Search Results

The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.

The EmbryoSlide+ ic8 dish is single use, sterile for embryo culture, handling, and preparation for transfer during assisted reproduction technology procedures. The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has eight culture wells. Each well holds a single embryo in 20µL of culture medium. In addition, four rinsing wells are available, each rinsing well holding 25-30μL medium. The culture area of the dish, comprising both the culture wells, must be covered with 1.6mL culture oil overlay to minimize osmolarity changes during culture in a dry environment.

I am sorry but this document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. This document is an FDA 510(k) premarket notification for a medical device (EmbryoSlide+ ic8 dish) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device.

While it mentions some specifications and testing performed (e.g., sterility, endotoxin testing, mouse embryo assay), it does not detail a formal study designed to prove the device meets specific acceptance criteria in the way you've outlined. The information provided is for regulatory clearance based on substantial equivalence, not a detailed clinical or comparative effectiveness study report.

Therefore, I cannot provide the requested table and detailed study information based on this document.

Ask a specific question about this device

The KIDScore D3 tool provides decision support for prediction of embryos developing to the blastocyst stage by scoring them according to their statistical viability.

Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.

The KIDScore D3 tool is only to be used with the EmbryoScope timelapse incubator systems.

The KIDScore D3 decision support tool is an adjunctive algorithm that is designed to support embryologists in their decision about which embryos are suitable for transfer. The tool is an optional accessory to the EmbryoViewer software. It is used in the "Compare & Select" function. The "D3" in the name refers to the use of the algorithm on Day 3 for aiding the embryologist in preparing for transfer of the embryo to the female patient.

KIDScore D3 utilizes the following manually annotated parameters to aid in identifying embryos that are suitable for transfer:

• Pronuclei (number of pronuclei): ●
• tPNf (time from insemination until pronuclei is fading) ●
• t2 (time from insemination to complete division to two cells) ●
• t3 (time from insemination to complete division to three cells) ●
• t4 (time for insemination to complete division to four cells) .
• t5 (time from insemination to complete division to five cells) ●
• t8 (time from insemination to complete division to eight cells) ●

The KIDScore D3 assigns scores by comparing the parameters above in embryos to the model criteria, one criterion at a time until the process stops either because the embryo did not pass one of the criteria in the sequence or because the last criterion in the model was reached. From the information available at day three of incubation, the KIDScore D3 divides embryos into five score groups (1-5, as described below):

• 0 = The embryo is not 2PN
• 1 = Initial development was too fast or the embryo displayed a direct cleavage from one to three cells
• 2 = The embryo was slow to develop
• 3 = Embryo development was irregular and the development pace increased from day two to day three
• 4 = Embryo development was irregular and the development pace slowed from day two to day three

and/or

The number of cells annotated at 66 hours was not as expected

5 = The embryo passed all of the avoidance criteria included in the model.

One or more computers running the EmbryoViewer software may be connected to the ES Server. KIDScore D3 is stored on the computer running the ES Server software. Calculations related to the model in KIDScore D3 are performed on the computer running the ES Server software.

This document describes the KIDScore D3 device, an adjunctive algorithm designed to support embryologists in selecting suitable embryos for transfer by predicting their likelihood of developing to the blastocyst stage.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the primary endpoint of the clinical study, which required the blastocyst Odds Ratio (OR) for the adjunct prediction to be statistically significantly greater than 1 for Good/Fair embryos (graded A, B, or C using Day 3 morphology).

Ask a specific question about this device

EmbryoScope+ consists of the following devices with the following indications for use:

The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.

The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.

The Embryo Viewer software is intended for displaying, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation 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 Viewer software does not control any hardware components in the EmbryoScope+ incubator.

The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters.

The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software must be used together to analyze the embryo images.

EmbryoScope+ consists of the following devices: EmbryoScope+ incubator, EmbryoSlide+ culture dish, EmbryoViewer software, and ES Server software.

The EmbryoScope+ incubator is a bench top embryo incubator with a time-lapse imaging function. It provides temperature control, and time-lapse microscopy at multiple focal planes. This device can hold up to 15 culture dishes (EmbryoSlide+ culture dish) in the incubation chamber. The culture dishes are placed on the dish holder in the EmbryoScope+ incubator. The holder provides direct heat transfer to the EmbryoSlide+ culture dish. The built-in microscope consists of an LED illumination unit and an inverted microscope/camera unit. During image acquisition, each culture dish located on the culture dish holder is rotated to the microscopy system and individual image stacks are acquired from all individual embryos in each culture dish.

The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reservoir has eight culture well is used to culture one embryo. Therefore, a total of 16 embryos can be cultured on one dish. Each dish includes four special wells that are only used for rinsing and handling the embryos either before or after incubation. An adhesive barcode label printed from the EmbryoViewer software is used to mark each dish. The barcode label contains two different 2D data matrices that provide information on the patient ID, treatment ID, and insemination time). The EmbryoSlide+ culture dish has a sterility assurance level of 10° and a shelf-life of four years. This device is subject to mouse embryo assay (MEA) and endotoxin testing before lot release.

The EmbryoViewer software is used for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. The data that can be viewed using this software includes embryo images, incubation details, alarms, log files and other instrument parameters. This software also includes a user annotation 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 neither controls any hardware components in the EmbryoScope+ incubator nor performs any diagnostics.

The ES Server software allows users to update and view common data. The server acts as the central unit, which stores data and controls the data flow to and from the connected devices. The server can be connected to multiple EmbryoScope+ incubators and computers with the EmbryoViewer software installed.

The provided text does not contain information about a "study that proves the device meets the acceptance criteria" in the format of a clinical trial or a specific comparative effectiveness study with human readers and AI assistance. Instead, it describes non-clinical performance testing conducted to support the substantial equivalence of the EmbryoScope+ device to its predicate devices.

The acceptance criteria are generally implied by the design specifications and testing standards mentioned.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

The text doesn't explicitly present a direct "acceptance criteria" vs. "reported performance" table for all aspects. However, it lists performance specifications for the EmbryoScope+ incubator and the results of various non-clinical tests.

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 describes non-clinical bench testing. For the Mouse Embryo Assay (MEA), the sample size is implicitly "one-cell mouse embryos" without a specific number. The data provenance is not mentioned (e.g., country of origin). The testing seems to be experimental/prospective in nature, rather than retrospective use of human patient data.

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

Not applicable. The document describes non-clinical performance and engineering testing (electrical safety, EMC, software V&V, bench performance, sterilization, package integrity, endotoxin, mouse embryo assay). These do not involve human experts establishing ground truth for a diagnostic AI system.

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

Not applicable, as this is non-clinical performance testing, not a clinical study requiring adjudication of expert interpretations.

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 MRMC comparative effectiveness study is mentioned. The device, EmbryoScope+, includes software (EmbryoViewer) with "user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection." However, the text details non-clinical testing for substantial equivalence, not a clinical study on human reader performance with or without AI assistance.

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

While the EmbryoViewer software includes "user-defined modeling function" to "aid in embryo selection," the substantial equivalence argument relies on comparing the entire system (incubator, software, dish) to predicate devices through non-clinical performance metrics. There is no specific mention of a standalone algorithm performance study without human involvement, particularly relating to "embryo selection" capability. The software primarily displays, stores, transfers images, and allows for user annotation and user-defined modeling, implying human-in-the-loop use. It explicitly states, "The EmbryoViewer software neither controls any hardware components in the EmbryoScope+ incubator nor performs any diagnostics."

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

For the non-clinical tests described:

• EmbryoSlide+ Culture Dish (MEA): The "ground truth" for the MEA test was defined by the biological outcome: "percent of embryos developed to the expanded blastocyst stage within 96 hours." This is an objective biological endpoint.
• Other non-clinical tests (electrical safety, EMC, metrology, etc.): Ground truth is established by adherence to engineering specifications, recognized standards (e.g., IEC, EN, ASTM, ISO, USP, ANSI/AAMI), and design specifications.

8. The sample size for the training set

Not applicable. The document does not describe a machine learning model that requires a training set in the conventional sense. The "user-defined modeling function" in the EmbryoViewer software suggests that users define their own criteria based on embryo development parameters, rather than the device itself being trained on a large dataset.

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

Not applicable, as no machine learning training set is described.

Ask a specific question about this device

The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only with the EmbryoScope device.

The Vitrolife A/S EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. The Vitrolife A/S EmbryoSlide culture dish is intended to be used with the EmbryoScope device that was previously cleared via K092183, K111715 and K133712. A previous version of the EmbryoSlide culture dish was cleared via K092183. Minor modifications have been made to the original EmbryoSlide culture dish as described below.

The proposed EmbryoSlide culture dish contains two types of wells which are only used for rinsing and handling the embryos before or after incubation and wells in which the embryos reside during incubation. The original EmbryoSlide culture dish included only wells for which the embryos reside during incubation.

This EmbryoSlide culture dishfits exactly on the culture dish holder in the incubator and holds a maximum of 12 embryos in separate micro wells. As with the original EmbryoSlide culture dish, the proposed EmbryoSlide culture dish contains a large oil reservoir with 12 wells for the incubation of 12 individual embryos. Each well has a volume of 25 ul. Inside each well there is a central depression where the embryo rests. The well has a diameter of approximately 250 um.

As described above, the proposed EmbryoSlide culture dish includes 4 special wells, two at each end of the culture dish that are intended for rinsing and general handling of the embryos either before or after incubation. Like the other wells, these handling/rinsing wells are designed to hold a volume of 25ul.

The provided document is a 510(k) summary for the Vitrolife A/S EmbryoSlide Culture Dish. It details the device, its intended use, and performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• MEA Testing: "tested per LOT" is mentioned, indicating ongoing quality control testing rather than a specific sample size for a single clearance study. The document does not specify a numerical sample size for the MEA test set used for this 510(k) submission.
• Cytotoxicity Testing: Not specified.
• Bacterial Endotoxins Testing: Not specified, also "tested per LOT".
• Data Provenance: Not explicitly stated but implied to be from laboratory testing conducted by the manufacturer, Vitrolife A/S. No country of origin for specific data or whether it was retrospective/prospective is detailed.

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

• Not applicable/Not mentioned. The testing described (MEA, cytotoxicity, endotoxins) are lab-based performance tests with objective endpoints, not requiring expert ground truth or interpretation in the way clinical studies or image analysis algorithms would.

4. Adjudication method for the test set

• Not applicable/Not mentioned. The tests are analytical/quantitative laboratory assays.

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 MRMC study was conducted or mentioned. This device is a culture dish, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is a physical labware product, not an algorithm.

7. The type of ground truth used

• The "ground truth" for the performance tests mentioned are defined by established biological and chemical assay standards:
  • MEA: Successful development of embryos to the blastocyst stage.
  • Cytotoxicity: Absence of adverse effects on cultured mammalian cells per USP and ISO 10993-5.
  • Bacterial Endotoxins: Concentration of endotoxins below a specified threshold per USP and .

8. The sample size for the training set

• Not applicable. This is a medical device (culture dish), not a machine learning model, so there is no training set in the AI context.

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

• Not applicable. As above, there is no training set for this type of device.

Ask a specific question about this device