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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.

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.

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Delivery of approximately 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump.

The IUI Catheter is a balloon catheter for slow release insemination. The catheter is placed in the uterus and sperm is injected through the catheter. The kit includes a standard BD 3 ml syringe and a mechanical actuator, as well as an ancillary component, a leg strap. Sperm is loaded into the syringe which is attached to the IUI catheter. The syringe is placed in a plastic, spring loaded mechanical actuator to press on the syringe plunger and deliver the sperm over a 3-4 hour period.

The provided text describes a 510(k) premarket notification for the "Fertiligent Slow Release IUI Catheter Kit". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically associated with novel technology or diagnostic devices.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test/training sets, expert qualifications, ground truth, and comparative effectiveness studies cannot be fully extracted from the provided document.

Here's a breakdown of what can be inferred or directly stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing: Specific quantitative performance metrics (e.g., success rates, complication rates, time to delivery accuracy) that would constitute "acceptance criteria" for a novel device.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: A "small clinical trial" was performed. The exact sample size is not disclosed.
• Data Provenance: Not explicitly stated, but clinical trials are typically prospective. The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable/Not Provided: For a device like an IUI catheter, "ground truth" in the diagnostic sense (e.g., disease diagnosis by expert consensus) is not directly relevant. The assessment of safety and effectiveness in a clinical trial would involve medical professionals observing outcomes, but their role isn't described as "establishing ground truth" in the context of an algorithm's performance.

4. Adjudication Method for the Test Set:

• Not Applicable/Not Provided: Adjudication methods (like 2+1 or 3+1) are typically used for evaluating human or AI interpretations of data where ambiguity exists. This is not described for the clinical trial of an IUI catheter.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• No: The document does not describe an MRMC study or any comparison of human readers with and without AI assistance. This device is a pure medical device (catheter and mechanical actuator), not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance:

• No: This device is a physical medical device; there is no standalone algorithm to evaluate.

7. Type of Ground Truth Used:

• Outcomes Data/Clinical Observation: For the small clinical trial, the "ground truth" would be the observed clinical outcomes related to the safety and effectiveness of the device (e.g., successful sperm delivery, absence of adverse events). This is inferred from the statement "lent support to the safety and effectiveness."

8. Sample Size for the Training Set:

• Not Applicable: There is no "training set" for an AI algorithm, as this is a physical medical device.

9. How Ground Truth for the Training Set Was Established:

• Not Applicable: As there is no training set for an AI algorithm, this question is not relevant.

Summary of Device and Evidence Presented:

The Fertiligent Slow Release IUI Catheter Kit is a balloon catheter for slow-release intrauterine insemination. The 510(k) submission primarily relies on demonstrating substantial equivalence to an existing legally marketed device (K032835 H/S Catheter) by stating identical technologies, materials, and function.

The evidence for safety and effectiveness includes:

• Non-clinical testing: Biocompatibility, endotoxin, HSSA, sterility validation, mechanical function, and shelf-life testing.
• Clinical testing: A "small clinical trial" which "lent support to the safety and effectiveness of the device." No further details on this trial (sample size, specific results, methodology) are provided in the summary.

Key takeaway: This document is a regulatory submission focused on substantial equivalence, not a detailed scientific paper describing the performance of a novel diagnostic or AI-driven medical device against pre-defined acceptance criteria. Therefore, many of the requested details related to AI/diagnostic performance studies are not present.

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