Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 colored latex sheath, which completely covers the penis with a closely fitted membrane. This device is a parallel sided, teat ended, flavored condom and is designed to conform to national and international voluntary standards, including ISO 4074, EN600 and ASTM D3492. The condom is offered in Chocolate, Chocolate/coconut. Chocolate/peppermint, and Chocolate/orange.

This 510(k) submission for the Durex Flavored Latex Condom does not contain the detailed study information typically found for AI/ML-based diagnostic devices. This is a premarket approval for a physical medical device (condom) and therefore, the acceptance criteria and study design are related to manufacturing standards and physical performance tests, rather than algorithmic performance.

However, I can extract the relevant information based on the typical requirements for such devices, even if it's not presented in the same format as for an AI study.

Here's a breakdown of the information based on your request, applied to the context of a latex condom:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in a typical AI/ML sense but rather refers to manufacturing quality control.

• Sample Size: Not explicitly stated as a single "test set" sample size. Condoms are produced in large batches, and statistical sampling methods (e.g., AQL - Acceptable Quality Level) are used for quality control testing of physical attributes from each batch. The actual number of condoms tested would depend on the batch size and the specific testing protocol (e.g., for burst tests, freedom from holes).
• Data Provenance: The testing is implied to be conducted by the manufacturer, SSL Americas, and its manufacturing partners (LS Rubber SDN and Thai Nippon Rubber Industry). It's a prospective internal quality control process during and after manufacturing.

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

In this context, "experts" are not human readers interpreting images, but rather the recognized standards bodies and material scientists/engineers who established the test methods and performance specifications for condoms.

• Number of Experts: Not applicable in the sense of AI ground truth. The "ground truth" for condom quality is defined by the established national and international standards (ISO, EN, ASTM).
• Qualifications of Experts: These standards are developed by committees of material scientists, engineers, medical professionals, and regulatory experts.

4. Adjudication Method for the Test Set

Not applicable in the sense of AI human reader adjudication. Product conformance to specifications is determined directly by objective physical and chemical tests against predefined limits set by the standards.

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 as this is a physical medical device, not an AI/ML-based diagnostic or assistive technology. There are no "human readers" interpreting "cases" with or without "AI assistance."

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

Not applicable. There is no algorithm being tested. The device is a standalone physical product.

7. The Type of Ground Truth Used

The ground truth is based on established national and international voluntary standards for latex condoms (e.g., ISO 4074, EN 600, ASTM D3492) regarding physical properties, material composition, and performance. In addition, FDA regulation 21 CFR 801.435 defines the ground truth for expiration dating.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for physical manufacturing of condoms. The manufacturing process itself is akin to a "training" process, where continuous monitoring, process controls, and adjustments are made to ensure consistent product quality, but it's not a dataset in the AI sense.

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

Not applicable. As above, there's no "training set." The "ground truth" for manufacturing quality is established by adhering to Good Manufacturing Practices (GMP) and the quality control parameters derived from the aforementioned international standards and internal specifications.

Ask a specific question about this device

Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers. Over the Counter

SSL's Medical Support Stocking is a compression stocking in the 14 -17mmHg range. It is composed of Polyamide / Elastane. A cotton feel Flight sock using air jet textured spun nylon.

The provided document describes a 510(k) premarket notification for a medical support stocking (Flight Sock), not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

However, I can extract the relevant information regarding the acceptance criteria and the study performed for this specific medical device.

Acceptance Criteria and Device Performance for SSL's Medical Support Stocking (Flight Sock)

The core "acceptance criteria" in this context is demonstrating substantial equivalence to legally marketed predicate devices, primarily through comparison of physical characteristics and intended use. The study performed focuses on this comparison.

| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
| :--------------------------- | :------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Compression Range | Equivalent compression in the 14-17 mmHg range to predicate devices. | The device is a compression stocking in the 14-17 mmHg range. Equivalent to predicate devices (Futuro's Venes Anti Embolism Stockings, K830696, and Jobst Travel Sock, K032325). |
| Composition | Equivalent materials to predicate devices. | Composed of Polyamide / Elastane (a cotton feel Flight sock using air jet textured spun nylon). Equivalent to predicate devices. |
| Intended Use | To help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers. | Same as the predicate devices. |

Study Information

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

   • The document implies a comparative equivalency study was performed against Futuro's Venes Anti Embolism Stockings (K830696).
   • The specific number of samples (e.g., individual stockings or tests) for the equivalency testing is not specified in the provided text.
   • Data Provenance: Not explicitly stated, but assumed to be internal testing by SSL Americas, Inc. (retrospective for the submission).

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

   • Not applicable. This is not an AI/ML study generating a diagnostic output. The "ground truth" here is the established characteristics and performance of the predicate device.

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

   • Not applicable. No human adjudication of results in the AI/ML sense. The equivalency was determined through direct comparison of physical properties (compression, composition).

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. This is not an AI/ML device, so no MRMC study was performed.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • The "ground truth" for the equivalency testing was the established characteristics and performance of the predicate devices (Futuro's Venes Anti Embolism Stockings and Jobst Travel Sock). This would involve physical measurements of compression and analysis of material composition.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

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

   • Not applicable.

Ask a specific question about this device

Durex Play™ 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™ is a clear colorless personal lubricant composed of purified water, Hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid, sodium hydroxide.

The provided text is a 510(k) Premarket Notification summary for Durex Play™ Personal Lubricant and the FDA's clearance letter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a study proving the device meets acceptance criteria.

The information present in the document pertains to:

• Device Description: Durex Play™ is a clear colorless personal lubricant composed of purified water, Hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid, sodium hydroxide.
• Intended Use: 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.
• Predicate Devices: K-Y Jelly Personal Lubricant (K955648) and AstroGlide (K935299).
• Substantial Equivalence: Durex Play™ is substantially equivalent to the predicate devices in intended use and similar in composition. All products are marketed as personal lubricants, safe to use with condoms, water soluble, and sold Over-the-Counter.

In summary, this document describes a regulatory filing based on substantial equivalence, not a clinical or performance study with the detailed aspects requested in the prompt.

Ask a specific question about this device

The DUREX Latex Condom with Male Genital Desensitizer Lubricant is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases. The male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation.

DUREX Latex Condom with Male Genital Lubricant is made of a natural rubber latex sheath with lubricant Desensitizer containing Benzocaine, an over-the-counter drug recognized as safe and effective by US FDA under 21 CFR 5300 for condom and 21 CFR Part 348 for external analgesic drug products for over-the-counter human use. The condom is a straightwalled, nipple-end condom with the nominal length of 180 mm and width of 52 mm as required by ASTM D-3492-97.

The provided text is a 510(k) Pre-market Notification for a latex condom, and as such, it does not contain the detailed information typically associated with clinical studies for device performance or AI/ML model evaluations. The document focuses on demonstrating substantial equivalence to a predicate device, which primarily relies on technological characteristics, safety, and intended use, rather than a rigorous performance study with acceptance criteria in the manner requested.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's an attempt to answer based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to compliance with ASTM D-3492-97 for "Rubber Contraceptives (Male Condoms)" as the primary standard for the device's technical specifications. While the exact acceptance criteria from this ASTM standard are not explicitly listed in the document, meeting this standard would imply passing its specified tests for dimensions, burst volume/pressure, and freedom from holes. The document states that both the proposed and predicate devices "are of the similar design meeting ASTM Standard (D3492) specification."

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

This information is not provided in the 510(k) summary. The document focuses on substantial equivalence based on design and material rather than a specific clinical performance test set. Data provenance is not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable and not provided. This is a device submission for a condom, not an AI/ML diagnostic device requiring expert ground truth for image or diagnostic interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

This information is not applicable and not provided. This is not an AI-assisted device.

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

This information is not applicable and not provided. This is not an algorithm-based device.

7. The Type of Ground Truth Used:

For the physical characteristics of the condom, the "ground truth" would be established by physical measurements and standardized tests as outlined in ASTM D-3492-97. For the desensitizer lubricant, the ground truth for safety and effectiveness is based on the FDA's existing recognition of Benzocaine as safe and effective under 21 CFR 5300 and 21 CFR Part 348.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This is not an AI/ML device relying on a training set.

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

This information is not applicable and not provided.

Summary of what is present in the document regarding "proof of meeting acceptance criteria":

The primary "proof" relies on the device meeting the ASTM D-3492-97 standard for male condoms and the fact that Benzocaine is a recognized over-the-counter drug for desensitizing purposes by the FDA. The submission states that the proposed device, with "variation merely in the lubricant application," is technologically similar to the predicate device and meets the same ASTM standard. The FDA's letter of clearance indicates that the agency determined the device is "substantially equivalent" to legally marketed predicate devices, implying that it meets the necessary safety and effectiveness requirements, including those indirectly referenced by the ASTM standard and Benzocaine's existing regulatory status. The FDA also specifically mentions the requirement to comply with 21 CFR 801.435 for expiration dating, supported by test data, which must be maintained by the manufacturer.

Ask a specific question about this device