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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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MedGyn IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.

MedGyn straight IUI, mini IUI, and curved, mini IUI catheters are used for intrauterine insemination for delivery of washed spermatozoa through the cervical os. The straight IUI is composed of a 21.4 cm length tube with subparts consisting of a polyethylene tube connecting with a polypropylene tube. The outer diameter of the polyethylene tube is 2.1 mm. That of the polypropylene tube is 2.75 cm. The tube is connected proximally to an ABS connector for attachment to a syringe. The mini IUI is exactly the same as the straight IUI except that the outer diameter of the inner polyethylene tube is 1.6 mm. The curved, mini IUI is exactly the same as the mini IUI except that it is slightly curved at its distal tip.

The provided text describes a 510(k) premarket notification for MedGyn IUI Catheters, asserting their substantial equivalence to a predicate device. The information primarily focuses on demonstrating that the new device does not raise different questions of safety and effectiveness, rather than providing a detailed study proving the device meets specific acceptance criteria in terms of efficacy or performance metrics typical for AI/software devices.

The document discusses various performance tests conducted to support the safety and shelf life of the device, which are physical properties rather than AI model performance metrics.

Here is a breakdown of the requested information based on the provided text, acknowledging that many fields will be "N/A" due to the nature of this medical device (a catheter) as opposed to a software or AI device.

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in terms of number of catheters or tests, but tests were "conducted on each version of the MedGyn IUI catheters." For biocompatibility tests, specific animal (rabbits, guinea pigs) and cell assays were used, but the exact number of samples or runs is not detailed.
• Data Provenance: Not explicitly stated, but assumed to be from internal lab testing conducted by MedGyn Products, Inc. or their contracted labs. Not applicable to country of origin, retrospective or prospective in the context of clinical data for AI.

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

• Number of Experts: Not applicable. The ground truth for these physical and biological tests (e.g., cytotoxicity, endotoxin levels, sperm motility) is established through standardized laboratory assays and objective measurements, not expert human interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. The tests are objective laboratory assays with defined pass/fail criteria, not subjective interpretations requiring adjudication.

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

• MRMC Comparative Effectiveness Study: No. This is a physical medical device (catheter), not an AI/software device that would involve human readers or AI assistance.

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

• Standalone Performance: No. This is not an algorithm or AI device.

7. The type of ground truth used

• Type of Ground Truth: The ground truth for the performance tests mentioned (biocompatibility, sterility, sperm survival, stability) is based on objective laboratory measurements and standardized assay results (e.g., USP <85> for endotoxin, ASTM F1980-07 for accelerated aging, microscopic evaluation for cytotoxicity).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

Summary based on the Provided Text:

The document describes the regulatory submission for IUI catheters, focusing on physical and biological safety testing to demonstrate substantial equivalence to a predicate device. It is not an AI or software-as-a-medical-device (SaMD) submission, so many of the requested criteria (like MRMC studies, AI performance metrics, training sets, and expert adjudication for nuanced interpretations) are not relevant to this document. The "studies" mentioned are laboratory tests designed to ensure device safety, biocompatibility, and functionality according to established medical device standards.

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The Stork® OTC 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 Stork® OTC contains a cervical cap inside a condom-like silicone sheath. It is used to collect semen into a cervical cap then deliver it to the outside of the cervix as an aid to conception. The Stork® OTC should be used during the ovulatory phase of the menstrual cycle. The Stork® OTC Cervical Cap should not be left in place for longer than six hours.

The Stork® OTC package includes: one Instructions for Use, one Conceptacle® and one plastic applicator. Once the couple has decided to attempt to become pregnant, the Stork® OTC Conception System Instruction for Use recommends using the device during female's most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle®, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle® from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cap is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervix. When the cervical cap is loaded onto the applicator (while it is still outside of the body), the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intra-vaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.

The provided text describes "The Stork® OTC," a conception assistance kit, and studies conducted to support its over-the-counter (OTC) use.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the exact sample size for the self-selection, labeling comprehension, simulated use, or clinical human factors/usability studies. It states "All primary endpoints were achieved in all three sections of the study" and "All subjects were able to use the device." Without specific numbers, the sample size remains unknown from the provided text.
• Data Provenance: The studies were described as "Performance Testing - Clinical" and "Performance Testing - Bench." These were conducted prospectively to demonstrate the device's suitability for over-the-counter use and safe application by lay users. The country of origin for the studies is not explicitly stated, but given the context of a 510(k) submission to the FDA, it's highly likely they were conducted in the United States.

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

• For the clinical human factors/usability testing where safety was assessed, it states: "These endpoints were verified by visual inspection and physical examination by the primary investigator." This indicates at least one expert (the primary investigator) was involved in establishing safety ground truth.
• Qualifications of the expert(s): The qualifications of the primary investigator are not explicitly detailed beyond being a "primary investigator" for a clinical study involving physical examination. It can be inferred they are a medical professional, likely a physician or gynecologist, qualified to conduct such examinations and verify safety endpoints related to the vaginal tract and cervical os.

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

• The document does not detail any specific adjudication method like 2+1 or 3+1 for the user studies or the primary investigator's findings. The verification appears to have been carried out by the "primary investigator" directly. Therefore, it implicitly suggests a "none" or "single expert review" adjudication for the clinical safety aspects. For user performance, the "correctness" of actions was likely directly observed and recorded.

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 (conception kit), not an AI-powered diagnostic tool requiring human reader interpretation of images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Not applicable. As stated above, this is a physical medical device and does not involve an algorithm. The testing focused on the standalone performance of users correctly applying the device without professional medical supervision.

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

• For Usability and Safety: The ground truth was primarily established through direct observation of user performance (for correct steps) and physical examination by a primary investigator (for safety endpoints like trauma/injury). This constitutes a form of expert assessment of physical outcomes.
• For Biocompatibility and Mechanical Testing: The ground truth was established through laboratory testing against established ISO standards and internal specifications (e.g., ISO 10993-1: 2009 for biocompatibility, specific pull strength measurements).

8. The sample size for the training set:

• The document does not mention a training set for the device's studies. The studies described are performance testing (self-selection, comprehension, simulated use, clinical human factors/usability, bench testing), which are typically considered validation or verification tests rather than training data for a device or algorithm.

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

• Not applicable, as no training set for the device's studies is mentioned in the provided text.

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The Focus Touch Conception System is indicated for assisted insemination in instances where low sperm count, sperm immobility, or hostile vaginal environment has been diagnosed. The system (cervical cap in a condom-like silicone sheath) is used to collect semen into a cervical cap, and then deliver the cap to the outside of the cervix as an aid to conception. It is to be used at home following physician instruction. The Focus Touch Conception System should not be left in place for longer than 6 hours.

The Focus Touch™ Conception System includes detailed Instructions for Use, one Conceptacle and one plastic applicator. The system can be purchased packaged in a quantity of one (1) or three (3) individually packaged systems.

Once the couple has decided to attempt to become pregnant, the Focus Touch™ Conception System Instruction for Use recommends using the device during female's most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cao is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervical cap is loaded onto the applicator (while it is still outside of the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intravaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.

The provided text describes the Focus Touch™ Conception System and its substantial equivalence to a predicate device. It details various aspects of the device and the testing performed, but it does not provide acceptance criteria in a quantitative format or a comprehensive study report with detailed performance metrics. The information is primarily focused on demonstrating equivalence through comparison and summary of tests.

Here's an attempt to extract and synthesize the requested information based on the provided text, acknowledging where specific details are missing:

Acceptance Criteria and Device Performance for Focus Touch™ Conception System

The provided documentation focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with explicit quantitative acceptance criteria and detailed performance results. The "performance" is largely reported as successful completion of specific tests, indicating the device met the implicit requirements for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission, precise numerical acceptance criteria and corresponding reported device performance for clinical effectiveness are not provided. Instead, the document outlines types of tests performed and their successful completion for demonstrating safety and functionality.

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • No specific numerical sample sizes are provided for the usability studies or bench testing, except that "all systems tested" met the pull strength requirement.
  • For the HSSA, the description "human sperm must demonstrate..." refers to the criterion for the test rather than the number of samples or subjects used in the actual test itself.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they involved active testing (bench, HSSA, usability studies).

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" for these tests relates to measurable physical or biological properties (biocompatibility, sperm motility, burst strength) or observable user behavior/feedback (usability studies), rather than expert interpretation of medical images or patient records. The "experts" would likely be laboratory technicians for bench tests or study coordinators/medical professionals for usability, but their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. The tests described are primarily objective (e.g., measuring burst pressure, checking for cytotoxicity) or involve direct observation/user feedback that doesn't typically require an adjudication method like 2+1 or 3+1.

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

Not applicable. This device is a physical medical device (conception assistance kit), not a diagnostic algorithm that would typically undergo an MRMC study. The study focuses on the device's physical and functional properties, biocompatibility, and usability.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is not an algorithm, but a physical device.

7. Type of Ground Truth Used

The "ground truth" for the tests mentioned includes:

• Laboratory-measured properties: Biocompatibility (cytotoxicity, irritation, sensitization), HSSA (sperm motility), mechanical properties (burst pressure, pull strength).
• User feedback/observation: For usability (comfort, ease of use, ability to manipulate and remove).
• Physical examination: To verify safety to the vaginal tract in Usability Study 1.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm requiring a "training set."

9. How Ground Truth for Training Set Was Established

Not applicable. As above, this is not an AI/ML device.

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The Sagami Polyurethane Semen Collection Device is intended to be used as an accessory to the Oves Cervical Cap to collect semen for transfer to the cap prior to insertion in artificial insemination procedures.

The subject device is a polyurethane condom.

Here's the analysis of the provided text regarding the acceptance criteria and study for the Conceivex Latex-free Semen Collector:

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results. Instead, it relies on a qualitative assessment of "no deleterious effects" compared to predicate devices.

Study Details

1. Sample size used for the test set and the data provenance:

   • Human Sperm Survival Assay: Not specified.
   • Mouse Embryo Assay: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here refers to the biological assays (sperm survival, embryo development) which are scientific measurements rather than expert interpretations.

3. Adjudication method for the test set: Not applicable. This concept typically applies to studies where human reviewers assess data against a standard, not to laboratory assays.

4. 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: Not applicable. This study focuses on the biological safety of a device material, not on AI-assisted diagnostic effectiveness.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical semen collector, not an algorithm.

6. The type of ground truth used:

   • Human Sperm Survival Assay: Biological assay measuring sperm viability/function.
   • Mouse Embryo Assay: Biological assay measuring embryo development.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI-driven device, so there is no training set in the conventional sense.

8. How the ground truth for the training set was established: Not applicable, as there is no training set. The "ground truth" for the testing (assays) was established through scientific measurement in laboratory conditions.

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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.

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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The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures utilizing washed spermatozoa.
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.

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This document is a 510(k) premarket notification decision letter from the FDA for several Intrauterine Insemination (IUI) and GIFT catheters manufactured by Gynétics Medical Products N.V.

Based on the provided text, there is no information about acceptance criteria or a study proving that the device meets those criteria.

The document primarily focuses on:

• Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This is a regulatory determination, not an assessment of performance against pre-defined acceptance criteria from a study described in this document.
• Regulatory Information: It details the regulation numbers, product codes, regulatory class, and general controls provisions of the Act that apply to the device.
• Marketing Authorization: It states that the letter allows the applicant to begin marketing their device.
• Indications for Use: It lists the intended uses for three specific devices:
  • IUI #4220: For intra uterine artificial insemination procedures utilizing washed spermatozoa.
  • Smooze #4225: For intra uterine artificial insemination procedures utilizing washed spermatozoa.
  • Seminor #4502: For intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. This type of information would typically be detailed in the 510(k) submission itself, not in the FDA's decision letter.

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The Delphin is to be used for embryo transfer and intra uterine insemination procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.

Emtrac Catheters are to be used for embryo transfer procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.

Semtrac Sets are to be used for embryo transfer procedures for in Semilac Sets are to be acount. In the substition technology (ART) procedures.

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I am sorry but this document is a 510(k) clearance letter from the FDA, not a study report. It states that the referenced medical devices (Emtrac, Delfin, and Semtrac Embryo Transfer and IUI Catheters) are substantially equivalent to legally marketed predicate devices.

Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Information on experts used for ground truth or adjudication methods.
• Details on MRMC comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets or how ground truth for training sets was established.

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As the Select IUI® (predicate device), TheCurve™ (new device) is a single use, sterile, disposable, flexible catheter designed to be used for intrauterine artificial insemination.

TheCurve, such as the Select IUI, comprises a long clear polyethylene tube that is tightly surrounded on three quarters of its proximal length by an outer, clear polypropylene sheath. This leaves 4.5 cm of the inner polyethylene tube exposed at the distal end of the device. The proximal inner tube and outer sheath circumferences are molded directly onto the distal end of a luer lock hub so that only the lumen of the inner tube can provide a channel for flow. This design results in a single-channel catheter with two segments each having different degrees of flexibility. The extreme distal tip of TheCurve™ is open as compared to the extreme distal tip of the Select IUI® which is closed and has two side openings. Both TheCurve and Select IUI have six (6) coloured graduation markings placed at 5, 6, 7, 8, 9, and 10 cm distance from the extreme distal tip of the catheter. The distal portion of TheCurve is curved while the distal portion of the Select IUI is straight.

The provided text describes a 510(k) submission for a medical device called "TheCurve™," an intrauterine insemination catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the "Select IUI®."

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly state "acceptance criteria" in a quantitative sense as might be found in a performance study with defined thresholds (e.g., minimum sensitivity, specificity). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on design, materials, function, and intended use. The "performance" is implicitly deemed acceptable if the device is found substantially equivalent to the already approved predicate.

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

The documents do not describe a formal "test set" or a study with human subjects (clinical trial) to evaluate the device's performance against specific acceptance criteria. This submission is a 510(k) for substantial equivalence based on device comparison and technical specifications, not a clinical performance study. Therefore, there's no sample size or data provenance in the context of a clinical test set.

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

Not applicable. As no clinical study or performance evaluation with a "ground truth" was conducted or reported, no experts were involved in establishing such ground truth for a test set. The "truth" in this submission relies on the comparison of engineering specifications and intended use to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was used.

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

Not applicable. This device is a manual medical instrument (an intrauterine insemination catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI performance is irrelevant.

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

Not applicable. This device is a manual medical instrument and does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and established safety and effectiveness of the predicate device (Select IUI®). The new device, TheCurve™, is compared against the predicate's specifications and intended use.

8. The Sample Size for the Training Set

Not applicable. Since there's no algorithm involved, there is no "training set."

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

Not applicable. Since there's no algorithm involved, there is no "training set" or ground truth for it.

In summary:

This 510(k) submission relies on a "benchmarking" or "comparison" approach rather than a clinical performance study with a defined test set and acceptance criteria. The "acceptance criteria" are implicitly met if the FDA determines the new device is substantially equivalent to the predicate device in terms of safety and effectiveness, despite some minor physical differences that are argued to either have no impact or slightly improve usability (e.g., curved tip for easier insertion). The evidence provided is primarily a detailed technical comparison of the new device with the legally marketed predicate device.

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