Search Results

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 205mm, nominal flat width 57mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dression material. This condom is designed to conform to established. national and international voluntary standards including ASTM D3492 and ISO 4074.

This document is a 510(k) summary for a male latex condom, focusing on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the context of an AI/ML device.

Therefore, many of the requested elements (1-9) which are relevant to studies proving a device's performance against specific acceptance criteria (especially for AI/ML or diagnostic devices) are not directly applicable or available in this submission for a medical device like a condom.

However, I can extract the information that is present concerning the device's conformance to standards, which serves as its "acceptance criteria" and "proof of meeting these criteria" in this specific context.

Here's the breakdown based on the provided text, with explanations for why certain fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission focuses on conformance to existing standards and demonstrating substantial equivalence to a predicate device based on material, design, and manufacturing process similarities, rather than a clinical trial or performance study with a "test set" in the sense of AI/ML or diagnostic device evaluation. Condom performance is typically evaluated through standardized physical tests (e.g., burst strength, leakage, dimensions) which are inherent to the ASTM and ISO standards it claims conformance with, but specific sample sizes for these tests are not provided in this 510(k) summary.

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

• Not Applicable. See explanation for point 2. No "ground truth" in the clinical or diagnostic sense is established by experts here. Conformance to standards is the primary "verification."

4. Adjudication method for the test set

• Not Applicable. See explanation for point 2.

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 a medical device (condom), not an AI/ML diagnostic or assistive technology.

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

• Not Applicable. This is a medical device (condom), not an AI/ML algorithm.

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

• Conformance to established national and international voluntary standards (ASTM D3492 and ISO 4074). The "ground truth" here is adherence to engineering and material specifications defined by these standards, along with documented material and manufacturing similarities to a previously cleared device.

8. The sample size for the training set

• Not Applicable. See explanation for point 2. This device doesn't involve a "training set" in the context of AI/ML.

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

• Not Applicable. See explanation for point 2.

Ask a specific question about this device

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.

Ask a specific question about this device

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 lubricated with silicone containing one of five flavors (strawberry, mint, vanilla, banana, or chocolate) and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

This is a 510(k) premarket notification for a medical device, which generally does not include detailed study reports or acceptance criteria tables in the same way a scientific publication or a PMA would. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness through extensive new clinical trials.

Based on the provided text, here's what can be extracted and inferred regarding acceptance criteria and supporting information:

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

The document states that the condom is designed to conform to established national and international voluntary standards, specifically ASTM D3492 and ISO 4074. While the document doesn't provide a direct table of acceptance criteria from these standards or the specific reported device performance values against each criterion, it asserts conformance.

For a latex condom, key performance criteria typically covered by these standards include:

• Physical Integrity (Burst Pressure and Volume): To ensure the condom does not break under intended use.
• Dimensions (Length, Width, Thickness): To ensure proper fit.
• Freedom from Holes: To prevent leakage.
• Tensile Properties (Elongation at Break, Tensile Strength): To confirm material strength and elasticity.
• Shelf Life/Stability: To ensure performance over time (though 510(k) typically defers to a separate labeling requirement for expiration dating, as noted in the FDA letter).

Since the submission is an Abbreviated 510(k), it relies on the consensus standards. The "reported device performance" is implicitly stated as "conforming" to these standards.

                                                                                            | "The design is in conformance with ASTM Latex Condom Standard D3492."

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

The document does not specify the sample size for any testing, the country of origin of the data, or whether the testing was retrospective or prospective. Such details are typically found in the full test reports referenced by the 510(k), but not included in this summary.

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)

This question is not applicable to this device submission. This device is a male latex condom, not an AI or diagnostic imaging device that involves expert interpretation or ground truth establishment in that context. The "ground truth" for a condom is its physical performance meeting specified engineering standards.

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

Not applicable, as this is not a study involving human readers or interpretation 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

Not applicable. This is not an AI or diagnostic device that would involve MRMC studies.

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

Not applicable. This is not an algorithm-based device. "Standalone performance" for a condom refers to its physical characteristics and integrity, which are tested against the consensus standards.

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

The "ground truth" for this device pertains to its physical and functional properties. These are established through performance testing against recognized national and international consensus standards (ASTM D3492 and ISO 4074). These standards define the acceptable performance parameters (e.g., minimum burst pressure, maximum number of holes allowed per batch).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

Ask a specific question about this device

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, nominal thickness 0.06mm and colored pink, yellow, green or black. It is lubricated with silicone and cornstarch is used as a dressing material. 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) Notification for a Male Latex Condom and does not contain information about a medical device that utilizes AI, nor does it detail a study with the specific criteria requested (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance).

The information in the document pertains to the regulatory submission for a physical medical device (a latex condom) and focuses on its substantial equivalence to a predicate device based on manufacturing standards and material properties, rather than performance metrics from a clinical study as would be relevant for an AI-powered device.

Therefore, I cannot fulfill the request to provide acceptance criteria and study details for an AI-powered device from the given text.

However, based on the information provided, I can construct a table of acceptance criteria and reported device performance related to the physical specifications and regulatory compliance of the latex condom as described in the 510(k) summary.

Acceptance Criteria and Reported Device Performance (Based on Latex Condom Specifications)

Regarding the specific questions about an AI device study:

1. A table of acceptance criteria and the reported device performance: See the table above for the physical device specifications. There is no information for an AI device.
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI device.
4. Adjudication method for the test set: Not applicable. This is not an AI device.
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 an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used: For a physical condom, "ground truth" would be the measured physical properties and adherence to manufacturing standards (e.g., length, width, thickness, burst strength, freedom from holes, packaging integrity). The document states conformance to ASTM D3492 and ISO 4074.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

Ask a specific question about this device

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, nominal thickness 0.06mm and is colored. It is lubricated with silicone containing flavoring, and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

The provided document is a 510(k) summary for a male latex condom, which is a medical device. However, it does not contain information about a study that proves the device meets acceptance criteria in the way that would typically be presented for an AI/software as a medical device (SaMD).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (LS Rubber Latex Condom; K020633) by showing that the new condom has the same intended use and technological characteristics and conforms to established voluntary standards (ASTM D3492 and ISO 4074). The acceptance criteria for medical devices like condoms are usually based on these established voluntary standards, which specify physical properties and performance requirements.

Therefore, I cannot directly answer your request in the format you provided for an AI/SaMD study. I will extract the relevant information regarding the device's conformance to standards, which serves as its "acceptance criteria" in this context, and explain why the other requested fields are not applicable.

Acceptance Criteria and Device Performance for UNIDUS Male Latex Condom

1. Table of Acceptance Criteria and Reported Device Performance

Explanation Regarding Other Requested Information:

The other requested information (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance, training set details) is not applicable to this 510(k) submission for a physical medical device like a condom. These fields are typically relevant for AI/Software as a Medical Device (SaMD) where performance is evaluated based on algorithm output against a ground truth established by experts or other definitive methods, often using large datasets of patient cases.

For this condom, "device performance" is assessed by physical and mechanical testing as per the referenced standards, not by an AI algorithm's diagnostic accuracy. The 510(k) process for such devices relies on demonstrating substantial equivalence and compliance with recognized consensus standards, rather than a clinical study comparing AI performance.

The submission states: "The design is in conformance with ASTM Latex Condom Standard D3492 and that the condom is made of natural rubber latex." This statement indicates that the device has undergone testing (e.g., burst tests, sterility tests, leakage tests) as specified by these standards, and the results met the requirements laid out in those standards. The 510(k) summary doesn't detail these specific test results but asserts compliance.

Ask a specific question about this device

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 lubricated with silicone and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

This document describes the 510(k) notification for a Male Latex Condom and does not contain information about an AI/ML powered device. Therefore, it is impossible to extract the requested information regarding acceptance criteria and studies related to AI/ML device performance.

The document provides details about:

• The manufacturer and contact information
• Device description (male latex condom, natural latex, straight-walled, reservoir tip, specific dimensions, lubricated with silicone, cornstarch as dressing material)
• Intended use (contraception and prophylaxis against STDs, including HIV)
• Technological characteristics (conformance with ASTM Latex Condom Standard D3492 and ISO 4074)
• Predicate device (Thai Nippon Condom; K982380)
• FDA's substantial equivalence determination for marketing the device
• Labeling requirements for latex condoms, specifically regarding expiration dating (21 CFR 801.435)

Since the request is specifically about acceptance criteria and studies for an "AI device," and this submission is for a physical medical device (a condom), the requested information cannot be provided from the given text.

Therefore, I cannot fulfill the request as the provided document does not pertain to an AI/ML powered device.

Ask a specific question about this device