(305 days)
ASP™-100 is intended to be used for follicle flushing during assisted reproduction procedures.
Indications For Use:
Follicle flushing.
ASP™-100 is a bicarbonate- and HEPES-buffered flushing medium for use during assisted reproduction procedures. Ready-to-use after equilibrium at +37 °C and 5% CO2.
The provided text describes the premarket notification for the ASP™-100 Assisted Reproduction Media. However, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and a detailed study proving device performance in the manner you've outlined for an AI/CAD-type device.
The document discusses biocompatibility testing and clinical experience but does not provide quantitative acceptance criteria or detailed study results with sample sizes, expert qualifications, or ground truth methodologies as would be expected for a diagnostic or AI-driven device.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance/Testing |
|---|---|
| Biocompatibility (general safety) | Cytotoxicity: Tested to ensure the media is not toxic to cells. |
| Rabbit Vaginal Irritation: Tested to ensure it does not cause irritation. | |
| Delayed Contact Sensitization: Tested for allergic reactions. | |
| Limulus Amebocyte Lysate (LAL) Assay: Performed on each lot to assure unacceptable levels of toxins are not present. | |
| Clinical Safety and Effectiveness (general) | "ASP™-100 has been used in assisted reproduction procedures for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use." (This is a qualitative statement of long-term use, not a quantitative study result). |
What is Not Provided: Specific quantitative thresholds for "acceptable levels" for the LAL assay, or specific outcomes/metrics from the biocompatibility tests (e.g., cell viability percentages, irritation scores).
2. Sample sized used for the test set and the data provenance
- Sample Size (Test Set): Not specified for any of the mentioned tests (cytotoxicity, irritation, sensitization, LAL assay).
- Data Provenance: Not specified. The "clinical experience" is retrospective and implied to be multinational ("many different assisted reproduction facilities").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The "ground truth" for the biocompatibility tests would generally be based on lab assay results interpreted by standard laboratory protocols, not expert consensus in the way a diagnostic image is interpreted. For "clinical experience," it's based on practitioners' observations over time.
4. Adjudication method for the test set
- Not specified, and likely not applicable in the requested format given the nature of the tests (biocompatibility assays).
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
- No. This device is an assisted reproduction medium, not an AI/CAD diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is entirely irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an algorithm-based device.
7. The type of ground truth used
- Biocompatibility Testing: The ground truth for these tests would be the results of the specific assays (e.g., cell viability, presence/absence of an inflammatory response, endotoxin levels). These are objective lab measurements rather than expert consensus on a diagnostic outcome.
- Clinical Experience: The "ground truth" here is the observed safety and effectiveness outcomes during routine clinical use, which is a form of real-world outcomes data.
8. The sample size for the training set
- Not applicable as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Device and Approval:
The ASP™-100 is a medical device (reproductive media), not an AI/CAD or diagnostic imaging device. Its premarket notification (K991345) focuses on demonstrating substantial equivalence to existing legally marketed predicate devices and confirming its biocompatibility and established clinical safety through long-term use rather than detailed performance metrics of a diagnostic tool. The "acceptance criteria" discussed are related to the safety and non-toxicity of the medium itself, as required for a substance that comes into contact with gametes and patients.
§ 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.