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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.

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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.

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The pHEM-CHEK is intended for checking the pH level of a woman's vagina.

The pHEM-CHEK is comprised of a flat probe on which a strip of phenaphthazine pH paper is mounted. One end of the probe will be textured for better gripping and a strip of phenaphthazine pH paper will be mounted on the flat surface of the opposing end. A color chart, provided by the manufacturer of the pH paper, will be enclosed in each box of probes.

This submission is a 510(k) for the pHEM-CHEK device, a pH paper mounted on a probe for checking the pH level of a woman's vagina. The submission argues for substantial equivalence to existing pH papers.

Here's an analysis of the requested information based solely on the provided text, acknowledging that much of the information typically found in a "study that proves the device meets acceptance criteria" is absent.

1. A table of acceptance criteria and the reported device performance

Based on the provided text, specific quantitative acceptance criteria or detailed performance results are not explicitly stated. The submission focuses on substantial equivalence to predicate devices rather than proving performance against defined criteria through a dedicated study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical performance study with a specific test set. The argument for substantial equivalence relies on the established use and properties of the pH paper itself, and biocompatibility testing was mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication is described.

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 device is a simple diagnostic tool (pH paper on a probe), not an AI-assisted diagnostic system. No MRMC study or AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a manual pH paper, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated for a formal study. The primary "ground truth" implicitly relied upon is the long-standing medical acceptance and use of phenaphthazine pH paper for vaginal pH testing, as documented in medical textbooks since 1950. The device's performance is assumed to be equivalent to these well-established methods.

8. The sample size for the training set

Not applicable. As this device is not an algorithm requiring training, there is no training set.

9. How the ground truth for the training set was established

Not applicable. No training set is described.

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