(240 days)
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.
§ 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.