Search Results

V-GRAD is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures.

V-GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes that is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures. Available as a 100 % stock solution (V-GRAD 100) and as 40% or 80% ready-to-use solutions (V-GRAD 40 and V-GRAD 80) with HEPES buffered Human Tubular Fluid (HTF) medium. V-GRAD 100 is a stock solution for preparing a density gradient system for semen preparation. The V-GRAD Kit consists of two bottles of V-GRAD 40 and V-GRAD 80. V-GRAD is aseptically filtered and provided in pre-sterilized 12 mL glass bottles closed with flourotec rubber stoppers and flip-tear off caps or 100 mL PET(G) bottles closed with HDPE screw caps. V-GRAD has a shelf-life of one year when stored at 2-8°C and can be used for up to seven days after bottle opening.

The provided text describes the regulatory clearance of a medical device, V-GRAD, which is a reproductive medium used for sperm separation. It outlines the device's technical specifications and compares them to a legally marketed predicate device (ORIGIO Gradient). However, the document primarily focuses on non-clinical performance testing to support substantial equivalence and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop system.

The device, V-GRAD, is a laboratory reagent (colloidal suspension for density gradient sperm separation), not an AI-powered diagnostic or assistive tool. Therefore, the concepts of "acceptance criteria" and "study" as typically applied to AI-driven medical devices (e.g., using a test set, expert ground truth, MRMC studies, standalone performance) are not applicable to the V-GRAD submission as described.

The "performance testing" mentioned in the document refers to traditional lab-based tests for reproductive media:

• Aseptic filtration and aseptic filling validation: Ensures the sterility of the manufacturing process.
• Shelf-life testing: Verifies that the product maintains its specifications (appearance, pH, osmolality, endotoxin, density, Human Sperm Survival Assay (HSSA), sterility) over its stated shelf life after accelerated aging and simulated use.
• Transportation testing: Ensures the product integrity during shipping.
• Sperm evaluation: Confirms that sperm separated using the device exhibit comparable motility, morphology, and purity to those separated with the predicate device.

Since the prompt asks for details related to AI/human-in-the-loop medical device evaluation, and the provided text does not describe such a device or study, I cannot fulfill the request using only the given input.

Therefore, for each point, the answer will be "Information not available in the provided text" or "Not applicable as the device is not an AI/human-in-the-loop system."

Based on the provided text, here is the information:

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

   • Acceptance Criteria and Reported Device Performance: The document lists "product specifications" that are met during shelf-life testing, which implicitly serve as acceptance criteria for the quality and performance of the medium itself. These are not performance metrics for an AI system.

     Criteria/Specification	Acceptance Limit (Implied)	Reported Performance (Implied, "met specifications")
     Appearance	Pink rose (V-GRAD 40), light pink (V-GRAD 80), colorless (V-GRAD 100)	Met
     pH	7.2-7.9	Met
     Osmolality (mOsm/kg)	310-340 (V-GRAD 40/80), 300-330 (V-GRAD 100)	Met
     Endotoxin (EU/mL)	)	No growth
     Sperm Evaluation (Motility, Morphology, Purity)	Comparable performance with predicate device and other cleared devices	Demonstrated comparable performance
     Shelf-Life	1 Year	Supported (met specifications at time 0 and after accelerated aging)

2. Sample sizes used for the test set and the data provenance: Information not available in the provided text. The studies described are non-clinical lab tests of the medium itself, not a clinical test set for an AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the device is not an AI/human-in-the-loop system requiring expert-adjudicated ground truth. The "ground truth" for V-GRAD's performance is established by standardized laboratory assays (e.g., pH meters, osmometers, endotoxin testing, HSSA).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as the device is not an AI/human-in-the-loop system.

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 as the device is not an AI/human-in-the-loop system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is not an AI/human-in-the-loop system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance of the V-GRAD medium, the "ground truth" is defined by established laboratory methods and controls for measuring characteristics like pH, osmolality, sterility, and the biological response in an HSSA. For "Sperm separated using the subject device were evaluated for motility, morphology, and purity," the ground truth would be the measurement outcomes from standard semen analysis techniques, compared to controls (predicate device or other cleared devices).

8. The sample size for the training set: Not applicable as the device is not an AI/machine learning system.

9. How the ground truth for the training set was established: Not applicable as the device is not an AI/machine learning system.

Ask a specific question about this device

V-VITFREEZE is intended for use in the vitrification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

V- VITWARM is intended for use in the thawing of vitrified of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

V-VITFREEZE AND V-VITWARM include a set of five media intended for use in the vitrification and thawing of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos as part of InVitro Fertilization (IVF) procedures.

V-VITFREEZE (2mL vials) includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol, trehalose (only in VS), and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then to VS.

Using this methodology, the permeating cryoprotectants can replace water in the oocyte or PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.

V-VITWARM (4mL vials) is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. It is composed of Thawing Solution (TS), Diluent Solution (DS) and Washing Solution (WS).

The base medium for the vitrification and thawing media includes water, salts, buffering agents, minerals, chelating agents, energy substrates, amino acids, hydroxypropyl cellulose, polymeric substance, gentamicin, and phenol red. Cryoprotectants in the media include ethylene glycol, (7.5% in ES and 15% in VS), DMSO (7.5% in ES and 15% in VS), and trehalose in VS, TS, and DS.

The five solutions in the V-VITFREZE and V-VITWARM kit are aseptically filtered (storage vials sterilized by radiation) and provided in polypropylene vials with high density polyethylene screw caps. They have a shelf-life of 12 months when stored at 2-8℃. Media in the vials can be used for up to seven days after vial opening.

This is an FDA 510(k) clearance letter for the V-VITFREEZE and V-VITWARM devices, which are reproductive media and supplements. The document describes the device, its intended use, and a comparison to a predicate device. It also summarizes non-clinical performance testing.

However, the provided text does not contain detailed acceptance criteria and the results of a specific study in the format requested (e.g., a table of acceptance criteria and reported device performance with statistical metrics like sensitivity, specificity, accuracy). It focuses on physical and biological characteristics of the media rather than performance metrics of an AI or diagnostic device.

Therefore, I cannot fulfill all parts of your request exactly as specified because the document does not describe the acceptance criteria and a study in the context of an AI or diagnostic device's performance in the way you've outlined.

The document does list certain specifications for the media and the tests conducted to ensure the media meets those specifications, which are a form of acceptance criteria for manufacturing and quality control. I will extract these details.

Here's the information that can be extracted relevant to acceptance criteria and testing, adapted to the context of the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance (as per non-clinical testing of the media):

*   **Bacterial Endotoxin:** Defined by Limulus Amebocyte Lysate (LAL) test standards (e.g., USP ).
*   **Mouse Embryo Assay (MEA):** Defined by the specified FDA guidance for ART devices, where successful development of a certain percentage of embryos to expanded blastocyst within 96 hours is the benchmark.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable.

Ask a specific question about this device

V-PVP is intended for use as an aid in the immobilization of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

V-PVP is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracvtoplasmic sperm iniection (ICSI) procedures.

V-PVP is a clear solution with a formulation consisting of polyvinylpyrrolidone, human serum albumin, physiological salts, HEPES Human Tubal Fluid (HTF), pyruvate, lactate, qlucose, and gentamicin. This product is aseptically filtered into 2 mL bottles with caps made from polypropylene copolymer and is provided in a volume of 0.5 mL. V-PVP has a one-year shelf-life when stored as recommended and can be used for up to seven days after opening.

The provided text describes the acceptance criteria and performance testing for a medical device called V-PVP, specifically for its premarket notification (K232125).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several specifications for V-PVP and indicates that shelf-life testing demonstrated the product met these specifications at time 0 and after accelerated aging. While specific numerical results for each test (e.g., exact pH measured) are not provided, the "acceptance criteria" themselves are listed as the "product specifications."

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

The document does not explicitly state the sample sizes for the performance tests conducted (e.g., number of replicates for pH, Osmolality, Endotoxin, MEA, HSSA, Sterility tests).

The data provenance is not specified in terms of country of origin, nor is it explicitly stated whether the studies were retrospective or prospective. However, based on the context of premarket notification for a new device, these would typically be prospective studies performed by the manufacturer to demonstrate compliance.

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

This information is not provided in the document. The tests described are primarily laboratory-based (chemical, physical, biological assays), not reliant on expert interpretation of complex clinical data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The performance tests are objective laboratory assays with well-defined measurement methods and acceptance ranges, not requiring human adjudication of ambiguous results.

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

This information is not applicable. V-PVP is a reproductive media/supplement, not an AI-powered diagnostic device that would involve human readers or MRMC studies. The "Comparative assessment of sperm immobilization of the subject device (7% PVP) to a 10% PVP comparator device" mentioned is a direct comparison of the substance's efficacy, not a human-AI interaction study.

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

This information is not applicable. V-PVP is a chemical solution, not an algorithm or software. Its performance is evaluated through laboratory assays, not by an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests is established by objective laboratory measurements and universally accepted biological and chemical standards.

• pH, Osmolality, Endotoxin: Measurements against recognized USP standards.
• MEA (Mouse Embryo Assay): A standard biological assay to assess toxicity or suitability for embryo development, with a specified percentage of embryo development as the "ground truth."
• HSSA (Human Sperm Survival Assay): A standard biological assay to assess the compatibility and non-toxicity to human sperm, with a specified percentage of control motility as the "ground truth."
• Sterility: Absence of microbial growth, a standard microbiological "ground truth."
• Clarity/Color: Visual inspection against an expected appearance.

8. The Sample Size for the Training Set

This information is not applicable. V-PVP is a formulated chemical product, not an AI model that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

Ask a specific question about this device

V-HYADASE is intended for the enzymatic removal of cumulus and corona radiata cells from oocytes prior to intracytoplasmic sperm injection (ICSI) procedures.

V-HYADASE is an assisted reproduction medium intended for the enzymatic removal of cumulus and corona radiata cells from oocyte prior to Intracytoplasmic Sperm Injection (ICSI) procedures. The medium is aseptically filtered and provided in a volume of 1 mL in pre-sterilized 2 mL polypropylene copolymer (PPCO) bottles with PPCO caps. V-HYADASE has a shelf-life of one-year when stored at 2-8°C and can be used for up to seven days after bottle opening.

Here's an analysis of the acceptance criteria and study information for the V-HYADASE device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the product specifications were "met at time 0 and after accelerated aging," indicating that the device performance for these criteria was within the defined acceptance limits.

Regarding the other requested information, the provided document does not contain the following details:

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

• The document mentions an MEA (Mouse Embryo Assay) but does not specify the number of embryos or test repetitions used for this specific test within the context of the device's performance validation.
• No information is provided about data provenance (country of origin, retrospective/prospective).

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 type of information is not relevant to the non-clinical performance testing described for this device, which involves laboratory assays and physical/chemical property measurements, not expert interpretation of outputs.

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

• Adjudication methods are typically associated with human-read studies or studies where subjective assessments are involved. This is not applicable to the non-clinical tests described.

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 study was conducted. This device is a reproductive media, not an AI-powered diagnostic tool.

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

• Standalone performance is not applicable to this device, as it is a chemical solution used in a laboratory procedure, not an algorithm.

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

• The ground truth for the non-clinical tests is established by the assay parameters themselves (e.g., pH meter readings, osmolality readings, microscopic observation of embryo development according to pre-defined criteria, sterility culture results, hyaluronidase activity assays).
• For the MEA, the "ground truth" is the observed development of embryos to the expanded blastocyst stage within the specified timeframe and percentage.

8. The sample size for the training set

• There is no "training set" in the context of this device's non-clinical performance testing. Training sets are relevant for machine learning algorithms.

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

• Not applicable, as there is no training set mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device, V-HYADASE, underwent a series of non-clinical performance tests to demonstrate its safety and effectiveness and substantial equivalence to a predicate device (Origio A/S SynVitro Hyadase K200680). The studies included:

• Sterile Filtration and Aseptic Fill Validation: Conducted per ISO 13408-1:2008 and ISO 13408-2:2018. This ensured the sterility of the final product.
• Shelf-Life Testing: This was a critical study to support the claimed 12-month shelf-life and 7-day open-vial stability. The testing involved demonstrating that all the acceptance criteria listed in the table above (Clarity/Color, pH, Osmolality, Endotoxin, MEA, Sterility, Hyaluronidase Activity) were met at the initial time point (time 0) and after accelerated aging (in accordance with ASTM F1980-21). Additionally, tests were performed on aged samples that had undergone 7 days of simulated use conditioning after bottle opening to verify the open-vial stability.
• Transportation Testing: Performed according to ASTM D4169-22 and USP to ensure the product's integrity during transport.

The conclusion drawn from these studies is that the "results of the performance testing described above demonstrate that V-HYADASE is as safe and effective as the predicate device and support a determination of substantial equivalence." This implies that all the stated acceptance criteria were successfully met during these non-clinical evaluations.

Ask a specific question about this device

Ask a specific question about this device

V-ONESTEP is intended for the in vitro culture of human embryos following fertilization until day 5/6 of development.

V-ONESTEP is a medium for culturing human embryos following fertilization up to day 6 of development. The device is provided sterile-filtered into pre-sterilized 20 ml glass or 10 ml PETG bottles. V-ONESTEP has a shelf-life of 90 days when stored at 2-8°C and can be use for seven days after opening bottles.

The provided text describes the 510(k) summary for V-ONESTEP, a reproductive medium. Here's an analysis of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text explicitly mentions a "1-cell mouse embryo assay (MEA)" as part of the performance testing.

• Sample Size: The text states, "One-cell mouse embryos were exposed to the subject device..." but does not specify the number of embryos used in this assay. It also mentions "in comparison with the control group" but doesn't elaborate on the size of the control group.
• Data Provenance: Not specified. It's unclear where the mouse embryos originated or if the study was retrospective or prospective, though performance testing for device clearance is typically prospective lab-based testing.

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

• Not Applicable. For this type of device (reproductive media), the ground truth is established through laboratory assays (MEA, pH, osmolality, endotoxin, sterility) rather than expert review of images or clinical outcomes. The device's performance is objectively measured against pre-defined thresholds.

4. Adjudication Method for the Test Set

• Not Applicable. As mentioned above, the ground truth is based on objective laboratory measurements, not expert consensus or 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 device is a reproductive medium, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This device is a fluid for culturing embryos; there is no algorithm or AI component. The "standalone performance" refers to the intrinsic performance of the medium itself as measured by the assays mentioned.

7. The Type of Ground Truth Used

• The ground truth for the performance evaluation relies on objective laboratory measurements based on established scientific methods and regulatory standards:
  • Chemical parameters: pH, osmolality.
  • Biological assay: 1-cell MEA (development to expanded blastocyst stage).
  • Contamination assessment: Endotoxin levels, Sterility (no growth).

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The formulation of the medium itself is developed through research and experimentation, but there isn't a "training set" like in machine learning.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question doesn't apply. The development of the medium's formulation would be based on scientific knowledge of embryo development requirements.

Ask a specific question about this device

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)

Ask a specific question about this device