(326 days)
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.
| Acceptance Criteria (Not explicitly stated in document, inferred) | Reported Device Performance (Not explicitly stated in document, inferred) |
|---|---|
| Accuracy of DTS single-pulse across the field of view (criteria not given) | "Validation of the accuracy and precision of DTS single-pulse across the field of view" was performed. The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying acceptable performance. No specific numerical values are given. |
| Accuracy of DTS multiple-pulse across the field of view (criteria not given) | "Validation of the accuracy and precision of DTS multiple-pulse (linear or curved plots) across the field of view" was performed. The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying acceptable performance. No specific numerical values are given. |
| RED-i target alignment (criteria not given) | "Validation of the RED-i target alignment feature" was performed. The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying acceptable performance. No specific numerical values are given. |
| Electrical Safety (IEC 61010-1:20117; IEC 60825-1:2014 compliance) | "Electrical Safety Testing: IEC 61010-1:20117; IEC 60825-1:2014" was performed. The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying compliance with the standards. |
| Electromagnetic Compatibility (IEC 61326-1:2013 compliance) | "EMC Testing: IEC 61326-1:2013" was performed. The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying compliance with the standard. |
| Software documentation (2005 FDA guidance compliance) | "Software documentation in accordance with the 2005 FDA guidance document 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' to support device software with a moderate level of concern." The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying compliance with the guidance. |
| Cybersecurity (2014 FDA guidance compliance) | "Cybersecurity information in accordance with the 2014 FDA guidance document 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'" The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying compliance with the guidance. |
| Reprocessing Validation (2015 FDA guidance compliance) | "Reprocessing: Validation testing conducted in accordance with the 2015 FDA guidance document, 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.'" The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying compliance with the guidance. |
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.
§ 884.6200 Assisted reproduction laser system.
(a)
Identification. The assisted reproduction 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.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.” See § 884.1(e) for the availability of this guidance document.