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VitaVitro Single Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

VitaVitro Double Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

The Oocyte Retrieval Needle is composed of a stainless steel needle protective sleeve, needle handle, suction catheter, silicone plug, vacuum catheter and taper joint. The device includes both dual lumen (ORND) and single-lumen needles (ORNS). Three models are available: ORNS-17G, ORNS-18G and ORND-17G. The oocyte retrieval needles are available in 17 or 18 gauge sizes and two lengths: 33 and 35 cm. The needles are provided with a suction catheter of 100 cm length and a vacuum catheter with a length of 35 cm, and the ORND-17G also includes a flushing catheter of 100 cm length. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound.

This product is a disposable, sterile medical device, sterilized by ethylene oxide.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VitaVitro® Oocyte Retrieval Needle.

This document describes a 510(k) premarket notification for a medical device, which typically compares a new device to an existing legally marketed predicate device to demonstrate substantial equivalence. It is important to note that 510(k) submissions generally do not involve clinical trials to prove efficacy against specific clinical outcomes in the same way a PMA (Premarket Approval) would. The focus is on demonstrating that the new device is as safe and effective as the predicate based on technological characteristics and performance testing.

Therefore, many of the questions regarding "study that proves the device meets the acceptance criteria" in a clinical sense, particularly those related to human-in-the-loop performance, effect sizes, and detailed ground truth establishment from patient data, are not typically part of a 510(k) submission for this type of device. The acceptance criteria here are primarily based on non-clinical performance testing demonstrating the device's technical specifications and safety.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not provide specific sample sizes for each individual test (e.g., how many devices for sterility, how many mouse embryos for MEA, etc.). It only lists the types of tests performed.

As these are non-clinical (laboratory/bench) tests for a 510(k) submission, the "data provenance" in terms of country of origin or retrospective/prospective human data is not applicable. The tests were performed on the device itself under controlled laboratory conditions, likely at the manufacturer's facility or a contracted testing lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the studies are non-clinical performance and safety tests, not human-centered clinical studies that require expert-established ground truth. The "ground truth" for these tests are objective, measurable criteria defined by the relevant ISO standards and FDA guidance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where human interpretation of medical images or patient data is involved to establish a "ground truth" often in cases of disagreement among experts. These performance tests rely on objective laboratory measurements and standardized methodologies.

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

No MRMC comparative effectiveness study was done, nor would it be expected for this type of device (an oocyte retrieval needle) in a 510(k) submission. This is a physical, sterile, single-use medical instrument, not an AI-powered diagnostic tool. The concept of "human readers improve with AI assistance" is irrelevant here.

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

This question is also not applicable. This device is not an algorithm or software. It is a physical medical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" here is defined by:

• International Standards (e.g., ISO, ASTM): These standards specify objective, measurable criteria and methodologies acceptable for evaluating medical device performance (e.g., sterility, biocompatibility, mechanical properties).
• FDA Guidance Documents: Specifically mentioned is the 2021 FDA guidance document for Mouse Embryo Assay, which defines the acceptance criteria for MEA performance.
• Device Specifications: The manufacturer's own design specifications for dimensions, flow rate, vacuum maintenance, etc., which are verified through testing.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI. Therefore, this question is not applicable.

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

As there is no training set for this device, this question is not applicable.

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