Search Results

Sheer Glyde Dams™ are a thin 10" x 6" natural rubber latex sheet specially designed as a barrier for use while performing cunnilingus (oral/vaginal sex) or anilingus (oral/anal sex [rimming]).

Sheer Glyde Dams™, when properly used, may help reduce the risk of catching or spreading many Sexually Transmitted Diseases ("STDs") such as syphilis, gonorrhea, chlamydia infections, genital herpes, and AIDS; however, they cannot eliminate the risk.

During intimate contact, lesions and various bodily fluids can transmit STDs. Therefore, the Sheer Glyde Dams™ should be applied each and every time before any such contact occurs.

WARNING: DO NOT USE DURING PENETRATING PENILE/VAGINAL OR PENILE/ANAL INTERCOURSE.

WARNING: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS IN SOME INDIVIDUALS. IF YOU EXPERIENCE A REACTION, STOP USING THIS PRODUCT AND CONTACT YOUR PHYSICIAN.

Sheer Glyde Dams™ are manufactured from good quality rubber latex conforming to ASTM 1076-88. The size of each Sheer Glyde Dams™ is 10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) by 0.08 millimeters thick (+ 0.0006 millimeters.) Sheer Glyde Dams™ are designed to be used while performing either cunnilingus or anilingus.

Qualification testing (biocompatibility, tensile strength/elongation, and virus) was previously performed to satisfactorily conclude that Sheer Glyde Dams™ operate as intended, when used properly. Finally, Sheer Glyde Dams™ are tested for a smooth surface (i.e.: the presence of cracks and blisters,) and are visually tested for holes, tears, foreign materials and the like, during the manufacturing process of each lot.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sheer Glyde Dams™:

The provided document is a 510(k) summary for the Sheer Glyde Dams, specifically relating to an addition to the indications for use (anilingus) rather than a de novo submission. As such, the information presented focuses on demonstrating substantial equivalence to the previously cleared device, not on proving initial effectiveness. Therefore, many standard study elements for proving device performance via clinical trials or extensive non-clinical testing for a new device are absent.

I will populate the table and answer your questions based only on the information available in the provided text. Many fields will be marked as "Not applicable" or "Not provided" because the document describes a change in indication for an already cleared device, not the initial approval of a new device.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not provided. The document states "Qualification testing (biocompatibility, tensile strength/elongation, and virus) was previously performed," implying these tests were done for the original 510(k) clearance, not specifically for this submission which adds an indication. No sample sizes are specified for any of these tests in this document.
   • Data Provenance: Not provided. The document does not specify the country of origin of any test data. The tests were "previously performed" which implies they are retrospective relative to this 510(k) submission.

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

   • Not applicable/Not provided. The document describes non-clinical performance and material testing, not a study involving expert-established ground truth for a diagnostic or screening device.

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

   • Not applicable/Not provided. This type of adjudication method is relevant for studies involving human interpretation or challenging cases, which is not described here.

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:

   • No. An MRMC study was not done. The device is a physical barrier (latex dam), not an AI-assisted diagnostic tool.

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

   • Not applicable. The device is a physical product, not an algorithm. The "standalone" performance refers to the device's inherent physical and biological barrier properties, which were part of the "qualification testing" for biocompatibility, tensile strength/elongation, and virus testing.

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

   • For the physical and barrier properties, the "ground truth" would be established by standardized laboratory testing methods (e.g., ASTM standards for material properties, lab protocols for virus barrier testing).
   • For the claim of reducing STD risk, the ground truth is based on the known barrier properties of latex, similar to condoms, where the intended use (as a barrier) is understood to reduce risk, rather than demonstrating 100% prevention through direct outcomes data for every STD.

7. The sample size for the training set:

   • Not applicable/Not provided. There is no "training set" as this is not a machine learning or AI device.

8. How the ground truth for the training set was established:

   • Not applicable/Not provided. No training set exists for this type of device.

Summary of the Document's Focus:

The provided 510(k) summary is for a change in the indications for use of an already cleared device. The core argument for substantial equivalence is that the product itself (Sheer Glyde Dams™) is identical to its predicate, and the new indication (anilingus) is simply an extension of its established barrier function, which was supported by previous "qualification testing" (biocompatibility, tensile strength/elongation, and viral barrier). The document explicitly states: "No additional testing is required as a result of the addition of the new indication for use. Testing is supportive of the new claim..." and "This new indication for use does not raise new issues of safety and effectiveness."

Ask a specific question about this device