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The BANANA Ribbed 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 natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has smooth surface on the body, curve-sided, reservoir ended, straight six ribbed line at closed end, nominal length, width, thickness condoms with an integral bead at the open end.

This document is a 510(k) summary for a male natural rubber latex condom. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of medical imaging software or AI. Instead, it describes the device, its intended use, and its substantial equivalence to predicate devices based on existing standards for rubber contraceptives.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document focuses on regulatory approval for a condom, not the performance of an AI or software-driven medical device.

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The Double Springers Nonoxynol 9 condom, is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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The provided text is a letter from the FDA to Medtech Products Limited regarding the substantial equivalence of their "Double Springers Nonoxynol 9 Lubricated Condom." This document is an FDA clearance letter and does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it meets the regulatory requirements for marketing. However, it does not describe the specific performance characteristics or the studies conducted to demonstrate those characteristics.

Therefore, I cannot provide the requested table and study details based on the given input.

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The Double Springers condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.

The provided text is a 510(k) summary for a natural rubber latex condom. It does not contain any information about a study with acceptance criteria and device performance data for an AI/ML powered device.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, type of ground truth, or training set information.

The document discusses the device's proprietary name ("Double Springers"), common name ("Latex Condom"), classification, and intended use for contraception and prophylactic purposes. It also mentions that the condom design conforms with ASTM Latex Condom Standard D 3492 and is a patented design (US Patent No: 5,836,308) with a special design to enhance acceptability.

The FDA's letter (pages 2-3 of the provided text) confirms the substantial equivalence of the "Double Springers" condom to legally marketed predicate devices, allowing it to proceed to market. It also provides guidance on labeling requirements for latex condoms regarding expiration dating.

In summary, this document is for a traditional medical device (latex condom) and does not involve AI/ML technology or studies related to its performance against acceptance criteria in an AI/ML context.

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Mighty Man (Dynamic Linkers) condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.

The provided text is a 510(k) summary for a latex condom, and it does not contain any information about acceptance criteria, device performance studies (beyond conformance to ASTM D 3492), or details about ground truth, sample sizes, or expert adjudication specific to an AI/ML device.

Therefore, I cannot fulfill your request for the specific information regarding an AI/ML device's acceptance criteria and studies from this document. This document is related to a traditional medical device (condom) and its premarket notification to the FDA to demonstrate substantial equivalence to a predicate device.

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The Love Lockers condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. Instead, the document is a 510(k) summary for a "Latex Condom" called "Love Lockers," outlining its classification, predicate device, description, intended use, and technological characteristics. It also includes an FDA clearance letter for the device.

Therefore, I cannot provide the requested table, sample sizes, expert information, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information as this data is not present in the provided text.

Ask a specific question about this device