(246 days)
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:
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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. |
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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. -
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. -
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. -
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. -
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. -
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. -
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. -
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.
§ 884.6120 Assisted reproduction accessories.
(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.