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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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For use in assisted reproduction procedures to ablate or thin the zona pellucida of an embryo to facilitate assisted hatching or recovery of cells for pre-implantation genetic diagnosis (blastomeres). The device can also be used on blastocyst stage embryos for biopsy of trophectoderm cells for preimplantation diagnosis procedures, and blastocyst collapse prior to vitrification procedures.

This submission includes two assisted reproduction laser systems, the LaserShot M and the NaviLase. The LaserShot M is a static laser system where the embryo is moved to the laser by moving the stage of the microscope. The LaserShot M components include a laser module (1.48 um infrared diode laser, class 1M), laser adapter to connect to the microscope, mirror block, laser objective (25X), USB camera, EyeWare Software, and an optional target pointer and footswitch. The NaviLase includes the same components as the LaserShot M. but also includes a motion module and a motion controller. These additional components allow the NaviLase to work in two modes, fixed and dynamic. In fixed mode, the NaviLase operates similarly to the LaserShot M. In dynamic mode, the laser can be directed to any location within the field of view. In addition, dynamic mode allows automated laser firing along a user-defined path (straight line, arc, etc.). The EveWare controls the device components, operates the laser, and takes images and records videos of embryo undergoing laser procedures. The software determines how many holes are drilled along this line and controls/restricts laser firing parameters to minimize localized heating of the embryo during these procedures. These laser devices have been designed to be fitted to compatible inverted microscopes.

Here's an analysis of the provided text regarding acceptance criteria and study details:

Overall Assessment: The provided document is a 510(k) summary for a medical device (NaviLase, LaserShot M). It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria or extensive study results that would typically be seen in a clinical trial report.

As such, there is no direct mention of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or a formal clinical "study" in the sense of a statistical power calculation or clinical outcomes trial proving the device meets such criteria. The 'Performance Testing' section describes engineering and functional tests to ensure the device operates as intended and is safe, but not a study to prove a specific clinical performance metric against a defined threshold.

The document primarily relies on comparing the subject device's technological features and performance to a legally marketed predicate device to establish substantial equivalence.

Detailed Breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there are no specific quantitative acceptance criteria (e.g., target accuracy, sensitivity, specificity) listed for the device's clinical effectiveness in terms of diagnostic or therapeutic outcomes, nor are there explicit "reported device performance" metrics against such criteria.

The "Performance Testing" section outlines tests conducted for:

• Reprocessing: Implicit acceptance criterion is compliance with the 2015 FDA guidance document.
• Electrical Safety and Electromagnetic Compatibility (EMC): Implicit acceptance criterion is compliance with IEC 60601-1:2005/AMD1:2012 (electrical safety) and IEC 61326-1:2012 (EMC).
• Software and Cybersecurity: Implicit acceptance criterion is compliance with 2005 FDA guidance for software (minor level of concern) and 2014 FDA guidance for cybersecurity.
• Laser Performance: Implicit acceptance criterion is compliance with recommendations in Section 7 of FDA's 2004 guidance document "Assisted Reproduction Laser Systems." Additional tests included demonstrating:
  • Compatibility with different microscope systems.
  • Alignment of the target pointer with the laser beam.
  • Validation of NaviLase dynamic targeting within the field of view.
  • Validation of NaviLase dynamic targeting system's ability to complete automated ablations under specific treatment modes (hole, hatching, thinning, trophectoderm).

No numerical performance metrics (e.g., laser ablation success rate, embryo viability post-procedure) are provided in this summary. The conclusion states that the testing "demonstrate[s] that the subject device is substantially equivalent to the predicate device," implying the performance was comparable and acceptable without providing specific numbers.

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

• Sample Size for Test Set: Not specified. The document refers to "testing" and "validation" but does not provide details on the number of embryos, oocytes, or experimental runs used for any of the performance tests.
• Data Provenance: Not specified. Given the nature of these tests (engineering, software, laser characteristics), it's likely internal lab testing rather than human subject data. There is no mention of country of origin or whether it's retrospective or prospective.

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

• Number of Experts/Qualifications: Not specified. For the laser performance and dynamic targeting validation, it's implied that there were either internal experts or a defined methodology to assess the successful completion of ablations and targeting. However, no details on the number or qualifications of these individuals, if any, are provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified. Given the nature of the tests (electromechanical, software, laser characteristics), it's unlikely a clinical adjudication method like 2+1 or 3+1 was used. These would typically involve objective measurements or pass/fail criteria based on engineering specifications.

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

• MRMC Study: No. The document does not describe an MRMC study. This device is an Assisted Reproduction Laser System, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting cases. Therefore, the concept of human readers improving with AI assistance is not applicable in this context.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Performance: Not applicable in the sense of an algorithm. The device has "EyeWare Software" that controls components, operates the laser, and determines ablation patterns. The "Validation of NaviLase dynamic targeting system's ability to complete automated ablations under specific treatment modes" could be considered a form of standalone performance evaluation for the software's ability to execute laser patterns, but it's not described as an "algorithm only" study comparing its output to a gold standard as one might see for an AI diagnostic algorithm.

7. Type of Ground Truth Used:

• Ground Truth: For the "Laser performance testing," the ground truth was likely based on physical measurements and visual confirmation (e.g., successful ablation, correct hole size, accurate targeting) against predefined technical specifications for the laser system's operation. For other tests (reprocessing, electrical safety, software), the ground truth is adherence to established regulatory and technical standards.

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device is a laser system, not a machine learning model that requires a "training set" in the conventional sense for learning patterns from data.

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

• Training Set Ground Truth: Not applicable for the reasons stated above.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through compliance with recognized standards and functional performance tests for a medical device. It does not contain the level of detail regarding clinical acceptance criteria, study design, sample sizes, or ground truth establishment that would be present in a submission for an AI/ML-driven diagnostic device or a comprehensive clinical trial report.

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For use in assisted reproduction procedures to ablate or thin the zona pellucida of an oocyte or embryo to facilitate assisted hatching or recovery of cells for pre-implantation genetic diagnosis (blastomeres). The device can also be used on blastocyst stage embryos for biopsy of trophectoderm cells for pre-implantation diagnosis procedures, and blastocyst collapse prior to vitrification procedures.

The Saturn 5 is the latest generation of ART laser systems manufactured by Research Instruments Limited. It is offered in two versions, the fixed and the active models and is designed to enable laser assisted hatching (LAH), laser assisted biopsy (LAB) and related procedures in assisted reproduction clinics. The system has been designed to be fitted to most commercially available inverted microscopes e.g. Olympus, Nikon and is also used with a PC and camera to provide an optical system and means of firing the laser. A foot pedal for firing the laser is available as an optional extra. The Saturn system comprises hardware, software and firmware. Hardware components include a control unit, armoured fibre optic patch lead, special 40x objective, a mirror module, motor module (active models only), IR filter and foot pedal (optional). This Saturn 5 system delivers two lasers; the main ablation laser and the pilot laser. Both laser beams are launched from the end of a fibre optic and collimated by an achromatic collimator. Saturn 5, RI Viewer software controls the movement of the laser, fires the laser and allows the user to take measurements and store images.

This document is a 510(k) Summary for the Saturn 5 Laser System, which is an assisted reproduction laser system. It outlines the device's characteristics, its intended use, and a comparison to its predicate device, the Saturn 3 Laser Systems.

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define "acceptance criteria" in a quantitative manner with reported performance values in a table. Instead, it relies on demonstrating substantial equivalence to a predicate device (Saturn 3 Laser Systems) and compliance with relevant safety and performance standards. The "reported device performance" is largely qualitative and based on compliance with these standards and the lack of reported incidents in a similar market.

However, we can infer the acceptance criteria and performance based on the summaries provided.

Inferred Acceptance Criteria and Reported Performance (Qualitative)

Summary of the Study provided (Non-Clinical Data)

The document describes a set of non-clinical tests and comparisons to establish substantial equivalence rather than a single, formal "study" with a specific design (like an RGD study).

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • No explicit "test set" in the traditional sense of a dataset for an algorithm. The testing involves compliance with standards and functional comparisons.
   • Data Provenance: The document states "The Saturn 5 laser system has been used extensively in the European market since May 2012." This suggests retrospective observation of real-world use for clinical safety and performance, but not a formally structured prospective study with a defined test set. The electrical safety, EMC, laser, and software tests are conducted in a controlled, prospective manner following established standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable as this is not a study requiring expert-derived ground truth for an AI/CAD system. The evaluation is based on compliance with engineering standards and functional similarity to a predicate.

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

   • Not applicable as this is not a study requiring adjudication of expert disagreement.

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 comparative effectiveness study was not done. This device is a laser system, not an AI/CAD system for interpretation by human readers.

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

   • Not applicable. The device is a tool operated by humans, not an autonomous algorithm for diagnosis or image interpretation. Its "performance" is assessed by its adherence to safety standards and its functional capability when used by an operator.

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

   • The "ground truth" for the various tests would be:
     • Electrical Safety & EMC: Compliance with the specifications and limits defined in IEC 60601-1:2005 and EN 60601-1-2:2007.
     • Laser Safety: Compliance with IEC60825:2008 and US 21CFR 1040.10 for laser classification.
     • Software Verification & Validation: Adherence to the specified functional requirements and absence of critical errors, as outlined in FDA's guidance for software in medical devices.
     • Functional Equivalence: Direct comparison of technological characteristics and operating principles with the legally marketed predicate device (Saturn 3 Laser Systems).
     • Clinical Safety/Performance: Absence of reported adverse events or incidents during "extensive" use in the European market.

7. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device that uses a training set for an algorithm.

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

   • Not applicable.

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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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Saturn Active is a Laser System 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 Saturn Active Laser System is a device that images, targets, and controls the power and pulse duration of a laser beam to ablate a small tangential hole in, or thin, the Zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.

The provided document is a 510(k) premarket notification for the "Saturn Active Laser System." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data to define and meet specific acceptance criteria in the way a novel device might.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

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

The document does not explicitly state "acceptance criteria" for the Saturn Active Laser System in a quantitative, measurable sense against specific performance metrics that a clinical trial would typically establish for a new device. Instead, it aims to demonstrate that its performance is "comparable to the predicate."

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 explicitly states: "Non-clinical Testing: Measurement of laser power and pulse lengths demonstrates that the Saturn 3 delivers pulse energies comparable to the predicate. With the alignment procedure correctly performed the co-alignment of the target and the ablated hole is within 1um, this is also comparable to the predicate."

• Sample size for the test set: Not specified for the non-clinical testing. It refers to "measurement of laser power and pulse lengths" and "alignment procedure" which implies laboratory testing, but no specific number of measurements or trials is given.
• Data provenance: Not explicitly stated but implies laboratory testing conducted by the manufacturer, Research Instruments Ltd., based in the United Kingdom.
• Retrospective or prospective: Not applicable as this is non-clinical testing of device characteristics rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The non-clinical testing described involves direct physical measurements of laser parameters (power, pulse length, co-alignment) rather than human interpretation or expert-established ground truth.

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

Not applicable, as there is no human interpretation or adjudication described for the non-clinical tests.

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

Not applicable. This device is a laser system for assisted reproduction, not an AI-powered diagnostic imaging tool that would typically involve human readers or MRMC studies.

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

The device itself is a standalone laser system. The "non-clinical testing" can be considered performance evaluation of the device in a standalone capacity (i.e., the laser system's output characteristics). The document focuses on demonstrating that the device's performance characteristics (laser energy, alignment accuracy, hole size) are comparable to its predicate.

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

For the non-clinical testing: The "ground truth" is intrinsically defined by the physical measurements themselves against established benchmarks of the predicate device's performance. For example, a power meter reading for laser energy, or a microscopic measurement for alignment and hole size.

8. The sample size for the training set

Not applicable. This is a medical device approval based on substantial equivalence to an existing predicate, not an AI/ML device that requires a training set.

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

Not applicable. No training set is mentioned in the context of this device.

Summary of Device and Approval Context:

The "Saturn Active Laser System" is being submitted for 510(k) clearance based on substantial equivalence to an existing device, the "Research Instruments Ltd. Saturn 3 Laser System." The primary claims for equivalence are based on:

• Shared components (control unit, laser sources, fiber optics, lenses, mirrors, objective).
• Similar intended use.
• Comparable technological characteristics (laser wavelength, power, pulse time, classification, objective magnification, etc.).
• The only significant difference is the addition of a motorized beam steering module in the Saturn Active.

The study that demonstrates the device meets the (implied) acceptance criteria is non-clinical testing. This testing confirmed:

• Measurement of laser power and pulse lengths shows the Saturn Active "delivers pulse energies comparable to the predicate."
• Co-alignment of the target and ablated hole is "within 1um," which is also "comparable to the predicate."
• Through these equivalent characteristics, the system is expected to "create the same sized holes in the embryo zona pellucida."
• The additional components and software were also "validated by non-clinical testing."

No clinical trials were performed with this specific device as it leverages the established safety and efficacy of its predicate through the substantial equivalence pathway.

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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 Saturn 3 Laser System 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 Saturn 3 Laser System is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.

The provided text describes a 510(k) premarket notification for the "Saturn 3 Laser System." This device is intended for assisted reproduction procedures. The submission focuses on demonstrating substantial equivalence to a predicate device, the Hamilton Thorne Zilos-tk (K050768). As such, the concept of "acceptance criteria" for performance and a study proving those criteria are met, in the sense of a new clinical trial establishing efficacy, is not explicitly presented for the Saturn 3 Laser System itself. Instead, the submission relies on demonstrating equivalence in key technical characteristics and referencing existing clinical evidence for similar technology.

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

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

The submission does not specify numerical "acceptance criteria" for the Saturn 3 Laser System's performance in the traditional sense. Instead, it asserts its equivalence to the predicate device in specific technical aspects and overall safety.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission references a clinical study for the general safety of laser drilling but doesn't detail a specific "test set" for the Saturn 3 Laser System in terms of sample size or provenance. The non-clinical testing refers to measurements, not a patient-based test set.

• Clinical Testing Sample Size: Not specified for a study specifically testing the Saturn 3 Laser System. The reference is to a published paper showing the safety of laser use on human embryos, implying it's not a de novo study for this specific device in this submission.
• Data Provenance (Clinical): "Reproductive BioMedicine Online 2005 Vol. 11, No. 6. 697-710" refers to a published scientific article, suggesting a peer-reviewed study. The text doesn't specify if it was retrospective or prospective or the country of origin of the data from that specific paper.
• Non-clinical Testing Sample Size: Not applicable in terms of patients; measurements of laser power, pulse length, and co-alignment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The clinical evidence cited is a published study on the effects of zona drilling, not a diagnostic device requiring expert consensus for ground truth on a test set. Non-clinical data involves objective measurements.

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

Not applicable, as there is no described test set requiring expert adjudication for ground truth.

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

Not applicable. The Saturn 3 Laser System is an active laser device for assisted reproduction, not a diagnostic device involving "human readers" or "AI assistance."

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

Not applicable. This is a hardware device with human operation, not an algorithm.

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

For the safety assertion: The clinical study referenced implies outcomes data related to "development of human biopsied embryos as revealed by blastomere viability, cytoskeletal analysis and molecular cytogenetics" in comparing different zona drilling methods. This serves as the "truth" for the safety claim.
For the technical characteristics: Objective physical measurements (e.g., laser power, pulse length, co-alignment accuracy) and feature comparison against the predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device that requires a training set.

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The OCTAX Laser Shot™ is a laser system for microsurgery on a cellular level, which works on a semiconductor basis. It is intended to be used to ablate a small tangential hole in the zona pellucida (assisted hatching) to be performed immediately prior to transfer on day 2 or day 3 in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as those with advanced maternal age, prior failed IVF, cyropreserved embryos, or abnormal zona pellucida characteristics. For safety reasons, the system should only be used if more than one embryo is available for transfer.

The OCTAX Laser Shot™ laser device is a microscope based micromanipulation tool for use in ART in In Vitro Fertilization laboratories. The device uses a 1.48 um infrared diode laser and has been supplemented with a miniature digital video camera and computer software allowing precise laser control, image storage and database and analysis functions.

The provided text does not contain a specific study with clearly defined acceptance criteria and detailed performance results that would allow for the direct creation of the requested table and comprehensive study description. Instead, it is a 510(k) Pre-Market Notification Summary Report focusing on demonstrating substantial equivalence to a predicate device.

The report references various "preclinical and clinical studies" and "many publications" over a 10-year period to support the device's efficacy, safety, and accuracy. However, it does not present a single, structured study with a clear set of acceptance criteria and the device's reported performance against those criteria.

Therefore, I cannot fulfill all parts of your request directly from the provided text.

Here's an attempt to derive some information based on the text, particularly concerning the substantial equivalence claimed:

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

The document frames "acceptance criteria" as meeting the characteristics of the predicate device (Hamilton Thorne Zona Infrared Laser Optical System (Zilos), K040045) to demonstrate substantial equivalence. Performance is, therefore, largely evaluated by comparison.

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 does not specify a distinct "test set" sample size for a focused study to prove acceptance criteria. Instead, it states: "The OCTAX Laser Shot™ system, and its predecessor, the Fertilase system have been used throughout the world for over 10 years. Its efficacy, safety and accuracy has been tested and retested over the years and noted in many publications."

This suggests the "test set" and provenance are based on a broad history of use and published literature rather than a single, controlled study described within this document. No specific countries of origin or retrospective/prospective nature are detailed for these aggregated "many publications."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document relies on the existing body of scientific literature and the long-term use of the device and its predecessor, implicitly assuming expert consensus within the field over time.

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

This information is not provided.

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

This document describes a laser microsurgery device, not an AI or imaging diagnostic device that would typically involve human "readers" or MRMC studies in the context of improving interpretation. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable here, and no such study is mentioned.

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

This is not an AI algorithm but a physical laser device controlled by software. The performance is inherently linked to human operation and control via the microscope and targeting system. There is no concept of "standalone" algorithm performance without human interaction for this device.

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

The ground truth for the device's efficacy, safety, and accuracy is indicated to be established over years of use and "many publications," implying a combination of:

• Scientific literature/published research: On the fundamental mechanics and effects of the laser.
• Clinical outcomes data: From reported IVF pregnancy successes and safety profiles over time.
• Expert experience/consensus: Widespread use and acceptance in ART laboratories.

8. The sample size for the training set

This is not an AI algorithm requiring a training set in the conventional sense. The "training" for the device's development and validation comes from the extensive historical use of the device itself and its predecessor, along with "fundamental safety studies published in the literature." Therefore, there isn't a defined "training set" sample size.

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

As above, there isn't a "training set" for an AI model. The device's "ground truth" (its demonstrated safety and effectiveness) was established through years of clinical use, "many publications," and fundamental scientific research, with Dr. Klaus Rink, a physicist, leading its development based on this experience.

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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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