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Found 38 results
510(k) Data Aggregation
(88 days)
Church & Dwight Co., Inc.
The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) is made of a natural rubber latex sheath, which covers the penis with a fitted membrane. A silicone-based lubricant is applied directly to the condom during packaging. The condom is a bulbous shaped condom with 7 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The condom meets the specifications of ASTM D3492-16. The condom has a nominal length of 200 mm, a nominal thickness of 0.095 mm, nominal flat widths of 53 mm measured 30 mm from the open end and 71 mm at the bulbous, closed end, and 800 mg of silicone lubricant per condom. The condoms are packaged in individually sealed laminate (plastic inner layer, foil middle layer, and cellophane outer layer). The foils are packaged in an outer consumer cardboard carton.
This document is a 510(k) Premarket Notification from the FDA regarding a condom. It does not describe an AI/ML device or its performance studies. Therefore, it is impossible to answer the request for information on acceptance criteria and study details for an AI/ML device based on the provided text.
The request asks for:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
None of this information is contained within the provided document, as it pertains to a physical medical device (condom) and not a software or AI/ML device. The document focuses on physical characteristics, biocompatibility, and adherence to established standards for condoms.
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(244 days)
Church & Dwight Co., Inc.
The TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
The TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is made of a styrene-isoprene-styrene copolymer sheath, which covers the penis with a fitted membrane, and a silicone lubricant applied directly to the exterior of the condom. The condom is straight-walled, smooth, and has a nipple end. The condom has a nominal length of 185 mm, a nominal flat width of 55 mm, a nominal thickness of 0.065 mm, and conforms to the requirements of ISO 23409:2011(E).
The provided text is related to the FDA 510(k) summary for a condom device (TROJAN SIS Synthetic Latex Condom). It details the device's characteristics, comparison to a predicate device, and summaries of non-clinical and clinical performance testing. However, the request asks for information pertaining to an AI/Software as a Medical Device (SaMD), specifically regarding its acceptance criteria and the study proving it meets these criteria.
The document discusses physical testing and a clinical trial for a physical medical device (condom), not an AI/SaMD. Therefore, many of the requested elements (e.g., number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to the content provided.
Based on the provided text, I can extract the acceptance criteria and study results for the condom's clinical performance, but it will not align with the implied AI/SaMD context of the questions.
If we interpret the request strictly for the provided information (condom device), here's the breakdown:
The document describes a clinical study (NCT05370196) to evaluate the performance of the TROJAN SIS Synthetic Latex Condom with Silicone Lubricant.
Acceptance Criteria and Device Performance (for the Condom)
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Non-Inferiority Limit) | Reported Device Performance (Upper Bound of one-sided 95% CI of difference, SIS - NRL) | Met Criteria? |
|---|---|---|---|
| Total Clinical Failure | Upper limit of 1-sided 95% CI of (SIS rate - NRL rate) ≤ 2.5% | 1.70% | Yes |
| Clinical Breakage | Upper limit of 1-sided 95% CI of (SIS rate - NRL rate) ≤ 2.0% | 1.67% | Yes |
| Clinical Complete Slippage | Upper limit of 1-sided 95% CI of (SIS rate - NRL rate) ≤ 2.0% | 0.44% | Yes |
Note: The reported performance values in the table are the upper bounds of the one-sided 95% confidence intervals for the difference in failure rates between the subject device (SIS) and the control (NRL). The primary objective was non-inferiority, meaning the SIS condom rate should not be significantly worse than the NRL control by more than the specified margin.
2. Sample size used for the test set and the data provenance:
- Test Set (Clinical Study Population):
- Couples enrolled: 300
- Couples completed study: 289
- Total condom uses contributing to analysis: 1,129 SIS condom uses and 1,130 NRL control condom uses.
- Data Provenance: Clinical trial conducted in California, USA. The study is described as a "randomized crossover clinical trial". This indicates a prospective data collection design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to this study. The "ground truth" for condom failure (breakage, slippage) was established by self-reports from the study participants (couples) during actual use, not by expert review of data/images.
4. Adjudication method for the test set:
Not applicable in the context of this condom study, as outcomes were self-reported failures rather than 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 was a study comparing two physical condom types, not an AI-assisted interpretation study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This refers to an AI algorithm's performance, which is not relevant to this device.
7. The type of ground truth used:
- Based on: Clinical self-reports of condom breakage and complete slippage during actual use by couples. This is a form of outcomes data from a user perspective.
8. The sample size for the training set:
- Not applicable. This device is a physical product (condom), not an AI algorithm that requires a training set. The study was a clinical performance evaluation.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical device.
In summary, the provided document details the performance testing and clinical study for a physical condom device, not an AI/Software as a Medical Device. Therefore, many of the questions related to AI/SaMD specific methodologies (like expert adjudication, MRMC, training sets, etc.) are not addressed in the text.
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(90 days)
Church & Dwight Co., Inc.
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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(58 days)
Church & Dwight Co., Inc.
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:
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit from Standards/Tests) | Reported Device Performance |
|---|---|---|
| Physical Performance | Airburst specifications (ASTM D3492-16) | Met airburst specifications of ASTM D3492-16 at baseline. |
| Shelf Life/Stability | Compliance with ASTM D3492-16 and ISO 4074:2015 over time; FDA expiration labeling requirements (21 CFR §801.435) | Initial expiration date set at 36 months, to be verified through real-time stability for 5 years. Results of physical testing data demonstrated stability. |
| Biocompatibility | Non-cytotoxic (ISO 10993-5) | Passed (results demonstrate biocompatibility). |
| Non-irritating (Rabbit Vaginal, Rabbit Penile, Primary Rabbit Skin Irritation) (ISO 10993-10) | Passed (results demonstrate biocompatibility). | |
| Non-sensitizing (Guinea Pig Maximization Sensitization) (ISO 10993-10) | Passed (results demonstrate biocompatibility). | |
| Non-acutely toxic (Acute Systemic Toxicity) (ISO 10993-11) | Passed (results demonstrate biocompatibility). | |
| Intent to Market | Substantial Equivalence to Predicate Device | Determined substantially equivalent (same intended use, indications for use, product code, dimensions, shelf-life, primary packaging; technological differences in rubber/lubricant formulations do not raise new safety/effectiveness questions as they match cleared reference devices). |
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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(164 days)
Church & Dwight Co., Inc
Replens Long-Lasting Vaginal Moisturizer is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to 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.
Replens Long-Lasting Vaginal Moisturizer is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. It is a smooth, white, homogenous vaginal gel packaged with a reusable applicator. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water, Glycerin, Mineral Oil, Polycarbophil, Carbomer Homopolymer Type B, Hydrogenated Palm Oil Glyceride, Sorbic Acid, Benzyl Alcohol, Ethylhexylglycerin, tocopherol, and Sodium Hydroxide. Replens Long-Lasting Vaginal Moisturizer is packaged in a 35g aluminum tube (14 applications), with a reusable two-piece, blue translucent, polyethylene applicator designed to dispense 2.5g of lubricant.
The reusable applicator is packaged with an over-wrap in clear, biaxially oriented polypropylene film. The subject device and applicator are packaged together in a carton with a consumer leaflet.
The provided document is a 510(k) Pre-market Notification from the FDA regarding a medical device, the Replens Long-Lasting Vaginal Moisturizer. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with a test set, expert ground truth, or MRMC studies.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or reader improvement) are not applicable to this type of regulatory submission. The goal here is to show that the new device is as safe and effective as the predicate device, primarily through non-clinical performance testing and comparison of technological characteristics.
However, I can extract information related to what is presented as "acceptance criteria" in the context of this submission, which are primarily product specifications and performance testing results.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents product specifications as the "acceptance criteria" for the device itself, rather than acceptance criteria for a diagnostic algorithm's performance. The "reported device performance" is essentially that the device meets these specifications.
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Implied by "demonstrated that the device can maintain its specifications") |
|---|---|---|
| Appearance | White to off-white smooth homogenous gel | Met |
| Odor | Odorless | Met |
| Viscosity | 30,000 - 130,000 cPs | Met |
| pH | 2.5 - 3.5 | Met |
| Osmolality | 1200 - 2000 mOsm/Kg | Met |
| Total Aerobic Microbial Count (TAMC) |
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(223 days)
Church & Dwight Co., Inc.
Pre-Seed™ Fertility Lubricant is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Pre-Seed™ Fertility Lubricant is compatible with sperm, oocytes, and can be used by trying to conceive couples. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
Pre-Seed™ Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
Pre-Seed™ Fertility Lubricant is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubrication. The product is also compatible with sperm, oocytes, and embryos, can be used by trying to conceive couples, and can also be used to lubricate diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
Pre-Seed™ Fertility Lubricant is packaged in a High-Density Polyethylene tube with a Polypropylene closure. A foil seal is present over the tube opening under the cap closure. The provided with single-use, piston type, Low Density Polyethylene applicators for delivering the product to the vagina.
The provided document is a 510(k) summary for the Pre-Seed™ Fertility Lubricant. It details the device's characteristics, indications for use, comparison with a predicate device, and the non-clinical performance data used to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Specification | Recommended Acceptance Criteria | Reported Performance (Pre-Seed™ Fertility Lubricant) |
|---|---|---|
| Appearance/Color | Hazy, colorless to slightly yellow, viscous liquid | Met acceptance criteria during shelf-life testing |
| Odor | Characteristic, no off odor (25 °C ± 2) | Met acceptance criteria during shelf-life testing |
| pH | 7.0-7.4 | Met acceptance criteria during shelf-life testing |
| Osmolality | 260-370 mOsm/kg | Met acceptance criteria during shelf-life testing |
| Viscosity | 2800-11500 cps | Met acceptance criteria during shelf-life testing |
| Total Aerobic Microbial Count (TAMC) - USP and | and | |
| Antimicrobial Effectiveness - USP | Bacteria: Not less than 2.0 log reduction from the initial count at 14 days. No increase from 14 days count to 28 days. Yeast & Mold: not increase from the initial calculated count at 14 and 28 days. | Met acceptance criteria during shelf-life testing |
| Endotoxin |
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(131 days)
Church & Dwight Co., Inc
Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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.
The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a hydrous, clear water-based personal lubricant with aloe and vitamin E that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is a clear, colorless viscous gel. The lubricant formula is thickened using sodium hyaluronate and hydroxyethylcellulose. It contains a pH buffer system to maintain a slightly acidic pH of 5.9 to 6.9, and is preserved using Symocide pH (Phenoxyethanol, Hydroxyacetophenone, Caprylyl Glycol, and Water).
The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) may be packaged in two (2) types of polyethylene terephthalate (PET) bottles. One bottle (PET), 5.5 fl. oz. with a screw on, flip-top polypropylene (PP) closure. An induction seal will be placed over the bottle. The second bottle (PET), 4.5 fl. oz., will be the same bottle material with a pump in the bottle. The pump and nozzle will be made of the same material as the flip-top cap (PP). The pump bottle will have a shrink band over the pump.
This document, K180764, is a 510(k) Premarket Notification for a personal lubricant, Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant). It is not a medical imaging AI device, and therefore does not contain information related to AI model training, testing, or human reader studies.
The acceptance criteria and performance data provided in this document pertain to the physical, chemical, and biological properties of the personal lubricant, and its compatibility with condoms, as well as its shelf life.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets those criteria, as this document is for a non-AI medical device.
However, I can extract the acceptance criteria and performance data relevant to this specific device (personal lubricant) as presented in the document.
Acceptance Criteria and Reported Device Performance (for Trojan™ Azul Personal Lubricant):
| Parameter | Acceptance Criteria (K180764 / Subject Device) | Reported Device Performance (K180764 / Subject Device) |
|---|---|---|
| Appearance | Clear Gel | Clear Gel |
| Color | Clear and colorless | Clear and colorless |
| Odor | Characteristic odor | Characteristic odor |
| pH | 5.9-6.9 | 5.9-6.9 |
| Viscosity | 1500-7500 | 1500-7500 |
| Osmolality | 250 - 550 (S001) | 250 - 550 (S001) |
| Antimicrobial Effectiveness | Meets Requirement | Meets Requirement |
| Total Aerobic Microbial Count (TAMC) |
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(57 days)
Church & Dwight Co., Inc
The Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
The Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a silicone-based lubricant containing low levels of sensory ingredients applied directly to the condom to create a perception of warming, cooling, and/or tingling. 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™ Chain Reaction Natural Rubber Latex Condom with Sensate 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 portion at the closed end of the condom has a flat-width of 65 mm.
The provided document is a 510(k) summary for a medical device, specifically a natural rubber latex condom. The document describes the device, its intended use, comparison to a predicate device, and performance testing.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
Important Note: The device described is a medical device (condom) and the performance testing focuses on biocompatibility, physical strength (airburst), and shelf-life, which are typical for such devices. This is not a software/AI-based device, therefore, many of the questions related to AI performance, human reader studies, ground truth for AI, etc., are not applicable to this document. The answers will reflect this.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Cytotoxicity (ISO 10993-5) | "The results of testing demonstrate that the subject device is biocompatible." (Specific values/pass/fail stated as 'biocompatible' rather than numerical) |
| - Rabbit Vaginal Irritation (ISO 10993-10) | "The results of testing demonstrate that the subject device is biocompatible." |
| - Rabbit Penile Irritation (ISO 10993-10) | "The results of testing demonstrate that the subject device is biocompatible." |
| - Primary Rabbit Skin Irritation (ISO 10993-10) | "The results of testing demonstrate that the subject device is biocompatible." |
| - Guinea Pig Maximization Sensitization (ISO 10993-10) | "The results of testing demonstrate that the subject device is biocompatible." |
| - Acute Systemic Toxicity (ISO 10993-11) | "The results of testing demonstrate that the subject device is biocompatible." |
| Physical Testing (Airburst): | |
| - Meet airburst specifications of ASTM D3492-16 Standard Specifications for Rubber Contraceptives (Male Condoms) | "Three (3) lots of Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant were tested at baseline and met airburst specifications of ASTM D3492-16 Standard Specifications for Rubber Contraceptives (Male Condoms)." (Specific quantitative airburst values or thresholds are not provided in this summary, but the report explicitly states the criteria were met). |
| Shelf Life/Stability: | |
| - Establish expiration date based on physical testing data following 21 CFR §801.435 as a guide | "Based on the evaluation of the results of the physical testing data, the expiration date has been initially set at 36 months and will be then verified through real-time stability through five (5) years in compliance with FDA expiration labeling requirements in 21 CFR §801.435." |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility: The specific number of animals (rabbits, guinea pigs) used for the tests is not detailed in this summary, but standard ISO 10993 protocols would involve a defined minimum number of animals. The data provenance would be laboratory testing conducted for C&D Co.
- Physical Testing (Airburst): "Three (3) lots" of condoms were tested. The exact number of condoms per lot is not specified, but implied to be sufficient for ASTM testing. Data provenance is laboratory testing.
- Shelf Life: Testing was ongoing to support 36-month initial dating, with real-time stability through five years. The sample size for this ongoing testing is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable as the device is a physical medical device (condom), not an AI/software device requiring expert interpretation for ground truth. The "ground truth" for this device lies in objective physical and biological test results (e.g., cell viability for cytotoxicity, physical airburst pressure, etc.) against established ASTM and ISO standards.
4. Adjudication Method for the Test Set
This question is not applicable as the tests performed are objective, laboratory-based physical and biological assays with defined pass/fail criteria according to international standards (ISO, ASTM). There is no "adjudication" between multiple human reviewers of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
This question is not applicable. MRMC studies are relevant for imaging or diagnostic devices where human readers interpret outputs, often with and without AI assistance, to assess changes in diagnostic accuracy. This is a physical condom, not an AI diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable. The device is a physical condom, not an algorithm. Therefore, no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
The ground truth used for this device's testing is based on:
- International Standards: Specific criteria defined in ISO 10993 series for biocompatibility and ASTM D3492-16 for physical condom properties (like airburst).
- Laboratory Measurements: Objective measurements derived from these standardized tests, which are interpreted directly against the standard's specifications (e.g., a certain pressure must be withstood, a certain level of cell viability or irritation score must not be exceeded).
8. The Sample Size for the Training Set
This question is not applicable. This is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of device.
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(60 days)
Church & Dwight Co., Inc.
The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.
The TROJAN SUPRA™ Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricated coating. The condom is a straight-walled, non-textured, nipple-end condom with a nominal length of 190 mm and a nominal flatwidth of 58 mm. This product has a 5-year shelf-life.
The provided text describes a 510(k) submission for a male condom, which is a Class II medical device. The submission focuses on a change to the device's labeling regarding personal lubricant compatibility. This type of device and submission does not fit the typical framework of AI/ML-driven diagnostic devices that would have the requested "acceptance criteria" and "study" details (e.g., test sets, ground truth, expert opinions, MRMC studies).
The information provided pertains to the regulatory review of a medical device (a condom) and its safety and effectiveness. The "performance testing" described is related to the physical properties of the condom and its compatibility with lubricants, not the diagnostic accuracy of an AI algorithm.
Therefore, many of the requested fields cannot be answered from the provided text as they are not applicable to this type of device and submission.
Here's an attempt to answer the applicable parts based on the input:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table format as one might see for an AI algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it implicitly refers to adherence to standards for condom performance. The primary "performance testing" mentioned is for lubricant compatibility.
| Acceptance Criteria (Implicit from standards/predicate device) | Reported Device Performance (Subject Device) |
|---|---|
| Burst volume (expected to be similar to predicate) | 9.4 dm³ |
| Burst pressure (expected to be similar to predicate) | 10.31 kPa |
| Compatibility with cleared personal lubricants | Results did not support all personal lubricants are compatible; permissible with FDA-cleared lubricants labeled for polyurethane condoms. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated. The document mentions "Condom compatibility testing was performed on Polyurethane condoms (subject device) with current commercial lubricant per ASTM D7661-10." The ASTM standard, if referenced, would contain details on sample size, but it's not provided here.
- Data provenance: Not explicitly stated. Likely laboratory testing of manufactured condoms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The testing relates to physical properties (burst, lubricant compatibility) measured against an ASTM standard, not interpretation by human experts.
4. Adjudication method for the test set:
Not applicable and not provided. The testing involves physical measurements, not expert review or 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 device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
The "ground truth" here would be defined by the physical specifications and performance requirements for condoms as established in standards (e.g., ASTM D7661-10) and regulatory guidelines, rather than expert consensus, pathology, or outcomes data in the context of diagnostic algorithms.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device that requires a training set.
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(59 days)
CHURCH & DWIGHT CO.,INC.
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
| Test Performed | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Biocompatibility: Cytotoxicity ISO Elution Method | Adherence to ISO 10993-5 (2009) | Passed |
| Biocompatibility: Acute Systemic Toxicity | Adherence to ISO 10993-11 (2006) | Passed |
| Biocompatibility: Primary Rabbit Skin Irritation | Adherence to ISO 10993-10 (2010) | Passed |
| Biocompatibility: Rabbit Vaginal Irritation | Adherence to ISO 10993-10 (2010) | Passed |
| Biocompatibility: Rabbit Penile Irritation | Adherence to ISO 10993-10 (2010) | Passed |
| Biocompatibility: Guinea Pig Maximum Sensitization | Adherence to ISO 10993-10 (2010) | Passed |
| Physical Testing | Met specifications of ASTM D3492-08 and ISO 4074 | Met specifications for all three tested lots |
| Shelf Life (Accelerated Stability Study) | Provide a 3-year (36 month) shelf-life | Found to have a 3-year (36 month) shelf-life |
| Shelf Life (Real-time Stability Study) | Verify 5-year (60 month) expiration dating (ongoing) | Will be verified according to 21 CFR 801.435 (ongoing) |
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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