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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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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.

The ZILOS-tk uses an infra-red [IR] laser beam [of wavelength in the range 1450

Here's an analysis of the provided text regarding the ZILOS-tk device's acceptance criteria and studies:

Acceptance Criteria and Device Performance

The submission for the ZILOS-tk device is primarily focused on extending its Indications for Use to include Laser-Assisted Blastomere or Trophectoderm Biopsy (LAB), in addition to its existing approval for Laser Assisted Hatching (LAH). The core argument for meeting acceptance criteria is that the device itself, its operation, and its effects on the zona pellucida are identical across both applications. Therefore, the safety and effectiveness demonstrated for LAH are directly transferable to LAB.

Study Information

1. Sample size used for the test set and the data provenance:

   • 3-day embryos (blastomere biopsy): More than six hundred embryos.
   • 5-day embryos (trophectoderm biopsy): More than 1000 embryos.
   • Data Provenance: "numerous laboratories throughout the world." The data appears to be retrospective as it's referred to as "evidence from the field use" and "ZILOS-tk has been applied to laser biopsy and PGD in numerous laboratories throughout the world." Specific countries are not listed, but "France" and "Singapore" are mentioned for other contexts.

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

   • This information is not provided in the document. The "ground truth" here is implied by the reported outcomes (no embryo damage, survival of procedures, successful PGD). However, there's no mention of a formal expert panel establishing a gold standard for these outcomes in the context of the study.

3. Adjudication method for the test set:

   • None explicitly mentioned. The document states "no reports of embryo damage have been found" and "all of which survived the procedure," suggesting aggregated reporting of outcomes rather than an adjudication process by multiple experts for each case.

4. 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, an MRMC study was not done. This device is a laser system for physical intervention on embryos, not an AI-based diagnostic or imaging device for "human readers." Therefore, this type of study is not applicable.

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

   • No, a standalone (algorithm only) study was not done. The ZILOS-tk is a physical device operated by a human. Its performance is always human-in-the-loop. The "performance data" provided refers to the outcomes of embryos after being treated with the device, which is an integrated human-device process.

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

   • The ground truth relied on is outcomes data (survival of embryos, absence of reported damage) and clinical success (successful PGD to prevent hereditary disease). This is implicitly validated by the medical community's continued use of the device and the successful delivery of healthy infants when PGD is employed.

7. The sample size for the training set:

   • Not applicable/Not specified. This device is a physical instrument, not an AI model that requires a "training set" in the conventional sense. The "training" here refers to the development and refinement of the device based on engineering principles and prior clinical experience with its predicate function (LAH).

8. How the ground truth for the training set was established:

   • Not applicable/Not specified. As it's not an AI model, the concept of a "ground truth for a training set" does not directly apply. The device's efficacy and safety for its initial indication (LAH) would have been established through prior clinical use, pre-market approvals (K040045), and scientific understanding of laser-zona interaction. This historical performance serves as the basis for arguing equivalence for the new indication.

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The Hamilton Thorne ZILOS-tk is 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 Cryopreserved embryos Abnormal zona pellucida morphology

The Hamilton Thorne Zona Infrared Laser Optical System [ZILOS-tkTM] 1480 nm Diode Laser for Laser Assisted Hatching [LAH].

This appears to be a 510(k) clearance letter from the FDA for a medical device called the "Zona Infrared Laser Optical System [ZILOS-tk™] 1480nm Diode Laser for Laser Assisted Hatching [LAH]".

The document does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. This type of information is typically found in the 510(k) summary submitted by the manufacturer, not in the clearance letter itself.

The clearance letter primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to "indications for use" but does not detail performance criteria or study results that would demonstrate how those indications are met.

Therefore, I cannot provide the requested table and study details based on the provided text.

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