Search Results
Found 54 results
510(k) Data Aggregation
(90 days)
0.04 ZERO ZERO FOUR Male Latex Condom
0.04 Zero Zero Four Male Latex Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The 0.04 ZERO ZERO FOUR Male Latex Condom is a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The subject condom is smooth surfaced with a reservoir tip, silicone lubricated, with a nominal length of 180 mm, nominal flat width of 54 mm, and nominal thickness of 0.042 mm. This condom conforms to current established national standard ASTM D3492: 2016.
The provided text describes information for a K243584 submission of a male latex condom. However, it does not contain information regarding an AI/ML device or studies proving its performance against acceptance criteria. The acceptance criteria and studies described relate to the physical properties, shelf-life, and biocompatibility of the condom itself, not an AI system.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI device meets the acceptance criteria using the provided text.
Here's what the document does discuss regarding acceptance criteria and performance of the condom:
While the document does not relate to an AI device, here's a breakdown of the condom's acceptance criteria and performance based on the provided text:
1. A table of acceptance criteria and the reported device performance (for the condom):
| Acceptance Criteria (Standard / Test) | Reported Device Performance (0.04 ZERO ZERO FOUR Male Latex Condom) |
|---|---|
| Air Burst Test Pressure (ASTM D3492-16) | > 1.0 kPa (met specifications) |
| Air Burst Test Volume (ASTM D3492-16) | 17 dm^3 (met specifications) |
| Water Leakage | No leakage |
| Shelf Life | 5 years |
| Cytotoxicity (ISO 10993-5:2009) | Not cytotoxic |
| Vaginal Irritation (ISO 10993-23:2021) | Non-irritating |
| Guinea Pig Maximization Sensitization (ISO 10993-10:2021) | Non-sensitizing |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Not systemically toxic |
2. Sample size used for the test set and the data provenance:
- Physical Testing (Airburst, Water Leakage): "Three (3) lots" of condoms were tested. The specific number of condoms within each lot is not provided.
- Shelf Life: Not explicitly stated as a sample size for a test set, but stability was established from "physical testing data" over a 5-year period.
- Biocompatibility: The sample sizes for the specific biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity) are not provided in the summary.
- Data Provenance: Not specified, but generally, such testing is conducted by the manufacturer or a contract lab. The country of origin for the data is not mentioned. The data is retrospective in the sense that it's reported after the tests were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable as the studies relate to physical and biological testing of a condom, not the performance of an AI system where expert-established ground truth would be required. The "ground truth" here is objective measurements against established international and national standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML study involving human readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable as this is not an AI/ML comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For physical tests (Air Burst, Water Leakage), the ground truth is established by objective measurements against quantitative specifications defined in standards like ASTM D3492-16.
- For biocompatibility tests, the ground truth is established by the in vitro and in vivo biological responses observed in standardized tests, interpreted against the criteria of ISO 10993 series standards.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML product. There is no "training set" for a physical device like a condom.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML product.
Ask a specific question about this device
(90 days)
Male Latex Condoms
Ask a specific question about this device
(158 days)
FAMA Male Latex Condoms
The FAMA Male Latex Condoms are used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The FAMA Male Latex Condoms are single-use, non-sterile condoms made of a natural rubber latex sheath, which covers the penis with a closely fitted membrane. The condoms have a smooth, dotted or ribbed surface and have a straight-walled nipple-end (SWNE) style within specifications listed in ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms are lubricated with no colorants and fragrances added. The product is made of natural rubber latex, additives are sulfur, zinc oxide, promoter PX, promoter ZDC, antioxidant 264, stabilizer casein, and silicone oil as lubricant. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
The provided text is a 510(k) summary for the FAMA Male Latex Condoms, a medical device. This document details the device's technical specifications, intended use, and its comparison to a predicate device to establish substantial equivalence for FDA clearance.
Crucially, the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML medical devices, specifying aspects like sample size for test/training sets, expert ground truth establishment, MRMC studies, and standalone performance.
However, the FAMA Male Latex Condoms are not an AI/ML medical device. They are a physical product (condoms) whose performance is evaluated based on physical and biological properties (e.g., length, width, thickness, burst pressure/volume, biocompatibility, shelf-life), not on an algorithm's diagnostic or predictive capabilities.
Therefore, the specific information requested regarding AI/ML device testing (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance, and adjudication methods) is not applicable to this document. The "studies" mentioned in the document are physical and biological performance tests, not AI model evaluations.
Summary of Device Performance and Acceptance Criteria (as applicable to a physical device):
The document provides acceptance criteria and performance data for the FAMA Male Latex Condoms based on physical and biological testing to meet established standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (from referenced standards ISO 4074:2015 & ASTM D3492-16) | Reported Device Performance (from K220576 510(k) Summary) |
|---|---|---|
| Nominal Length | 180 ± 10 mm (ASTM D3492-16) | 180 ± 10 mm |
| Nominal Width | 53 ± 2 mm (ASTM D3492-16) | 53 ± 2 mm |
| Nominal Thickness (Plain) | (Specific range within standards) | 0.046 - 0.047 mm |
| Nominal Thickness (Dotted) | (Specific range within standards) | 0.068 - 0.069 mm |
| Nominal Thickness (Ribbed) | (Specific range within standards) | 0.074 - 0.075 mm |
| Burst Pressure | ≥ 1.0 kPa (ISO 4074:2015 & ASTM D3492-16) | ≥ 1.0 kPa |
| Burst Volume | ≥ 18 dm³ (ISO 4074:2015 & ASTM D3492-16) | ≥ 18 dm³ |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic | Met all requirements (non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic) |
| Shelf Life | Predefined acceptance criteria for stability (21 CFR 801.435) | 5 years (samples met predefined acceptance criteria) |
2. Sample size used for the test set and the data provenance:
- The document states that "The FAMA Male Latex Condoms were tested at baseline and met all the requirements of ISO 4074:2015 -Natural rubber latex male condoms – Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms)."
- For Biocompatibility, "Biocompatibility studies... were performed in accordance with... ISO 10993-1, -5, -10, -11."
- For Shelf-Life, "accelerated stability evaluations conducted as required in 21 CFR 801.435."
- Specific sample sizes for each test are not detailed in this 510(k) summary. These details would typically be found in the full test reports referenced by the standards (e.g., how many condoms were burst-tested).
- Data Provenance: The manufacturing entity is "Shanghai Personage Hygiene Products Co.,Ltd." located in Shanghai, China. The testing was conducted by or on behalf of this company, presumably according to international standards. The nature of the physical and stability testing is inherently prospective in the sense that the manufactured devices are subjected to these tests to evaluate their properties.
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 physical device. "Ground truth" for physical and biological properties is established by adherence to validated test methods and measurement protocols defined in international standards (ISO, ASTM, FDA regulations), not by expert consensus on interpretations of complex data like medical images.
4. Adjudication method for the test set:
- Not Applicable. As a physical device, testing involves quantitative measurements (e.g., length, burst pressure) and standardized biological assays, 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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physical properties (length, width, thickness, burst pressure/volume): The "ground truth" is defined by the objective, measurable parameters specified in the ASTM and ISO standards, measured using calibrated equipment and standardized test methods.
- For biocompatibility: The "ground truth" is established by the results of validated biological assays (e.g., cytotoxicity, sensitization, irritation, systemic toxicity tests) as per ISO 10993 series. These tests have defined endpoints and criteria for determining toxicity.
- For shelf-life: The "ground truth" is established through stability testing that demonstrates the device maintains its performance and safety characteristics over time under specified conditions, according to 21 CFR 801.435.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
In conclusion, the document successfully demonstrates that the FAMA Male Latex Condoms meet the required physical and biological acceptance criteria by adhering to recognized international standards and FDA regulations for medical devices, thereby establishing substantial equivalence to the predicate device. The detailed questions regarding AI/ML device performance are not relevant to this product.
Ask a specific question about this device
(274 days)
Male Latex Condom
The Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving a device meets any such criteria.
The document is an FDA 510(k) clearance letter for a "Male Latex Condom" (K203536). It states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. It also outlines regulatory requirements such as registration, labeling, and good manufacturing practices. The "Indications for Use" section specifies that the condom is for contraception and prophylactic purposes.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample sizes and data provenance
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Training set sample size and ground truth establishment
Ask a specific question about this device
(241 days)
Non-spermicidal Lubricated Male Latex Condom
Non-spermicidal Lubricated Male Latex Condoms are intended to prevent pregnancy, HIV/AIDS and other sexually transmitted infections.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a Non-spermicidal Lubricated Male Latex Condom. This type of device is subject to performance standards and does not typically involve the kind of AI-driven performance criteria, ground truth studies, or human-in-the-loop assessments described in your request. Your request is tailored for an AI/ML medical device, which this product is not.
Therefore, I cannot extract the information you requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI-specific performance metrics from this document because it is not relevant to a condom.
The document primarily focuses on:
- The device being substantially equivalent to a legally marketed predicate device.
- Compliance with general controls provisions of the Act (e.g., registration, labeling, good manufacturing practices).
- Indications for Use (preventing pregnancy, HIV/AIDS, and other STIs).
- Classification as an Over-The-Counter device.
To provide the information you're looking for, I would need a document related to an AI/ML-based medical device.
Ask a specific question about this device
(140 days)
Male Latex Condoms
The Latex Condom for Men is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
The Latex Condom for Men is a single-use, non-sterile condom made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is designed to conform to the standards including ASTM D3492 and ISO 4074. The condoms have either a smooth, dotted, or ribbed surface and have a straight walled nipple-end (SWNE) style within ASTM standard specifications D3492 Table 1 requirements, e.g., minimum length 160 mm, maximum width 54mm, and minimum thickness of 30μM.
The provided text describes a 510(k) premarket notification for a medical device: "Latex Condom for Men." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets individual acceptance criteria through a clinical trial or a multi-reader, multi-case study, which are typical for AI/CADe devices.
Therefore, the requested information elements related to AI/CADe studies (e.g., sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document as it pertains to a physical medical device (condom) and its regulatory approval based on material and performance standards.
However, I can extract the acceptance criteria and performance data that are presented in the context of this device.
1. A table of acceptance criteria and the reported device performance
The device's performance is demonstrated through adherence to recognized standards and specific physical properties. The acceptance criteria are implicit in the "Specification" column for the physical parameters and explicit in meeting the relevant ISO and ASTM standards.
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance (Latex Condom for Men) |
|---|---|
| Standards Met: | |
| ISO10993-5:2009 for determining cytotoxicity | Acceptance criteria met |
| ISO10993-10:2010 for determining sensitization | Acceptance criteria met |
| ISO10993-11:2006 for determining systemic toxicity | Acceptance criteria met |
| ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms) | Conforms to standard |
| ISO4074:2015 Natural rubber latex condoms – Requirements and test methods | Conforms to standard |
| Physical Parameters: | |
| Nominal Length | $180 \pm 10$ mm |
| Nominal Width | $52 \pm 2$ mm |
| Nominal Thickness | 0.06 - 0.07 mm |
| Primary Package Material | Aluminum film |
| Lubricant | Silicone oil |
| Dusting | Silicon dioxide |
| Intended Use | Contraception and prophylactic against STDs |
| Application | Single Use |
| Material | Natural rubber latex |
| Color | Natural |
| Packaging Method | Heat-sealing |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-clinical tests" but does not specify sample sizes or data provenance for these tests. It indicates the location of the manufacturer (Zhejiang, China) and the correspondent (Shanghai, China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is not a study requiring expert readers for ground truth determination, but rather laboratory testing against physical and chemical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The "tests" mentioned are non-clinical, laboratory-based evaluations of the condom's material properties and physical dimensions against established international standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document is for a physical medical device (condom), not an AI/CADe device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is for a physical medical device (condom), not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established international and national standards and specifications for natural rubber latex condoms (e.g., ASTM D3492-16, ISO 4074:2015, ISO10993 series for biocompatibility). The device's physical properties and material safety are evaluated against these objective, quantifiable criteria.
8. The sample size for the training set
This is not applicable. This document is for a physical medical device (condom) and does not involve AI or machine learning algorithms that require training sets.
9. How the ground truth for the training set was established
This is not applicable. This document is for a physical medical device (condom) and does not involve AI or machine learning algorithms that require training sets with associated ground truth.
Ask a specific question about this device
(242 days)
MALE LATEX CONDOM
Nulatex Natural Male Latex Condom is used for contraception and prophylactic purposes. (To help prevent pregnancy and transmission of sexually transmitted infection)
Not Found
The provided document is an FDA 510(k) premarket notification approval letter for a male latex condom. It does not contain information about the acceptance criteria and study data for a medical device's performance characteristics beyond the general statement of substantial equivalence to predicate devices.
Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document. This kind of information is typically found in the submission package that precedes the approval letter, which is not provided here.
Ask a specific question about this device
(295 days)
MALE LATEX CONDOM
The Nulatex Male Natural Rubber Latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Male Latex Condom. (No Particular Brand Name) Natural Smooth, Natural Ribbed, Natural Studded(Dotted), Natural 3 in 1, Natural ultrathin, Pink Smooth, Pink Ribbed, Pink Studded(Dotted),Pink 3 in 1, Pink Ultrathin with/or without Strawberry flavored.
The provided text is a 510(k) substantial equivalence determination letter from the FDA for a Male Latex Condom. It does not contain information about acceptance criteria, device performance, or a study report as typically found in submissions for AI/ML-powered medical devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document only confirms that the device is substantially equivalent to legally marketed predicate devices for contraception and prevention of sexually transmitted infections.
Ask a specific question about this device
(45 days)
BILLY BOY MALE LATEX CONDOM
The BillyBoy male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The BillyBoy condoms are Dotted/Beaded and New Condom models.
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. These condoms have a length of ≥175mm, a width of 52mm. The thickness is 0.10 mm. The air burst test pressure is ≥1 k Pa and air burst test volume is ≥18 dm. The primary packaging material is a foil package. The on surface lubricant is silicon oil. The term Dotted refers to the irregular surface of the condom. The irregular surface is not applied externally but is achieved in the molding process. The glass mold has an engraved pattern of semispherical pits replicated as a pattern of small round tips on the surface of the condom. This results in an exterior surface that has a pattern of small raised areas best described as a dotted pattern. The New Condom is defined as a condom of increased thickness relative to some of the other BillyBoy types.
The provided document describes a 510(k) summary for BillyBoy Dotted (Beaded) Condoms and BillyBoy New Condoms. This summary focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving a device meets acceptance criteria through a clinical study with human or image data. Therefore, many of the requested categories regarding clinical studies, expert involvement, and ground truth are not applicable to this type of regulatory submission.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document states that the device's performance was evaluated against specific standards. The acceptance criteria are essentially defined by these standards, and the reported performance is "passed all."
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D3492 (tensile force, elongation, tensile strength (before and after aging), bursting volume, bursting pressure, freedom from holes, microbiological cleanliness, length, wall thickness, visual characteristics) | Passed all |
| ISO 10993 (Biocompatibility) | Compliant with ISO 10993 |
| FDA's guidance for male latex condoms | Test plans developed to meet specified requirements |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact sample size used for the performance testing. It generally refers to "the devices" being evaluated.
- Data Provenance: The testing was conducted by MAPA GmbH in Zeven, Germany. The data provenance is from internal testing reports and certificates. The studies were likely prospective, as they involved testing newly manufactured condoms to ensure compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a physical device (condom), and its performance is assessed against engineering and biological standards, not through expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Performance testing for condoms involves objective measurements and adherence to specifications, not adjudications by experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the specified requirements and methodologies outlined in the ASTM D3492 standard for male latex condoms and the ISO 10993 standard for biocompatibility. These standards define the acceptable physical and biological properties.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. No training set exists for this device.
Ask a specific question about this device
(125 days)
BILLY BOY MALE LATEX CONDOM
The Billy Boy condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The condoms are available in Cylindrical shape, in transparent color and with Nivesse aroma. The models include the BillyBoy, BillyBoy Scented, BillyBoy Special Comfort and BillyBoy Extra Lubricated.
The BillyBoy condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is Cylindrical. These condoms have a length of 175 -185mm ±10mm, a width of 52.0 -55.0 mm ±2.0mm. The thickness is 0.04-0.08 mm. The air burst test pressure is ≥1 k Pa and air burst test volume is ≥18 dm². The primary packaging material is a foil package. The on surface lubricant is silicon oil.
The provided document describes the acceptance criteria and a study demonstrating that the Billy Boy Male Latex Condoms meet those criteria, primarily through compliance with ASTM D3492.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Billy Boy Male Latex Condoms are defined by their compliance with ASTM D3492, which is the standard for male latex condoms. The reported device performance is that the condoms passed all required specifications of this standard.
| Acceptance Criteria (Defined by ASTM D3492) | Reported Device Performance (Billy Boy Male Latex Condoms) |
|---|---|
| Compliant with ASTM D3492 | Passed all required specifications of ASTM D3492 |
| Air burst test pressure ≥ 1 k Pa | ≥ 1 k Pa (stated as characteristic, implicitly passed) |
| Air burst test volume ≥ 18 dm² | ≥ 18 dm² (stated as characteristic, implicitly passed) |
Additionally, specific dimensional characteristics are detailed and compared to predicate devices for substantial equivalence:
| Characteristic | ASTM D3492/Predicate Criteria (examples) | Billy Boy Performance |
|---|---|---|
| Length | 160mm (Twin Lotus), 195mm (Kimono Maxx), 205mm (Trojan Her Pleasure) | 175 - 185mm ±10mm (BillyBoy), ≥ 175 mm (Special Comfort) |
| Width | 52 ± 2mm (Twin Lotus), 52mm (Kimono Maxx), 55mm (Trojan Her Pleasure) | 52.0 - 55.0 mm ±2.0mm (BillyBoy), (55 ± 2) mm (Special Comfort) |
| Thickness | 0.08 ± 0.01 mm (Twin Lotus), 0.07 mm (Kimono Maxx) | 0.04-0.08 mm |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "BillyBoy condoms were tested to the standard and passed all required specifications." However, it does not specify the sample size used for this functional testing.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the device is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for condom performance is established by objective physical testing against a recognized standard (ASTM D3492).
4. Adjudication Method for the Test Set
This information is not applicable for physical device testing against a standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable as this is not an AI/imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical device and not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on objective performance measurements against established engineering and material standards, specifically ASTM D3492 for male latex condoms. This standard covers physical properties such as dimensions, air burst pressure and volume, and biocompatibility.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI device that requires a training set. The manufacturing process of condoms involves quality control and testing, but these are not referred to as "training sets" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is not an AI device.
Ask a specific question about this device
Page 1 of 6