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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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VitaVitro Embryo Transfer Catheter is used to place in vitro fertilized (IVF) embryos into the uterine cavity

The VitaVitro Embryo Transfer Catheters are sterile (ethylene oxide), single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. They have a three-year shelf-life.

The device includes five catheter models that are composed of a transfer catheter and a guide catheter (some with obturator).

The 172 mm length Guide catheters have OD 2.4 mm for straight (Models ET-SI and ET-S) and OD 2.2 mm for the curved version type (Model ET-A).

The curved version type (Model ET-A) has an additional adjustable positioner which aids in positioning the device to the targeted depth within the uterine cavity during a procedure. Both types have a rounded/blunt tip and marker bands at the distal tip to aid in catheter placement. The guide catheter is delivered through the cervix first and is used to guide the insertion of the transfer catheter holding the embryos into the uterine cavity.

The 240 mm transfer catheter with an OD 0.95 mm is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) is connected to the connector of the transfer catheter and is used to deliver the embryos into the uterine cavity.

The 200 mm obturator with OD 1.3 mm is an optional accessory for the device. It has a rounded/blunt closed tip. The obturator is used to provide additional support (increase rigidity) during guide catheter placement and to assess the placement of the device prior to conducting an actual embryo transfer procedure.

The provided text describes the VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) and its substantial equivalence to a predicate device. However, this document does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance as initially requested in the prompt.

The document details the non-clinical performance data for a medical device (a catheter), not a software or AI-driven diagnostic device. Therefore, the specific questions related to AI/algorithm performance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training/test set sample sizes are not applicable to the information provided.

The "acceptance criteria" discussed in the document are related to the physical and biological performance of the catheter, such as sterilization, biocompatibility, and functional integrity.

Here's an attempt to answer the questions based only on the provided text, recognizing that it does not align with the implied context of AI/algorithm performance:

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

Regarding the other questions, the provided text does not contain the requested information as it pertains to an embryo transfer catheter and not an AI-powered device:

2. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are lab tests on physical device properties and biological interaction (MEA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on established laboratory standards and measurements, not expert human interpretation of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the listed tests is based on scientific and engineering standards (e.g., ISO for biocompatibility and sterilization, ASTM for mechanical properties, USP for endotoxin), and biological assay results (MEA).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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This product is intended for the in vitro culture of human embryos following fertilization until Day 5/6 of development.

VitaVitro® 1-Step Culture Media product intended for the in vitro culture of embryos from fertilization until day 5/6 of development. It is an aseptically filtered, bicarbonate-buffered media containing physiological salt solutions, gentamicin, and human serum albumin. It is ready to use after warming to 37°C and equilibration in a CO2 environment.

The provided text describes the acceptance criteria and the studies performed for the VitaVitro® 1-Step Culture Medium. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: The document does not explicitly state a specific numerical sample size for the 1-cell Mouse Embryo Assay (MEA) test set. It mentions "One-cell mouse embryos" were exposed, implying a cohort of embryos was used. Without further detail, a precise number cannot be provided.
• Data Provenance: The study was conducted by Shenzhen VitaVitro Biotech Co., Ltd. in China. The data would therefore be prospective for this specific device.

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

• The document does not mention the use of human experts to establish ground truth for the 1-cell MEA test. The assessment of blastocyst development appears to be an objective, quantifiable biological outcome rather than a subjective interpretation requiring expert consensus.

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

• Not applicable. As noted above, the assessment for the 1-cell MEA is an objective biological outcome, not a subjective interpretation requiring adjudication.

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:

• Not applicable. This is a medical device for in vitro culture media, not an AI-powered diagnostic or imaging device that would involve human readers.

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

• Not applicable. This is a medical device for in vitro culture media. Its performance is assessed through biological outcomes (embryo development), not through an algorithm's output.

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

• For the 1-cell MEA, the ground truth is an objective biological outcome: the percentage of embryos that developed to the expanded blastocyst stage within 96 hours. This is a direct measurement of embryo viability and developmental capacity in the presence of the culture medium.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, and therefore does not have a "training set" in the conventional sense. The studies described are performance verification tests.

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

• Not applicable. As noted above, there is no "training set" for this type of medical device.

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