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The FIRST RESPONSE® One-Step Digital Pregnancy Test is an in vitro diagnostic test device that incorporates a digital read out of the test result for the early detection of pregnancy (hCG in urine) by the lay user prior to the expected menses

The FIRST RESPONSE® One-Step Digital Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is a device intended for use by the lay user in the early detection of pregnancy by the detection of hCG, a placental hormone in urine. The FIRST RESPONSE® One-Step Digital Pregnancy Test labeling provides for the use of the test as early as three (3) days before the expected period. [Refer to K992232.] The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions via component reagents that are striped onto a chromatographic strip contained within a plastic housing, which is integral with the digital component that reads and displays. the result of the immunochemical reaction on the Display Screen of the device housing, as opposed to an analog display of the predicate device. The immunochemical reagents that are striped onto a chromatographic strip are unchanged from the predicate FIRST RESPONSE® One-Step Pregnancy Test.

Following the instructions for use provided with the device, the test is performed by placing the Absorbent Tip into the urine stream (alternatively a cup of urine may be used) for 5 seconds, then allowing the test to continue for 3 minutes. During this time, a blinking clock icon appears on the Display Screen of the device housing to indicate that the test is working. After the elapse of 3 minutes, a digital display of the result appears on the Display Screen: a "YES+" test result indicates that the pregnancy hormone (hCG) was detected (pregnant); a "-- NO" test result indicates that the pregnancy hormone (hCG) was not detected (not pregnant). A " ? " (question mark) appears when a test error has occurred.

This document describes the FIRST RESPONSE® One-Step Digital Pregnancy Test (K040866). While it provides details on the device, its intended use, and technological characteristics, it does not contain the specific acceptance criteria or the study data that proves the device meets those criteria.

Therefore, I cannot directly provide the requested table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, or training set details from the provided text.

The document mainly focuses on the 510(k) summary, which outlines the device's substantial equivalence to predicate devices, and the FDA's clearance letter. This type of regulatory submission summarizes the device and its intended use but typically does not include the detailed study protocols, results, and acceptance criteria that would be found in a full clinical or performance study report.

To answer your request, I would need access to the actual performance study report, which is not included in the provided snippets.

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The TROJAN® PASSION BERRY™ Gel patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. The TROJAN® PASSION BERRY™ Gel is principally designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. The TROJAN® PASSION BERRY™ Gel may be used with condoms.

The TROJAN® PASSION BERRYTM Gel personal lubricant is formulated as a clear, high viscosity gel with a pink color and lubricant is lonnalise as agrance and packaged in a clear plastic 2.5 oz. tube.

The provided text is a 510(k) summary and an FDA clearance letter for a personal lubricant. It does NOT contain information about a study with acceptance criteria and device performance as typically understood for AI/ML medical devices. The document explains that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance, rather than proving performance against specific acceptance criteria through a clinical or algorithmic study.

Therefore, I cannot fulfill the request as it pertains to AI/ML device studies, acceptance criteria, and ground truth establishment, because the provided input document does not contain this information.

Specifically, the document focuses on:

• Predicate Device Equivalence: The primary method for clearance is demonstrating substantial equivalence to pre-amendment devices or previously cleared devices (H•R® Lubricating Jelly and TROJAN® FOR WOMEN Personal Lubricant). This typically involves comparing characteristics like intended use, technological characteristics, and safety and effectiveness profiles, rather than setting and meeting performance metrics from a new study.
• Device Description and Intended Use: Information is provided on the physical properties and intended use (supplemental vaginal lubrication during sexual intercourse, compatible with condoms).
• Regulatory Classification: The device is classified under 21 CFR §884.5300 as a Condom (later reclassified as Patient Lubricant [21 CFR §880.6375] in the summary).

The request's points, such as "sample size used for the test set," "number of experts used to establish the ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," and "standalone performance," are all highly relevant to the evaluation of AI/ML-driven medical devices. However, this type of data is not applicable to the clearance pathway described in the provided document for a personal lubricant.

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The TROJAN® CRYSTAL CLEAR Liquid is principally designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. The TROJAN® CRYSTAL CLEAR Liquid may be used with condoms. The TROJAN CRYSTAL CLEAR Liquid patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

The TROJAN® CRYSTAL CLEAR Liquid personal lubricant is a water-soluble, greaseless, unscented, clear, colorless liquid, 2.1 oz of which is packaged in a clear plastic bottle.

The provided text is a 510(k) Summary for a personal lubricant (TROJAN® CRYSTAL CLEAR Liquid). This type of regulatory submission in the medical device field typically focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information required to answer your questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Here's why the requested information is not present based on the provided text:

• Acceptance Criteria & Device Performance: For a personal lubricant, the primary "performance" relates to its physical and chemical properties (e.g., pH, viscosity, osmolality) and biocompatibility, as well as its ability to provide lubrication. The document states "There are no exceptional technological characteristics associated with TROJAN® CRYSTAL CLEAR Liquid." and compares its formulation to "conventional water-soluble lubricant bases" and predicate devices. It does not provide a table of performance metrics or acceptance criteria for these characteristics.
• Study That Proves Device Meets Acceptance Criteria: The submission is a 510(k) for substantial equivalence. This means the manufacturer is arguing their new device is as safe and effective as a legally marketed predicate device (H·R® Lubricating Jelly and TROJAN® FOR WOMEN Personal Lubricant). It does not typically involve a clinical study designed to demonstrate performance against specific, pre-defined acceptance criteria.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These are all elements typically found in clinical studies, particularly for diagnostic devices or those requiring complex performance evaluation. A lubricant does not necessitate such studies for a 510(k) submission. The "study" here is essentially a comparison of the new lubricant's formulation and intended use to existing, legally marketed lubricants, demonstrating similarity rather than novel performance.

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