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Polyisoprene Extra Large Condoms are used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).

The Polyisoprene Extra Large Condom is a male contraceptive prophylactic device made from synthetic polyisoprene rubber latex with a lubricant coating containing silicone gel with fragrance oil. The fragrance oil acts as a masking agent to minimize odor originated from the condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 200 ± 10mm, width 60 ± 2mm, and thickness 0.070 ± 0.01mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 5-year shelf-life.

The provided text pertains to the 510(k) premarket notification for a medical device (Polyisoprene Extra Large Condom) and does not describe AI/ML device performance or the specific criteria and studies typically associated with such devices (e.g., studies involving human readers, ground truth establishment by experts, or training set details). The document focuses on demonstrating the substantial equivalence of the new condom to a predicate device, primarily through non-clinical performance testing and leveraging clinical testing from the predicate device.

Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported device performance or answer questions regarding MRMC studies, standalone AI performance, and specifics of training/test sets as these concepts do not apply to the provided medical device submission for a condom.

The document discusses:

• Acceptance Criteria for the condom: Primarily adherence to ISO standards (ISO 23409:2011, ISO 4074:2015) for physical properties (dimensions, tensile strength, air burst, etc.), biocompatibility, barrier properties, package integrity, and shelf life.
• Performance Testing for the condom: Non-clinical tests were conducted to demonstrate compliance with the above standards and non-inferiority to natural rubber latex condoms in mechanical properties.
• Clinical Performance Testing: Leveraged from the predicate device, which demonstrated non-inferiority in breakage and slippage rates compared to a natural rubber latex condom.

Without information on an AI/ML component, the requested details about acceptance criteria, ground truth, sample sizes for AI training/testing, and expert involvement for ground truth establishment are not present in the provided text.

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The 45 Micron Polyisoprene Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections STIs).

The 45 Micron Polyisoprene Condom is a male contraceptive prophylactic device made from synthetic rubber (Polyisoprene latex) with a lubricant coating containing silicone gel with fragrance oil (Sensual Masking). The fragrance oil acts as a masking agent to minimize odor originated from the condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190 ± 10mm, width 53 ± 2mm, and thickness 0.045 ± 0.005mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life.

The provided document (K231908 510(k) Summary for 45 Micron Polyisoprene Condom) describes the acceptance criteria and the study that proves the device meets those criteria for a condom. This is not a medical imaging device or an AI/ML-enabled device, therefore, many of the requested elements of your prompt are not applicable (e.g., number of experts for ground truth, MRMC study, sample size for training set, etc.).

However, I can extract and present the available information most relevant to your request format, making it clear what information is and isn't provided in the context of this specific regulatory submission for a condom.

Acceptance Criteria and Device Performance for 45 Micron Polyisoprene Condom

1. Table of Acceptance Criteria and Reported Device Performance

For a condom, "performance" is primarily assessed through physical integrity, barrier properties, and clinical failure rates (breakage/slippage). The document refers to meeting various ISO standards and FDA guidance rather than listing specific numerical acceptance criteria (e.g., a "pass/fail" for an imaging diagnostic would have specific sensitivity/specificity targets).

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

• Biocompatibility: Leveraged from predicate device submission, with additional specific tests on the subject device. Sample sizes not explicitly stated for each test, but standard for biocompatibility studies.
• Physical Performance: Not explicitly stated for each test, but testing was "for compliance" with standards.
• Package Integrity: 3 lots of the subject device.
• Barrier Properties/Permeability: 3 test lots of the subject polyisoprene condom, one lot of the commercially available predicate device, and a natural rubber latex condom comparator.
• Shelf Life: "All samples" met criteria, specific number not stated.
• Clinical In-Use Slip/Break: Over 267 couples were included in the study.
• Data Provenance: The submission is from Suretex Limited, located in Thailand. The study details (where it was conducted, retrospective/prospective) are not explicitly stated, but clinical performance studies for regulatory submissions are typically prospective and conducted under Good Clinical Practice (GCP) guidelines. The document states it "followed a protocol prepared to meet the FDA guidance".

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

• This question is not applicable as this is a physical medical device (condom) and not a medical imaging or AI diagnostic device. "Ground truth" for condom performance is established through objective physical and chemical testing, and clinical observation of real-world use rather than expert interpretation of images.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in imaging studies where interpretations from multiple readers need to be reconciled. For a condom, performance is measured objectively (e.g., breakage, slippage, physical properties).

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 question is not applicable as this is not an AI/ML-enabled medical device.

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

• This question is not applicable as this is not an AI/ML-enabled medical device.

7. The Type of Ground Truth Used

• For physical properties (tensile strength, air burst, etc.): Objective measurements against predefined ISO and ASTM standards.
• For biocompatibility: Laboratory testing results against established limits for toxicity, irritation, and sensitization.
• For barrier properties: Laboratory viral penetration testing.
• For clinical in-use performance (breakage/slippage): Direct observation of events (breakage or slippage) during actual use by participating couples. Non-inferiority was established by statistical comparison to a control latex condom.

8. The Sample Size for the Training Set

• This question is not applicable as this is a physical medical device and not an AI/ML-enabled device. There is no concept of a "training set" in this context.

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

• This question is not applicable as this is a physical medical device and not an AI/ML-enabled device.

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The LifeStyles NRL Textured Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The LifeStyles® NRL Textured Condom is indicated for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections). The condom is a single use device made of a noncolored natural rubber latex sheath that covers the penis with a closely fitted membrane. The condom is textured with dots along its straight shaft, includes a reservoir tip at the closed end to contain semen, and is coated with a silicone lubricant. The LifeStyles® NRL Textured Condom has a nominal length of 190 mm, width of 53 mm, and thickness of 0.08 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.

The provided text describes the 510(k) premarket notification for a medical device, specifically a condom. It details the device's characteristics, comparison to a predicate device, and non-clinical performance testing. However, the request asks for information related to a study proving a device meets acceptance criteria for an AI/algorithm-based medical device, including details like sample sizes, expert ground truth establishment, MRMC studies, and training set information.

The provided document does not contain any information about an AI/algorithm-based medical device study. The "LifeStyles® NRL Textured Condom" is a physical medical device, not an AI or algorithm-driven one. Therefore, I cannot extract the requested information from the given text as it is not present.

The document discusses:

• Device Name: LifeStyles® NRL Textured Condom
• Regulation: 21 CFR § 884.5300 Condom, Class II
• Performance Testing: Biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity), Physical Property Testing (conformance to ASTM D3492-16 and ISO 4074:2015 for parameters like lubricant quantity, length, width, thickness, burst volume, burst pressure), and Shelf-Life (5 years based on accelerated stability).

These are all standard tests for a physical condom and do not relate to the evaluation of an AI or algorithm.

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OFNat Lubricant (L15) is a personal lubricant for vaginal and 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

OFNat Lubricant (L15) is a non-sterile, water-based personal lubricant for vaginal and penile application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.

Its formulation consists of water (aqua), propanediol, okra extract, hydroxyethylcellulose, sodium lactate, benzoic acid, and flaxseed gum.

OFNat Lubricant (L15) is sold as an over-the-counter (OTC) product and is packaged in 80 ml black HDPE bottle and 5 ml sachet.

This document describes the OFNat Lubricant (L15) device, a personal lubricant. It primarily focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The information provided is characteristic of a regulatory submission rather than a clinical study report. Therefore, some of the requested data points (like expert qualifications, adjudication methods, MRMC studies, or training set details) are not typically included in such documents and are absent here.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are described as "Specifications" in "Table 1: Device Specifications for OFNat Lubricant (L15)". The reported device performance is indicated by the statement that "the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life" based on accelerated aging results.

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

The document does not specify exact sample sizes for each test (e.g., how many batches were tested for viscosity, how many animals for biocompatibility). The studies are non-clinical (laboratory and in-vitro, with some in-vivo for biocompatibility) and relate to product quality and safety, not clinical efficacy in humans.

• Test Set Sample Size: Not explicitly stated for individual tests.
• Data Provenance: The testing appears to be conducted by the manufacturer as part of their regulatory submission. The country of origin for the data (where the tests were physically performed) is not specified, but the applicant (Suretex Limited) is in Thailand. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.

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

This information is not provided. For non-clinical tests like those described (e.g., viscosity, pH, microbial counts, biocompatibility), the "ground truth" is typically established by validated laboratory methods and adherence to international standards rather than expert consensus on interpretations of complex medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. This device is a personal lubricant, and the testing involves laboratory measurements and standard biological assays rather than human interpretation or adjudication of results in the way one might for diagnostic AI.

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

No, an MRMC comparative effectiveness study was not done. Such studies are typically for diagnostic devices, especially those involving human interpretation of imaging, to assess reader performance with and without an AI aid. This device is not a diagnostic AI.

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

Not applicable. This device is a physical product (personal lubricant), not an algorithm or AI. All performance tests are considered "standalone" in the sense that they evaluate the product itself against set specifications.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on:

• Established laboratory measurement standards: e.g., USP for Viscosity, USP for pH, USP for Osmolality, USP for Microbial Counts, USP for Pathogen Presence, USP for Antimicrobial Effectiveness.
• International biocompatibility standards: ISO 10993 series for Cytotoxicity, Sensitization, Vaginal Irritation, and Acute Systemic Toxicity.
• Condom compatibility standard: ASTM D7661-10(R) 2017.
• Manufacturer's defined specifications: for properties like appearance, color, and odor, which are then verified through testing.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device (a physical personal lubricant). The manufacturing process and formulation development might involve iterative testing, but this is not analogous to training an AI algorithm.

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

Not applicable, as there is no training set for this device.

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The Microthin Natural Rubber Latex Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The Microthin Natural Rubber Latex Condom is a male contraceptive made of natural rubber latex that completely covers the penis with a closely fitted membrane sheath. The condom is provided lubricated with silicone oil. The condom is straight-walled, with a smooth surface and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 170mm ± 10mm, width 52 ± 2mm, and thickness 0.035mm ± 0.005mm. The condom conforms to the recognized standards ASTM D3492-16 Standard Specification for Rubber Contraceptives (male condoms) and ISO 4074:2015 Natural Rubber Latex Condoms - Requirements and test methods. The condom has a 5-year shelf-life.

The provided text is related to a 510(k) premarket notification for a medical device (Microthin Natural Rubber Latex Condom). It details the device's characteristics, comparison to a predicate device, and summaries of non-clinical performance testing. However, it does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML powered medical device, which is what your request is specifically asking for.

The request asks for details about:

• A table of acceptance criteria and reported device performance (in the context of AI performance metrics like sensitivity, specificity, AUC).
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

None of this information is present in the provided document, as it is describing a physical product (a condom) and not an AI/ML device.

The document does mention "acceptance criteria" in the context of a physical product's performance validation (e.g., airburst specifications, biocompatibility), but these are not the kind of acceptance criteria you are asking for (which are relevant to AI/ML performance).

Therefore, I cannot fulfill your request for information related to an AI/ML powered medical device study based on the provided text.

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