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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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