(218 days)
In the treatment of infertile couples by ICSI, PICSI is indicated for the selection of mature sperm for injection.
The PICSI™ Sperm Selection Device is a sterile, plastic culture dish with three microdots of hyaluronan hydrogel attached to the dish and three locating lines emoussed on the bottom exterior of the dish to aid the operator to find the microdots. Mature sperm attach themselves to hyaluronan through specific receptors on the sperm plasma membrane. At temperatures from 18-28° C, mature sperm attach firmly to the hyaluronan microdot and no longer exhibit progressive movement, although their tails beat and they are capable of motility. Such sperm are removed from the hyaluronan by micropipet for intracytoplasmic sperm injection (ICSI).
Here's an analysis of the provided information regarding the PICSI™ Sperm Selection Device, focusing on the acceptance criteria and the study that proves its performance:
Considering the device is an Assisted Reproduction Media Labware (a physical culture dish with hyaluronan hydrogel), the "acceptance criteria" here refer to the performance specifications of the product itself, primarily its chemical and physical properties, and its functional performance in a lab setting, rather than a diagnostic device's accuracy metrics (like sensitivity/specificity).
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the PICSI dish to predicate devices (Sperm Catch™ and FALCON® IVF Round Dish) across several attributes. Since explicit "acceptance criteria" (numerical thresholds that must be met) are not directly stated, I will infer them from the comparison table as the performance of the predicate devices or general industry standards for such products where available.
| Factor/Attribute | Acceptance Criteria (Inferred from Predicate Devices/Standards) | Reported Device Performance (PICSI Dish) |
|---|---|---|
| Method of facilitating sperm selection and capture by micropipette | Slows progressive movement (Sperm Catch) / N/A (FALCON) | Stops progressive movement |
| Active Ingredient | Hyaluronan (solution) (Sperm Catch) / N/A (FALCON) | Hyaluronan (hydrogel attached to Petri dish) |
| Sperm fraction subject to selection | Total motile fraction (Sperm Catch) / N/A (FALCON) | Mature motile fraction |
| Useful Operating Temperature | 30-37° C (Sperm Catch) / 0-37°C (FALCON) | 18-28° C |
| Minimum time for set up and selection of sperm | 10 min (Sperm Catch) / N/A (FALCON) | 15 min |
| Storage conditions | (?) Refrigerated (Sperm Catch) / (?) Dry, room temperature (FALCON) | Dry, room temperature |
| Shelf Life | Unknown (Sperm Catch, FALCON) | 1 year (anticipated to be extended as aging studies are completed) |
| Sterility | Filtration sterilized (Sperm Catch) / Radiation sterilized (FALCON) | Radiation sterilized |
| Endotoxin | 24h survival in human sperm survival assay) (Sperm Catch) / Compatible (2-cell Mouse Embryo Assay, ≥70% conversion in 72h) (FALCON) | Compatible (1-cell Mouse Embryo Assay, ≥75% conversion in 96h) |
| Fertilization Rates (Clinical Trial) | No statistically significant difference from predicate device (implied standard from Sperm Catch) | No statistically significant differences compared to Sperm Catch. |
| Quality of resulting embryos (Clinical Trial) | No statistically significant difference from predicate device | No statistically significant differences compared to Sperm Catch in average number of cells in 3-day embryos, number of 3-day embryos with 8+ cells, morphological characterization of 3-, 5-, 6-day embryos. |
| Disposition of embryos (Clinical Trial) | No statistically significant difference from predicate device | No statistically significant differences compared to Sperm Catch for 3- and 6-day embryos. |
2. Sample size used for the test set and the data provenance
- Sample Size for the test set: Not explicitly stated. The document mentions "a clinical trial involving side-by-side fertilization of oocytes by ICSI, using sperm selected on PICSI and in Sperm Catch." This suggests a comparative study, but the number of patients, oocytes, or sperm samples is not provided.
- Data Provenance: Not specified in terms of country of origin. The study is described as a "clinical trial," implying prospective data collection, though the timeframe or specific study design details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device for use in an assisted reproduction laboratory, not a diagnostic imaging or AI device requiring expert interpretation for ground truth. The "ground truth" here is the biological outcome (fertilization rates, embryo quality, embryo disposition) observed in a clinical setting. The assessment of these outcomes would typically be done by trained embryologists and clinicians, but no specific number or qualifications are mentioned as "experts" for ground truth establishment.
4. Adjudication method for the test set
Not applicable. As a clinical trial assessing biological outcomes, there wouldn't typically be an adjudication method in the sense of resolving conflicting expert opinions on a diagnosis. The outcomes (e.g., fertilization rates, embryo morphology) are usually objectively measured and reported.
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
Not applicable. This device is not an AI algorithm or an imaging device to be interpreted by human readers. It's a labware product used in an assisted reproduction procedure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. Its function is to facilitate sperm selection by laboratory personnel during ICSI.
7. The type of ground truth used
The ground truth used was clinical outcomes data related to fertilization and early embryo development. Specifically:
- Fertilization rates
- Average number of cells in 3-day embryos
- Number of 3-day embryos with 8 or more cells
- Morphological characterization of 3-, 5-, and 6-day embryos
- Disposition (outcomes) of 3- and 6-day embryos
8. The sample size for the training set
Not applicable. This device is a physical labware product, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.