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

The Latex Condom for Men is a single-use, non-sterile condom made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is designed to conform to the standards including ASTM D3492 and ISO 4074. The condoms have either a smooth, dotted, or ribbed surface and have a straight walled nipple-end (SWNE) style within ASTM standard specifications D3492 Table 1 requirements, e.g., minimum length 160 mm, maximum width 54mm, and minimum thickness of 30μM.

The provided text describes a 510(k) premarket notification for a medical device: "Latex Condom for Men." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets individual acceptance criteria through a clinical trial or a multi-reader, multi-case study, which are typical for AI/CADe devices.

Therefore, the requested information elements related to AI/CADe studies (e.g., sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document as it pertains to a physical medical device (condom) and its regulatory approval based on material and performance standards.

However, I can extract the acceptance criteria and performance data that are presented in the context of this device.

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

The device's performance is demonstrated through adherence to recognized standards and specific physical properties. The acceptance criteria are implicit in the "Specification" column for the physical parameters and explicit in meeting the relevant ISO and ASTM standards.

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

This information is not provided in the document. The document refers to "non-clinical tests" but does not specify sample sizes or data provenance for these tests. It indicates the location of the manufacturer (Zhejiang, China) and the correspondent (Shanghai, China).

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 is not applicable as this is not a study requiring expert readers for ground truth determination, but rather laboratory testing against physical and chemical standards.

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

This is not applicable. The "tests" mentioned are non-clinical, laboratory-based evaluations of the condom's material properties and physical dimensions against established international 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

This is not applicable. This document is for a physical medical device (condom), not an AI/CADe device that involves human readers or AI assistance.

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

This is not applicable. This document is for a physical medical device (condom), not an algorithm or software device.

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

The "ground truth" for this device's performance is based on established international and national standards and specifications for natural rubber latex condoms (e.g., ASTM D3492-16, ISO 4074:2015, ISO10993 series for biocompatibility). The device's physical properties and material safety are evaluated against these objective, quantifiable criteria.

8. The sample size for the training set

This is not applicable. This document is for a physical medical device (condom) and does not involve AI or machine learning algorithms that require training sets.

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

This is not applicable. This document is for a physical medical device (condom) and does not involve AI or machine learning algorithms that require training sets with associated ground truth.

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Nulatex Natural Male Latex Condom is used for contraception and prophylactic purposes. (To help prevent pregnancy and transmission of sexually transmitted infection)

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The provided document is an FDA 510(k) premarket notification approval letter for a male latex condom. It does not contain information about the acceptance criteria and study data for a medical device's performance characteristics beyond the general statement of substantial equivalence to predicate devices.

Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document. This kind of information is typically found in the submission package that precedes the approval letter, which is not provided here.

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

Male Latex Condom. (No Particular Brand Name) Natural Smooth, Natural Ribbed, Natural Studded(Dotted), Natural 3 in 1, Natural ultrathin, Pink Smooth, Pink Ribbed, Pink Studded(Dotted),Pink 3 in 1, Pink Ultrathin with/or without Strawberry flavored.

The provided text is a 510(k) substantial equivalence determination letter from the FDA for a Male Latex Condom. It does not contain information about acceptance criteria, device performance, or a study report as typically found in submissions for AI/ML-powered medical devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document only confirms that the device is substantially equivalent to legally marketed predicate devices for contraception and prevention of sexually transmitted infections.

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

Male Natural Rubber Latex Condom Straight side or Contoured or Flared in Shape, either Textured or Non-textured, Lubricated or Non-lubricated, Non-color or Colored and Flavored or Non-flavored

The provided text is a 510(k) premarket notification approval letter for a male natural latex condom. It does not contain information about the acceptance criteria and study proving device performance as typically expected for an AI/ML medical device. This document is a regulatory approval for a physical medical device (condom), not a software or AI-based device, and therefore the requested information categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set) are not applicable.

The letter confirms that the device, a "Male Natural Latex Condom," is substantially equivalent to legally marketed predicate devices for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). This substantial equivalence determination is based on the device meeting established performance standards for condoms, which are physical tests rather than AI/ML performance metrics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding studies in the context of an AI/ML device, because this document pertains to a traditional medical 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 )

Latex Condom with Dotted/Ribbed Surface and Contour-walled Shape

This document describes a 510(k) premarket notification for a "Latex Condom with Dotted/Ribbed Surface and Contour-walled Shape" and does not contain information related to an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving the device meets those criteria, as typically found in submissions for such AI-driven devices.

The document is a clearance letter from the FDA, confirming substantial equivalence of a condom product to existing legally marketed devices. It primarily discusses regulatory compliance, labeling requirements, and the intended use of the condom for contraception and prevention of sexually transmitted diseases. There is no mention of any AI or machine learning components associated with this 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).

Male Latex Condom with Ribbed Surface (No Particular Brand Name)

The provided document is a 510(k) clearance letter for a medical device (male natural rubber latex condom with ribbed surface) and does not describe or contain information about a study to prove the device meets acceptance criteria. It primarily focuses on the FDA's determination of substantial equivalence based on the provided indications for use and regulatory compliance.

Therefore, I cannot provide the requested information for the following reasons:

1. No acceptance criteria or device performance data is presented. The letter does not detail specific performance metrics, thresholds, or results from any tests.
2. No study is described. The document is a regulatory approval letter, not a scientific study report. It states that the device is substantially equivalent to legally marketed predicate devices but does not elaborate on the data or studies supporting this claim in terms of performance metrics.

To answer your request, a document detailing the actual performance testing, results, and acceptance criteria used by the manufacturer (Pleasure Latex Products SDN.BHD.) for their condom would be required. This letter only signifies that the FDA has reviewed the manufacturer's submission (which would have included such data) and deemed it sufficient for market clearance.

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The Qingdao Shuang 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, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip, and is designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074, and EN 600. This condom is lubricated with silicone.

The provided document describes a 510(k) Notification for a Male Latex Condom and discusses its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria.

The 510(k) summary mentions that the device is "designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074, and EN 600." It also states "This condom has the same technological characteristics as the predicate condom identified above. The design of both products conforms with ASTM Latex Condom Standard D3492 and the condom is made of natural rubber latex."

Based on this, the acceptance criteria would be those defined within these standards, and the study proving compliance would involve testing the condom's physical properties against the requirements of these standards. However, the specific results of such tests, sample sizes, ground truth establishment, or expert involvement are not detailed in this document.

Therefore, I cannot populate all the requested sections with information directly from the provided text. I will indicate where information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified in the provided document.
• Data provenance: Not specified in the provided document. Testing against standards would typically involve prospective testing of manufactured batches.

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

• This type of information (number and qualifications of experts) is not typically relevant for the performance testing of a physical product like a condom against established engineering standards. The ground truth would be based on the objective measurements and specifications defined in the standards themselves.

4. Adjudication method for the test set

• Not applicable as the assessment is against objective physical standards, 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

• Not applicable. This is not a diagnostic device involving human reader interpretation or AI.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used

• The ground truth for device performance would be the objective specifications and limits outlined in the referenced voluntary standards (ASTM D3492, ISO 4074, EN 600) for male latex condoms. These standards define acceptable ranges for physical properties (e.g., burst volume, burst pressure, tensile strength, dimensions, freedom from holes).

8. The sample size for the training set

• Not applicable. This is not a machine learning model; thus, there is no "training set."

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

• Not applicable. This is not a machine learning model; thus, there is no "training set."

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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).

Male Natural Rubber Latex Condom with Vanilla Flavor, 56 mm width

The provided text is a 510(k) clearance letter from the FDA for a male latex condom. It discusses the regulatory classification, general controls, and labeling requirements for the device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or MRMC studies for AI devices.

Therefore, I cannot provide the requested information based on the given input. The document is for a medical device (a condom), not an AI/ML powered device.

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