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Nunc IVF 4-Well Dishes are intended for preparing, storing, manipulation or transferring human gametes or embryos for in-vitro fertilization (IVF), or other in vitro ferilization techniques and cell culture.

Nunc IVF PetriDishes are intended for preparing, storing, manipulation or transferring human gametes or embryos for in-vitro fertilization (IVF), or other in vitro fertilization techniques and cell culture.

The Nunc IVF PetriDishes and the Nunc IVF 4-well Dish are injection molded polystyrene dishes with either a single well or 4 wells and a polystyrene lid. The single well dishes are available in diameters of 35, 60 and 90 mm. Both single well and 4-well configurations are made with a clear polystyrene lid. The polystyrene used for the dishes and lids is a virgin crystal-grade polystyrene, which has successfully passed the USP class VI test for cytotoxicity. The polystyrene is identical with the same Polystyrene use in the predicate device. For the 4-well configuration, the interface between the dish and the lid is designed with one cut off corner, hence the lid cannot be turned, and therefore cross contamination can be minimized. The dish is designed in such a way that when the lid is mounted on the dish, dishes can be stacked. The lid can be removed with one hand, which eases the use of the plate. The Nunc IVF tissue culture dishes are terminally sterilized by gamma irradiation to achieve SAL of 10-6. The dishes are non-pyrogenic as tested by LAL, and nonembryotoxic as tested by one cell mouse embryo assay (MEA). The Nunc IVF tissue culture dishes are disposable and intended for single use.

This submission is for a 510(k) premarket notification for a medical device. 510(k)s demonstrate substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with formal acceptance criteria. Therefore, the information provided does not contain the typical details of a study designed to meet specific acceptance criteria as would be found in a Premarket Approval (PMA) application.

However, I can extract the information related to the device's performance claims and how they compare to a predicate device, which serves a similar purpose to acceptance criteria in the context of a 510(k).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission, "acceptance criteria" are generally understood as demonstrating that the new device shares the same fundamental scientific technology, intended use, and similar performance characteristics (safety and effectiveness) as a legally marketed predicate device. The "reported device performance" is the evidence presented to show this similarity.

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

This document does not describe a "test set" in the traditional sense of a clinical study with human subjects or a defined dataset. The assessment for a 510(k) is heavily based on comparison to a predicate device and existing regulatory standards.

• Cytotoxicity Test: The polystyrene materials successfully passed the USP class VI test for cytotoxicity. The sample size for this test is not specified, nor is the data provenance (e.g., country of origin, retrospective/prospective).
• Sterility Test: Achieved SAL of 10⁻⁶. This is a standard measure for sterility, not a typical "dataset" or "test set" with a specified sample size of observations.
• Non-pyrogenic Test (LAL): The dishes are non-pyrogenic as tested by LAL. No sample size or data provenance is specified.
• Non-embryotoxic Test (MEA): The dishes are non-embryotoxic as tested by one-cell mouse embryo assay. No sample size or data provenance is specified.

These are standard laboratory tests required for devices of this type, indicating compliance with recognized methods rather than a statistically powered clinical study.

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

Not applicable. This is not a study involving expert review for ground truth establishment. The "ground truth" here is compliance with recognized standards (USP Class VI, SAL 10⁻⁶, LAL, MEA) and substantial equivalence to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" or adjudication process described as typically found in clinical trials with human readers.

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 submission for laboratory plasticware for IVF, not an AI-powered diagnostic device. No MRMC study was performed.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is established by:

• Compliance with recognized standards: USP Class VI for cytotoxicity, SAL of 10⁻⁶ for sterility, LAL for non-pyrogenicity, and 1-cell mouse embryo assay (MEA) for non-embryotoxicity.
• Substantial equivalence: Comparison to the performance and characteristics of the legally marketed predicate device (Nunc IVF Multidish 4 Well Nunclon).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device. There is no "training set."

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

Not applicable. There is no "training set" or corresponding ground truth establishment process.

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The plate is a sterile non-pyrogenic, Embryotoxicity tested singleuse plasticware intended for preparing, manipulating or transferring gametes and embryos in group of the many of the in vitro fertilization techniques, and cell culture

Not Found

Based on the provided text, this document is a 510(k) clearance letter for the Nunc IVF Multidish 4 wells Nunclon. It's a regulatory approval document and does not contain the acceptance criteria or a study description of the type requested for an AI/CADe device.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. The FDA's review for such devices generally focuses on manufacturing, labeling, and other general controls, not on a detailed performance study as would be required for a novel AI/CADe system.

Therefore, I cannot provide the requested information from this document. It does not include:

1. A table of acceptance criteria and reported device performance: This document doesn't define performance criteria or report on device performance based on a study.
2. Sample size, data provenance: Not applicable to this type of regulatory submission.
3. Number/qualifications of experts, adjudication method: Not applicable.
4. MRMC comparative effectiveness study: Not conducted for this type of device.
5. Standalone performance study: Not conducted.
6. Type of ground truth used: Not applicable.
7. Sample size for training set, how training ground truth was established: Not applicable, as this is not an AI/ML device.

The "Indications for use" states that the device is "a sterile non-pyrogenic, Embryotoxicity tested single-use plasticware interface for preparing, handling, manipulating or transferring gametes or embryos in vitro in conjunction with many of the in vitro fertilization techniques, and cell culture." This describes the intended function of the laboratory dish itself, not the performance of an analytical or AI algorithm.

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