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Denudation Pipettes are used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART).

Denudation Pipettes are not intended for biopsy of cells from oocytes or embryos.

The Denudation Pipettes are extruded polycarbonate capillary tubes that are pulled at one end to form a tapered tip. They have an outer diameter (OD) of 0.9mm at the proximal end and fit into an actuating device. All tips are approximately 90mm in length and depending on the size of the pipette have a volumetric capacity of 18.6-21.9µl.

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

• 80μm, 130μm, 140μm, 150μm, 160μm, 170μm, 180μm, 190μm, 210μm, 230μm, 250μm, 270μm, 290μm.

The Denudation Pipettes are radiation sterilized and provided in a sterile pouch, supplied in two packaging options. Each pouch contains 5 or 10 pipettes. All pipettes are intended for single use and disposable.

This 510(k) clearance letter is for Denudation Pipettes, a Class II medical device used in assisted reproductive technologies. This type of device is an instrument and does not fit the typical format for AI/ML-enabled devices so I have focused on the relevant mechanical and biological performance characteristics.

Acceptance Criteria and Device Performance

There is no single study described that proves the device meets all acceptance criteria. Instead, a series of non-clinical performance tests were conducted.

Here's a table summarizing the acceptance criteria and the reported device performance for the Denudation Pipettes:

Study Details for Acceptance Criteria

The document describes non-clinical performance testing rather than a single clinical study with patients. The testing focused on demonstrating the safety and effectiveness of the device's materials, manufacturing, and functionality.

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

• Mouse Embryo Assay (MEA): The sample size refers to the number of embryos used. The document does not specify the exact number of embryos tested, but it refers to the "2021 FDA guidance Mouse Embryo Assay for Assisted Reproduction Technology Devices," which would dictate the appropriate sample size and methodology.

• Endotoxin (LAL): The sample size would be the number of devices or extracts from devices tested. This is not explicitly stated.

• Sterilization Validation: This involves testing biological indicators and dose mapping; sample sizes for these are defined by ISO 11137 standards.

• Package Integrity and Shelf Life: Sample sizes would relate to the number of packages/devices tested at various time points and under different conditions. These are guided by the referenced ASTM standards.

• Device Dimension Validation: This involves measuring a sample of manufactured pipettes; the sample size is not specified.

• Data Provenance: This is not applicable in the usual sense (e.g., country of origin for clinical data) as these are non-clinical, laboratory-based tests conducted by the manufacturer or their designated testing facilities.

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

• This question is not applicable for this device and the presented non-clinical testing. Ground truth (e.g., disease presence) is not established by human experts in these types of performance tests. For MEA, the "ground truth" is whether an embryo develops into an expanded blastocyst, which is an observable biological outcome measured by trained laboratory personnel. For other tests, measurements are taken against defined specifications.

4. Adjudication method for the test set:

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies between human readers' interpretations of data (e.g., medical images). Here, the tests involve objective measurements (e.g., percentages, concentrations, physical dimensions) or standard pass/fail criteria according to established protocols.

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 question is not applicable as this device is a physical tool (pipette) and not an AI-enabled device designed to assist human readers (e.g., radiologists). Therefore, no MRMC study or AI assistance evaluation was performed.

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

• This question is not applicable as this device is a physical tool and does not involve any algorithm or AI for standalone performance evaluation.

7. The type of ground truth used:

• Quantitative Measurements: For most tests (Endotoxin, Dimensions, Seal Strength), the ground truth is established by objective, measurable values that must fall within predefined specifications.
• Biological Outcome: For the Mouse Embryo Assay (MEA), the ground truth is the biological viability and development of mouse embryos to an expanded blastocyst stage. This is a recognized and standardized method for assessing the toxicity of materials coming into contact with gametes or embryos.
• Compliance with Standards: For sterility, package integrity, and shelf life, the ground truth is compliance with the requirements and methodologies outlined in the referenced ISO and ASTM standards.

8. The sample size for the training set:

• This question is not applicable. There is no "training set" in the context of this device's non-clinical performance testing. Training sets are relevant for machine learning algorithms.

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

• This question is not applicable for the same reason as above.

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