(142 days)
ORIGIO® Sequential Fert™ is for the fertilization of oocytes in vitro.
ORIGIO® Sequential Cleav™ is for the culture of embryos until the 2-8 cell stage. ORIGIO® Sequential Cleav™ can also be used for embryo transfer at day 2 or 3.
ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are aseptically filtered, non viscous solutions, light pink or colorless solutions, which are ready to use by professionals within assisted reproduction.
ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are contained in 10 mL or 60 mL transparent polyethylene terephthalate glycol (PETG) bottles with high density polyethylene (HDPE) closures, available in card board boxes of 1 x 10 mL and 1 x 60 mL bottles. The bottles and boxes are individually labeled. The boxes also contain instruction for use provided as package insert.
This document describes the ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ medical devices. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria from a standalone clinical study.
Therefore, a table of "acceptance criteria" and "reported device performance" specifically for the device's diagnostic performance (like sensitivity/specificity) is not provided in the typical sense of a diagnostic medical device. Instead, the "acceptance criteria" are implied by the comparison to predicate devices' specifications and functional properties through various laboratory tests.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally expressed as ranges or thresholds for various physicochemical properties and biological performance in comparison to predicate devices and recognized ART media. The reported device performance is stated to meet these specifications.
| Characteristic | Acceptance Criteria (ORIGIO® Sequential Fert™) | Reported Device Performance (ORIGIO® Sequential Fert™) | Acceptance Criteria (ORIGIO® Sequential Cleav™) | Reported Device Performance (ORIGIO® Sequential Cleav™) |
|---|---|---|---|---|
| pH | 7.3-7.5 | Meets specification (implied) | 7.2-7.4 | Meets specification (implied) |
| Osmolality (mOsm/kg) | 277-293 | Meets specification (implied) | 272-288 | Meets specification (implied) |
| Endotoxin (EU/mL) | =80%` in the table, implying this was maintained. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the context of diagnostic device performance (e.g., patient data for sensitivity/specificity). Instead, the "testing" refers primarily to:
- Physicochemical analyses: pH, osmolality, endotoxin, sterility performed on batches of the manufactured media. The sample size for these manufacturing release tests is not specified but would typically follow internal quality control procedures.
- Mouse Embryo Assay (MEA): This is a biological test performed on mouse embryos to assess the media's ability to support embryo development. The sample size for MEA is stated as achieving "≥80%," indicating a pass/fail criterion rather than a detailed study sample size. The provenance of these mouse embryos or the exact number tested is not detailed.
- Stability Studies: Conducted to determine shelf life, testing pH, osmolality, endotoxin, HSA concentration, MEA, and sterility over time. The sample size (number of batches, number of samples per batch/time point) for these studies is not specified.
- Biocompatibility Testing: Performed for ORIGIO® Sequential Cleav™. This involves standardized in vitro and in vivo tests (cytotoxicity, sensitization, irritation). The sample size for these specific tests is not provided, but generally involves a predetermined number of test samples.
All data described appears to be retrospective (part of product development and qualification) and is generated by ORIGIO a/s (Denmark) or contracted laboratories.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This product is an in vitro fertilization (IVF) medium, not a diagnostic device that requires expert ground truth for interpretation of discrete outputs. The "ground truth" for its performance is assessed through its physical and chemical properties and its ability to support embryo development (MEA), which are objective laboratory measurements, not subjective expert interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
N/A. As this is not a diagnostic device or a study involving human interpretation, an adjudication method for a "test set" is 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
N/A. No MRMC study was conducted. This device is an IVF medium, not an AI or imaging device involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. There is no algorithm or AI component to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this product's performance is established by:
- Physicochemical standards: pH, osmolality, endotoxin levels are measured against predefined acceptable ranges.
- Biological performance standards: The Mouse Embryo Assay (MEA) serves as a biological ground truth, where successful development of mouse embryos (≥80% 1-cell MEA) indicates the medium's suitability.
- Comparison to predicate devices: The "ground truth" for substantial equivalence is met by demonstrating that the new devices have comparable technological characteristics and performance to legally marketed predicate devices.
8. The sample size for the training set
N/A. This is not a machine learning or AI device, so there is no training set in that context. The "training" in product development refers to formulation optimization and initial testing, but no specific "training set" of data is mentioned.
9. How the ground truth for the training set was established
N/A. See above.
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.