(85 days)
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
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| User could read and understand labeling.* | Found to be "well designed, readable and understandable." |
| User could record accurate results.* | Found to be "well designed, readable and understandable" and "demonstrated reasonable test performance." |
| Not affected by anticipated variation in user technique.* | "Was not affected by anticipated variation in user technique." |
| Overall test performance is reasonable and acceptable.* | "Demonstrated reasonable test performance" and "test performance characteristics of this version of the pHEM-ALERT are reasonable and acceptable." |
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.
§ 862.1550 Urinary pH (nonquantitative) test system.
(a)
Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.