Search Results

The pHEM-ALERT® test measures vaginal pH and is intended for use by women who have any of the following vaginal symptoms: Itching - Burning - Unpleasant odor - Unusual discharge This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have normal menstrual periods (periodic vaginal bleeding) or who may currently be pregnant. If you are pregnant, always discuss your symptoms and the result of this test with your healthcare provider and NEVER treat yourself.

The pHEM-ALERT provides a method for the lay user to measure her vaginal pH. The pHEM-ALERT test is comprised of a plastic probe with pH paper on one end, a color chart and a package insert. The plastic probe is in the shape of small flat key. pHEM-ALERT is indicated for measuring vaginal pH for the purpose of differentiating normal and abnormal conditions in symptomatic women. The device is inserted into the vagina and the measurement taken.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) summary for the pHEM-ALERT device. It focuses on:

• Sponsor and device identification: FemTek, LLC, and the pHEM-ALERT.
• Predicated device: The previously cleared pHEM-ALERT (K012230).
• Indications for Use: What the device is intended for (measuring vaginal pH for symptomatic women, including pregnant women).
• Device Description: A plastic probe with pH paper, a color chart, and a package insert.
• Reason for submission: Changes to the package insert regarding a warning about STDs and allowing use by pregnant women.
• FDA correspondence: The FDA's letter of substantial equivalence, confirming that the device can be marketed.

This 510(k) specifically concerns modifications to labeling for an already cleared device, not a new device requiring performance studies to establish its effectiveness against acceptance criteria. Therefore, the detailed information requested about a study and acceptance criteria (sample size, ground truth, experts, etc.) is not present in this document.

Ask a specific question about this device

The pHEM-ALERT® test mcasures vaginal pH (acidity) and is intended for use by women who have any of the following vaginal symptoms: Itching, Burning, Unpleasant odor, Unusual discharge. This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have follow-up by your neartheate provider. This device is not validated for use in pregnant women.

The pHEM-ALERT provides a method for the lay user to measure her vaginal pH. The pHEM-ALERT test is comprised of a plastic probe with pH paper on one end, a color chart and a package inscrt. The plastic probe is in the shape of small flat key. pHEM-ALERT is indicated package miser. "The present of differentiating normal and abnormal conditions in for modeling vagina price is inserted into the vagina and the measurement taken.

The provided text describes the pHEM-ALERT device, its intended use, and two clinical studies conducted to support its substantial equivalence to a previously marketed device. However, it does not explicitly state specific acceptance criteria (e.g., minimum accuracy percentages or precision values) that the device needed to meet. Instead, it concludes that the device demonstrated "reasonable test performance" and "acceptable" characteristics.

Based on the provided information, here's an attempt to answer the questions:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria (e.g., "X% of users understood the labeling"). The stated performance is a qualitative summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "Two clinical studies" were designed and carried out.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies were conducted "in support of the Substantial Equivalency" by FemTek, LLC (Pasadena, CA) and Joel S. Faden, Ph.D., Inc. (Rockville, MD), suggesting they were likely conducted in the US. The studies were designed to address the needs of the "lay user," implying they were prospective studies involving actual users.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

• Not explicitly stated.

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

• No MRMC or AI-assisted study was mentioned. The device is a simple pH paper for lay users, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Not applicable. The device is a "pH paper" used by a "lay user" with a "color chart." It's a physical, user-interpreted test, not an algorithm.

7. The Type of Ground Truth Used

• The document implies that the ground truth for "accurate results" and "reasonable test performance" would have been established against a reference method for vaginal pH measurement, likely a laboratory pH meter or a clinical expert's assessment, but this is not explicitly stated. The focus of the studies was on the lay user's ability to read and understand the device and its labeling, and to get "accurate results" which infers comparison to a true pH value.

8. The Sample Size for the Training Set

• This device is not an AI/machine learning product, so there is no "training set" in that sense. The "clinical studies" described would serve as the validation/test set for demonstrating user comprehension and reasonable performance.

9. How the Ground Truth for the Training Set Was Established

• Not applicable as there is no training set mentioned for an algorithm.

Ask a specific question about this device