(58 days)
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.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.