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The Béa Applicator is indicated for over-the-counter home use by couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count, sperm immobility or unfavorable vaginal environment. The Béa Applicator contains a Béa Cervical Cap which is used to contain, deliver, and retain semen near the cervical opening as an aid to conception. The Béa Applicator should be used during the ovulatory phase of the menstrual cycle. The Béa Cervical Cap should not be left in place for longer than 5 hours.

The Béa Applicator is an over-the-counter (OTC) device for use by couples as an aid to conception that have been unable to get pregnant naturally due to low sperm count, low sperm motility, or an unfavorable vaginal environment. The Applicator is provided to the users pre-assembled with the silicone cervical cap and a funnel to guide the semen into the cervical cap. Semen is poured from a sterile semen container into the cervical cap, which is located in the Applicator. The user inserts the Applicator into the vagina and deploys the cervical cap at or near the cervix by turning the handle. The Applicator is removed from the vagina and the cervical cap is left for up to five (5) hours to allow sperm to travel through the cervical canal. The user then removes the cervical cap from the vagina using its attached retrieval string and disposes of it. All components of the Béa Applicator are single-use only. The applicator and cervical cap components are non-sterile, while the semen collection container is provided sterile.

The provided FDA 510(k) clearance letter and summary for the Béa Applicator (K242031) describes the device, its intended use, comparison to a predicate device, and summaries of non-clinical and clinical performance testing. However, it does not explicitly state acceptance criteria in a quantitative, measurable format or provide a detailed study that directly proves the device meets such criteria in the way typically expected for AI/diagnostic devices.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device by showing that:

• Its indications for use are similar.
• Its technological characteristics, despite some differences, do not raise new questions of safety and effectiveness.
• Non-clinical and clinical performance testing supports its safety and effectiveness for its intended use.

Therefore, many of the requested points below cannot be directly extracted from the provided text, as they pertain more to studies evaluating the performance of a diagnostic or AI algorithm against specific, predefined performance metrics. The Béa Applicator is a physical medical device for aid to conception, not a diagnostic or AI tool.

Here's an analysis based on the information provided, addressing as many points as possible and noting where information is not available:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for Béa Applicator (K242031)

Given that the Béa Applicator is a physical medical device for aid to conception and not a diagnostic or AI device, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" deviates from what would be expected for software or AI-based devices. For this device, "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device and showing the device performs its intended mechanical and biological functions safely and effectively.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA summary does not present a formal table of acceptance criteria with corresponding performance metrics in a quantitative manner as one might see for diagnostic sensitivity/specificity. Instead, the "acceptance criteria" for this type of device are implicitly met by passing various safety and functional tests and demonstrating successful usability.

2. Sample Size for the Test Set and Data Provenance

• Human Factors Validation Study (US-based):
  • Self-Selection: 68 participants (initial study) + 11 participants (low literacy cohort) = 79 total
  • Label Comprehension & Simulated Use: 15 participants (initial study) + 4 participants (low literacy cohort with revised labeling) = 19 total
  • Actual Use: 26 participants (initial study) + 5 participants (low literacy cohort) = 31 total
• Data Provenance: US-based, prospective ("individuals representing the US population participated"). The study assessed different health literacy levels.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable in the context of this device and study. The human factors and usability studies focused on user interaction, comprehension, and device function, not on expert-adjudicated diagnostic "ground truth." The ground truth for successful actual use (e.g., correct positioning, semen retention, no injury) was observed directly by study personnel or self-reported, not established by experts adjudicating individual cases.

4. Adjudication Method for the Test Set

This information is not applicable. There was no "ground truth" to adjudicate in the typical diagnostic sense. The results of the usability and actual use studies (e.g., successful cap placement, no trauma) appear to be direct observations or user feedback, not requiring an adjudication process for disagreement between multiple assessors.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used to compare the performance of human readers, with and without AI assistance, for diagnostic tasks. The Béa Applicator is a physical device for aid to conception, not a diagnostic tool or an AI-assisted interpretation system.

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

Not Applicable. The Béa Applicator is a physical device, not an algorithm. Its performance is always in conjunction with human use. The performance tests evaluate the device's physical and biological properties (e.g., biocompatibility, semen compatibility, structural integrity) and its usability by intended users.

7. The Type of Ground Truth Used

The "ground truth" for the various tests can be categorized as:

• For Biocompatibility & Shelf-Life: Established scientific standards (ISO 10993) and predefined physical/chemical material specifications.
• For Human Sperm Survival Assay (HSSA): A defined physiological threshold (≥ 80% motility after 24 hours), which acts as a "ground truth" for sperm compatibility.
• For Usability/Actual Use: Direct observation of user actions, comprehension of instructions, and clinical outcomes (e.g., correct positioning, semen retention, absence of trauma/injury) as observed or reported by study participants and investigators.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The device's design is based on engineering principles, material science, and user research.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI/ML model, there is no ground truth establishment for such.

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The FERTI.LILY Conception Cup is indicated for over-the-counter home use. It is for couples who have been unable to conceive naturally and who have received a diagnosis of low sperm immobility or unfavorable vaginal environment. After intercourse, the FERTI.LILY Conception Cup is placed around the cervix. It retains semen near the cervical os (the passage between the vaginal cavity and the uterus) as an aid to conception. The FERTI.LIL Y Conception Cup should be used during the ovulatory phase of the menstrual cycle. The FERTI.LILY Conception Cup should not be left in place for longer than one hour.

The FERTI.LILY Conception Cup is a non-sterile, silicone, over-the-counter (OTC) device for use by couples as an aid to conception that have been unable to get pregnant naturally due to low sperm count, low sperm motility, or an unfavorable vaginal environment. After intercourse, the device is placed in the vagina, the cup-like receptable is deployed using an integrated deployment cord, and the device is positioned over the cervix to physically situate semen near the cervical os. The FERTI.LIL Y Conception Cup can be left in the vagina for a maximum duration of one hour. The FERTI.LILY Conception Cup includes a stem to assist with removal from the vagina.

The provided document describes the FERTI.LILY Conception Cup and studies demonstrating its safety and effectiveness. However, it does not present a formal "acceptance criteria" table with specific quantified performance metrics and how the device explicitly meets them for clinical outcomes. The document focuses on non-clinical performance (biocompatibility, shelf life, reprocessing, use-life) and clinical usability/label comprehension studies.

Therefore, I cannot create a table of acceptance criteria for clinical efficacy from the provided text, as those specific criteria are not explicitly stated for clinical outcomes. The clinical studies primarily assess usability, label comprehension, and successful insertion/removal, rather than a direct measure of conception success compared to a numerical target.

However, I can extract the reported performance from the studies provided and infer the "acceptance criteria" based on the successful outcomes and study goals as described in the text.

Here's the information parsed from the provided text:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not detail specific "test sets" in the context of a machine learning or AI algorithm. Instead, it describes human subject studies. Based on the description:

• Clinical Studies (Test for Usability/Comprehension):
  • First Study: 75 naive subjects enrolled, 74 completed.
  • Second Study: 41 naive subjects completed.
  • Third Study (FCC-001): 15 subjects enrolled.
  • Fourth Study (FCC-002): 15 subjects enrolled, all 15 completed.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study participants. However, it mentions "demographic information representative of the US population" in the conclusion of the clinical studies section, suggesting participants were likely from the US or a population representative of the US. All studies appear to be prospective clinical studies as they involve subject enrollment and active data collection related to device use and comprehension.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The concept of "ground truth" and "experts" as typically seen in AI/ML validation (e.g., radiologist interpreting images) is not directly applicable here. The "ground truth" for the usability and comprehension studies was established by the study design itself and the observation/assessment of subject actions and self-reported understanding.

• In the Third Study (FCC-001) and Fourth Study (FCC-002), a "physician" or "HCP (Health Care Provider)" assessed correct deployment and positioning over the cervical os, semen remaining in the cup, and potential vaginal injury/trauma. The number or specific qualifications (e.g., years of experience) of these HCPs/physicians are not specified.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used when multiple human readers interpret data, and discrepancies need to be resolved. This is not mentioned as part of the usability or comprehension studies described, as they primarily involve objective observation or direct assessment by a single observer (e.g., study staff, physician) of a subject's actions or understanding.

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

No MRMC comparative effectiveness study was mentioned. The studies focused on the performance, usability, and comprehension of the FERTI.LILY Conception Cup itself, not on comparing AI assistance to unassisted human readers, as this is not an AI-driven device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone algorithm performance study was done because the FERTI.LILY Conception Cup is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the studies was primarily based on:

• Observed actions/behavior: Successful insertion, deployment, removal, adherence to instructions.
• Subject self-reporting: Ease of use, satisfaction (FCC-001).
• Direct assessment by HCP/physician: Correct positioning over the cervical os, semen volume, vaginal injury/trauma (FCC-001, FCC-002).
• Defined knowledge endpoints: Correct answers to comprehension questions related to labeling.

8. The Sample Size for the Training Set

The concept of a "training set" is not relevant here as the device is a physical product and not an AI/ML algorithm that requires training data.

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

Not applicable, as there is no training set for this device.

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The Oves Cervical Cap is indicated for use in artificial insemination procedures in situations in which low sperm count, sperm immotility, or hostile vaginal environment have been diagnosed. The Oves Cervical Cap removes scmen from the vaginal environment and concentrates the sperm at the opening of the cervical os, thus facilitating sperm contact with cervical mucosa.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Oves Cervical Cap. This type of document does not typically contain information about acceptance criteria or specific study results showing device performance in the way a clinical study report or a premarket approval (PMA) application summary would.

The letter primarily addresses the substantial equivalence of the Oves Cervical Cap to legally marketed predicate devices and outlines the regulatory requirements, including labeling limitations. It states that the "safety and effectiveness of the Oves Cervical Cap for contraception have not been established." This indicates the device was NOT cleared for contraception, but for "artificial insemination procedures in situations in which low sperm count, sperm immotility, or hostile vaginal environment have been diagnosed."

Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth information, MRMC studies, or standalone performance) from this document. This kind of detail would typically be found in the 510(k) submission itself (which is not publicly available in detail) or a summary of safety and effectiveness if it were a PMA.

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