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The [ SURE™ ] probe cover is intended to be placed on Ultrasound Probes used in natural body orifices such as vagina to facilitate cleaning and sanitization of the probe.

SURE ™ Latex Ultrasonic Probe Cover

This document is a 510(k) clearance letter from the FDA for a medical device called "SURE™ Latex Ultrasonic Probe Cover". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory compliance, not performance metrics derived from a study.

Therefore, I cannot provide the requested information based on this document.

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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 [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 [No varticular 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 [No particular brand name]

The provided text is an FDA 510(k) clearance letter for a Male Latex Condom and does not contain the detailed information required to answer your request regarding acceptance criteria and study particulars for a medical device's performance.

Specifically, the document:

• Approves the device as substantially equivalent to a predicate device.
• Mentions regulatory class, applicable CFR sections, and general controls.
• Discusses labeling requirements for latex condoms, including expiration dating and real-time test data.
• States the Indications For Use.

However, it does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any specific test set.
3. Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
4. The type of ground truth used, training set sample size, or how ground truth was established for a training set.

This type of information is typically found in the 510(k) submission itself (which often includes summary data and test reports), not in the FDA's clearance letter. The clearance letter confirms that the FDA has reviewed the submission and found the device to be substantially equivalent.

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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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When used in accordance with manufacturer's instruction, condoms are effective form of contraception. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital warts, gonorthea, hepatitis B and syphilis.

Not Found

I apologize, but the provided text relates to an FDA 510(k) clearance letter for a "SURE" Condom (Natural Rubber Latex Contraceptive) from 1999. This document does not contain information about the acceptance criteria and study details for a device in the context of modern AI/medical device evaluations as described in your request.

The letter pertains to regulatory clearance for a physical contraceptive product, not an AI-powered diagnostic or therapeutic device. Therefore, I cannot extract the requested information such as test set sample sizes, expert qualifications for ground truth, or multi-reader multi-case studies, as these concepts are not applicable to the content of this document.

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