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The Durex 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 condom is nipple-ended with minimal dimensions of Width: 52 mm, Length: 160 mm min., Thickness: 0.03 mm min.

This document is a 510(k) summary for a Durex Lubragel Male Latex Condom and does not contain information about the acceptance criteria or a study proving that a device meets those criteria. It is a notification of intent to market a medical device, asserting substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table and study details.

Here's why the provided text doesn't contain the requested information:

• Type of Document: This is a 510(k) premarket notification. Its primary purpose is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not to present a comprehensive study proving specific performance acceptance criteria for a novel device.
• Focus on Equivalence: The document explicitly states that the device "has the same technological characteristics as the predicate device," "has the same dimensions, the same physical properties, is manufactured on identical manufacturing equipment utilizing the same raw materials and formulation." The only difference noted is the substitution of an alternative lubricant.
• No Performance Study Details: There is no mention of a performance study with a test set, ground truth, experts, or sample sizes. The claim for the device's performance relies on its similarity to the predicate device and conformance with ASTM standards.
• No AI Component: The request specifically asks about "human readers improve with AI vs without AI assistance" and "standalone (i.e. algorithm only without human-in-the-loop performance)." This document describes a physical medical device (a condom) and has no AI component.

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The Durex 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 condom is nipple-ended with minimal dimensions of Width: 52 mm, Length: 160 mm min., Thickness: 0.03 mm min.

This document is not a study; it is a 510(k) premarket notification for a medical device. A 510(k) submission demonstrates that a device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials. Therefore, the information requested in the prompt regarding acceptance criteria, study design, and performance metrics is not directly applicable or available within this type of regulatory document.

However, based on the provided text, I can infer some aspects related to "acceptance criteria" through the lens of substantial equivalence and identify what is being presented as "device performance."

Here's an interpretation based on the 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k), "acceptance criteria" are not performance metrics in the clinical sense, but rather a demonstration that the new device shares the same fundamental scientific technology and intended use as the predicate device, and any differences do not raise new questions of safety or effectiveness. The "device performance" in this context refers to the characteristics that maintain substantial equivalence.

• Length: 160 mm min.
• Thickness: 0.03 mm min.
  The document states it has "the same dimensions" as the predicate. |
  | Material: Same as predicate device (natural rubber latex). | "made of a natural rubber latex sheath." |
  | Manufacturing Process & Quality Program: Same as predicate. | "manufactured on identical manufacturing equipment utilizing the same raw materials and formulation." "The same Quality Program is in effect." |
  | Differences from Predicate: Any differences do not raise new questions of safety or effectiveness. | The only difference is "the substitution of an alternative lubricant (non-spermicidal)." The submission implies this change does not raise new questions of safety or effectiveness, as it received 510(k) clearance. |
  | Labeling Compliance: Adherence to specific labeling regulations for latex condoms, including expiration dating (21 CFR 801.435). (Note: This is post-submission guidance, not pre-market performance data). | Though not explicitly "criteria" for the substantial equivalence determination, the FDA letter informs the applicant that "labeling for latex condoms... must comply with User Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435." This requires supporting test data for expiration dates (though not submitted in the 510(k)). This is a crucial post-market compliance "acceptance." |

For the remaining points, the information explicitly requested (sample sizes, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is typically found in dedicated performance studies or clinical trials, which are not part of this 510(k) submission.

Regarding the specific questions:

2. Sample sized used for the test set and the data provenance: Not applicable. This document does not describe a clinical study or a test set in the sense of performance evaluation. It refers to "test data developed under the conditions specified in 801.435(d)" for expiration dating, but provides no details on sample size or provenance for this data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no test set or ground truth established by experts described in this regulatory submission.

4. Adjudication method for the test set: Not applicable. No test set requiring adjudication 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 a condom, not an AI-assisted diagnostic or imaging device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a performance study for this device. The "ground truth" for substantial equivalence is primarily the legally marketed predicate device's characteristics and the relevant ASTM standards.

8. The sample size for the training set: Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable.

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A latex rubber condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and the spread of sexually transmitted diseases.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding the clearance of Durex Colors and Scents Latex Rubber Condoms (K980174). It does not contain information about acceptance criteria, study details, or performance data for a device in the manner requested by your prompt (e.g., sample sizes, expert qualifications, ground truth, or MRMC studies).

The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the indications of preventing pregnancy and the spread of sexually transmitted diseases. However, it does not provide the specific technical acceptance criteria or the study data that would demonstrate how the device meets such criteria.

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An examination glove is a disposable device intended for medical purposes "An examinon Eroro is a carperation or finger to prevent contamination between patient and examiner."

Regent™ Safetex™ Sterile Latex Medical Examination Glove, Powder-Free,Less than 50mcg/gram Total Protein

This document is a 510(k) clearance letter from the FDA for a medical device: Regent™ Safetex™ Sterile Latex Medical Examination Glove, Powder-Free, Less than 50mcg/gram Total Protein.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is primarily an FDA letter clearing the device for market based on substantial equivalence to a predicate device. It defines the product and its intended use, but it does not detail any performance studies, test results, or the methodologies used to establish such results.

Therefore, I cannot provide the requested information based on the provided text.

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A Latex Rubber Condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and spread of sexually transmitted diseases.

Latex Rubber Condom

I am sorry, but the provided documents (FDA 510(k) clearance letters and "Indications For Use" forms) do not contain the specific information required to answer your request regarding the acceptance criteria and the study that proves a device meets those criteria.

These documents are primarily concerned with the regulatory clearance of the Durex® Ultra Comfort Latex Rubber Condoms, establishing substantial equivalence to a predicate device, and outlining its intended "Indications For Use."

The detailed information you are asking for, such as:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study details
6. Standalone performance
7. Type of ground truth used
8. Training set sample size
9. How ground truth for the training set was established

...would typically be found in the premarket notification (510(k) submission itself, which includes detailed testing protocols, results, and often references to specific standards (e.g., ISO standards for condoms). The clearance letters only provide a summary of the FDA's decision based on that submission.

Therefore, I cannot provide an answer based on the given text.

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A latex condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and spread of sexually transmitted diseases.

Rubber Latex Condom (Magnesium and Calcium Carbonate Finishing agents

This document is an FDA 510(k) clearance letter for Durex® Latex Condoms, not a study evaluating acceptance criteria for a medical device. Therefore, I cannot extract the requested information as it is not present in the provided text.

The document indicates that the device (Durex® Latex Condoms) was found substantially equivalent to devices marketed prior to May 28, 1976. Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device. This process does not typically involve the detailed acceptance criteria and study data often found in premarket approval (PMA) applications or clinical trials.

The text provided in the prompt is an FDA clearance letter and an "Indications for Use" statement, not a scientific study report. Therefore, it does not contain information about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The primary information conveyed is the FDA's regulatory decision regarding market clearance for the Durex® Latex Condoms based on substantial equivalence.

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