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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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