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Lorals are used as a barrier when engaging in oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.

Lorals are wearable, single-use, natural rubber latex oral dams that are placed over the vagina and/or anus during oral sexual contact. Lorals are designed similar to underwear, with a region that covers the genital region and a waistband to keep the dam in place, all made from natural rubber latex. The dams are available in two designs, Shortie and Bikini, which provide the same coverage of the genital region, but have different waistband heights, based on user preference. Each design is available in 3 different gusset sizes. The dams are scented with vanilla fragrance and are provided in black only.

The provided text describes a 510(k) premarket notification for a medical device called "Lorals," which are oral dams. This submission is for demonstrating substantial equivalence to a predicate device, not for proving an AI device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for an AI device is not applicable to this document.

However, I can extract the information related to the performance testing conducted for the Lorals device, which can be thought of as "acceptance criteria" for a non-AI medical device in the context of demonstrating substantial equivalence.

Here's the relevant information:

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

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

• Sample size: Not explicitly stated. The document mentions "Performance testing was performed on the subject device per the FDA recognized standard ISO 29942:2011" and similar for biocompatibility. These standards typically specify sample sizes, but the exact numbers used for Lorals are not in this summary.
• Data provenance: Not specified. It's bench testing, so it's not patient data and would be prospective in nature.

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

• Not applicable. This relates to a human-in-the-loop or AI evaluation, which is not described for this device. The testing is laboratory-based physical and biocompatibility testing.

4. Adjudication method for the test set:

• Not applicable. This relates to interpretation of clinical data by multiple experts, which is not relevant here.

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 an AI device.

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

• Not applicable. This is not an AI device.

7. The type of ground truth used:

• For physical properties (tensile strength, tear resistance, freedom from holes, dimensions, etc.): Objective measurements defined by the ISO 29942:2011 standard.
• For biocompatibility: Laboratory test results evaluated against the criteria established in the ISO 10993 series of standards.

8. The sample size for the training set:

• Not applicable. This section is for an AI device.

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

• Not applicable. This section is for an AI device.

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The SancDam™ Latex Oral Dam is used as a barrier when engaging in oral/vaginal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.

The SancDam™ Latex Oral Dam are rectangular shaped, non-porous, intact polymer films made of natural rubber latex that are placed over the vagina or anus during oral sexual contact. The dam is used as a physical barrier to cover the external female genitalia or the anal area. The SancDam™ has a smooth surface on both sides. The size of the SancDam™ is 155 mm (± 5 mm) by 254 mm (± 5 mm) by 0.07 mm (± 0.02 mm). The SancDam™ available in 4 different flavors and colors versions as listed below: Pink Strawberry, Green Mint, Yellow Vanilla, Purple Grape.

This document is a 510(k) Premarket Notification for the SancDam™ Latex Oral Dam. It outlines the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, the device in question is a Latex Oral Dam, which is a physical barrier used during oral/vaginal and oral/anal sex to reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.

The document does not describe an AI/ML-driven device or study parameters that align with the request for information on acceptance criteria and study proving device meets acceptance criteria for such a device. The tests performed are standard non-clinical bench tests for a latex barrier device.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device from this document. The document describes a physical medical device, not a software or AI-based one.

No information provided in the document covers the following requested points:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, number of experts, adjudication methods, or ground truth types related to an AI performance study.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Training set details for an AI model.

The document focuses on non-clinical testing for a physical latex product and comparison to a predicate device for substantial equivalence, not on the performance of an AI/ML algorithm.

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The Harmony® Latex & the Harmony® Polyisoprene Dams are used as a barrier when engaging in oral/vaginal and oral/ anal sex to help reduce the transmission of bodily fluids, harmful pathogens and sexually transmitted infections.

The Harmony® Latex and Harmony® Polyisoprene Dams are rectangular shaped non-porous, intact polymer film that are placed over the vagina or anus during oral sexual contact. The dam provides coverage to the external female genitalia or to the anal acts as a physical barrier to infectious agents responsible for the transmission of sexually transmitted infections (STIs). Both Harmony® Latex and Harmony® Polyisoprene Dams are 152.4 mm (6") x 254 mm (10") and 0.12 mm thick. The Harmony® Latex Dam contains natural polyisoprene rubber and the Harmon® Polyisoprene Dam contains synthetic polyisoprene rubber. The dams are slightly scented with vanilla fragrance and are provided in natural color.

This document is a 510(k) summary for the Harmony® Latex Dams and Harmony® Polyisoprene Dams. It outlines the acceptance criteria and supporting studies for these devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the international standard ISO 29942:2011 Prophylactic dams -- Requirements and test methods and the 2020 FDA guidance Use of International Standard ISO 10993-1. The specific ranges or thresholds for these criteria are not provided in the document, but it states that "All test results were acceptable."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for each test in the acceptance criteria section. The data provenance is also not specified in terms of country of origin or whether it was retrospective/prospective. The testing appears to be prospective bench testing performed on manufactured Harmony® Latex and Harmony® Polyisoprene Dams.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable as the device is a physical barrier (dam) and the testing involves non-clinical bench tests (mechanical, barrier, biocompatibility), not interpretation of medical images or patient data that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as #3. Bench testing results are typically objectively measured against specified standards, not adjudicated by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This section is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation of results, especially in the context of AI assistance. The Harmony® Dams are physical barrier devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This section is not applicable. There is no algorithm or AI component in the Harmony® Dams. The performance evaluated is the physical and biological properties of the device itself.

7. Type of Ground Truth Used

The ground truth used for the non-clinical tests is established by international standards and FDA guidance. For example:

• ISO 29942:2011 specifies requirements and test methods for prophylactic dams.
• ISO 10993 series outlines biological evaluation of medical devices.
  The ground truth is therefore defined by the specifications and thresholds outlined in these recognized standards.

8. Sample Size for the Training Set

This section is not applicable. There is no "training set" as this device is not an AI/ML algorithm or a diagnostic tool that learns from data.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reason as #8.

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The Line One Trust Dam is used as a barrier when engaging in oral/vaginal sex and oral/anal sex to help reduce the transmission of bodily fluids, harmful germs, and sexually transmitted diseases.

This oral dam is made of natural rubber latex, which completely covers a person's pubic areas during oral genital stimulation. This dam has a smooth surface (both sides), nominal lay flat width 154 mm, nominal length 250 mm, and nominal thickness 0.07mm. It is non- lubricated, and food grade cornstarch is used as a dressing material.

The condoms from which the oral dams are made conform to current established national and international voluntary standards which include ASTM D3492:2008; and have been previously cleared by the USFDA (ref: K070830).

The condoms will be offered in the following Colors and Flavors:

1. Yellow Banana
2. Red Strawberry
3. Green Mint

The provided document is a 510(k) Pre-Market Notification for a male latex condom (Trust Dams). This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with detailed acceptance criteria and expert-read studies.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria for an AI/algorithm-based device and the study proving it meets those criteria. Specifically:

• No acceptance criteria table or reported device performance is present because this is a physical medical device (condom), not an AI algorithm. The performance is assessed against established standards for latex condoms.
• No sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details are provided, as these are concepts relevant to AI/algorithm validation, not to the pre-market notification for a physical medical device like a condom.
• No training set details are relevant here.

The document indicates that the device (Trust Dams) is made from natural rubber latex condoms that conform to established national and international voluntary standards, specifically ASTM D3492:2008 Male Latex Condom Standard. The predicate device is "Sheer Glyde Dams (K990067)", and the condoms from which the oral dams are made were previously cleared by the USFDA (K070830).

The "technological characteristics" section states: "This oral dam has the same technological characteristics as the listed predicate device identified above. The latex condoms (sheaths) from which the dams are made conform with the ASTM D3492:2008 Male Latex Condom Standard." This conformity to an established industry standard is the primary basis for demonstrating substantial equivalence for this type of device.

In summary, the provided text does not contain information about an AI or algorithmic device study. It details the 510(k) submission for a physical medical device (latex dam) and bases its substantial equivalence on adherence to existing condom standards.

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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."

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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)

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.

1. 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.

2. 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.

3. 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.

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

   • 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.

5. 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.

6. 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.

7. 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.

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

   • This question is not applicable as there is no training set.

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