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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

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

• Non-pyrogenic (LAL) and Non-embryotoxic (MEA): The document states "Each finished batch of pipettes is tested". This implies a continuous testing process rather than a single, fixed test set size. The specific number of pipettes tested per batch for these assays is not provided.
• Data Provenance: The document does not explicitly state the country of origin for the data for these performance tests. Given that Research Instruments Ltd. is based in the UK, it's reasonable to infer the testing was conducted in the UK or by laboratories recognized by UK/EU standards, but this is not explicitly stated. The studies are prospective in the sense that they are routine batch release tests.
• Sterilization, Packaging, and Shelf Life Validation: These are validation studies performed on representative samples, not on a batch-by-batch basis. The specific sample sizes for these validation studies are not provided in the document.

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

This information is not applicable to the provided document. The performance tests described (LAL, MEA, sterilization, packaging, and shelf life) are objective laboratory and engineering tests, not subjective assessments requiring expert consensus.

4. Adjudication method for the test set:

This information is not applicable. The tests are objective and do not involve human adjudication in the way medical image analysis or clinical trials might. The acceptance criteria themselves serve as the 'adjudication' standard.

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:

This information is not applicable. This device is a microtool for assisted reproduction, not a diagnostic AI system or an imaging device that would typically involve human readers or AI assistance in interpretation.

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

This information is not applicable. This device is a physical tool, not an algorithm.

7. The type of ground truth used:

• Non-pyrogenic (LAL): The ground truth is established by a quantitative measure of endotoxin levels, with an objective threshold of "< 20 EU/device." This is a laboratory assay.
• Non-embryotoxic (MEA): The ground truth is established by the survival and development rate of mouse embryos to blastocyst stage within a specified timeframe, with an objective threshold of "≥ 80% blastocyst after 120h." This is a biological assay.
• Sterilization validation: The ground truth is compliance with international standards (ISO 11137-1:2006 and ISO 11137-2:2007) which dictate methods for achieving and verifying sterility assurance levels.
• Packaging validation: The ground truth is compliance with international and ASTM standards (ISO 11607-2:2006, ASTM F1980-07, ASTM F1886-09, ASTM F2054-13, and ASTM F1929-12) which define performance requirements for sterile barrier systems.
• Shelf life: The ground truth is the device maintaining its "specifications" (which would include the LAL, MEA, and physical characteristics) over time, as measured by real-time aging studies.

8. The sample size for the training set:

This information is not applicable. This device is a physical instrument, not a machine learning model that requires a training set. The descriptions relate to manufacturing and quality control processes.

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

This information is not applicable. As stated above, this device does not involve a training set.

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