(270 days)
pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide are personal lubricants, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
The pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide lubricants are non-sterile, silicone-based personal lubricants. These over-the-counter products are formulated to be clear, non-irritating, non-greasy, and odorless. The pjur® silicone based lubricants contains neither a contraceptive nor a spermicide.
The provided document is a 510(k) Premarket Notification for silicone-based personal lubricants (pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide). It describes the device, its intended use, and performance data from various tests. However, it does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested, which is typically associated with AI/ML device evaluations in a clinical context.
The document instead focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. The "performance data" section details the results of biocompatibility and condom compatibility testing, which are the types of tests conducted to support safety and effectiveness for this kind of medical device.
Therefore, many of the requested fields are not applicable or cannot be extracted from this specific document, as it pertains to a chemical-based product, not an AI/ML device requiring clinical study data, ground truth establishment, or human reader performance metrics.
Here's an attempt to answer based on the spirit of the request, interpreting "acceptance criteria" as the successful demonstration of safety standards for a personal lubricant, and explaining why other fields are not applicable:
Description of Acceptance Criteria and Device Performance for pjur® Group Silicone-Based Lubricants
This document describes the regulatory submission for personal lubricants, not an AI/ML device. Therefore, the "acceptance criteria" are related to established safety and performance standards for personal lubricants, primarily encompassing biocompatibility and condom compatibility, rather than typical AI/ML performance metrics like accuracy, sensitivity, or specificity against a clinical ground truth.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Regulatory Standards) | Specific Acceptance Criteria (Implied/Explicit from test results) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device must not be cytotoxic. Device must not be sensitizing. Device must not be irritating (intracutaneous, vaginal). Device must not show systemic toxicity. Device must not produce signs of allergenic potency. | Cytotoxicity: Not cytotoxic. Intracutaneous Irritation: Non-irritating. Sensitization: Non-sensitizing (sensitization rate: 0% in Guinea Pig Maximization Study). Vaginal Irritation: Non-irritating. Systemic Toxicity: No signs of systemic toxicity. Allergenic Potency: No signs of allergenic potency. "All test results were satisfactory and support that the subject device poses no undue biocompatibility risk." |
| Condom Compatibility | Device must be compatible with natural rubber latex condoms. Device must be compatible with polyurethane condoms. Device must be compatible with polyisoprene condoms. | Testing using ASTM D7661 demonstrated that the pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide lubricants are compatible with natural latex, polyurethane, and polyisoprene condoms. |
Details on the "Study" (Performance Testing)
The "study" in this context refers to the performance testing conducted to demonstrate the safety and effectiveness of the personal lubricants according to established medical device standards, primarily ISO 10993-1 and ASTM D7661.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of samples (e.g., animals for biocompatibility, lubricant batches for condom testing) used in each test. It refers to general testing procedures (ISO 10993-1, ISO 10993-10 for sensitization, ASTM D7661 for condom compatibility).
- Data Provenance: The document implies the data was generated specifically for this regulatory submission by the submitter (pjur group Luxembourg SA). The location of the testing laboratories is not specified, nor is the country of origin of the test materials (e.g., condoms, test chemicals). It is prospective testing for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the device is not an AI/ML algorithm or requires interpretation by human experts to establish "ground truth" in a diagnostic sense. The "ground truth" for these tests comes from established laboratory methodologies and measurements (e.g., absence of cell lysis for cytotoxicity, skin reaction scores for irritation, condom burst pressure for compatibility).
4. Adjudication method for the test set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in evaluating diagnostic AI outputs. The evaluation of lubricant performance is based on objective laboratory measurements against defined thresholds.
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 question is not applicable. This document describes a personal lubricant, not an AI/ML system, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a personal lubricant, not a standalone algorithm.
7. The type of ground truth used
- The "ground truth" for this device's performance is based on objective laboratory measurements and tests against established biological and material science standards. For example:
- Biocompatibility: In vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity) biological responses measured according to ISO 10993 series.
- Condom Compatibility: Physical properties of condoms (e.g., burst pressure, volume) measured after lubricant exposure according to ASTM D7661.
8. The sample size for the training set
- This question is not applicable. "Training set" refers to data used to train an AI/ML model. This document describes a physical product (lubricant) which does not have a training set in this context. The formulation development and optimization of the lubricant would have involved various experimental iterations, but these are not referred to as a "training set."
9. How the ground truth for the training set was established
- This question is not applicable for the same reasons as point 8.
§ 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.