(89 days)
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.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Same intended use as predicate devices | Intended for checking the pH level of a woman's vagina, same as predicate pH papers. |
| Same safety as predicate devices | Biocompatibility testing was conducted and findings presented (details not provided). Argued that mounting on a probe does not raise new safety issues. |
| Same effectiveness as predicate devices | Uses phenaphthazine pH paper, which has been used and recommended for vaginal pH testing since 1950. Argued that mounting on a probe does not alter effectiveness. |
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.
§ 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.