(269 days)
The FERTI.LILY Conception Cup is indicated for over-the-counter home use. It is for couples who have been unable to conceive naturally and who have received a diagnosis of low sperm immobility or unfavorable vaginal environment. After intercourse, the FERTI.LILY Conception Cup is placed around the cervix. It retains semen near the cervical os (the passage between the vaginal cavity and the uterus) as an aid to conception. The FERTI.LIL Y Conception Cup should be used during the ovulatory phase of the menstrual cycle. The FERTI.LILY Conception Cup should not be left in place for longer than one hour.
The FERTI.LILY Conception Cup is a non-sterile, silicone, over-the-counter (OTC) device for use by couples as an aid to conception that have been unable to get pregnant naturally due to low sperm count, low sperm motility, or an unfavorable vaginal environment. After intercourse, the device is placed in the vagina, the cup-like receptable is deployed using an integrated deployment cord, and the device is positioned over the cervix to physically situate semen near the cervical os. The FERTI.LIL Y Conception Cup can be left in the vagina for a maximum duration of one hour. The FERTI.LILY Conception Cup includes a stem to assist with removal from the vagina.
The provided document describes the FERTI.LILY Conception Cup and studies demonstrating its safety and effectiveness. However, it does not present a formal "acceptance criteria" table with specific quantified performance metrics and how the device explicitly meets them for clinical outcomes. The document focuses on non-clinical performance (biocompatibility, shelf life, reprocessing, use-life) and clinical usability/label comprehension studies.
Therefore, I cannot create a table of acceptance criteria for clinical efficacy from the provided text, as those specific criteria are not explicitly stated for clinical outcomes. The clinical studies primarily assess usability, label comprehension, and successful insertion/removal, rather than a direct measure of conception success compared to a numerical target.
However, I can extract the reported performance from the studies provided and infer the "acceptance criteria" based on the successful outcomes and study goals as described in the text.
Here's the information parsed from the provided text:
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
| Performance Metric (Inferred Acceptance Criteria) | Reported Device Performance |
|---|---|
| Non-Clinical Performance | |
| Biocompatibility (Non-irritating, non-sensitizing, not acutely/systemically toxic) | The results of testing demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic. |
| Shelf Life (Maintain specifications over 36 months for color, appearance, odor, dimensions, volume, tensile testing, hardness, HSSA) | A real-time shelf-life study verified the FERTI.LILY Conception Cup maintained its specifications over its entire 36-month shelf-life for the assessed parameters. |
| Reprocessing (No protein or total organic carbon residuals after reprocessing) | Reprocessing validation found protein and carbon residuals did not remain on the FERTI.LILY Conception Cup after full reprocessing. |
| Use-Life (Maintain specifications after maximum simulated deployment and reprocessing for 3 months for color, appearance, odor, dimensions, volume, tensile testing, hardness, HSSA) | Testing on newly manufactured devices and devices after maximum simulated deployment and reprocessing steps (for 3 months use-life) showed devices were within specification range for each assessed parameter. |
| Human Sperm Survival Assay (HSSA) (≥ 80% motility after 2-hour exposure to the Conception Cup) | Yes, ≥ 80% motility after 2-hour exposure to the Conception Cup. |
| Clinical Performance (Usability & Label Comprehension) | |
| Self-Selection, Label Comprehension, Virtual Simulated Use (80% comprehension for each knowledge endpoint) | First Study: Prespecified target comprehension level of 80% for each knowledge endpoint related to self-selection, label comprehension, and simulated-use was met. |
| Labeling Revisions Comprehension (80% comprehension for each knowledge endpoint) | Second Study: The target comprehension level (80%) of each knowledge endpoint tested was met. |
| At-Home Usability (Successful insertion) & Label Comprehension (Clear understanding) | Third Study (FCC-001): 87% of subjects were able to successfully insert the device. 15 subjects demonstrated clear understanding of the package directions. |
| Usability and Safety (Successful use, correct insertion, no device-related adverse events or deficiencies) | Fourth Study (FCC-002): All 15 subjects were able to successfully use the device in both in-clinic and at-home settings. All (100%) subjects correctly inserted the device, and no device-related adverse events or device deficiencies were observed. All specified outcomes were met. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not detail specific "test sets" in the context of a machine learning or AI algorithm. Instead, it describes human subject studies. Based on the description:
- Clinical Studies (Test for Usability/Comprehension):
- First Study: 75 naive subjects enrolled, 74 completed.
- Second Study: 41 naive subjects completed.
- Third Study (FCC-001): 15 subjects enrolled.
- Fourth Study (FCC-002): 15 subjects enrolled, all 15 completed.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study participants. However, it mentions "demographic information representative of the US population" in the conclusion of the clinical studies section, suggesting participants were likely from the US or a population representative of the US. All studies appear to be prospective clinical studies as they involve subject enrollment and active data collection related to device use and comprehension.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" and "experts" as typically seen in AI/ML validation (e.g., radiologist interpreting images) is not directly applicable here. The "ground truth" for the usability and comprehension studies was established by the study design itself and the observation/assessment of subject actions and self-reported understanding.
- In the Third Study (FCC-001) and Fourth Study (FCC-002), a "physician" or "HCP (Health Care Provider)" assessed correct deployment and positioning over the cervical os, semen remaining in the cup, and potential vaginal injury/trauma. The number or specific qualifications (e.g., years of experience) of these HCPs/physicians are not specified.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1 or 3+1) are typically used when multiple human readers interpret data, and discrepancies need to be resolved. This is not mentioned as part of the usability or comprehension studies described, as they primarily involve objective observation or direct assessment by a single observer (e.g., study staff, physician) of a subject's actions or understanding.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The studies focused on the performance, usability, and comprehension of the FERTI.LILY Conception Cup itself, not on comparing AI assistance to unassisted human readers, as this is not an AI-driven device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone algorithm performance study was done because the FERTI.LILY Conception Cup is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the studies was primarily based on:
- Observed actions/behavior: Successful insertion, deployment, removal, adherence to instructions.
- Subject self-reporting: Ease of use, satisfaction (FCC-001).
- Direct assessment by HCP/physician: Correct positioning over the cervical os, semen volume, vaginal injury/trauma (FCC-001, FCC-002).
- Defined knowledge endpoints: Correct answers to comprehension questions related to labeling.
8. The Sample Size for the Training Set
The concept of a "training set" is not relevant here as the device is a physical product and not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).