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510(k) Data Aggregation
(238 days)
Medium for culture of embryos from fertilization to blastocyst stage
G-TL™ is an aseptically filtered and manufactured bicarbonate-buffered physiological medium ready to use after warming to 37°C and equilibration in a CO2 environment. It is designed to be used by professionals within assisted reproduction. G-TL™ is intended for the culture of human embryos from fertilization to the time of embryo transfer. G-TL™ is contained within a 30ml transparent polyethyleneterephthalate glycol (PETG) bottle with high density polyethylene (HDPE) closures. Both the bottle and box are individually labeled and each box contains a package insert.
The G-TL™ device is a medium for the culture of human embryos. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with acceptance criteria for device performance in human subjects.
Here's an analysis based on the provided text, addressing your points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Device Manufacturer for Comparison) | Reported Device Performance (G-TL™) | Predicate Device Performance (CSC™ Complete) |
|---|---|---|
| pH: Within physiological range | 7.30 ±0.1 | 7.25-7.54 |
| Osmolality (mOsm/Kg): Within physiological range | 270 ±5 | 265 ±5 |
| Sterility Assurance Level (SAL): | 10^-3 | 10^-3 |
| Bacterial Endotoxin (EU/ml): | <0.25 | <0.25 |
| Mouse Embryo Assay (% expanded blastocyst on Day 5): ≥80% | ≥80% | ≥80% |
| Storage Conditions: | Store dark +2 to 8°C | Store dark +2 to 8°C |
| Embryo development/viability (compared to predicate in MEA): No differences | No differences | N/A (as it's the comparator) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions a "one-cell mouse embryo assay (MEA)" as the test method. However, it does not specify the sample size (i.e., the number of mouse embryos or experiments) used in this assay.
- Data Provenance: The study was an "animal study during product development." It can be inferred that the data is prospective as it was conducted to validate the new device. The country of origin for the data is not explicitly stated, but the submitting company is Vitrolife, Inc. based in Englewood, CO, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Ground truth in this context typically refers to the confirmed outcome against which the device's performance is measured.
- For the technical specifications (pH, osmolality, SAL, endotoxin), the "ground truth" is established by standard laboratory measurement techniques, not human experts.
- For the Mouse Embryo Assay (MEA), the assessment of "expanded blastocyst on Day 5" would involve expert observation and scoring, likely by trained embryologists or laboratory technicians. However, the document does not specify the number or qualifications of experts involved in establishing this ground truth.
4. Adjudication Method for the Test Set
- Given that the MEA involves standardized biological endpoints (percentage of expanded blastocysts), it's unlikely that a formal adjudication method like "2+1" or "3+1" (common in image-based diagnostic studies) would be used.
- The results are likely based on objective counts and percentages validated by direct observation. The document does not describe any specific adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is not relevant for an IVF culture medium. The study performed compared the device to a predicate device using a mouse embryo assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- The G-TL™ is an IVF culture medium, not an algorithm or an AI device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. Its performance is evaluated through its biological effect on embryos.
7. The Type of Ground Truth Used
- For the technical specifications (pH, osmolality, etc.), the ground truth is based on standard analytical measurements (e.g., pH meters, osmometers, bacterial culture for SAL, LAL assay for endotoxin).
- For the mouse embryo assay, the ground truth is based on biological outcomes (percentage of expanded blastocysts) observed in a controlled in-vitro environment, which in itself serves as an indicator of embryo viability and developmental competence.
8. The Sample Size for the Training Set
- The document does not mention a training set. This is expected as the G-TL™ is a physical culture medium, not an AI model that requires training data. The "animal studies during product development" mentioned could be considered development/optimization studies, but not a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- As there is no training set in the context of an AI device, this question is not applicable to the G-TL™ culture medium.
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