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The twoplus Applicator is indicated for over-the-counter home use by individuals who choose not to conceive through intercourse. The twoplus Applicator kit allows for semen collection and the vaginal canal. The twoplus Applicator should be used during the ovulatory phase of the menstrual cycle.

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I am sorry, but the provided text does not contain information about the acceptance criteria or any study details that prove the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "twoplus™ Applicator". It primarily discusses regulatory compliance and general information regarding the device's classification and marketing.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets and data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method.
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. Whether standalone performance was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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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.

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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The Mosie Baby Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or choose not to conceive through intercourse, for semen collection and the delivery of semen or donor sperm to the vaginal canal. The Mosie Baby Kit should be used during the ovulatory phase of the menstrual cycle.

The Mosie Baby Kit is an over-the-counter (OTC) device intended for intravaginal insemination (IVI) at home. The Mosie Baby Kit includes the following components:

• Two Mosie syringes
• Two Mosie collection cups
• Instructions for Use.
  Each component is single-use only and supplied non-sterile. 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 sperm into the syringe. The syringe is used to withdraw the semen from the collection cup and deploy the semen intravaginally. The syringe features a rounded front end with a slotted tip opening. The syringe has a rounded stopper that fits within the rounded end of the syringe to aid in sperm delivery from the syringe to the vagina. The syringe also contains flanges designed to aid in device handling during use.

The provided text describes the regulatory clearance of the Mosie Baby Kit and includes summaries of non-clinical and clinical performance testing. However, it does not describe an AI/ML-driven medical device and therefore does not contain information related to multi-reader multi-case (MRMC) studies, ground truth establishment by experts, or the effect size of AI assistance.

The document primarily focuses on the physical and functional characteristics of a medical device (a home insemination kit) and regulatory requirements for its approval for over-the-counter use.

Based on the provided document, here's an attempt to answer the questions, highlighting where the information is not applicable to AI/ML devices:

Acceptance Criteria and Device Performance (Based on Mosie Baby Kit Document)

Since this is not an AI/ML device, the acceptance criteria are not in terms of AI model performance metrics like sensitivity, specificity, or AUC. Instead, they relate to the physical and functional properties of the device, as well as user comprehension and self-selection for an over-the-counter product.

Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information (Addressing AI/ML-specific questions where applicable, or stating N/A)

1. A table of acceptance criteria and the reported device performance:

   • See the table above.

2. Sample sizes used for the test set and the data provenance:

   • Shelf-Life, Bioburden, HSSA, Functional Testing: Test articles were subjected to accelerated aging conditions. Specific sample sizes for each test are not explicitly stated, but are implied to be sufficient for the tests mentioned (e.g., "samples" for HSSA, "test articles" for bioburden).
   • Biocompatibility Testing: Not specified as a "test set" in the context of an AI model, but rather as individual tests performed on device materials. Specific sample sizes for cytotoxicity, sensitization, and irritation tests are not provided.
   • Clinical Performance Testing (User Studies):
     • Self-Selection Study: 32 participants (15 contraindicated female participants and 17 non-contraindicated female participants).
     • Human Factors Validation Study: 30 participants (15 self-administered, 15 administered to a female recipient).
   • Data Provenance: The document states that participants in the clinical performance studies were "representative of the intended user in the United States." The studies appear to be prospective user studies conducted to evaluate the device's usability and label comprehension.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A for this device. This device is not an AI/ML diagnostic tool that requires expert-established ground truth for image/data interpretation. Ground truth for the user studies was based on the defined indications for use, contraindications, and correct understanding/performance of tasks as defined by the manufacturer and assessed by the study design.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A for this device. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in expert-based review of medical images/data, which is not relevant here. The user studies' "ground truth" was based on whether participants correctly understood instructions or performed tasks as intended, as assessed by study protocols.

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 study was not done. This is not an AI/ML diagnostic device, so a study comparing human reader performance with and without AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A for this device. This device is a physical product (insemination kit), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the physical tests (bioburden, HSSA, biocompatibility, functional), the "ground truth" was defined by established laboratory testing standards (e.g., USP, ISO, ASTM) and manufacturer specifications.
   • For the user studies (self-selection, human factors), the "ground truth" was based on predefined correct answers for comprehension questions and successful completion of tasks as outlined in the Instructions for Use (IFU) and verified by study observers. Essentially, it's a task-based performance and comprehension ground truth as defined by the device's labeling and intended use.

8. The sample size for the training set:

   • N/A. This is not an AI/ML device that requires a training set. The data presented are from verification and validation studies of the physical device and user interaction.

9. How the ground truth for the training set was established:

   • N/A. As there is no training set for an AI/ML model, this question is not applicable.

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