(303 days)
The condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).
The device is a condom that is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, teat-ended, silicone-lubricated condom with nominal length 180 ± 2mm, nominal width 53.5 ± 2mm, and nominal thickness of 0.04 mm. This condom conforms to the recognized standards ASTM D3492-16 and ISO 4074:2015.
The provided text describes the 510(k) summary for the "Extremely Thin 003, ZERO ZERO THREE" male latex condom. It discusses the device's characteristics, its comparison to a predicate device, and performance testing data.
This document does not describe an AI/ML medical device. Therefore, a study proving an AI/ML device meets acceptance criteria, including specifics like sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, cannot be extracted from this text. The acceptance criteria and performance data pertain only to the physical properties and biological compatibility of condoms.
However, I can extract the acceptance criteria and reported device performance for the condom itself based on the provided text.
Acceptance Criteria and Device Performance (for the condom)
Based on the provided text, the device is a condom, not an AI/ML-driven medical device. Therefore, the acceptance criteria and performance data relate to the physical and biological properties of the condom.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Standard & Values) | Reported Device Performance |
|---|---|---|
| Biocompatibility | - Cytotoxicity: Per ISO 10993-5:2009 | Demonstrated to be biocompatible |
| - Sensitization: Guinea pig maximization sensitization testing per ISO 10993-10:2010 | Demonstrated to be biocompatible | |
| - Vaginal Irritation: Per ISO 10993-10:2010 | Demonstrated to be biocompatible | |
| - Acute Systemic Toxicity: Per ISO 10993-11:2006 | Demonstrated to be biocompatible | |
| Physical Testing | - Airburst specifications: Met ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods, and ASTM D3492:2016 - Standard Specification for Rubber Contraceptives (Male Condoms). | Met airburst specifications |
| Shelf-Life Stability | 5 years shelf-life. Per 21 CFR §801.435. All samples must meet predefined acceptance criteria. | All samples met predefined acceptance criteria. (5 years) |
| Dimensions (Nominal) | - Nominal Width: 53.2 ± 2 mm (Proposed Device Specification) | 53.2 ± 2 mm (implicitly met as per device specification) |
| - Nominal Length: 180 ± 10 mm (Proposed Device Specification) | 180 ± 10 mm (implicitly met as per device specification) | |
| - Nominal Thickness (30mm): 0.039 ± 0.0013 (Proposed Device Specification) | 0.039 ± 0.0013 (implicitly met as per device specification) | |
| - Nominal Thickness (90mm): 0.039 ± 0.001 (Proposed Device Specification) | 0.039 ± 0.001 (implicitly met as per device specification) | |
| - Nominal Thickness (150mm): 0.039 ± 0.001 (Proposed Device Specification) | 0.039 ± 0.001 (implicitly met as per device specification) | |
| Bursting Pressure | 1.42 ± 0.10 kPa (Proposed Device Specification) | 1.42 ± 0.10 kPa (implicitly met as per device specification) |
| Bursting Volume | 35.4 ± 3.83 dm3 (Proposed Device Specification) | 35.4 ± 3.83 dm3 (implicitly met as per device specification) |
Study Details (for the condom):
As the product is a condom and not an AI/ML device, the following points address what can be inferred or what is not applicable from an AI/ML perspective.
2. Sample size used for the test set and the data provenance:
* Sample Size: For physical testing, "Three lots of devices were tested at baseline." The specific number of condoms per lot is not stated. For biocompatibility, typical regulatory testing involves a sufficient number of samples as per the respective ISO standards, but the exact count is not provided.
* Data Provenance: Not explicitly stated, however, the testing was conducted to meet international (ISO) and US (ASTM, CFR) standards, implying a controlled laboratory environment typically adhering to Good Manufacturing Practices. The origin isn't specified (e.g., country), but it's for a US-marketed product. The data collection would be prospective, as it's part of the premarket submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not Applicable: For a condom, "ground truth" in the context of expert review (like for image interpretation) is not relevant. Performance is determined by objective physical and biological tests against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not Applicable: Adjudication methods are relevant for subjective assessments, typically in clinical readings or image interpretations. Condom performance is assessed through objective measurements against 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 an AI/ML related study type. The product is a physical device (condom).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not Applicable: This is an AI/ML related study type. The product is a physical device (condom).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for the condom's performance is established by objective measurements and chemical/biological assays according to recognized consensus standards (ASTM D3492-16, ISO 4074:2015, and ISO 10993 series) and regulatory requirements (21 CFR §801.435). This includes measurements for dimensions, bursting pressure/volume, and results from biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity).
8. The sample size for the training set:
* Not Applicable: This pertains to AI/ML model development. For a non-AI/ML device, there is no "training set."
9. How the ground truth for the training set was established:
* Not Applicable: This pertains to AI/ML model development. For a non-AI/ML device, there is no "training set" or corresponding ground truth establishment in this manner.
§ 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.