared to three days of incubation. No adverse effects of image acquisition were observed."

• Sample Size: Not explicitly stated. The phrase "Clinical data" suggests a study was performed, but the number of embryos, patients, or cycles included in this "clinical data" is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics).
• Retrospective/Prospective: Not explicitly stated. However, "Clinical data showed..." implies an analysis of collected data, which could be either. The comparison to "three days of incubation" suggests either a prospective comparative trial or a retrospective analysis comparing cohorts.

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

This section is not applicable in the context of this device and submission. The "ground truth" here is objective clinical outcomes (ongoing pregnancies, observed adverse events), not a subjective assessment requiring expert consensus on image interpretation or similar tasks that an AI might perform.

4. Adjudication method for the test set

This section is not applicable. The "test set" here refers to clinical data for human fertility outcomes, not a set of items requiring human adjudication (like medical images).

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

This section is not applicable. The EmbryoScope™ is an IVF incubator with an imaging system; it is not an AI-powered diagnostic device for which human reader performance would be assessed with or without AI assistance.

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

This section is not applicable. The device is an incubator and imaging system, not a standalone algorithm. Its "performance" is its ability to maintain a suitable environment and acquire images effectively, ultimately supported by clinical outcomes.

7. The type of ground truth used

The ground truth used for assessing the device's effectiveness was clinical outcomes data, specifically:

• Rates of ongoing pregnancies.
• Observation of adverse effects potentially related to image acquisition or the extended incubation period.

8. The sample size for the training set

This section is not applicable. The device is not an AI model that requires a training set in the conventional sense. The "training" for the device would be its engineering, design, and manufacturing processes, supported by non-clinical testing (electrical safety, EMC, environmental, operating performance) rather than a data training set.

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

This section is not applicable for the reasons stated above. The "ground truth" for the device's design and engineering is established through engineering principles, regulatory standards (e.g., IEC 60601-1), and extensive non-clinical testing to ensure hardware and software functionality, safety, and performance within specified environmental controls.

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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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