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The TROJAN™ Fire & Ice male natural rubber latex condom with lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).

The TROJAN™ Fire & Ice lubricated male natural rubber latex condom is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane, and a lubricant applied directly to the exterior of the condom that creates a perception of warming and cooling. The condom is bulbous shaped and smooth (no ribs) with a reservoir tip and meets the specifications of ASTM D3492-16. The condom has a nominal length of 185 mm and a nominal flat width of 54 mm, measured 30 mm from the open end. The bulbous part at the closed end of the condom has a flat width of 65 mm.

This document is a 510(k) Pre-Market Notification from the FDA regarding a new condom (TROJAN™ Fire & Ice lubricated male natural rubber latex condom). It is not a medical AI/software device and therefore does not contain information on acceptance criteria and validation studies for AI/ML algorithms.

The request asks for information relevant to the validation of a medical device software/AI, such as acceptance criteria, study methodologies, sample sizes for training and testing, ground truth establishment, expert qualifications, and MRMC studies. This type of information is found in clearances for AI/ML medical devices, which the provided document is not.

Therefore, I cannot fulfill the request using only the provided text. The document details the clearance of a physical medical device (a condom) and its non-clinical performance testing (physical testing, shelf-life, biocompatibility), which are entirely different from the validation of a software algorithm.

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The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).

The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a warming lubricant applied directly to the condom to create a perception of warming. The condom is a bulbous shaped condom with 11 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant meets the specifications of ASTM D3492-16. The condom has a nominal length of 185 mm and a nominal flat width of 54 mm, measured 30 mm from the open end. The bulbous part at the closed end of the condom has a flat width of 65 mm.

While the provided text describes the performance testing and safety testing conducted for the TROJAN™ Her Pleasure Warming male natural rubber latex condom, it does not explicitly use the term "acceptance criteria" in a structured table or provide a detailed study that directly proves the device meets specific acceptance criteria in the way a clinical trial or AI model validation study would.

Instead, the document details a 510(k) Premarket Notification for a medical device seeking substantial equivalence to a legally marketed predicate device. In this context, "acceptance criteria" are implicitly met by demonstrating that the device performs equivalently to established standards (ASTM D3492-16, ISO 4074:2015) and passes various safety evaluations (biocompatibility).

Here's an attempt to structure the information according to your request, acknowledging that some details, especially regarding a "study that proves the device meets acceptance criteria" in the context of AI or specific clinical efficacy endpoints, are not present for this type of device (a condom):

Acceptance Criteria and Device Performance for TROJAN™ Her Pleasure Warming Condom

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Physical Testing (Airburst): "Three (3) lots" of condoms were tested. No specific number of individual condoms per lot is provided.
• Shelf Life: The stability was established through "physical testing data using a protocol that followed 21 CFR §801.435 and met the requirements of both ASTM D3492-16 and ISO 4074:2015." The sample size (number of condoms tested over time) is not explicitly stated.
• Biocompatibility: The text lists several specific tests (e.g., Rabbit Vaginal Irritation, Guinea Pig Maximization Sensitization). The "sample size" for these biological tests typically refers to the number of animals or cell cultures used, which is not detailed in this summary.
• Data Provenance: Not explicitly stated, but given these are standard tests for medical device approval in the US, it's implied they were conducted in a controlled lab environment. It is not specified if the data is retrospective or prospective, but testing for device approval is inherently prospective relative to market entry.

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

This type of information is generally not applicable to the evaluation of a condom for physical and biological safety. The "ground truth" for condom performance is established by adherence to internationally recognized standards (ASTM D3492-16, ISO 4074:2015) and standard biocompatibility testing protocols, not by expert consensus on clinical readings or interpretations. Labs performing these tests are accredited to do so.

4. Adjudication Method for the Test Set:

Not applicable in the context of objective physical and biological tests. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where expert consensus is needed to establish a "ground truth" for complex diagnostic or treatment outcomes, often involving subjective interpretation (e.g., imaging reads). Here, results are pass/fail based on objective measurements and established thresholds.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic devices (like AI-assisted imaging software) to evaluate how AI impacts human reader performance. The device here is a physical contraceptive/prophylactic, not a diagnostic tool requiring human interpretation.

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

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

7. The Type of Ground Truth Used:

The "ground truth" for the performance of this device is based on:

• Objective Standards: Adherence to established international and national standards for rubber contraceptives (e.g., ASTM D3492-16, ISO 4074:2015) for physical properties like airburst and stability.
• Standardized Biocompatibility Protocols: Results from well-defined biological evaluations (ISO 10993 series) for cytotoxicity, irritation, sensitization, and acute systemic toxicity.

8. The Sample Size for the Training Set:

Not applicable. As a physical product, there is no "training set" in the machine learning sense. The development of the condom involves engineering, material science, and manufacturing processes, not algorithm training.

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

Not applicable, as there is no training set in the context of this device. The development and verification processes for condoms rely on established scientific and engineering principles, material specifications, and regulatory standards rather than machine learning ground truth establishment.

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CUPID Brand Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Not Found

This document is an FDA 510(k) clearance letter for CUPID Brand Male Natural Rubber Latex Condoms. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as one would typically find for a novel diagnostic device or AI algorithm.

The 510(k) pathway for condoms relies on demonstrating substantial equivalence to legally marketed predicate devices, meaning the product performs similarly to existing, cleared products. For condoms, this typically involves demonstrating compliance with recognized standards for physical properties, rather than a clinical study with acceptance criteria in the way a diagnostic AI would have.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily focuses on regulatory clearance based on substantial equivalence.

If this were a document for a software as a medical device (SaMD) or an AI-powered diagnostic device, the requested information would be crucial for its clearance. However, for a condom, the regulatory requirements and supporting data are different.

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The Trojan XOXO Intense Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The Trojan™ XOXO™ Intense Ribbed Natural Rubber Latex Male Condom with Silicone and Aloe Vera OE Lubricant [Trojan™ XOXO™ Intense Ribbed condom] is a natural rubber latex sheath, which completely covers the penis with a fitted membrane. A silicone base lubricant containing Aloe Vera OE is applied directly to the condom. The condom is a bulbous reservoir end shape and relies on ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male condom) and ISO 4074:2002 Natural Rubber Latex Condoms - Requirements and test methods. The condom has ribs on the shaft and bulb. The Trojan™ XOXO™ Intense Ribbed condom has a nominal length of 185 ± 10 mm, a nominal thickness 0.09 ± .01mm, nominal flat-width of 54 ± 2 mm measured 30 mm from the open end and 65±2 mm bulb flat width. The Trojan™ XOXO™ Intense Ribbed condom is individually packaged into a foil container. Multiple individually foiled condoms may be packaged in a carton.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility Testing: The specific sample sizes for each animal study (rabbit skin, vaginal, penile irritation, guinea pig sensitization) are not explicitly stated in the provided document, but implied by the ISO standards. The tests are prospective as they are performed on the new device according to established protocols.
• Physical Testing: "Three (3) lots" of the Trojan™ XOXO™ Intense Ribbed condom were tested. The data provenance is internal to the manufacturer's testing process. The document does not specify the country of origin of the data, but the testing conforms to international (ISO) and US (ASTM) standards.
• Shelf-Life Testing: The accelerated stability study was conducted on a sample of the product. The real-time stability study is ongoing. The specific sample sizes are not detailed in this summary.

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

Not applicable. This is a medical device (condom) and the assessment relies on standardized physical and biological performance tests, not on expert clinical interpretation of images or data. The "ground truth" is defined by the passing criteria of the specified international and national standards (ISO and ASTM).

4. Adjudication method for the test set

Not applicable. The tests are objective and based on measurable parameters defined by the ISO and ASTM standards. There is no subjective interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic or interpretive device.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

The ground truth for the device's performance is established by regulatory and industry standards. Specifically:

• Biocompatibility: ISO 10993 series standards.
• Physical Testing: ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms) and ISO 4074: Natural Rubber Latex Condoms Requirements and Test Methods.
• Shelf-Life: 21 CFR 801.435.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As noted above, there is no training set for this device.

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The Trojan XOXO Thin condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The Trojan™ XOXO™ Thin Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant [Trojan™ XOXO™ Thin condom] is a natural rubber latex sheath, which completely covers the penis with a fitted membrane. A silicone base lubricant containing Aloe Vera OE is applied directly to the condom. The condom is a straight wall nipple end shape consistent with ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male condom). The Trojan™ XOXO™ Thin condom has a nominal length of 180 ± 10 mm, a nominal thickness of 0.07 ± 0.01 mm, and a nominal flat- width of 52 ±2 mm, measured 30 mm from the open end.

The provided text describes the 510(k) premarket notification for the Trojan™ XOXO™ Thin Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant. It states that the device is substantially equivalent to a legally marketed predicate device (Trojan™ (TM-TBD) Latex Condom with Lubricant, K912901).

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

First, it's crucial to understand that this document describes a medical device (condom), not an AI or software device. Therefore, the questions related to AI-specific elements like "test set," "ground truth," "MRMC study," "standalone algorithm performance," and "training set" are not applicable to this submission. The "device" in this context is a physical product.

Acceptance Criteria and Device Performance (Physical Testing):

The document explicitly states that the Trojan™ XOXO™ Thin condom was tested against the specifications of ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms). This ASTM standard defines the acceptance criteria for male condoms, which typically include properties like burst volume and pressure, tensile strength, elongation, freedom from holes, and dimensions.

While the document doesn't list the specific numerical acceptance criteria from ASTM D3492-08 in a table, it does state the device's performance relative to that standard.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

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

   • Physical Testing: "Three (3) lots of Trojan™ XOXO™ Thin condom were tested and met specifications of ASTM D3492-08".
   • Biocompatibility Testing: The specific sample sizes for each biocompatibility test (e.g., number of rabbit subjects, guinea pigs, cell cultures) are not provided in this document. These would be defined within the respective ISO standards.
   • Data Provenance: The document does not explicitly state the country of origin, but it implies internal testing by Church & Dwight Co., Inc. and/or a contracted lab following international standards (ASTM, ISO). It is retrospective in the sense that the testing was completed before the 510(k) submission.

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

   • Not applicable in the context of AI. For a physical device like a condom, the "ground truth" is defined by the objective, measurable parameters outlined in the ASTM and ISO standards (e.g., laboratory measurements for dimensions, burst tests, biological responses). The "experts" would be the qualified laboratory technicians and scientists performing the tests and interpreting the results according to the standard protocols. Their qualifications are inherent in their ability to perform validated tests.

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

   • None in the sense of expert adjudication for an AI output. The adjudication for a physical device test involves meeting predefined numerical specifications or observed biological responses as per the established test methods.

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:

   • Not applicable. This device is a physical condom, not an AI system.

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

   • Not applicable. This device is a physical condom, not an AI system. The performance is the intrinsic performance of the physical product.

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

   • The "ground truth" for the physical characteristics and biocompatibility of the condom is based on objective, standardized measurements and observations as defined by:
     • ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms) for physical properties.
     • ISO 10993 series (e.g., ISO 10993-5, -10, -11) for biological evaluation of medical devices (biocompatibility).

7. The sample size for the training set:

   • Not applicable. There is no "training set" for a physical device in the AI sense. The manufacturing process of condoms involves quality control checks throughout production, but this is not analogous to an AI training set.

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

   • Not applicable. As above, there is no AI training set. The "ground truth" for ensuring manufacturing quality aligns with general quality system regulations (21 CFR Part 820) and specifications derived from standards like ASTM D3492-08.

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The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a glycol-based lubricant containing low levels of sensory ingredients applied directly to the condom to create a perception of warming and tingling. The condom is a bulbous shaped condom consistent with ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male condom) with a reservoir end. The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is designed with ribs on its shank and on its bulb. The condom has a nominal length of 185 mm and a maximum nominal flat-width of 54 mm, measured 30 mm from the open end. The bulbous portion at the closed end of the condom has a flat-width of 65 mm.

The provided text describes the regulatory filing for a male condom and does not contain information about a study proving that an AI-powered device meets acceptance criteria. The document discusses the substantial equivalence of a new condom product (TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant) to a predicate device, focusing on its physical characteristics, biocompatibility, and shelf-life, rather than AI performance.

Therefore, I cannot fulfill your request for the specific points related to acceptance criteria and an AI study, as this information is not present in the provided text.

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The Karex condom is used for contraceptive and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight sided or contoured , textured or non textured ,with a reservoir tip; nominal length 180mm, nominal width 53mm, and nominal thickness 0.07mm. It is nonlubricated or lubricated with silicone and cornstarch is used as a dressing material. The condom is either colored or non colored, flavored or non flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

The provided text describes a 510(k) premarket notification for a Male Natural Rubber Latex Condom, not a device that utilizes AI or requires complex studies with ground truth or expert adjudication to establish performance. The document focuses on demonstrating substantial equivalence to pre-existing predicate devices.

Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of regulatory submission. The performance criteria for a condom are physical and biological, verified through laboratory testing and material analysis, rather than clinical or AI-based assessments.

Here's how the information that is applicable can be extracted and presented, with explanations for the non-applicable sections:

Acceptance Criteria and Device Performance for Male Latex Condom

The acceptance criteria for this male latex condom are based on conformance to established national and international voluntary standards, specifically ASTM D3492 and ISO 4074, for its physical properties and biocompatibility. The performance is demonstrated by stating compliance with these standards and by establishing substantial equivalence to predicate devices that have already met these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. For physical and biocompatibility testing of condoms, various sample sizes would be used for each specific test (e.g., burst tests, tensile strength, cytotoxicity). These are typically defined by the standards (ASTM D3492, ISO 4074) themselves.
• Data Provenance: The device manufacturer, Karex Industries Sdn. Bhd., is based in Johor, Malaysia. The testing would have been conducted by or for this company, likely in Malaysia or accredited labs adhering to international standards. The evaluation of color pigments and flavorings is noted to have occurred "as part of the Predicate Device formulations," implying reliance on prior data or testing reports for those components.

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

Not applicable. For a male latex condom, "ground truth" is established through standardized laboratory testing against international specifications (ASTM, ISO), rather than expert consensus on clinical or imaging data. The experts involved would be engineers, chemists, and quality assurance specialists performing the tests according to the established protocols.

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

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to interpretation of complex data (e.g., medical images) by multiple human readers. For condom testing, results are objective measurements (e.g., burst pressure, elongation, presence/absence of cytotoxic effects) that either meet or fail the specified criteria.

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 medical device (condom) and not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

Not applicable. There is no algorithm involved in the performance of a latex condom.

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

The "ground truth" for this device is based on objective measurements from physical, chemical, and biological laboratory tests against the specific requirements and thresholds defined by international and national standards (ASTM D3492, ISO 4074, ISO 10993). This is analogous to a standard for a material property, rather than an interpretation of complex data.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable. As there is no training set for an AI model, this question is not relevant.

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The Karex condom is used for contraceptive and for prophylactic purposes ( to help prevent pregnancy and the transmission of sexually transmitted diseases).

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight walled, contoured or flared with a reservoir tip; nominal length 180mm, nominal width 53mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. The condom is colored and flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

The provided text describes a 510(k) summary for a male latex condom. It does not present a study with acceptance criteria and device performance results in the way a typical AI/software device would.

Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and adherence to established standards for safety and performance of condoms.

Therefore, many of the requested categories for AI/software devices (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding acceptance criteria and the methods used to show compliance for this specific device.

Acceptance Criteria and Reported Device Performance

For this male latex condom, the "acceptance criteria" are compliance with established national and international voluntary standards, and the reported "device performance" is its demonstration of conforming to these standards. The device is also evaluated for biocompatibility and oral toxicity of its components.

As this is a physical medical device (condom) and not an AI/software device, the following points are largely not applicable or cannot be extracted from the provided text.

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

• Not applicable in the context of AI/software testing. For physical devices like condoms, testing involves batch sampling and physical/chemical tests. The specific sample sizes for material conformance or performance tests (e.g., burst tests) are not detailed in this summary but would be part of the underlying design control documentation. The data provenance would be from manufacturing and testing facilities.

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

• Not applicable. Ground truth for a physical product's performance against industry standards is established through standardized testing methodologies, not expert consensus on interpretations.

4. Adjudication method for the test set:

• Not applicable. Standardized tests yield objective results (e.g., a burst pressure, a chemical concentration), not subjective interpretations requiring adjudication.

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 type of study is specific to AI-assisted human interpretation in diagnostic or screening tasks.

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

• Not applicable. There is no algorithm or software component described that would operate in a standalone manner.

7. The type of ground truth used:

• The "ground truth" here is compliance with established national and international voluntary standards (ASTM D3492, ISO 4074) for condom performance and biocompatibility and toxicity requirements (ISO 10993) for materials. This is based on objective measurements and established thresholds derived from scientific understanding and extensive testing in the field.

8. The sample size for the training set:

• Not applicable. There is no AI/machine learning component requiring a training set.

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

• Not applicable. There is no AI/machine learning component.

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THE [No particular brand name] condom is used for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Male Natural Rubber Latex Condom

This document discusses the FDA's acceptance of a 510(k) premarket notification for a male natural rubber latex condom. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Such information would typically be detailed in the 510(k) submission itself, which this letter is a response to, rather than the approval letter.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth, as none of that information is present in the provided text.

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The NRS Global Partners male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight sided, contoured or flared in shape, either textured or non-textured, with a reservoir tip; nominal length 180-mm, nominal width 53-mm, and nominal thickness 0.07mm. It is lubricated with silicone or Astroglide™, and USP grade cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074. This condom is identical to the predicate device with respect to design, physical properties, and formulation.

The provided document is a 510(k) premarket notification for a male latex condom. It is a regulatory submission for a medical device and, therefore, does not contain information about a clinical study with acceptance criteria, device performance, sample sizes, expert ground truth, or MRMC studies in the context of AI/algorithm performance.

Instead, the submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device (Innolatex Male Latex Condom; K002393). This typically involves showing that the new device has the same intended use and technological characteristics as the predicate device, and that any differences do not raise new questions of safety or effectiveness.

The "acceptance criteria" in this context would generally refer to the standards that the condom must meet (e.g., burst strength, freedom from holes) to be considered safe and effective, as outlined in recognized national and international voluntary standards like ASTM D3492 and ISO 4074. The "device performance" would be the results of testing conducted against these standards.

Here's how to interpret the request in the context of this document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074." and "The design is in conformance with ASTM Latex Condom Standard D3492 and that the condom is made of natural rubber latex."

This indicates that the acceptance criteria are defined by these standards. However, the specific quantitative pass/fail criteria (e.g., minimum burst volume, maximum number of holes per batch) and the actual test results (reported device performance) are not provided in this summary document. Such data would typically be found in the full 510(k) submission, not in the summary or the FDA's decision letter.

2. Sample Sizes Used for the Test Set and Data Provenance:
Not applicable in the context of an AI/algorithm study. The document only references conformance to standards, which would involve testing batches of condoms. No details are given about the number of condoms tested or their origin.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This is not a study involving expert annotation or ground truth generation in the way an AI study would.

4. Adjudication Method:
Not applicable.

5. MRMC Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:
For a latex condom, "ground truth" would be established through physical and mechanical testing against predefined standards (e.g., burst tests, leak tests, dimensional measurements, shelf-life studies). The document implies that such testing was done ("conformance with ASTM Latex Condom Standard D3492"), but does not detail the specific results or the methodology for establishing the "truth" beyond adherence to these standards.

8. Sample Size for the Training Set:
Not applicable. Condoms are not "trained" in the AI sense. The manufacturing process is validated and controlled, and batches are tested for quality.

9. How the Ground Truth for the Training Set Was Established:
Not applicable.

Summary based on the provided text:

The document states that the male latex condom is designed to conform to and is in conformance with ASTM D3492 and ISO 4074 voluntary standards. These standards define the acceptance criteria for various physical and mechanical properties of latex condoms (e.g., burst volume and pressure, dimensions, freedom from holes). However, the specific quantitative "acceptance criteria" from these standards and the "reported device performance" (i.e., the actual test results demonstrating conformance) are not detailed in this 510(k) summary. The submission's core assertion is that the device is "identical to the predicate device with respect to design, physical properties, and formulation," implying that its performance would be substantially equivalent and therefore also conform to these established standards.

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