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The Durex synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

This condom is made of a synthetic polyisoprene rubber sheath, which completely I his condom is made or lead of the membrane. This device is a shaped, teat ended, lubricated condom. Synthetic polyisoprene is the synthetic form of natural lubricated condom. Bylinene perfisen as natural rubber, a material commonly used for poryisoprono raover of condoms made by SSL from synthetic polyisoprene have been shown to have similar performance properties as natural rubber latex condoms and conform to the relevant physical test requirements of national and international connomi to tare referant patural rubber latex male condoms, ISO 4074:2002, and Volunary Sandards of the synthetic condom standard ASTM D6324-05.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Durex Synthetic Polyisoprene Male Condom

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list numerical acceptance criteria in a dedicated table format. Instead, it relies on demonstrating equivalence to predicate devices and conformance to established standards. The acceptance criteria are implicitly those set by the referenced standards and the performance of the predicate device.

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

• Clinical Investigation: "A clinical investigation was conducted in 2007... using the predicate device... as the control condom." The specific sample size for this clinical study is not explicitly stated in the provided text.
• Consumer User Evaluation: Conducted "in the UK and Italy during 2004". The specific sample size is not explicitly stated.
• Data Provenance:
  • Clinical Investigation: Prospective (conducted in 2007) and global (implicitly, as it refers to US FDA guidelines but typical for such studies to have international sites, though specific country not mentioned for this study itself, only for predicate use).
  • Consumer User Evaluation: Prospective (conducted in 2004) in the UK and Italy.
  • Physical Testing: Performed as part of manufacturing and submission process; provenance is the manufacturer and testing labs.
  • Biocompatibility/Viral Penetration: Lab-based studies.

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

This type of information is not applicable in the context of condom testing. Ground truth for condom performance is established through objective physical measurements, viral penetration assays, and clinical outcomes (breakage, slippage) observed by study participants and collected by trained clinical staff. There isn't a need for expert consensus on individual "cases" in the way it applies to image interpretation or diagnosis.

4. Adjudication Method for the Test Set

This is not applicable in the traditional sense of medical device studies involving expert interpretation or diagnostic outcomes. For clinical breakage and slippage, the events are typically recorded by the users and confirmed by study staff. Discrepancies would be resolved through standard clinical trial monitoring and data validation procedures rather than an adjudication panel of experts.

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

This is not applicable. This is a device for contraception and disease prevention, not an interpretative medical device or AI-assisted diagnostic tool. Therefore, there are no "human readers" or "AI assistance" in the context of its primary function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This device is a physical product (a condom), not an algorithm or AI system.

7. The Type of Ground Truth Used

• Physical Properties: Objective measurements against international and domestic standards (e.g., tensile strength, burst volume, length, width).
• Biocompatibility: Laboratory test results demonstrating non-toxicity, non-irritation, etc., as per ISO 10993 and FDA guidelines.
• Viral Penetration: Laboratory test results using viral challenge models.
• Clinical Performance: User-reported clinical outcomes (breakage and slippage) during actual use in a controlled clinical setting, compared to the predicate device.
• Consumer User Evaluation: User satisfaction, preference, and comfort reported by study participants.
• Post-Market Surveillance: Real-world consumer complaint data.

8. The Sample Size for the Training Set

This is not applicable in the context of device approval for a physical product like a condom. There isn't a "training set" in the machine learning sense. The device is manufactured based on established specifications and tested against those specifications and performance benchmarks derived from predicate devices and standards.

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

This is not applicable for the reasons stated in point 8. The "ground truth" for manufacturing a condom to a certain standard is the set of specifications and physical properties required by the relevant ASTM/ISO standards and the performance profile of the predicate device, which itself was established through a historical process of testing and clinical use.

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The Durex Play™ Tingling aqueous based Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturise and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is only compatible with natural rubber latex condoms.

Durex Play™ Tingling aqueous based personal lubricant is a slightly hazy/clear, water soluble personal lubricant.

The provided text is for a 510(k) premarket notification for a personal lubricant, not a medical device that would require the typical performance studies described in your request. Therefore, most of the requested information regarding acceptance criteria, study findings, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not applicable to this type of submission.

This submission focuses on demonstrating substantial equivalence to a predicate device, Durex Play™ Personal Lubricant (K032124), rather than proving specific performance metrics against defined acceptance criteria for a diagnostic or therapeutic device. The key elements for this type of submission are typically:

• Intended Use Compatibility: Ensuring the new device's intended use is substantially equivalent to the predicate.
• Material Compatibility: Proving the formulation and materials are safe and compatible with intended use (e.g., condom compatibility).
• Biocompatibility (if applicable): Testing for irritation or sensitization.
• Performance (functional): Ensuring the lubricant functions as expected (e.g., lubrication properties).

Given the nature of the device (a personal lubricant), the "acceptance criteria" and "study" are not presented in the format one would expect for a diagnostic AI device. The approval is based on "substantial equivalence" to a predicate device.

Here's an attempt to address your points based on the provided text, highlighting what is and isn't available:

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

• Acceptance Criteria: Not explicitly stated as quantitative metrics in the provided text. The FDA's acceptance is based on the determination of "substantial equivalence" to the predicate device. This implies that the device must perform similarly and safely for its intended use as the predicate. The crucial "performance" for a lubricant typically involves:

  • Lubrication effectiveness: Enhancing ease and comfort of intimate sexual activity.
  • Moisturizing properties.
  • Condom compatibility: "This product is compatible with natural rubber latex condoms."
  • Safety: Not causing irritation or adverse reactions.

• Reported Device Performance: The text states the device's intended use is "to moisturise and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." It also explicitly states, "This product is compatible with natural rubber latex condoms." The implication (by FDA approval) is that the submission provided data demonstrating these claims were met, and no significant differences from the predicate device were found. Specific quantitative performance data is not included in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not provided: The provided 510(k) summary does not contain information about specific test sample sizes or data provenance for performance testing. For a device like a lubricant, testing often involves bench testing (e.g., viscosity, pH, osmolality, condom compatibility testing) and biocompatibility studies, which would have their own sample sizes but are not detailed here.

3. 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)

• Not Applicable: This type of medical device (personal lubricant) does not involve ground truth establishment by experts in the sense of diagnostic interpretation (e.g., radiologists reviewing images). The assessment is based on physical/chemical properties and biological safety.

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

• Not Applicable: Adjudication methods are relevant for subjective interpretations, often in diagnostic imaging or clinical trials with ambiguous endpoints. This is not pertinent to a personal lubricant's evaluation for substantial equivalence.

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

• No: This is entirely irrelevant to a personal lubricant. MRMC studies and AI assistance are typically for diagnostic imaging or similar interpretation tasks.

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

• No: This is irrelevant as there is no algorithm associated with a personal lubricant.

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

• Not Applicable / Ground Truth by Proxy: For a lubricant, "ground truth" would be established by laboratory standards for material properties (e.g., pH, viscosity, osmolality), standardized biocompatibility testing (e.g., cytotoxicity, irritation, sensitization assays), and validated methods for condom compatibility. This isn't "ground truth" in the diagnostic sense but rather objective compliance with established performance standards for such products.

8. The sample size for the training set

• Not Applicable / No Training Set: There is no "training set" for an AI algorithm in the context of a personal lubricant.

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

• Not Applicable / No Training Set: There is no "training set" for an AI algorithm in the context of a personal lubricant.

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Durex Play™ Soft & Sensual™ is a personal lubricant, for vaginal or penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms only.

Durex Play Soft & Sensual Lubricant is a clear, colorless, unperfumed vaginal lubricant with a pH similar to the normal pH range of the vagina.

This document describes a 510(k) premarket notification for a personal lubricant, not a medical device that requires clinical performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies in the way requested.

The submission for Durex Play Soft & Sensual Lubricant (K071626) primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, not on proving clinical effectiveness through detailed performance metrics against pre-defined acceptance criteria.

Therefore, the information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or not provided in this type of regulatory submission for this product.

Here's why and what information is relevant from the document:

Key Takeaways from the Document:

• Device Type: Personal lubricant, classified as a Class II medical device (Regulation Number: 21 CFR §884.5300, Product Code: NUC).
• Regulatory Pathway: 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.
• Predicate Devices: Durex Play™ personal lubricant (K032124), Durex Play™ Assorted Temptations lubricants (K060098), Durex Play™ Warmer lubricant (K042563), KY liquid (K955648), and Lifestyles (K033076).
• Basis for Substantial Equivalence: The document states the proposed and predicate devices are: "non-sterile, water-soluble, chemically preserved, multi-dose lubricants, and compatible with natural rubber latex condoms." The intended use and labeling are also considered substantially equivalent.
• "Acceptance Criteria" in a 510(k) Context: For this type of device and regulatory pathway, the "acceptance criteria" isn't a specific set of clinical performance metrics, but rather the demonstration that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through comparison of technical characteristics, intended use, and performance data if relevant (e.g., biocompatibility testing, lubricant compatibility with condoms), rather than complex clinical outcomes studies.

Regarding your specific questions:

1. Table of acceptance criteria and reported device performance: Not applicable. There are no clinical performance metrics or acceptance criteria presented in this type of 510(k) submission for a personal lubricant. The "performance" is demonstrated by its similarity to already approved lubricants.
2. Sample sizes used for the test set and data provenance: Not applicable for clinical performance. Any testing (e.g., for biocompatibility or condom compatibility) would have its own sample size, but that is not detailed here in the context of human clinical data for establishing performance.
3. Number of experts used to establish ground truth and qualifications: Not applicable. This type of submission does not involve expert review for clinical ground truth.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is not a diagnostic device where human readers are interpreting results.
6. Standalone performance (algorithm only without human-in-the loop performance): Not applicable, as this is not an algorithm-driven device.
7. Type of ground truth used: Not applicable. For material performance (e.g., condom compatibility), the "ground truth" would be established by standardized laboratory testing methods, not clinical outcomes.
8. Sample size for the training set: Not applicable. This is not an AI/ML-driven device requiring training data.
9. How the ground truth for the training set was established: Not applicable.

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Durex Play ™ Massage gel is intended as a moisturiser for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity. This lubricant has been shown to be compatible only with condoms made from natural rubber latex and synthetic polyisoprene.

Durex Play™ Massage gel personal lubricant is a clear, colorless, water soluble personal lubricant.

This document is a 510(k) premarket notification for a personal lubricant, Durex Play™ Massage gel. It focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a study with acceptance criteria and device performance evaluation in the typical sense of a medical diagnostic device.

Therefore, the requested information elements related to clinical study design, test sets, ground truth establishment, and expert involvement are not applicable in this context. The 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through comparison of intended use, technological characteristics, and performance data if relevant to safety or effectiveness claims.

Here's a breakdown of the available information based on your request, highlighting what is not applicable (N/A) given the nature of a 510(k) for a personal lubricant:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• N/A. The provided document does not describe a "test set" in the context of a performance study for this device. The submission focuses on demonstrating substantial equivalence to predicate devices, not on a clinical performance study with a test set of data.

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

• N/A. No expert ground truth establishment for a test set is described. The FDA's review process and the determination of substantial equivalence are made by regulatory experts based on the submitted documentation and comparison to predicate devices, rather than through expert review of a clinical test set for this product type.

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

• N/A. No test set or adjudication method is described.

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:

• N/A. This device is a personal lubricant, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and AI-related effectiveness are irrelevant to this submission.

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

• N/A. This device is a personal lubricant, not an algorithm. Standalone performance as described is irrelevant.

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

• N/A. The concept of "ground truth" as typically applied in diagnostic device studies (e.g., pathology for cancer detection) is not applicable here. The "truth" in this 510(k) submission is the demonstration of substantial equivalence to already legally marketed devices based on intended use, technological characteristics, and safety profiles.

8. The sample size for the training set:

• N/A. As this is not an AI/algorithm-based device, there is no "training set."

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

• N/A. Not applicable, as there is no training set for this device.

In summary, for a 510(k) submission for a personal lubricant, the primary "study" is the comparison to predicate devices to demonstrate substantial equivalence. The provided document indicates that the device's formulation is "very similar" to existing Durex Play™ products and shares the same intended use as other legally marketed lubricants (K-Y Jelly, Astroglide, etc.). The FDA's issuance of the 510(k) clearance signifies their agreement that the Durex Play™ Massage gel lubricant is substantially equivalent to these predicate devices for its intended use.

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Durex Play ™ Temptations Assorted Lubricants are intended as moisturizers for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

Durex Play™ Temptations Assorted personal lubricants are clear, colorless, water soluble personal lubricants.

This appears to be a 510(k) premarket notification for a personal lubricant, not a study describing acceptance criteria and device performance. The provided text details the submission information, general device information, predicate devices, device description, intended use, and a letter from the FDA stating substantial equivalence.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth), and training set information is not available in the provided document.

The document primarily focuses on demonstrating that the "Durex Play™ Temptations Assorted Lubricants" are substantially equivalent to already legally marketed predicate devices, which is the basis for a 510(k) clearance. Clinical studies with performance metrics as typically required for AI/ML devices are not part of this type of submission.

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Durex latex condom used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

The condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a straight walled , teat ended, coloured condom containing either red, yellow, orange or green pigment. The condoms are lubricated with a water based flavoured lubricant containing either lychee, guava, pineapple, mango or kiwi scent.

The device is designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492-03.

Here's an analysis of the provided information regarding the Durex Male Latex Colored Condom with Scented Lubricants, focusing on acceptance criteria and supporting studies:

It's important to note that this 510(k) application (K052959) is for a medical device that is a physical product (a condom), not a software-based AI/ML device. Therefore, many of the typical AI/ML-specific questions (like effect size of AI assistance, standalone algorithm-only performance, training set details, or complex ground truth establishment) are not applicable in this context. The "acceptance criteria" here refer to the device's conformance to established international and domestic standards for condoms, rather than performance metrics of an AI algorithm.

Acceptance Criteria and Device Performance for Durex Male Latex Colored Condom with Scented Lubricants

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a numerical sample size for the "test set" in the context of device testing. It states: "Physical testing and release testing of the finished product revealed results in conformance with required specifications."

• Sample Size: Not explicitly stated. The testing would have been done on a manufacturing batch or sample of the produced condoms.
• Data Provenance: Not explicitly stated, but it would be prospective testing conducted on manufacturing samples of the device itself. The country of origin of the data would likely be where the manufacturing and quality control testing took place (e.g., the manufacturer's facility or a contracted lab).

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

• This question is not applicable to this type of device (physical condom). "Ground truth" in this context refers to the established standards (ISO 4074:2002 and ASTM D3492-03) and the objective measurements performed against these standards (e.g., burst pressure, dimensions, tensile strength, freedom from holes).
• The "experts" involved would be a combination of engineers, quality control specialists, and regulatory affairs personnel who conduct and interpret the physical and chemical tests according to the established methodologies outlined in the referenced standards. Their qualifications would typically include expertise in materials science, mechanical engineering, and quality assurance relevant to rubber products.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert interpretations of data in diagnostic or AI studies. For a physical device like a condom, conformance to standards is determined through objective physical and chemical testing with pre-defined pass/fail criteria, not consensus among experts adjudicating subjective findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, And Effect Size

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices (especially imaging) where human readers interpret patient cases, often with and without AI assistance, to assess the AI's impact on human performance. This is irrelevant for a physical contraceptive device like a condom.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• No, this is not applicable. The device is a physical product (condom), not an algorithm or software. There is no AI component to assess in a standalone mode.

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on objective measurements against established engineering and material standards. Specifically, the ground truth is defined by the requirements and test methods outlined in ISO 4074:2002 and ASTM D3492-03. This includes parameters like:
  • Dimensions (length, width, thickness)
  • Burst volume and pressure (critical for tensile strength and hole prevention)
  • Freedom from holes
  • Package integrity
  • Material composition properties
  • Lubricant quantity and type

8. The Sample Size for the Training Set

• This question is not applicable as there is no AI/ML model being "trained" for this physical device. The "training" for such a device involves developing and refining the manufacturing process, which is based on material science, engineering principles, and previous experience with similar products, rather than a data-driven training set in the AI sense.

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

• This question is not applicable for the same reasons as #8. The establishment of "ground truth" (i.e., performance characteristics) for manufacturing and design would be based on:
  • Extensive material science research and development for rubber latex.
  • Adherence to internationally recognized standards (ISO, ASTM) which are developed through expert consensus, rigorous testing, and clinical experience over many years to define what constitutes a safe and effective condom.
  • Feedback from previous product generations and market surveillance.

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Durex Play™ Tingling Lubricant is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

Durex Play™ Tingling personal Lubricant is a clear, colorless, spearmint scented personal lubricant composed of silicone fluid and sweetened spearmint aroma concentrate.

The provided text is a 510(k) premarket notification summary for a medical device, Durex Play™ Tingling Lubricant. This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain any information about acceptance criteria, a study validating performance against such criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods.

Therefore, I cannot provide the requested table and information based on the given input, as the document focuses on regulatory submission for substantial equivalence rather than a detailed performance study. The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, often without requiring new clinical trials or detailed performance studies if equivalence can be established through design, materials, and intended use.

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This Durex latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a shaped, teat ended, transparent condom lubricated with a spearmint scented lubricant, and is designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492 except where noted.

The provided text is a 510(k) premarket notification for a Durex 'Tingling Pleasure' Male Latex Condom. It is a submission for a medical device that claims substantial equivalence to previously approved devices, rather than a study proving performance against acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, expert ground truth, sample sizes, and comparative effectiveness studies is not applicable to this type of regulatory submission as presented in the provided document.

This submission focuses on demonstrating that the new condom is essentially the same as already legally marketed condoms with minor modifications (primarily the addition of a spearmint scent). The FDA's letter states they have determined the device to be "substantially equivalent" to predicate devices, which means it meets the general controls provisions of the Act.

Here's an attempt to address the request based on the provided text, indicating where information is not applicable:

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

Since this is a substantial equivalence claim for a condom, the acceptance criteria are based on established standards for condoms (ISO 4074:2002 and ASTM D3492) and similarity to predicate devices. The document does not explicitly list numerical acceptance criteria in a table or present new experimental performance data for this specific device beyond its physical description and intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The provided document is a 510(k) summary for premarket approval based on substantial equivalence to existing devices. It does not describe a new clinical or laboratory study with a specific test set, sample size, or data provenance in the way a novel device might. The "data" here refers to the comparison of the new device's characteristics to those of its predicates, and its conformance to established standards.

3. 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)

Not applicable. Ground truth, in the context of device performance studies, is not a concept directly applied to this 510(k) submission. The "ground truth" for a condom is its ability to prevent pregnancy and STDs, which is well-established for latex condoms. The submission relies on this existing knowledge and the performance of predicate devices.

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

Not applicable. There was no test set requiring expert adjudication for this type of regulatory submission.

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 a study involving human readers or AI assistance. It's a submission for a physical medical device (condom).

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for a condom's effectiveness is established through historical data and extensive use of similar devices for contraception and STD prevention, reflecting long-term outcomes for devices conforming to established standards. This submission leverages that pre-existing understanding rather than generating new outcomes data.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.

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

Not applicable. There is no "training set" or explicit ground truth establishment process described for this regulatory submission.

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Durex Play™ Warmer™ is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

Durex Play Warmer™ is a clear colorless personal lubricant composed of Purified Water, Hydroxyethyl Cellulose (Natrosol 250), Propylene Glycol, Benzoic Acid, Sodium Hydroxide, Sodium Saccharin, Glycerol.

This 510(k) summary for Durex Play Warmer™ personal lubricant does not contain information about acceptance criteria or a study proving the device meets those criteria, as such studies are typically not required for Class II devices seeking substantial equivalence via the 510(k) pathway.

The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or meeting specific performance criteria through a standalone study.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Description: Composition and general characteristics.
• Intended Use: What the lubricant is designed for.
• Substantial Equivalence: Comparison to existing predicate devices (K-Y Jelly and AstroGlide) based on intended use, composition, and marketing.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or ground truth establishment.
• Expert involvement or adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithmic performance.
• Ground truth types or training set details.

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Durex latex condom used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

The condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a shaped, teat ended, lubricated condom which is lubricated with a water based warming lubricant.

This document is a 510(k) premarket notification for a Durex Male Latex Condom with Warming Lubricant. It does not describe a study that proves the device meets acceptance criteria in the way a medical device AI/algorithm submission would. Instead, it demonstrates substantial equivalence to predicate devices based on conformity to existing standards and physical testing.

Here's an analysis of the provided text in the context of your request, highlighting what is and isn't present:

This submission is for a physical medical device (condom with lubricant), not an AI/algorithm. Therefore, many of the requested criteria regarding AI performance studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance) are not applicable or described in the provided text.

However, I can extract the relevant information regarding the device's conformance to standards and the basis for its safety and effectiveness.

Acceptance Criteria and Reported Device Performance (as much as can be inferred):

Explanation of the Study and Device Conformance (where applicable):

1. A table of acceptance criteria and the reported device performance
   See table above. The document states, "The device is designed to conform to national and international voluntary standards, including ISO 4074 and ASTM D3492, except where noted." And for the finished product, "Physical testing and release testing of the finished product revealed results in conformance with required specifications."

2. Sample size used for the test set and the data provenance
   Not explicitly stated in the provided text. For a physical device, testing involves material properties and functional tests, often using batches or statistical samples, which are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   Not applicable as this is not an AI/algorithm submission requiring expert-established ground truth. Conformance to standards is the primary "ground truth" for this type of device.

4. Adjudication method for the test set
   Not applicable as this is not an AI/algorithm submission.

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 a physical device, not an AI/algorithm.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
   Not applicable. This is a physical device, not an AI/algorithm.

7. The type of ground truth used
   The "ground truth" for this device's acceptance is its conformance to established national and international voluntary standards (ISO 4074 and ASTM D3942) and its physical/release testing specifications.

8. The sample size for the training set
   Not applicable. There is no AI/algorithm training set for this physical device.

9. How the ground truth for the training set was established
   Not applicable. There is no AI/algorithm training set. The "ground truth" for the device's safety and effectiveness is established through its design, materials, manufacturing processes, and testing that demonstrate conformance to recognized engineering and product standards for condoms and lubricants. The substantial equivalence argument relies on comparing these characteristics to legally marketed predicate devices.

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