(328 days)
Glyde Dam Lollyes Mare a thin 10" x 6" natural rubber latex sheet specially designed as a barrier for use while performing cunnilingus (oral/vaginal sex) ONLY, and are not intended for use during oral/anal sex.
Glyde Dam Lollyes™, 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 Glyde Dam Lollyes™ 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.
Glyde Dam Lollyes are manufactured from good quality rubber latex conforming to ASTM 1076-88. The size of each Glyde Dam Lollyes is 10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) by 0.08 millimeters thick (± 0.0006 millimeters.) Glyde Dam Lollyes are designed to be used while performing cunnilingus.
Qualification testing (biocompatibility, tensile strength/elongation, and virus) has been performed to satisfactorily conclude that Glyde Dam Lollyes operate as intended, when used properly. Finally, Glyde Dam Lollyes 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.
This document describes a 510(k) submission for "Glyde Dam Lollyes," a latex dental dam. The submission focuses on demonstrating substantial equivalence to a predicate device (Trojan Brand Latex Condoms) rather than a direct clinical performance study with acceptance criteria for a novel medical device. Therefore, a direct table of acceptance criteria and reported device performance, and information typically associated with a clinical study (sample size, expert ground truth, MRMC study, standalone performance) for an AI/device, are not present in this document.
However, based on the provided text, I can extract information relevant to the device's "acceptance criteria" in the context of a 510(k) submission for substantial equivalence, and the tests performed to support that claim.
Acceptance Criteria and Reported Device Performance (in the context of 510(k) Substantial Equivalence)
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (Glyde Dam Lollyes) | Outcome |
|---|---|---|---|
| Material Conformance | ASTM 1076-88 | Manufactured from good quality rubber latex conforming to ASTM 1076-88 | Met |
| Physical Dimensions | Size: 10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) | 10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) | Met |
| Thickness | Thickness: 0.08 mm (± 0.0006 mm) | 0.08 millimeters thick (± 0.0006 millimeters) | Met |
| Biocompatibility | Acceptable safety profile for human contact | Qualification testing performed | Supportive of claims |
| Tensile Strength/Elongation | Mechanical integrity for intended use | Qualification testing performed | Supportive of claims |
| Virus Barrier | Efficacy as a barrier against viruses | Qualification testing performed | Supportive of claims |
| Surface Smoothness | Absence of cracks and blisters | Tested for smooth surface (i.e.: the presence of cracks and blisters) during manufacturing | Met |
| Visual Inspection | Absence of holes, tears, foreign materials | Visually tested for holes, tears, foreign materials and the like during manufacturing | Met |
Note: The "acceptance criteria" here are aligned with demonstrating substantial equivalence to a legally marketed predicate device (Trojan Brand Latex Condoms) and ensuring the device operates as intended and defined in its description. The "reported device performance" refers to the results of the non-clinical tests conducted.
Study Information (Based on 510(k) Submission)
Given that this is a 510(k) premarket notification for a Class II medical device, the "study" described is a set of non-clinical tests aimed at demonstrating substantial equivalence rather than a traditional clinical trial following AI/diagnostic device protocols.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document** does not specify a discrete "test set" sample size** for biocompatibility, tensile strength/elongation, or virus testing. These tests are generally performed on a representative sample of manufactured devices (e.g., specific lots).
- Data provenance is not explicitly stated beyond the fact that Glyde USA, Inc. performed the testing. It is implied these are prospective tests conducted on their manufactured product.
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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 question is not applicable in the context of this 510(k) submission. The "ground truth" for the non-clinical tests (like material properties or virus barrier) is established by standardized laboratory methods and scientific principles, not by expert human consensus in the way clinical diagnostic ground truth is established.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods are relevant for clinical studies where human interpretation or consensus is required to establish ground truth or resolve discrepancies in findings. The tests described are laboratory-based.
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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 question is not applicable. An MRMC comparative effectiveness study is used for diagnostic devices, particularly AI-driven ones, to assess the impact of the device on human reader performance. Glyde Dam Lollyes is a barrier device, not a diagnostic tool, and has no AI component or human "reading" aspect.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. Glyde Dam Lollyes is not an algorithm or AI-driven device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical tests relied upon were:
- Standardized material specifications (e.g., ASTM 1076-88 for latex).
- Laboratory test methods for physical properties (tensile strength, elongation, dimensions, thickness).
- Virological testing protocols to assess barrier efficacy against viruses.
- Visual inspection criteria for manufacturing defects.
- The "ground truth" for the non-clinical tests relied upon were:
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The sample size for the training set
- This question is not applicable. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established
- This question is not applicable as there is no training set.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.