(48 days)
The plate is a sterile non-pyrogenic, Embryotoxicity tested single use plasticware intended for preparing, storing, manipulating or transferring human gametes or incended for proparing, (IVF), or other in vitro fertilization techniques or cell culture.
Biogenics BioQuad™ 4-Well IVF Culture Dish
This document is a 510(k) clearance letter from the FDA for the Biogenics BioQuad™ 4-Well IVF Culture Dish. It states that the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria as typically found in a clinical or performance study report for AI/CADe systems.
The information requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) pertains to the evaluation of AI/CADe systems or diagnostic devices where performance metrics like sensitivity, specificity, or AUC are typically assessed against a ground truth.
For a physical device like an IVF culture dish, the "acceptance criteria" and "study" are different. They would typically involve:
-
Acceptance Criteria for an IVF Culture Dish:
- Sterility (e.g., meeting USP standards or equivalent)
- Non-pyrogenicity (e.g., Limulus Amebocyte Lysate (LAL) test results)
- Embryotoxicity (e.g., mouse embryo assay (MEA) or human embryo assay (HEA) results demonstrating no adverse effect on embryo development)
- Biocompatibility (e.g., ISO 10993 standards)
- Material safety (e.g., leachables/extractables testing)
- Physical dimensions and integrity
- Functionality (e.g., ability to sustain culture, gas exchange properties, no visible defects)
- Labeling accuracy and legibility
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The "Study" for an IVF Culture Dish: This would be a series of laboratory tests and assays designed to demonstrate compliance with the above acceptance criteria. These are often described in the 510(k) submission itself but are not detailed in this particular summary letter from the FDA.
Therefore, I cannot populate the table or answer most of your specific questions based on the provided text. The document only confirms the device's clearance and indications for use.
However, I can extract the following limited information which is relevant to the type of device:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance (as implied by FDA clearance and indications) |
|---|---|
| Sterility | Sterile (stated in Indications for Use) |
| Non-pyrogenicity | Non-pyrogenic (stated in Indications for Use) |
| Embryotoxicity | Embryotoxicity tested (stated in Indications for Use) |
| Intended Use | Intended for preparing, storing, manipulating, or transferring human gametes/embryos in IVF or other in vitro fertilization techniques or cell culture. (stated in Indications for Use) |
Regarding the remaining questions, the provided text does not contain the information requested for an AI/CADe system study. Here's why and what kind of information would be needed for a physical device like this:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable in this context. For an IVF dish, this would refer to the number of dishes tested for sterility, pyrogenicity, or the number of embryo assays performed. The document doesn't provide this.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For an IVF dish, "ground truth" is established by laboratory assay results (e.g., bacterial growth, LAL test results, embryo development scores).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Lab tests have objective pass/fail criteria.
- 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 for AI/diagnostic image interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for AI performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, ground truth would be based on validated laboratory assay results (e.g., absence of microbial growth for sterility, specific LAL units for pyrogenicity, embryo viability/development rates for embryotoxicity).
- The sample size for the training set: Not applicable in this context. There is no AI model being trained.
- How the ground truth for the training set was established: Not applicable. There is no AI model being trained.
§ 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.