(302 days)
The Eeva™ Petri Dish is intended to be used to hold human oocytes and embryos during handling and culture.
The Eeva™ Petri Dish is 39mm in diameter with a lid and consists of a large center well containing 16 or 25 micro-wells. The Eeva Petri dish also contains three smaller outer rings, approximately 7mm in diameter each, which are intended to hold media drops for rinsing the oocytes or embryos.
The Eeva™ Petri Dish is constructed of polystyrene and is non-pyrogenic and non-embryotoxic.
The provided text describes the "Eeva™ Petri Dish," which is an IVF tissue culture dish. The document is primarily a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in the context of demonstrating safety and effectiveness as an IVF tissue culture dish, rather than a diagnostic AI device with performance metrics like sensitivity/specificity.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Proxy for Performance Goal) | Reported Device Performance |
|---|---|
| Non-pyrogenic | Tested by LAL; found to be non-pyrogenic |
| Non-embryotoxic | Tested by 1-Cell Mouse Embryo Assay (MEA); results showed ≥ 80% of embryos developed to expanded blastocyst stage within 96 hours |
| Intended Use Equivalence | Substantially equivalent in intended use, Indications for Use, materials and design to the predicate device (SunIVF Embryo Corral Dish). Both devices are used to culture embryos during IVF procedures. |
| Material Equivalence | Constructed of 100% virgin polystyrene, same as predicate. |
| Functionality Equivalence | Both devices allow for the segregation of embryos while immersed in the same drop of culture media. |
| Sterilization Equivalence | Both are single-use only and gamma irradiation sterilized. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-pyrogenic (LAL test): The sample size for the LAL test is not specified. The data provenance is not mentioned (e.g., country of origin, retrospective/prospective).
- Non-embryotoxic (MEA test): The sample size (number of embryos or tests) for the 1-Cell Mouse Embryo Assay is not specified. The data provenance is not mentioned.
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 information is not applicable as the studies performed (LAL and MEA) are laboratory-based tests for material properties and biological compatibility, not expert-opinion-based evaluations of a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the tests described. The LAL and MEA tests have specific, objective measurement endpoints.
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
There was no MRMC comparative effectiveness study and no AI component mentioned in the provided text. This device is a petri dish, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone algorithm performance study as this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Non-pyrogenic: Ground truth is established by the LAL (Limulus Amebocyte Lysate) assay, which detects bacterial endotoxins. This is an objective, standardized laboratory test.
- Non-embryotoxic: Ground truth is established by the 1-Cell Mouse Embryo Assay (MEA), which assesses the device's impact on embryo development. The criterion for success is a predefined percentage (e.g., ≥ 80%) of embryos developing to a specific stage (expanded blastocyst). This is an objective, standardized biological assay.
- Substantial Equivalence: The ground truth for this aspect is the comparison of device characteristics (intended use, materials, design) to a legally marketed predicate device, as determined by regulatory review.
8. The sample size for the training set
This information is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/machine learning device.
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.