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The manufactured microtools are to be used for Assisted Reproductive Technology (ART) and Reproductive Medicine (RM), and the specific pipette indication is as follows:

Injection Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for intracytoplasmic sperm injection (ICSI)

Holding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for holding oocyte or embryo during ICSI or biopsy

Biopsy Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s)

Polar Body Biopsy Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from occytes, which may be done in order to perform pre implantation genetic diagnosis on the genetic material in the biopsied cell(s)

Assisted Hatching Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to create a defect in the zona pellucida chemically using Tyrode's acid solution in order to perform assisted hatching of embryos

Denuding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to denuding cumulus cells from oocytes by delivering enzymes to aid separation

Partial Zona Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to cut zona pellucida to create a defect in the zona pellucida mechanically in order to perform assisted hatching of embryos mechanically

Device Description

The following Jieying Microtools are made of glass capillary tubing. They range in sizes and have various degrees of beveled angles as necessary for each individual application. They are gamma radiated and tested for endotoxin and mouse embryo. These devices are assisted reproduction microtools/pipettes that are used in the laboratory to denude, micromanipulate, or hold human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.

a. Injection pipette;
b. Holding pipette;
c. Biopsy pipette;
d. Polar body biopsy pipette;
e. Denuding pipette;
f. Partial zona dissection (PZD) pipette;
g. Assisted hatching (AH) pipette.

AI/ML Overview

The provided document describes Jieying Laboratory Inc.'s micro-manipulation pipettes and their equivalence to predicate devices, focusing on the safety and performance characteristics for regulatory approval.

Acceptance Criteria and Device Performance:

Acceptance Criteria	Reported Device Performance
LAL (Limulus Amboycte Lysate) Testing:	Each batch performs LAL testing. Level of endotoxin units must be < 20 EU/device.
Endotoxin levels	All test samples met the < 20 EU/device requirement.
MEA (Mouse Embryo Assay) Testing:	1-cell zygotes cultured with the broken tip of the pipette for 96 hours in 37°C, 5% CO2 incubator. Product is non-toxic if ≥ 80% embryos develop to blastocyst stage.
Embryo development to blastocyst stage	All test samples showed ≥ 80% of embryos developing to blastocyst stage, indicating non-toxicity.
Sterility Testing:	Samples over two years of age undergo sterility testing.
Sterility of aged samples	All test samples passed sterility testing.
Shelf-Life Evaluation:	Defined shelf-life based on testing.
Shelf-life	Shelf-Life has been set at two years.

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the specific sample sizes for the LAL, MEA, and sterility tests. It refers to "each batch" for LAL and "samples" for MEA and sterility testing.
- The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be internal testing conducted by Jieying Laboratory Inc.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. The ground truth for these tests (endotoxin levels, embryo development, sterility) is established by quantitative laboratory assays with predefined thresholds, not by expert consensus.
Adjudication Method for the Test Set: Not applicable. The tests are laboratory assays with clear pass/fail criteria, not subjective assessments requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not relevant for the described safety and performance tests of micro-manipulation pipettes. These are not imaging devices or diagnostic tools requiring human interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI/algorithm-based device. The "device" refers to physical micro-manipulation pipettes.
The type of ground truth used:
- LAL Testing: Quantitative measurement of endotoxin units (EU/device).
- MEA Testing: Percentage of 1-cell zygotes developing to the blastocyst stage.
- Sterility Testing: Confirmation of absence of microbial growth.
The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context would refer to the development and validation of the manufacturing processes and quality control methods.
How the ground truth for the training set was established: Not applicable, as there is no training set in the context of an AI/ML device. For the manufacturing and quality control processes, the "ground truth" is established through standard laboratory methods and regulatory guidelines (e.g., ISO, FDA guidance) for medical device manufacturing and testing.

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