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The LYKOS Assisted Reproduction Laser with Dynamic Target System (DTS) is intended for in vitro fertilization (IVF) laboratory use in assisted reproduction procedures to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate assisted reproduction hatching procedures and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening.

The LYKOS with DTS is comprised of hardware, software and firmware. Hardware components include a laser control unit, communication cable, optional foot pedal, microscope mount(s) and a 40x objective. Fully integrated within the objective is the laser, a rotating mirror frame and motors that rotate the mirror and control the direction of the laser beam. The objective can be mounted on most commercially available inverted microscopes. The laser hardware interfaces with a computer and camera, providing a live image of the objective's field of view on the computer monitor. The system also records images and videos of the laser procedures.

The system includes three laser modes: Clinical, Multipulse, and Validation. The Clinical Mode includes laser settings recommended for zona thinning and embryo hatching procedures. The Multipulse Mode allows the use of a series of laser pulses and is intended for trophectoderm biopsy procedures. The Validation Mode is intended to validate the proper operation of the laser including RED-i and laser alignment.

Targeting of the laser beam (i.e., either aiming its direction or plotting its ablation path) may be performed in two modes: fixed direction or DTS. In the fixed direction mode of operation, the direction of the beam remains fixed and the embryo is manually guided to the laser by the user. In the DTS Mode, the embryo remains fixed and the direction of the laser is computer-controlled, navigating a user defined plot as drawn on the computer monitor. The system can be programmed to aim and fire the laser anywhere in the field of view or along a user-defined ablation path.

In both Manual and DTS modes, because the laser operates in the invisible infrared wavelength (lambda = 1460 mm), to aim and visually verify the position of the laser beam at all times prior to firing, the laser is concentrically aligned with a visible red LED beam (RED-i). Through an automated mapping and verification system using the X-Y coordinates of the computer monitor, the laser can be aimed and an ablation path plotted and verified by the user prior to each use.

The provided text describes the Hamilton Thorne LYKOS™ Assisted Reproduction Laser with Dynamic Targeting System (DTS). However, it does not contain a detailed study report with specific acceptance criteria and device performance results in a table format, nor does it include information on sample sizes for test/training sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.

The document is a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to a predicate device (SATURN 5™ Laser System). It outlines the device's intended use, technological characteristics, and a summary of performance testing performed.

Here's an attempt to answer your request based on the available information, with significant limitations due to the missing details:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Laser Performance Testing in accordance with the 2004 FDA guidance document 'Assisted Reproduction Laser Systems - Class II Special Controls Guidance Document for Industry and FDA Staff.'" It also lists specific validation tests. However, the specific acceptance criteria (e.g., "accuracy must be within X microns") and the reported device performance (e.g., "accuracy achieved Y microns") for these tests are not provided in the document.

The document states that the testing demonstrated the device is "substantially equivalent to the predicate device," implying that the performance met the necessary thresholds for equivalence, but without quantifying them.

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

This information is not provided in the document. The laser performance testing, validation of accuracy and precision, RED-i alignment, electrical safety, EMC, software, cybersecurity, and reprocessing validation are mentioned, but the specific sample sizes used for these tests are not disclosed.

3. 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 nature of the device (a laser system for assisted reproduction procedures) suggests that "ground truth" might relate to the physical accuracy of the laser's targeting and ablation, rather than interpretation of biological data by experts in the typical clinical AI context.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study is not mentioned in the document. The performance testing outlined focuses on the device's technical specifications and functionality (e.g., laser accuracy, electrical safety, software compliance), rather than clinical outcomes or human reader performance with or without AI assistance. This device is an instrument used by a human, not an AI diagnostic tool.

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

This concept is not directly applicable in the context of this device. The LYKOS DTS is an "assisted reproduction laser system," meaning it is a tool operated by a human user (e.g., an embryologist). Its "dynamic targeting system" (DTS) uses computer control to navigate the laser, but it's not described as an AI algorithm making independent decisions or diagnoses without human supervision. The performance testing focuses on the accuracy and precision of the laser's operation and mapping capabilities, which are functions of the system, not a standalone diagnostic algorithm.

7. The type of ground truth used

For the laser performance tests (accuracy and precision of single/multiple pulses, RED-i alignment), the "ground truth" would likely refer to physical measurements and precise calibrations of the laser's output and aiming mechanics, compared against known targets or reference points. It would not typically involve "expert consensus," "pathology," or "outcomes data" in the way these terms are used for diagnostic AI. For regulatory compliance (electrical safety, EMC, software, cybersecurity, reprocessing), the "ground truth" is compliance with the respective international standards and FDA guidance documents.

8. The sample size for the training set

This information is not provided in the document. As this device is a laser system and not a machine learning diagnostic algorithm, the concept of a "training set" in the sense of data used to train an AI model is unlikely to apply directly. However, if any internal models or algorithms were developed, the data used for their development is not disclosed.

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

This information is not provided in the document, as the concept of "training set" and associated ground truth establishment for AI models is not directly addressed.

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GM501 Wash with Phenol Red and Gentamicin is intended for in vitro procedures involving handling and micromanipulation of human oocytes and embryos outside of a CO2 incubator. Include oocyte and embryo washing (e.g. after oocyte aspiration, after hyaluronidase treatment to remove cumulus cells, before and after cryopreservation, and before embryo transfer) and micromanipulation procedures (e.g. assisted hatching). GM501 Wash with Phenol Red and Gentamicin is not intended for use in transferring embryos into the uterine cavity.

GM501 Wash with Phenol Red and Gentamicin is a ready-to-use solution providing supporting conditions for human oocytes and embryos during in vitro Assisted Reproduction Technology (ART) procedures taking place outside of a CO2 incubator, including washing and micromanipulation procedures. GM501 Wash is aseptically filled into sterilized bottles (20 and 50 ml) and has a six-month shelf-life when stored as recommended. This product can also be used for up to seven days after bottle opening.

GM501 Wash with Phenol Red and Gentamicin is identical to the predicate GM501 Wash with the exception of the addition of gentamicin sulfate (10 mg/liter) and phenol red (3 mg/liter).

Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to address your specific points:

1. A table of acceptance criteria and the reported device performance

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GM501 SpermAir is intended for the handling and preparation of sperm for use in assisted reproduction procedures. GM501 SpermAir is not intended for use in intrauterine insemination procedures.

GM501 SpermActive is intended for the handling and preparation of sperm for use in assisted reprocedures. GM501 SpermActive is not intended for use in intrauterine insemination procedures.

GM501 SpermAir and GM501 SpermActive are ready-to-use solutions for handling and preparation of sperm cells during assisted reproduction procedures. Both devices are aseptically filled into sterilized bottles and sealed. GM501 SpermAir comes in three volumes: 2 ml, 20 ml, and 50 ml. GM501 SpermActive comes in two volumes: 20 ml and 50 ml. Both media have a six-month shelf-life when stored as recommended and can be used for up to seven days after opening.

Here's a breakdown of the acceptance criteria and study information for the GM501 SpermAir and GM501 SpermActive devices, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

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GM501 Mineral Oil is intended for use as an overlay for culture of gametes, zygotes, or embryos in Assisted Reproduction Technology (ART) and micro-manipulation procedures.

GM501 Mineral Oil is light, mineral oil (paraffin oil) which is used to overlay cell culture media during Assisted Reproductive Technology (ART) or In Vitro Fertilization (IVF) procedures. The oil overlay is intended to protect the culture medium from evaporation in the incubator, limiting potential temperature, osmolality and pH changes in the medium.

GM501 Mineral Oil is aseptically filtered and provided in bottles of 100 ml and 500 ml. This product has an 18-month shelf-life when stored as recommended.

The provided text appears to be an FDA 510(k) summary for a medical device called "GM501 Mineral Oil." It does not describe an AI medical device or a study involving human readers or AI.

Therefore, I cannot provide the information requested for acceptance criteria and a study proving a device meets these criteria, especially concerning AI, human readers, or expert evaluations. The document focuses on demonstrating substantial equivalence of a mineral oil product to a predicate device, based on similar indications for use, materials, specifications, and shelf-life, rather than providing performance data from a clinical or AI-specific study.

The closest information provided to "acceptance criteria" are the "Specification" values in the table on page 4, which are chemical and biological characteristics of the mineral oil product rather than performance metrics for an AI algorithm.

Table of Acceptance Criteria and Reported Device Performance (based on provided text):

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GM501 Wash is intended for in vitro procedures involving handling and micromanipulation of human occytes and embryos outside of a CO> incubator. Include oocyte and embryo washing (e.g. after oocyte aspiration, after hyaluronidase treatment to remove cumulus cells, before and after cryopreservation, and before embryo transfer) and micromanipulation procedures (e.g. assisted hatching). GM501 Wash is not intended for use in transferring embryos into the uterine cavity.

GM501 Wash is a ready-to-use solution providing supporting conditions for human oocytes and embryos during in vitro Assisted Reproduction Technology (ART) procedures taking place outside of a CO2 incubator, including washing and micromanipulation procedures. GM501 Wash is aseptically filled into sterilized bottles (20, 50 and 500 ml) and has a six-month shelf-life when stored as recommended. This product can also be used for up to seven days after bottle opening.

Here's a breakdown of the acceptance criteria and study information for the GM501 Wash device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "test set" sample size for evaluating the device as a whole. However, it mentions the following for the Mouse Embryo Assay (MEA):

• Sample Size for MEA: "One-cell mouse embryos were exposed to GM501 Wash for one hour..." The specific number of embryos used is not provided.
• Data Provenance: The origin of the mouse embryos (e.g., country) is not specified. The study appears to be a prospective evaluation of the new device.

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

This information is not provided in the document. The ground truth for the MEA and other tests (pH, osmolality, etc.) is based on scientific and regulatory standards, not expert consensus on individual cases.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluations are objective laboratory tests with defined criteria, not 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a reproductive media product, not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.

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

Not applicable. This is not an algorithm or AI device. The phrase "standalone" as typically used in AI/software evaluation does not apply here. The device's performance is inherently "standalone" in that its intrinsic physical and biological properties are tested.

7. The Type of Ground Truth Used

The ground truth used for each parameter is based on:

• Established scientific/regulatory standards and specifications:
  • pH, Osmolality, Endotoxin: Standard laboratory measurements against defined numerical ranges.
  • Sterility: Absence of microbial growth, per USP .
  • Aseptic Filling Validation: Compliance with international and FDA guidelines (ANSI/AAMI/ISO 13408 series, FDA Guidance).
  • Mouse Embryo Assay (MEA): The biological response of mouse embryos (% developing to blastocyst stage) against a defined percentage threshold (>80%). This is an established biological assay used in reproductive media testing to assess toxicity and developmental support.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product (reproductive media), not a machine learning model, so there is no concept of a "training set."

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

Not applicable. As there is no training set for a machine learning model, this question does not apply.

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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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