(205 days)
LifeStyles® Smooth™ 2-in-1 Massage & 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. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
LifeStyles® Smooth™ 2-in-1 Massage & Lubricant is a non-sterile, water-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a non-staining, non-sticky, biocompatible gel-like liquid, with a strawberry aroma, that is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser
The provided text describes a 510(k) submission for a personal lubricant, not an AI-powered medical device. Therefore, the questions related to AI device performance, training sets, ground truth, expert opinions, and MRMC studies are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through various physical, chemical, and biological compatibility tests.
If this were an AI medical device submission, the following information would be required:
Acceptance Criteria and Device Performance for an AI-Powered Medical Device
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| [Specific AI Metric 1] | [Threshold/Range for Metric 1] | [Actual Device Performance for Metric 1] |
| [Specific AI Metric 2] | [Threshold/Range for Metric 2] | [Actual Device Performance for Metric 2] |
| [Specific AI Metric 3] | [Threshold/Range for Metric 3] | [Actual Device Performance for Metric 3] |
| (Add more rows as needed for all relevant metrics) |
2. Sample Size and Data Provenance
- Test Set Sample Size: [Number] of cases (e.g., images, patient records).
- Data Provenance:
- Country of Origin: [List of countries where data was collected]
- Retrospective/Prospective: [State whether the data was retrospective, prospective, or a mix of both. If mixed, specify proportions or characteristics of each.]
3. Experts for Ground Truth Establishment
- Number of Experts: [Number]
- Qualifications of Experts: [Detailed qualifications for each expert or group of experts, e.g., "Board-certified radiologists with an average of 15 years of experience in oncologic imaging, including sub-specialty training in breast MRI interpretation."]
4. Adjudication Method for Test Set Ground Truth
- Adjudication Method: [Describe the method used, e.g., "2+1 consensus (two initial reads, third expert resolves disagreement)," "3+1 (three initial reads, majority rules, fourth expert resolves persistent disagreement)," "Majority vote," "No adjudication, single expert reads."]
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? [Yes/No]
- If Yes:
- Effect Size of Human Reader Improvement (AI vs. Without AI Assistance): Human readers showed an improvement of [Quantifiable metric, e.g., "X% increase in AUC," "Y reduction in false positives per case," "Z% increase in sensitivity while maintaining specificity"] when assisted by AI compared to unassisted reads.
6. Standalone Algorithm Performance
- Was a standalone (algorithm only) performance study done? [Yes/No]
- If Yes, Report Standalone Performance: [Report relevant metrics for the algorithm alone, e.g., "Standalone sensitivity was X% and specificity was Y%," "Standalone AUC was Z."]
7. Type of Ground Truth Used
- Type of Ground Truth: [Specify the definitive source of truth for the test set, e.g., "Expert consensus," "Histopathology/Pathology results," "Longitudinal patient outcomes data," "Clinical follow-up," "Hybrid (e.g., expert consensus confirmed by pathology for a subset)."]
8. Training Set Sample Size
- Training Set Sample Size: [Number] of cases.
9. Ground Truth Establishment for Training Set
- Method for Establishing Ground Truth: [Describe how the ground truth for the training data was established. This can be similar to the test set ground truth methods but often involves more automated or scalable approaches, e.g., "Labeling by expert radiologists (same qualifications as test set experts)," "Programmatic labeling based on EMR data and pathology reports," "Crowdsourcing with expert review," "Hybrid approach combining automated extraction with targeted expert review."]
§ 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.