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510(k) Data Aggregation
(173 days)
V-DENUPET is 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 oocytes and embryos during assisted reproductive techniques (ART). V-DENUPET is not intended for biopsy of cells from oocytes or embryos.
The V-DENUPET is a polycarbonate micropipette. All tips are 90 mm in length, and depending on the size of the tip have a volumetric capacity of 20-25 µl. All pipettes have an outer diameter of 900 µm at the proximal end that is connected to an aspiration device.
The V-DENUPET is supplied in a range of inner diameter sizes at the distal end as shown below:
- Sizes 125 µm, 135 µm, 140 µm, 150 µm, and 175 µm are suitable for oocyte . denudation.
- Sizes 175 µm, 200 µm, 275 µm, 300 µm, and 600 µm are suitable for oocyte . and embryo handling.
V-DENUPET micropipettes are radiation sterilized and provided in a sterile pouch containing a polypropylene vial containing 10 micropipettes. Each pipette is for single-use only.
The provided text describes the V-DENUPET, a micropipette used in Assisted Reproductive Technologies (ART). However, it does not include acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/algorithm performance. The document is an FDA 510(k) summary for a medical device (a micropipette), focusing on non-clinical performance testing for physical characteristics, sterility, and biocompatibility, not for an AI device.
Therefore, I cannot provide the requested information about acceptance criteria for an AI device, study details, sample sizes, expert qualifications, or MRMC studies, as this information is not present in the provided text.
The closest relevant information from the document is related to the device's performance criteria, not an AI algorithm:
Acceptance Criteria and Reported Device Performance (Non-AI device)
| Acceptance Criteria (V-DENUPET) | Reported Device Performance (V-DENUPET) |
|---|---|
| Sterilization Validation | Per ISO 11137-1:2006 and ISO 11137-2:2013 |
| Package Integrity Testing | Seal strength (ASRM F88/F88M-15 equivalent), Burst (ASTM 2054-07), Dye Penetration (ASTM F1929-98) |
| Shelf Life Testing (Device Function) | |
| - MEA testing (1-Cell) | ≥80% hatched blastocysts at 96 hours (at Time 0 and 36 months) |
| - Endotoxin (LAL, USP<85>) | <0.05 EU/device (at Time 0 and 36 months) |
| - Device dimensions | Maintained (at Time 0 and 36 months) |
| - Appearance/cleanliness | Maintained (at Time 0 and 36 months) |
I cannot answer the following questions based on the provided text, as it pertains to an AI/algorithm study, and the document describes a physical medical device:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
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