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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

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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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Vita Vitro® Sperm Washing Medium is intended for preparation and washing of sperm for use in assisted reproduction procedures. Vita Vitro® Sperm Washing Medium is also intended for use in intrauterine insemination procedures.

VitaVitro® Sperm Gradient Medium is intended for separation of motile sperm from seminal fluid for use in assisted reproduction procedures.

VitaVitro® Sperm Washing Medium and VitaVitro® Sperm Gradient Medium are ready-to-use solutions intended for preparing sperm for use in assisted reproductive procedures:

• VitaVitro® Sperm Washing Medium is for sperm washing and for intrauterine insemination procedures.
• VitaVitro® Sperm Gradient Medium is for sperm density-gradient centrifugation and separation from seminal fluid.

Both devices have a similar base formulation; however, the VitaVitro® Sperm Gradient Medium formulation differs as it contains silane silica and does not contain Human Serum Albumin (HSA). The silane silica in the VitaVitro® Sperm Gradient Medium (upper layer 80%) generates the density gradient for sperm separation procedures.

The subject devices are aseptically filtered, colorless solutions, contained in transparent and sterilized (gamma irradiation) polyethylene terephthalate glycol (PETG) bottles, sealed with high density polyethylene (HDPE) closures, provided in cardboard boxes, individually labeled and with an instruction for use provided as a package insert.

The devices are provided in the following volumes:

• VitaVitro® Sperm Washing Medium: 30mL, 60mL, and 125mL
• VitaVitro® Sperm Gradient Medium: 12mL, 30mL, and 125mL

Both devices have a two-year shelf-life when stored as recommended. These devices are for single-used only.

The provided text describes two medical devices, VitaVitro® Sperm Washing Medium and VitaVitro® Sperm Gradient Medium, and their substantial equivalence to predicate devices. However, the document does not contain information about a study that assesses a device's performance against detailed acceptance criteria in the context of AI/ML or image analysis, which the requested output format implies. The acceptance criteria described are for the physicochemical properties and biological performance of the media themselves, not for an AI device.

Therefore, many of the requested fields cannot be populated as they are not relevant to the provided text. I will fill in the relevant information based on the provided document.

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

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

The document does not specify a distinct "test set" in the context of AI/ML or image analysis. Performance testing was conducted on samples of the media devices themselves. The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned for these tests.

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

Not applicable. The ground truth for the performance of these media is established by standardized laboratory tests (e.g., USP monographs, ISO standards, ASTM standards) rather than expert consensus on complex diagnostic interpretations.

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

Not applicable. This concept is typically relevant for studies involving human interpretation and is not mentioned for the chemical, physical, and biological testing of these media.

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 not an AI/ML device, nor does the document describe any MRMC studies involving human readers or AI assistance.

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

Not applicable. This is not an AI/ML device.

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

The ground truth for the media's performance is established through:

• Standardized analytical measurements (e.g., pH, osmolality, specific gravity, endotoxin levels).
• Standardized microbiological testing (sterility).
• Standardized biological assays (Human Sperm Survival Assay, biocompatibility tests).
• Functional assessment of sperm separation effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable.

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VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization.

VitaVitro® Gamete Buffer Medium is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI).

VitaVitro® Flushing Buffer Medium is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures.

This submission includes three media products:

• . VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization. Media provided in volumes of 30 ml and 60 ml.
• . VitaVitro® Gamete Buffer Medium intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI). Media provided in a single volume of 60 ml.
• . VitaVitro® Flushing Buffer Medium intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection. Media provided in volumes of 60 ml and 125 ml.

All devices are aseptically filled into radiation-sterilized PETG bottles, are single-use only, and have a shelf-life of six-months when stored as recommended at 2-8°C.

The device in question consists of three media products: VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, and VitaVitro® Flushing Buffer Medium. The provided document is a 510(k) Summary, which is a premarket notification to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This type of submission focuses on comparing the new device against existing ones rather than providing a standalone clinical study for efficacy against a disease endpoint. Therefore, the information regarding acceptance criteria and studies is framed within the context of demonstrating substantial equivalence.

Here's the breakdown of the acceptance criteria and the studies performed to meet them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for each test conducted. It states that "The testing... apply to each of the subject media products," indicating that tests were performed on samples of each of the three media.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, as it's part of a 510(k) submission, the testing would have been conducted by or for the manufacturer (Shenzhen VitaVitro Biotech Co., Ltd., China) as part of their premarket activities. These were non-clinical performance studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to the non-clinical performance studies described. The "ground truth" for these tests refers to the established scientific and regulatory standards (e.g., USP monographs, ISO standards, ASTM standards, FDA guidance documents) for chemical, biological, and physical properties of the media. The "experts" would be the scientists and technicians conducting the validated assays and interpreting results against predefined quantitative specifications.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative laboratory assays with predefined acceptance criteria. There is no subjective interpretation or need for expert adjudication in the way typically seen in image or clinical diagnostic studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is not relevant for this type of medical device (reproductive media). These studies are typically used to assess the diagnostic performance of software or imaging devices where human readers interpret results.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in a sense. The studies described are standalone performance evaluations of the physical and biological characteristics of the media products themselves. There is no "human-in-the-loop" component to the performance of these media, as they are chemical formulations used in assisted reproduction, not diagnostic tools interpreted by humans in real-time. The in-vitro performance (e.g., MEA) demonstrates the intrinsic function of the media in supporting embryo development.

7. Type of Ground Truth Used

The ground truth for these non-clinical studies is based on:

• Established scientific and regulatory specifications: pH, Osmolality, Endotoxin limits are set by pharmacological and regulatory standards.
• Biological performance standards: MEA (Mouse Embryo Assay) is a standard biological assay used to assess the suitability of media for supporting embryo development. The "ground truth" here is the observed blastocyst development rate in comparison to established benchmarks (≥80%).
• Sterility and Biocompatibility Standards: Ground truth is defined by the absence of microbial growth and the lack of adverse biological reactions (cytotoxicity, sensitization, irritation) as determined by validated test methods (e.g., USP , ISO 10993 series).

8. Sample Size for the Training Set

Not applicable. These are finished medical products (media formulations), not algorithms or AI models that require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for these media products.

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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:

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