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This system is intended to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as advanced maternal age, prior failed IVF procedures, cryopreserved embryos, or abnormal zona pellucida morphology, and in IVF patients undergoing PGD to avoid genetic disease or aneuploidy.

There are two configurations offered. The ZILOS-tk has already been cleared [510(k) K063636], and the LYKOS is a new design version. The assembled Infrared Laser Optical System (ZILOS-tk) is the same length as a microscope 40x objective and can be fitted onto the turret of any inverted microscope. In addition a slightly different configuration is offered (Infrared Laser Optical System LYKOS system) in which the laser is integrated within a microscope 40X objective. As with Zilos-tk, it mounts on the turret of any inverted microscope and has the same intended use.

The ZILOS-tk and LYKOS are used in the reproductive laboratory for cutting a hatching hole in the zona pellucida (ZP) of embryos. The hole cut in the zona pellucida can be used to extract blastomere(s) for PGD. The devices can also be used to cut a herniated trophectoderm-cell biopsy from the embryo.

The devices use an infra-red [IR] laser beam [of wavelength in the range 1450

The provided text describes a 510(k) premarket notification for the ZILOS-tk and LYKOS devices, which are Assisted Reproduction Laser Systems. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way typically seen for a new diagnostic or AI-powered device.

Therefore, many of the requested elements (like human reader improvement, specific sample sizes for training/test sets, expert qualifications for ground truth in a clinical study, etc.) are not explicitly stated because the submission's purpose is different.

However, I can extract information related to the non-clinical testing performed to demonstrate equivalence.

Here's the breakdown of the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a new algorithm or diagnostic. Instead, the "acceptance criteria" appear to be that the devices (ZILOS-tk and LYKOS) perform equivalently to their predicate devices in terms of physical and functional characteristics. The Reported Device Performance is essentially a statement of equivalence.

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

• Test Set Sample Size: Not explicitly stated. The "testing" mentioned is non-clinical and pertains to device specifications and functional equivalence rather than a clinical trial with a "test set" of patient data.
• Data Provenance: Not applicable in the context of this 510(k) submission, as it focuses on non-clinical engineering and functional testing. No human or patient data is described.

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

• Number of Experts: Not applicable. The ground truth for this submission is based on engineering specifications and the established performance of predicate devices, not expert human assessment of medical images or clinical outcomes.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there is no human-read test set requiring adjudication mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This type of study is not described in the document. The submission is for an assisted reproduction laser system, not an imaging interpretation or diagnostic algorithm requiring human reader comparison.
• Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable. The device is a tool used by human operators, but the submission doesn't assess the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: No, not in the typical sense of an algorithm. The ZILOS-tk and LYKOS are physical laser systems with integrated software. The "performance" assessment is of the device's technical specifications and functional output, not a standalone diagnostic algorithm. Non-clinical bench testing was performed to verify system parameters.

7. Type of Ground Truth Used

• Ground Truth Type:
  • Predicate Device Specifications: The primary "ground truth" for demonstrating substantial equivalence is the established performance and specifications of previously cleared predicate devices (Hamilton Thorne Infrared Laser Optical system (Zilos-tk) (K063636) and Research Instruments Saturn 3 laser system (K060764)).
  • Engineering and Bench Test Standards: Electrical, optical, and mechanical specifications are tested against established engineering standards and validated performance. For example, "laser pulse duration, laser pulse power, laser mean power limits, RED-i directionality and laser focus have all been tested."

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device in the sense of requiring a "training set" of data for an algorithm. The "training" in this context would refer to engineering development and calibration.

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

• Ground Truth for Training Set Establishment: Not applicable for an AI/ML algorithm training set. The "ground truth" for the device's development and validation is based on established physics principles, engineering design, and functional requirements for assisted reproduction laser systems, benchmarked against the predicate devices.

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