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EZ-Tip pipettes are for denudation, i.e. removing the cumulus from an occyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). EZ-Tips are not intended for biopsy of cells from oocytes or embryos.

The EZ-Grip provides aspiration and expulsion capabilities to plastic pipettes when fitted during assisted reproduction procedures.

The EZ-Tip pipette is an extruded medical grade polycarbonate capillary that is pulled at one end to form a tapered tip. It has an outer diameter (OD) of 0.9 mm at the proximal end and fits to an actuating device such as the EZ-Grip. All tips are approximately 90 mm in length and depending on the size of the tip they have a volumetric capacity of 15.9 - 25.4 µl.

Pipette Tips are supplied in a range of inner diameter (ID) sizes at the distal end as shown below:

• Size 75 µm, 200 µm, 250 µm, 290 µm, 600 µm are suitable for specimen handling
• Sizes 125 µm, 135 µm, 145 µm, 155 µm, 170 µm are suitable for denudation

The EZ-Tip is supplied sterile in one of two packaging options; individually blister packed or pouch packed in a vial containing 20 tips. All pipettes are intended single use and disposable.

The EZ-Grip is a hand held, reusable actuator or pipeter for plastic pipettes. It consists of a machined aluminium barrel containing stainless steel and PTFE internal working mechanisms, a titanium plunger wire and medical grade silicone and nylon seals. The plunger mechanism is designed to be compatible with 0.9 mm OD plastic pipettes and it has an aspiration volume range of 0.2 µl to 3 µl with a blow-out volume of 1.4 µl above the adjusted aspiration volume setting.

The EZ-Grip is supplied non-sterile with validated protocols for cleaning and sterilization included in the Instructions for Use.

The provided document describes the non-clinical testing and assessment of the EZ-Tip and EZ-Grip devices to demonstrate their substantial equivalence to predicate devices (The Stripper micropipet and micropipeter tips and The Stripper device, respectively). The study does not involve human subjects or AI, but rather focuses on physical, chemical, and biological performance characteristics relevant to assisted reproductive techniques (ART).

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• EZ-Tip MEA & Endotoxin Testing: Three lots of EZ-Tip were tested.
• EZ-Grip MEA Testing (Plunger Wires): Three lots of EZ-Grip plunger wires were tested.
• EZ-Grip Device Life Bench Testing: Not explicitly stated as a number of devices, but it involved simulating one year of use (16,000 actuations) on at least one device.
• Provenance: All tests described are non-clinical, laboratory-based assessments of the physical device components and their interaction with biological samples (mouse embryos). The data provenance is from laboratory testing and not from human clinical data, nor is country of origin of the data specified beyond the company being in the UK.

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

This information is not applicable as the described studies are non-clinical and do not involve human diagnostic assessment or expert-determined ground truth in the typical clinical sense. The "ground truth" here is objective laboratory measurements (e.g., percentage of hatched blastocysts, endotoxin levels, physical performance metrics).

4. Adjudication Method for the Test Set

This information is not applicable as the described studies are non-clinical and do not involve human diagnostic assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A MRMC comparative effectiveness study was not done. This study is focused on the non-clinical performance of medical devices for ART, not comparative effectiveness of human readers or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No. This is not an AI/algorithm-based device. It is a physical medical device (pipettes and a pipettor).

7. The Type of Ground Truth Used

• For Mouse Embryo Assays (MEA): The "ground truth" is the observed biological outcome of mouse embryo development (percentage of hatched blastocysts), which is a direct biological measure.
• For Endotoxin Testing: The "ground truth" is the measured endotoxin level, a chemical quantification.
• For Sterilization, Packaging, and Bench Testing: The "ground truth" is compliance with established international standards and internal product specifications for physical and functional performance.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/machine learning study.

9. How the Ground Truth for the Training Set was Established

Not Applicable. There is no "training set" as this is not an AI/machine learning study.

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To maintain the temperature of human reproductive tissue such as occytes and embryos through an assisted reproduction (AR) cycle.

The RI Witness Embryology Heated Plate is designed to maintain the temperature of embryos and other reproductive tissues placed in dishes on the surface of the device. It is typically installed in a flow hood or on a work bench and comprises of a central clear window within a solid baseplate containing the temperature controller. There are 5 heating circuits, one for the window that uses ITO coated glass and the other 4 use power resistors screwed in thermal contact to the aluminium base plate.

The provided text describes the RI Witness Embryology Heated Plate, a device designed to maintain the temperature of human reproductive tissues. However, the document does not contain information about a study that measures the device's performance against detailed acceptance criteria in the manner requested (e.g., in a clinical trial with human subjects, or a detailed analytical study with a specified sample size, ground truth, and expert involvement).

The document is a 510(k) summary for the device, focusing on demonstrating substantial equivalence to a predicate device. It details non-clinical performance data related to electrical safety, EMC, wireless technology, software verification, and bench testing. These tests are primarily focused on safety and engineering performance, rather than clinical efficacy or accuracy in the context of an AI/algorithm-driven device as implied by the request's structure.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a summary of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

The document lists some technical specifications and mentions various types of bench testing performed. From this, we can infer some internal acceptance criteria related to these technical specifications and tests.

• Time to reach temperature set point
• Maximum temperature
• Stability of temperature control
• Uniform distribution of temperature across the device
• Liquid ingress
• Volatile organic compound emissions
• Cable integrity up to 84°C
• Thermal Cycling Life Test
• Packaging Verification |
  | Biological Effect of Radiofrequency Exposure | Mouse embryo assay performed to measure the effects of exposure to radiofrequency. (The text states the test was done, implies acceptable results as it concludes substantial equivalence). |

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any of the tests. The "mouse embryo assay" implies a biological sample, but the number of embryos or replicates is not mentioned.
• Data Provenance: The device is manufactured in the United Kingdom by Research Instruments Ltd. All testing appears to be non-clinical bench testing conducted by or for the manufacturer. The "mouse embryo assay" is the only test that could be considered biological, but specific details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The tests performed are primarily engineering and safety assessments, not evaluations requiring expert human interpretation of images or clinical data.

4. Adjudication method for the test set:

• Not applicable. No expert adjudication process is described for the types of tests conducted.

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 not an AI/algorithm-driven diagnostic tool that assists human readers. It is a heated plate for medical samples.

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

• Not applicable. This device is not an algorithm.

7. The type of ground truth used:

• For the engineering/safety tests: Standards (e.g., IEC 60601-1:2012, IEC 60601-1-2:2014, FDA guidance for wireless technology) and defined performance specifications (e.g., temperature accuracy, heating range).
• For the mouse embryo assay: Biological outcomes in mouse embryos, implicitly compared against a control or expected norm for viability/development. Specific details are not provided.

8. The sample size for the training set:

• Not applicable. The device is not an AI/machine learning algorithm requiring a training set in this context.

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

• Not applicable.

In conclusion, the provided document is a regulatory submission focused on substantial equivalence of a medical device (a heated plate). It describes engineering and safety tests rather than performance against acceptance criteria for an AI or imaging diagnostic device. As such, most of the requested information regarding study design, sample sizes, expert involvement, and ground truth in a clinical or AI context is not present.

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