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510(k) Data Aggregation
(192 days)
PherDal**®** At-Home Insemination Kit
The PherDal® At-Home Insemination Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or have chosen not to conceive through intercourse, for semen collection and the delivery of semen to the vaginal canal. The PherDal® At-Home Insemination Kit should be used during the ovulatory phase of the menstrual cycle.
The PherDal® At-Home Insemination Kit is a sterile, over-the-counter (OTC) medical device intended for intravaginal insemination (IVI) at home. It consists of three sets of sterile, single-use, plastic syringes and semen collection cups, and Instructions for Use. The collection cup is used to hold and contain the sperm and work in conjunction with the syringe when it is time to transfer the syringe. The syringe is used to withdraw the semen from the collection cup and deploy the semen intravaginally.
The provided text details the 510(k) submission for the PherDal® At-Home Insemination Kit and includes non-clinical and clinical performance data. However, it does not describe an AI/algorithm-based medical device. Therefore, the questions related to AI device performance metrics, algorithm-specific ground truth establishment, MRMC studies, and effect sizes are not applicable to this document. The document focuses on the physical device's performance, user comprehension, and biocompatibility.
I will provide information based on the available text relevant to the device's acceptance criteria and the studies performed.
Here's an analysis of the acceptance criteria and study information provided for the PherDal® At-Home Insemination Kit:
1. A table of acceptance criteria and the reported device performance
The document provides acceptance criteria for various non-clinical tests and a target threshold for clinical (user comprehension) studies.
| Test Category | Specific Test / Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Vaginal Irritation | Non-irritating, non-sensitizing | Demonstrated to be non-irritating and non-sensitizing. |
| Sterilization | Sterilization Assurance Level (SAL) | 10⁻⁶ | Achieved 10⁻⁶ SAL. |
| Transport Testing | Ability to withstand shipping rigors | Demonstrated per ASTM D4169-22 | Demonstrated ability to withstand shipping rigors. |
| Shelf-Life | Overall shelf-life | 5 years | Study conducted to 5-year shelf-life (accelerated aging). |
| Packaging Integrity | Maintain sterile barrier (Seal strength, integrity, width, bubble leak) | Meet specified standards (ASTM F88/F88M-15, F1886/F1886M-16, F2203-13, F2096-11) | Verification performed using the specified ASTM methods. (Implied successful, as it supports substantial equivalence). |
| Functional Testing (Syringe) | Visual inspection, Dimensional inspection, Freedom from liquid leakage, Force to operate piston, Fit of plunger stopper | Meet specified standards (ISO 7886-1:2017 clauses) | Functional testing conducted on new and aged devices. (Implied successful, as it supports substantial equivalence). |
| Functional Testing (Collection Cup) | Visual inspection, Dimensional inspection | Not explicitly stated, but implied to meet functional requirements | Functional testing conducted on new and aged devices. (Implied successful, as it supports substantial equivalence). |
| Human Sperm Survival Assay (HSSA) | Syringe and cup materials not sperm-toxic; control motility at 24 hours | ≥80% of control motility at 24 hours | Syringes and collection cups shown to meet the HSSA acceptance specification (≥80% of control motility at 24 hours) at all time points assessed. |
| Self-Selection Study | Ability of users to determine if they should use the product based on label | Not explicitly stated, but high success desired | 98.9% (86 of 87) of all study participants successfully determined product suitability. 97.0% (33/34) success for those with low health literacy. |
| Labeling Comprehension Study | Understanding of product label by users (all questions) | ≥90% correct answers (comprehensive set of questions) | All questions answered correctly by at least 90% of study participants (range 95-100%). At least 90% of low health literacy participants answered correctly (range 91-100%). Target threshold of at least 90% success was met. |
2. Sample sized used for the test set and the data provenance
- Self-Selection Study:
- Sample Size: 87 biological female participants (47 contraindicated, 40 non-contraindicated).
- Data Provenance: The participants were stated to be "representative of the U.S. demographic." The study appears to be a prospective design, as participants actively determined utility based on provided labeling.
- Labeling Comprehension Study:
- Sample Size: 164 biological female participants.
- Data Provenance: The participants were stated to be "representative of the U.S. demographic." The study appears to be a prospective design, as participants actively answered questions based on reviewing the labeling.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the studies described (Self-Selection and Labeling Comprehension) do not involve expert-established ground truth in the context of diagnostic interpretation (e.g., radiology). Instead, the "ground truth" for these studies is the correct understanding or appropriate self-selection based on the device's labeling and intended use, which is assessed directly from user responses in a controlled study environment.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in image interpretation studies where multiple readers assess cases and disagreements need to be resolved to establish a robust ground truth. The studies here are user comprehension and self-selection studies, where participant responses are directly evaluated against predefined correct answers based on the device's instruction for use.
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
This information is not applicable. The device is an at-home insemination kit, not an AI-assisted diagnostic tool or system designed to improve human reader performance. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. As previously stated, this is a physical medical device and not an AI algorithm.
7. The type of ground truth used
For the clinical studies (Self-Selection and Labeling Comprehension), the "ground truth" was established by the correct answers based on the official Instructions for Use and device labeling. For instance, a correct understanding of a warning or an accurate self-determination of whether the kit is indicated for them. This is a form of definitive outcome based on regulatory and instructional content, not a medical "pathology" or "outcome data" in the traditional sense.
For the non-clinical tests (biocompatibility, sterilization, functional testing, HSSA), the "ground truth" or standard of success was adherence to established international and FDA-recognized standards and predefined specifications (e.g., ISO, ASTM standards, specified motility percentages).
8. The sample size for the training set
This information is not applicable. "Training set" refers to data used to train an AI algorithm. This device is not an AI algorithm.
9. How the ground truth for the training set was established
This information is not applicable. This device is not an AI algorithm.
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