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Water-based lubricant is intended for penile, vaginal and/or anal application to moisturize and lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubricant. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

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The provided FDA 510(k) clearance letter for the "Water-based Lubricant" device (K250142) does not contain the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a clearance letter, which confirms that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and provides contact information but does not typically include the technical details of performance studies.

Therefore, I cannot extract the following information from the provided text:

1. Table of acceptance criteria and the reported device performance: This information is not present in the clearance letter.
2. Sample size used for the test set and the data provenance: This information is not present in the clearance letter.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present in the clearance letter.
4. Adjudication method for the test set: This information is not present in the clearance letter.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done and any effect size: This information is not present in the clearance letter.
6. If a standalone (algorithm only) performance was done: This information is not present in the clearance letter.
7. The type of ground truth used: This information is not present in the clearance letter.
8. The sample size for the training set: This information is not present in the clearance letter.
9. How the ground truth for the training set was established: This information is not present in the clearance letter.

The clearance letter focuses on the regulatory determination of substantial equivalence, the device's classification, and general regulatory requirements, rather than the specifics of the performance testing. To obtain the requested information, one would need to refer to the actual 510(k) submission document filed by Global Protection Corp. for the Water-based Lubricant.

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Plain water-based lubricant is a water-based lubricant intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Plain Water-based Lubricant

I'm sorry, I cannot fulfill this request. The provided document is an FDA 510(k) clearance letter for a "Plain Water-based Lubricant." This document is a regulatory communication from the FDA to the manufacturer, indicating that the device has been cleared for marketing.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical study methodologies (such as MRMC studies or standalone performance). The letter focuses on regulatory compliance and substantial equivalence to a predicate device, not on detailed performance study results.

Therefore, I cannot extract the requested information about device performance and study details from the provided text.

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The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).

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I apologize, but the provided FDA 510(k) clearance letter for the ONE Nitrile Condom does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found for AI/medical imaging devices.

The document primarily focuses on regulatory approval, substantial equivalence to a predicate device, and general controls for medical devices. It outlines:

• The FDA's determination of substantial equivalence for the ONE Nitrile Condom (K243967).
• Regulatory classifications (Class II, Product Code MOL).
• Applicable regulations (e.g., Quality System regulation, UDI Rule).
• General information about FDA oversight of medical devices.
• The intended use of the device (contraception and STI prevention).

Therefore, I cannot extract the detailed information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) because it is not present in this specific FDA clearance letter for a condom.

These types of details are typically found in regulatory submissions for AI-enabled medical devices or diagnostic tools, which undergo rigorous performance validation studies. A condom, while a medical device, is evaluated based on different performance metrics (e.g., burst strength, freedom from holes, dimensions) that are validated through standard tests rather than AI-specific evaluations.

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The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (ONE Nitrile Condom). This document does not contain the specific information needed to answer your request regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies for a device's performance.

The letter confirms the device's clearance for marketing and provides regulatory information, but it does not delve into the technical validation studies that would include acceptance criteria and performance data.

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Powder-Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder-Free Nitrile Examination Glove

The provided text is a 510(k) summary for a medical device (Powder-Free Nitrile Examination Gloves). It confirms the device's regulatory classification and that it has been deemed substantially equivalent to a predicate device. However, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of performance metrics that would typically apply to an AI/ML or diagnostic device.

The regulatory review for these gloves focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through adherence to established standards for examination gloves (e.g., physical properties, barrier integrity, biocompatibility). The document does not describe a performance study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies that would be relevant to the questions posed.

Therefore, I cannot provide the requested information based on the input text. The questions asked are generally applicable to the validation of AI/ML-based medical devices or diagnostic tools, not to a Class I non-powdered patient examination glove.

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Intended for barrier protection during procedures of endocavity ultrasound examination and diagnosis to help prevent transfer of microorganism, body fluids and particulate material.

Natural Rubber Latex Ultrasound Transducer Probe Covers

The provided text is an FDA 510(k) clearance letter for a medical device: "Natural Rubber Latex Ultrasound Transducer Probe Covers." This document does not contain information about acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria.

The submission is for a physical medical device (ultrasound probe covers), not an AI/ML software device. Therefore, the questions regarding AI/ML device performance, ground truth, expert consensus, and training/test sets are not applicable to the content provided.

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The ONE Male Condom is used for contraception to help reduce the risk of pregnancy during vaginal intercourse and for prophylactic purposes to help reduce the transmission of sexually transmitted infections (STIs) during vaginal or anal intercourse. The ONE Male Condom should be used with a condom compatible lubricant when used for anal intercourse.

The ONE Male Condom is a natural rubber latex sheath that completely covers the penis. The condom is straight walled with a reservoir tip and is silicone lubricated. The ONE Male Condom is available in 56 sizes and consists of three different condom types, standard, thin, and fitted.

This document provides information about the acceptance criteria and supporting studies for the ONE Male Condom.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ONE Male Condom are based on various performance aspects, primarily referencing ISO 4074-15 and ASTM D3492-16. The reported device performance consistently met these criteria.

2. Sample Size for Test Set and Data Provenance

• Sample Size (Clinical Study - Test Set):
  • Enrollment: 252 MSM (men who have sex with men) and 252 MSW (men who have sex with women) were enrolled.
  • Sex Acts Analyzed: 4,884 total anal or vaginal sex acts using study condoms (2,351 anal intercourse acts, 2,533 vaginal intercourse acts).
  • Condom Samples: Each participant received 5 of each of the three condom types (standard, thin, fitted), totaling 15 condoms per participant. The "n" in the clinical failure table denotes the number of sex acts performed with each condom type.
  • Bench Testing: 125 samples of each proposed size for dimensional analysis, water leak, airburst, and freedom from holes testing.
• Data Provenance: Retrospective, conducted in Atlanta, Georgia at two sites of the Rollins School of Public Health at Emory University. The clinical study results were published in 2019 in the E Clinical Medicine Journal.

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

The provided text does not explicitly state the number of experts used to establish ground truth for the clinical study test set or their specific qualifications (e.g., radiologist with 10 years of experience).

• Ground Truth Establishment: The primary endpoint, total clinical failure (slippage, breakage, or both), was assessed through a self-administered electronic daily coital diary completed by the study participants. This indicates that the "ground truth" for clinical failure was largely based on participant self-reporting, not independent expert review of individual events.
• Study Investigators: While study investigators were involved in training participants and collecting information during biweekly visits, their role in establishing the "ground truth" for each specific failure event is not detailed beyond overseeing the data collection process. Participants and investigators were blinded to condom assignment.

4. Adjudication Method for the Test Set

The primary outcome of clinical failure (slippage, breakage, total clinical failure) was determined by self-reported data from electronic daily coital diaries completed by the participants. There is no mention of an independent adjudication method (e.g., 2+1, 3+1) for the reported clinical failure events.

• The study design followed ISO 29943-1:2017 Condoms - Guidance on clinical studies - Part 1: Male Condoms, clinical function studies based on self-reports.

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

No. This was not a multi-reader multi-case comparative effectiveness study. It was a clinical study evaluating the performance of the condom directly, not an AI-assisted detection or diagnosis device that would involve human readers. Therefore, there is no information about the effect size of human readers improving with AI vs without AI assistance.

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

Yes, a form of standalone performance was assessed through bench performance testing (dimensional analysis, water leak, airburst, freedom from holes, visible defects) where the device's physical properties were directly evaluated against specified static criteria. The clinical study, while involving human use, evaluated the device's performance directly and the "algorithm" here is the physical condom itself, without a human-in-the-loop for interpreting results.

7. Type of Ground Truth Used

• Clinical Study: The ground truth for clinical failure events (slippage, breakage) was established through participant self-report via an electronic daily coital diary. Adverse event rates were also self-reported.
• Bench Studies: The ground truth for bench performance was based on objective measurements against established standards (ISO 4074-15, ASTM D3492-16) for physical properties like dimensions, airburst pressure/volume, and freedom from holes.
• Biocompatibility: Ground truth was based on standardized in-vitro and in-vivo biological tests (e.g., MEM Elution Test, Guinea Pig Maximization, Vaginal Irritation Test, Acute Systemic Toxicity).

8. Sample Size for the Training Set

The concept of a "training set" as typically understood in AI/ML (machine learning) is not directly applicable here as this is a physical medical device, not a software algorithm being trained on data.

However, if "training set" refers to data used to inform the design and manufacturing of the condom, the context mentions:

• The device is identical in material composition and manufacturing to condoms cleared in K081886, K122219, K141059, and K150072. This implies a large historical manufacturing and testing dataset that "trained" the understanding of condom properties.
• Biocompatibility and bench performance testing leveraged data from these previously cleared condoms.

Therefore, while not a formal "training set" for an algorithm, the underlying knowledge base for the device's design and material properties is extensive, derived from a history of manufacturing and testing.

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

Again, in the context of a physical medical device, not an AI/ML model, the "ground truth" for the knowledge base that underpins the ONE Male Condom's design and manufacturing (analogous to a training set) was established through:

• Adherence to International Standards: The device conforms to ISO 4074-15 and ASTM D3492-16, which are established standards based on extensive research and consensus regarding condom safety and performance. These standards define the "ground truth" for acceptable physical properties and performance.
• Historical Data and Prior Clearances: Leverage of data from four previously cleared condom submissions (K081886, K122219, K141059, K150072). This means that previous rigorous testing (clinical, bench, biocompatibility) on structurally and materially identical condoms established the "ground truth" for their safety and effectiveness, which is now being applied to the ONE Male Condom.
• Manufacturing Experience: The accumulated manufacturing experience for these identical devices contributes to the understanding of consistent product quality and performance parameters.

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The Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

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I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving a device meets any such criteria.

The document is an FDA 510(k) clearance letter for a "Male Latex Condom" (K203536). It states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. It also outlines regulatory requirements such as registration, labeling, and good manufacturing practices. The "Indications for Use" section specifies that the condom is for contraception and prophylactic purposes.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance
• Sample sizes and data provenance
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Training set sample size and ground truth establishment

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Non-spermicidal Lubricated Male Latex Condoms are intended to prevent pregnancy, HIV/AIDS and other sexually transmitted infections.

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The provided document is a 510(k) clearance letter from the FDA for a Non-spermicidal Lubricated Male Latex Condom. This type of device is subject to performance standards and does not typically involve the kind of AI-driven performance criteria, ground truth studies, or human-in-the-loop assessments described in your request. Your request is tailored for an AI/ML medical device, which this product is not.

Therefore, I cannot extract the information you requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI-specific performance metrics from this document because it is not relevant to a condom.

The document primarily focuses on:

• The device being substantially equivalent to a legally marketed predicate device.
• Compliance with general controls provisions of the Act (e.g., registration, labeling, good manufacturing practices).
• Indications for Use (preventing pregnancy, HIV/AIDS, and other STIs).
• Classification as an Over-The-Counter device.

To provide the information you're looking for, I would need a document related to an AI/ML-based medical device.

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The (no particular brand name) condom, is intended to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. In addition, if properly used, it can reduce the risk of pregnancy.

Non-spermicidal Lubricated male Latex Condom

The provided text is a scanned letter from the FDA regarding the 510(k) clearance for a "Non-spermicidal Lubricated male Latex Condom". It outlines the regulatory status and requirements for such devices.

However, the provided document does not contain any information about acceptance criteria for a device, nor does it describe any study (clinical or otherwise) that proves the device meets specific acceptance criteria.

The document primarily focuses on:

• The FDA's decision of "substantial equivalence" for the device based on a 510(k) submission.
• Regulatory requirements for marketing the device, including general controls, specific regulations like 21 CFR 801.435 for condom labeling and expiration dating, and Good Manufacturing Practice (GMP).
• The "Indications for Use" statement for the condom.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and a study from this document. The prompt asks for details about a study, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, none of which are present in these pages.

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