(225 days)
Delivery of approximately 1ml of sperm into the uterus over 3-4 hours using a controlled release pump.
The subject device is a balloon catheter for slow release intrauterine insemination. The catheter is placed in the uterus and sperm is injected through the catheter. The subject device is provided with a standard 3 ml syringe, a mechanical actuator, and a leg strap. Sperm is loaded into the syringe, and the syringe is attached to the IUI catheter. The syringe is placed in the mechanical actuator to deliver the sperm over a 3-4 hour period.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of typical medical device performance evaluation (e.g., accuracy, sensitivity, specificity for diagnostic devices, or specific performance metrics for therapeutic devices).
The document is a US FDA 510(k) clearance letter for a "Fertiligent Slow Release IUI Catheter Kit". The core of this submission (K141666) is to allow for patient self-removal of the device at home, which was a change from a previous predicate device (K092579) that required removal under clinical supervision.
The relevant section states: "The safety of patient self-removal of the subject device was evaluated as a substudy (n=80) within a multi-center, randomized, open-label, cross-over study comparing the subject device to conventional 'bolus' IUI. The study results demonstrated that a typical IUI patient can self-remove the subject device."
Based on this, I can provide the following partial information related to what was studied, but not a table of acceptance criteria or performance metrics as you might expect for an AI algorithm or a device with quantifiable performance output like a diagnostic tool.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or performance metrics in a quantifiable sense (e.g., specific thresholds for success/failure rates, accuracy, etc.). The study's reported outcome is qualitative: "The study results demonstrated that a typical IUI patient can self-remove the subject device." This suggests the "acceptance criterion" was likely that a high percentage of patients could successfully and safely self-remove the device, but the specific percentage/threshold is not mentioned.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Patients can safely and effectively self-remove the device. | "The study results demonstrated that a typical IUI patient can self-remove the subject device." |
2. Sample size used for the test set and the data provenance
- Sample Size: n=80 (for the self-removal substudy)
- Data Provenance: The study was a "multi-center, randomized, open-label, cross-over study". The country of origin is not specified but is implied to be within the scope of where such FDA-related studies are conducted (likely US or internationally recognized clinical sites). It was a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not explicitly provided in the document. For a study on patient self-removal, the assessment of safety and effectiveness would likely be made by the patients themselves (reporting successful removal, adverse events) and potentially by clinicians overseeing the study. The criteria for "successful self-removal" are not detailed.
4. Adjudication method for the test set
This information is not provided.
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 done. This device is a physical medical device (catheter) for sperm delivery, not an AI or imaging device with "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this question is not applicable as the device is a physical catheter, not an algorithm.
7. The type of ground truth used
The "ground truth" for the self-removal substudy would likely have been the actual successful or unsuccessful removal of the device by the patient, along with the occurrence or non-occurrence of adverse events related to the removal, as documented by patients and/or clinicians. This would fall under observed outcomes data.
8. The sample size for the training set
This information is not applicable. The device is a physical product, not an AI algorithm that requires a training set. The clinical study was for performance evaluation, not for training a model.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).