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510(k) Data Aggregation
(141 days)
The Conceivex Conception Kit is indicated for assisted insemination in situations in which low sperm count, sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for longer than 6 hours.
The Conceivex Conception Kit includes the following literature: Instructions for Use, a "Conception Wheel" to help plan in timing a pregnancy, a "Conception Journal" booklet to assist in charting the fertility cycle and keep track of medical information, and a Medical Provider Note to alert the woman's health care provider that she is trying to become pregnant.
The kit contains three identical boxes, each of which contain: one Oves Cervical Cap, one cervical cap for practice, one Avanti Semen Collection Condom, eight Ovulation Predictors, a Pregnancy Test, and a sample of 'Pre Vaginal Lubricant. The three boxes enable the woman to try to conceive by using the Kit through three ovulation cycles.
Once the couple has visited with a physician and decides they would like to become pregnant, they begin recording details of their cycle in the Conception Journal. Next, using the ovulation predictor, they identify their most fertile day in a given month. During sex they use the semen collector and afterwards transfer the specimen into the Conception Cap. The Conception Cap is then placed over the cervix for 4-6 hours. At the end of the woman's cycle, she uses the Conceivex pregnancy test kit to determine if conception has been achieved.
The provided text K063227 describes the Conceivex Conception Kit, which focuses on assisted insemination using a cervical cap and a semen collection condom. The submission is for new indications for use for existing components (Oves Cervical Cap and Durex Avanti Polyurethane Condom) within the kit.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of predetermined acceptance criteria with quantitative targets for performance. Instead, the "acceptance criteria" are implied to be that the devices, with their new indications for use (home use for the cervical cap and semen collection for the condom), are "as safe and effective as the predicate devices."
The reported device performance is described qualitatively rather than with specific metrics.
Acceptance Criteria (Implied) | Reported Device Performance |
---|---|
Condom: No deleterious effects on human semen or embryo development with new indication (semen collection). | Human Sperm Survival Assay: Demonstrated no deleterious effects on human semen. |
Mouse Embryo Test: Demonstrated no deleterious effects on embryo development. | |
Cervical Cap: Lay user able to understand revised Instructions for Use and correctly manipulate/insert the cap without direct supervision with new indication (home use for assisted insemination). | Clinical Testing (Cap): Demonstrated that the lay person can understand the revised Instructions for Use and manipulate and insert the cap correctly without direct supervision. |
Overall: Devices with new Indications for Use are as safe and effective as their predicates. | Overall: The results of the testing demonstrate that the devices with the new Indications for Use are as safe and effective as their predicates, leading to a conclusion of Substantial Equivalence. |
2. Sample size used for the test set and the data provenance
- Sample size: The document does not specify the sample size for any of the tests (Human Sperm Survival Assay, Mouse Embryo Test, or the clinical testing for the cap).
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of submission. The studies described are laboratory and user performance tests rather than diagnostic or interpretative studies requiring expert ground truth establishment in that typical sense. The "ground truth" for the cap's usability would likely be determined by observing lay users' ability to follow instructions and correctly use the device.
4. Adjudication method for the test set
Not applicable. The described tests do not involve expert adjudication in the context of diagnostic performance.
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, an MRMC comparative effectiveness study was not conducted. This submission is for medical devices for assisted reproduction, not for an AI diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The device itself (cervical cap, condom) is evaluated for its physical properties and user-friendliness with its new indications.
7. The type of ground truth used
- Condom: The ground truth for the condom's safety regarding semen and embryo development would be established through laboratory assays (Human Sperm Survival Assay and Mouse Embryo Test) designed to quantify any deleterious effects. The "ground truth" is a scientific measure of biological response.
- Cervical Cap: The ground truth for the cap's usability by a lay person would be established through direct observation and assessment of user performance against predefined criteria for correct understanding and manipulation/insertion. This is a form of usability or human factors testing where the ground truth is successful completion of tasks.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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