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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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Biopsy pipettes are used in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cell(s).

The Biopsy pipette is part of the RI Pipettes range. Other pipettes available in this range include ICSI Injection, ICSI Holding, and Assisted Hatching pipettes.

Biopsy pipettes are offered in a range

• ID sizes - 14μm, 20μm, 25μm, 30μm, 40μm .
• bend angles 0°, 15°, 20°, 25°, 30°, 35°, 40°, 45° .
• . tip profiles - flat , non-spiked (bevelled), spiked

All pipettes in this range are manufactured from very fine borosilicate glass, packed individually into a Twista-Pak (primary packaging) and sealed in a medical pouch. They are then batch sterilised by gamma irradiation.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: RI Pipettes - Biopsy

1. Table of Acceptance Criteria and Reported Device Performance

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The RI MSC is intended to prepare sperm by migration-sedimentation method for the assisted reproduction techniques of intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI).

The Research Instruments Migration Sedimentation Chamber (RI MSC) is sterile, non-pyrogenic proven by Limulus Amebocyte Lysate and non-toxic to sperm proven by Human Sperm Survival Assay (HSSA). The RI MSC is disposable and labelled for single use, individually packaged in medical pouches and sold in boxes of twenty (x20) units. The RI MSC is manufactured from medical grade polystyrene and its surfaces are untreated. It is injection moulded as a completed unit, housing a central well with a surrounding gallery. The cylinder is 74 mm in height with a top OD of 16.5 mm and fluid capacity of 6 ml (approx) if completely filled; however, during recommended procedures it accommodates 1-2 ml of culture medium. The RI MSC facilitates the migration sedimentation technique. The migration sedimentation technique utilizes the innate 'swimming' ability of sperm to separate vigorous, A-motile sperm from non-motile or abnormal sperm and ejaculate debris.

The provided 510(k) summary for the Research Instruments Migration Sedimentation Chamber (RI MSC) details non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. It primarily focuses on material safety and performance for sperm compatibility.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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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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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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ICSI injection micropipettes are used for injecting spermatozoa into the . cytoplasm of an oocyte during intracytoplasmic sperm injection (ICSI). -

• Holding micropipettes are used to anchor the oocyte under vacuum during . intracytoplasmic sperm injection (ICSI).
• Assisted hatching micropipettes are used to direct Tyrode's solution onto the . zona of an oocyte, thus creating a hole and enabling the oocyte to hatch.
• Denuding pipettes are used to strip the cumulus from oocytes prior to . intracytoplasmic sperm injection (ICSI).

ICSI injection micropipette (spiked and non-spiked) ICSI holding micropipette Assisted hatching / zona drilling micropipette Denudation pipette

There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) clearance letter from the FDA for a set of micropipettes, confirming that the devices (K991261) are substantially equivalent to legally marketed predicate devices. It discusses regulatory classification, general controls, and good manufacturing practices, but does not include any performance data or study details.

Therefore, I cannot provide the requested information.

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