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This [MULTIPLE BRAND] latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for male natural rubber latex condoms. It indicates that the device has been found substantially equivalent to a legally marketed predicate device for contraception and prophylactic purposes.

The document discusses:

• The trade name of the device and its classification.
• The regulatory framework for medical devices.
• The intended use of the condom.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any study.
3. Details about experts or ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. The type of ground truth used.
8. Training set sample sizes or ground truth establishment for a training set.

Therefore, I cannot answer your request based on the provided input.

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The Power Stick Male Latex Condom is used for controptive fic fower belen cric purposes (to help prevent pregnancy and for prophylaction of sexually transmitted diseases).

This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. These two types of condoms, ribbed and dotted-ribbed, are at a nominal length of 170mm., a nominal width of 52 mm (±2mm) and are at a nominal thickness of .06 mm (±.02 mm).

The provided text describes a 510(k) premarket notification for a male latex condom device, not an AI/ML powered device. Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or present in this document.

The document focuses on demonstrating substantial equivalence to a predicate device by conforming to established standards for male latex condoms.

Here's an analysis based on the provided text, using the closest applicable information:

Acceptance Criteria and Reported Device Performance

Study Information (as applicable to a physical device/510(k))

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "All physical testing and final release testing," which implies that a sample of manufactured condoms would have been tested against the specified standards. The provenance of this testing data (e.g., in-house testing by the manufacturer or third-party lab) is not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device like a condom, "ground truth" is established by physical measurement and testing against international and domestic standards, not by expert consensus in an observational or diagnostic context.
3. Adjudication method for the test set: Not applicable. The testing would involve objective measurements (e.g., length, width, thickness, burst pressure tests as per standards) rather than subjective interpretation requiring adjudication.
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 is a physical medical device, not an AI/ML diagnostic or assistive technology.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used: The "ground truth" for this device's performance would be the specifications outlined in the referenced standards (ASTM D3492, ISO 4074, EN 600) and the device's own design specifications (e.g., nominal length, width, thickness). These standards define acceptable ranges for various physical properties and performance characteristics (e.g., integrity under stress, lubricity).
7. The sample size for the training set: Not applicable. There is no "training set" in the context of a physical device like a condom. Manufacturing processes are refined through engineering and quality control, not machine learning training.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) submission for a conventional male latex condom, demonstrating conformance to recognized standards for physical devices. It does not contain the types of studies or data relevant to AI/ML powered devices.

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This latex condom has the same intended use as the predicate condoms. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a parallel sided, teat ended, lubricated condom and is designed to conform to national and international voluntary standards, including ISO 4074, EN600 and ASTM D3492.

The provided text describes the Durex studded/ribbed Latex Condom Premarket approval [510(k)], but it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document states: "The Durex latex condoms conforms to the ASTM D3492, ISO 10993 and ISO 4074:2002 standards, except were variances are noted. Conformance to these standards is described on the following pages." and "All physical testing and final release testing revealed results in conformance with required specifications."

However, these "following pages" or the "required specifications" that would detail the specific acceptance criteria (e.g., burst pressure, freedom from holes, length, width) and the results of the studies performed to meet those criteria are not included in the provided text.

Therefore, I cannot fulfill your request for the detailed table and study information based on this input.

To answer your request, the following information would be needed from the full 510(k) submission:

• Specific acceptance criteria: The numerical thresholds for each physical and performance test outlined in ASTM D3492, ISO 10993, and ISO 4074:2002 that the device must meet.
• Reported device performance: The actual test results obtained for the Durex studded/ribbed Latex Condom against each of those specific criteria.
• Details of the study/testing methodology: This would include information on sample size, data provenance, and how ground truth was established, if applicable for the specific tests conducted (e.g., burst pressure, holes, dimensions).

Without this specific content from the mentioned "following pages," any attempt to fill in the table and study details would be speculative and not based on the provided document.

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Condoms are latex sheaths, intended to completely cover the penis during sexual intercourse for contraception and prophylaxis, an aid to the prevention of sexually transmitted diseases (STDs). If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.

Caution Condoms - Male latex condoms lubricated, with and without Nonoxynol-9

This document is a 510(k) clearance letter for "Caution Condoms - Male latex condoms, lubricated, with and without Nonoxynol-9." It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or performance evaluation document for a diagnostic or AI-based device.

The letter confirms that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device's indications for use and general controls, rather than a specific performance study against defined acceptance criteria in the manner requested.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and performance study details from this document. The document primarily concerns regulatory clearance for a medical device (condoms) based on substantial equivalence, not a detailed performance study with specific metrics, sample sizes, or ground truth establishment relevant to the provided questions.

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Durex latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

This condom is made of a natural rubber colored latex sheath, which completely covers the penis with a closely fitted membrane. This device is a parallel sided, teat ended, flavored condom and is designed to conform to national and international voluntary standards, including ISO 4074, EN600 and ASTM D3492. The condom is offered in Chocolate, Chocolate/coconut. Chocolate/peppermint, and Chocolate/orange.

This 510(k) submission for the Durex Flavored Latex Condom does not contain the detailed study information typically found for AI/ML-based diagnostic devices. This is a premarket approval for a physical medical device (condom) and therefore, the acceptance criteria and study design are related to manufacturing standards and physical performance tests, rather than algorithmic performance.

However, I can extract the relevant information based on the typical requirements for such devices, even if it's not presented in the same format as for an AI study.

Here's a breakdown of the information based on your request, applied to the context of a latex condom:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in a typical AI/ML sense but rather refers to manufacturing quality control.

• Sample Size: Not explicitly stated as a single "test set" sample size. Condoms are produced in large batches, and statistical sampling methods (e.g., AQL - Acceptable Quality Level) are used for quality control testing of physical attributes from each batch. The actual number of condoms tested would depend on the batch size and the specific testing protocol (e.g., for burst tests, freedom from holes).
• Data Provenance: The testing is implied to be conducted by the manufacturer, SSL Americas, and its manufacturing partners (LS Rubber SDN and Thai Nippon Rubber Industry). It's a prospective internal quality control process during and after manufacturing.

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

In this context, "experts" are not human readers interpreting images, but rather the recognized standards bodies and material scientists/engineers who established the test methods and performance specifications for condoms.

• Number of Experts: Not applicable in the sense of AI ground truth. The "ground truth" for condom quality is defined by the established national and international standards (ISO, EN, ASTM).
• Qualifications of Experts: These standards are developed by committees of material scientists, engineers, medical professionals, and regulatory experts.

4. Adjudication Method for the Test Set

Not applicable in the sense of AI human reader adjudication. Product conformance to specifications is determined directly by objective physical and chemical tests against predefined limits set by the standards.

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 as this is a physical medical device, not an AI/ML-based diagnostic or assistive technology. There are no "human readers" interpreting "cases" with or without "AI assistance."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. There is no algorithm being tested. The device is a standalone physical product.

7. The Type of Ground Truth Used

The ground truth is based on established national and international voluntary standards for latex condoms (e.g., ISO 4074, EN 600, ASTM D3492) regarding physical properties, material composition, and performance. In addition, FDA regulation 21 CFR 801.435 defines the ground truth for expiration dating.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for physical manufacturing of condoms. The manufacturing process itself is akin to a "training" process, where continuous monitoring, process controls, and adjustments are made to ensure consistent product quality, but it's not a dataset in the AI sense.

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

Not applicable. As above, there's no "training set." The "ground truth" for manufacturing quality is established by adhering to Good Manufacturing Practices (GMP) and the quality control parameters derived from the aforementioned international standards and internal specifications.

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The UNIDUS Condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is either lubricated with silicone or non-lubricated; with cornstarch as a dressing material, and Benzocaine (an over-the-counter drug generally recognized as safe and effective by the USFDA) placed inside the condom for desensitizing the male genitals. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

The provided text describes a 510(k) submission for a male latex condom. It mostly focuses on the regulatory process, the device's description, and its intended use, rather than a detailed study proving the device meets specific acceptance criteria in the way a medical imaging AI device study would.

Therefore, for many of the requested points, the information is not available in the provided document. I will fill in what can be inferred and state when information is not present.

Acceptance Criteria and Device Performance

The core of the acceptance criteria for this device (a male latex condom) is compliance with established national and international voluntary standards. The document specifically mentions ASTM D3492 and ISO 4074. While it doesn't provide a table of performance against specific measurable criteria within these standards, the statement "The design is in conformance with ASTM Latex Condom Standard D3492 and the condom is made of natural rubber latex" implies that the device meets the criteria outlined in these standards.

Note: The document states the device "is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074." It then explicitly states "The design is in conformance with ASTM Latex Condom Standard D3492." The actual performance data (e.g., burst pressure, leakage, tensile strength tests specified by these standards) is not included in this summary but would have been part of the full 510(k) submission.

Study Details

1. Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The evaluation is focused on adherence to standards rather than a clinical trial with a "test set" in the context of an AI device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a condom, "ground truth" is typically defined by adherence to manufacturing specifications and performance standards, not expert interpretation of diagnostic images.
3. Adjudication method for the test set: Not applicable.
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 is not an AI device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device (male latex condom), the "ground truth" would be the device meeting the physical and material specifications outlined in the applicable standards (ASTM D3492, ISO 4074). This would involve laboratory testing for properties like burst strength, freedom from holes, dimensions, etc.
7. The sample size for the training set: Not applicable. This is not an AI device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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The Kwikeze Male Condom Applicator facilitates correct positioning (donning) of a male latex condom prior to sexual intercourse. The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

The Kwikeze™ Male Condom Applicator is an elliptical ring made of polyethylene plastic. When packaged, the applicator is collapsed on self-scored lines in a manner that allows the condom to be loosely positioned within the inner-folds of the ring. The collapsed applicator is held in position with a polyurethane band. The condom is stretched slightly to position it on top of the applicator. This configuration allows the condom to rest un-stretched until time of use. After opening the sealed foil package, and prior to use, the band is removed allowing the ring and condom to expand to its original oval shape. The device when pulled opened expands the attached condom enough to allow for easy insertion and correct positioning of the condom on the erect penis.

This document is a 510(k) summary for the Kwikeze™ Male Condom Applicator. It's a pre-market notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The document does not contain specific acceptance criteria or an explicit study proving the device meets those criteria, as such detailed performance data is typically not required for a 510(k) submission unless an entirely new technological principle is involved.

For devices like a condom applicator, the substantial equivalence relies more on demonstrating that the new device does not raise new questions of safety or effectiveness compared to the predicate, and that it performs as intended without compromising the function of the condom itself. The key elements presented are:

• Intended Use: The Kwikeze™ applicator facilitates correct orientation and donning of a male condom for contraception and prophylactic purposes, similar to the predicate device.
• Technological Characteristics: It's a single-use polyethylene plastic ring. Condoms used with it must have 510(k) clearance and conform to ASTM Latex Condom Standard D3492. This emphasizes that the primary safety and effectiveness of the condom itself is established separately, and the applicator's role is ergonomic.

Given the nature of the device and the 510(k) summary, the document does not include detailed clinical study data with acceptance criteria for performance metrics like sensitivity, specificity, or reader agreement, which are typically found in submissions for diagnostic or more complex therapeutic devices.

Therefore, many of the requested fields cannot be directly answered from the provided text.

Here's an attempt to fill in the table and information based on the provided text, noting where information is not available due to the nature of a 510(k) for this type of device:

1. Table of acceptance criteria and the reported device performance

"The study that proves the device meets the acceptance criteria"

The provided document does not describe a specific study with quantitative data to demonstrate meeting acceptance criteria in the typical sense of a clinical trial for a diagnostic or therapeutic device. Instead, the 510(k) process for a device like this relies on demonstrating "substantial equivalence" to a predicate device based on:

1. Similar intended use.
2. Similar technological characteristics impacting safety and effectiveness.
3. Meeting recognized standards (e.g., ASTM for condoms used with the applicator).
4. Not raising new questions of safety or effectiveness.

The FDA's letter of "substantial equivalence" (K031007) is the primary "proof" that the device is deemed safe and effective for its intended use, based on the information provided in the 510(k) submission, which would include descriptions of the device, its function, materials, and comparison to the predicate. The 510(k) summary provided here is a high-level overview.

Detailed Information (as far as available from the text):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Available. The document does not describe a test set or specific performance data from a study. As a condom applicator, its primary safety and effectiveness are tied to whether it aids in correct condom placement without damaging the condom or harming the user. Such assessment might involve usability testing or non-clinical verification, but details are not provided here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable / Not Available. There is no mention of a "test set" requiring ground truth established by experts in the context of this 510(k) summary.

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

   • Not Applicable / Not Available. No test set or adjudication method is described.

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 is not relevant to a condom applicator, which is a physical medical device, not an AI-assisted diagnostic tool.

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

   • Not Applicable. This is not an algorithmic device.

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

   • Not Available. No formal "ground truth" as typically defined for diagnostic performance is mentioned. The ground truth for this type of device would likely be its ability to correctly apply a condom without tearing or misplacement, and this would be assessed through usability and non-clinical testing rather than expert-adjudicated clinical cases.

8. The sample size for the training set

   • Not Applicable / Not Available. The document does not describe a training set for an algorithm.

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

   • Not Applicable / Not Available. The document does not describe a training set for an algorithm.

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The Mercator male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. The condom has either a smooth or textured (dotted and/or ribbed) surface. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

Here's an analysis of the provided text regarding acceptance criteria and study details for the Mercator Male Latex Condom:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list a table of acceptance criteria with corresponding performance data from a specific study. Instead, it states that the device's design "is in conformance with ASTM Latex Condom Standard D3492" and "ISO 4074." These standards inherently contain acceptance criteria for various condom properties (e.g., burst strength, leakage, dimensions).

Therefore, the table below represents the implied acceptance criteria based on the referenced standards and the device's claim of conformance. The "Reported Device Performance" is inferred from the device's substantial equivalence claim and compliance with these standards.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the studies that demonstrate conformance to ASTM D3492 and ISO 4074. The submission primarily relies on the claim of conformance to established voluntary standards.

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

This information is not applicable or not provided in the context of this 510(k) notification. The evaluation of condom performance against standards like ASTM D3492 and ISO 4074 typically relies on standardized laboratory testing protocols, not expert consensus on individual "cases" in the medical sense.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or diagnostic results by human readers to establish a "ground truth" when a gold standard is not immediately available. For a device like a condom, performance is assessed through objective physical and material testing against predefined criteria in standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess improvements in diagnostic accuracy. It is not relevant for a male latex condom.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, a standalone "algorithm only" study was not conducted or mentioned. This concept applies to AI/ML software as a medical device (SaMD) where the algorithm performs a diagnostic or predictive task without direct human intervention. This device is a physical medical device (condom), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance, as established by its conformance to ASTM D3492 and ISO 4074, is based on objective, standardized physical and mechanical test results. For example:

• Physical Testing: Water leakage tests, burst pressure and volume tests using specialized equipment.
• Dimensional Measurements: Using calipers or other precision measuring tools.
• Material Analysis: Ensuring the material is natural rubber latex.

These tests are the "ground truth" for determining if the condom meets the performance requirements of the standards.

8. The Sample Size for the Training Set

This information is not applicable or not provided. "Training set" refers to data used to train an AI/ML algorithm. This device is a physical product, not an AI/ML system.

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

This information is not applicable or not provided for the reasons stated above (not an AI/ML device).

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The [No particular brand name] condom is used for contraception and for prophylactic purposes ( to help prevent pregnancy and the transmission of sexually transmitted diseases).

[No Particular Brand Name] Colored and/or Flavored Male Natural Rubber Latex Condom, 52mm or 56mm Nominal Width with Smooth or Dotted or Ribbed or 3 in 1 ( Dotted / Ribbed / Contoured) Surface Lubricated with Silicone Oil or Nonoxynol-9 Spermicide.

This document is a 510(k) clearance letter from the FDA for a conventional medical device (male latex condoms), not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics (like MRMC studies, standalone performance, ground truth for training data, etc.) is not applicable to this document.

The document discusses the substantial equivalence of the "Colored and Flavored Male Latex Condom (No Particular Brand Name)" to legally marketed predicate devices and mentions general controls provisions and specific labeling requirements for latex condoms (e.g., expiration dating per 21 CFR 801.435). However, it does not contain the kind of detailed study reports or performance metrics typically found for AI/ML device submissions.

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The LifeStyles, Contempo or private label Male Latex Condom with Desensitizing Lubricant is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. Additionally, the male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condom should be applied before any such contact.

These condoms are male contraceptive and prophylactic devices fabricated of natural rubber latex with lubricant containing Benzocaine, an over-the-counter drug generally recognized as safe and effective by the U.S. FDA as a male genital desensitizer (21 CFR Part 348 - External Analgesic Drug Products for Over-the-Counter Human Use). The condoms are designed as fitted sheaths with an integral ring at the open end and a reservoir at the closed end to contain semen. These condoms are designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074 and EN 600.

The provided text is a 510(k) summary for a male latex condom with a desensitizing lubricant. It discusses the device's description, intended use, and technological characteristics, and includes the FDA’s response letter. However, it does not contain any information about specific acceptance criteria or the results of a study designed to prove the device meets such criteria.

The document states that the condoms are "designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074 and EN 600." While these standards include performance requirements for condoms, the specific acceptance criteria (e.g., burst pressure, freedom from holes) the sponsor used for this particular submission are not listed, nor are the results of any testing against these criteria presented in this summary.

Therefore, I cannot provide the requested information in a table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details from the text provided.

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