(30 days)
The intended use of the Unotech AccuStrip hCG-Urine is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy. We intend to market this product to physicians' office laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.
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Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for AccuStrip™ hCG-Urine
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the AccuStrip™ hCG-Urine device seem to be implicitly defined by its agreement with a predicate device (Unotech AccuTest™ hCG-Urine) and its ability to detect hCG at specific concentration ranges.
| Acceptance Criteria | Device Performance (AccuStrip™ hCG-Urine) |
|---|---|
| Clinical Agreement with Predicate Device (Unotech AccuTest™ hCG-Urine): | 100% agreement (89 positive, 110 negative) |
| Low-End hCG Detection: | Detects hCG at 25 mIU/mL (10/10 samples positive) |
| High-End hCG Detection: | Detects hCG at 1,000,000 mIU/mL (10/10 samples positive) |
| Specificity (0 mIU/mL hCG): | 0% positive (0/10 samples positive) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 208 urine specimens were tested for clinical comparison with the predicate device. For sensitivity testing, 10 samples were used at each of 9 different hCG concentrations (0, 25, 50, 10², 10³, 10⁴, 10⁵, 5x10⁵, and 10⁶ mIU/mL), totaling 90 samples.
- Data Provenance: The clinical study was conducted in "three physicians' office laboratories." The origin of the urine specimens is described as "Clinical subjects included female patients seeking confirmation of pregnancy, those who were confirmed pregnant, and 19 post-menopausal women," implying the data is from relevant patient populations, likely in the US where the physicians' offices are located. The study is prospective in the sense that the new device was tested on collected samples alongside the predicate. Clinical subjects are mentioned, suggesting a patient-derived dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth.
- For the clinical agreement study, the "ground truth" for the AccuStrip™ hCG-Urine was established by its agreement with the Unotech AccuTest™ hCG-Urine, which is the predicate device. It's assumed the predicate device itself provides an accepted standard.
- For the sensitivity study, the "ground truth" was based on known, spiked concentrations of hCG in urine samples.
4. Adjudication Method for the Test Set
No explicit adjudication method is described. For the clinical comparison, the primary method was direct agreement with the predicate device's results. For the sensitivity testing, the results were compared against known hCG concentrations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of the AccuStrip™ hCG-Urine compared to another device and against known concentrations. It does not evaluate human readers' improvement with or without AI assistance, as this is a diagnostic test kit, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation was conducted. The AccuStrip™ hCG-Urine is a diagnostic strip test, and its results are read directly, likely by a healthcare professional or lab technician. The studies described – clinical agreement and sensitivity testing – assess the performance of the device itself (the "algorithm" in a broad sense for a chemical test), independent of interpretive assistance for its users beyond the inherent design of the test.
7. The Type of Ground Truth Used
- For the clinical comparison, the ground truth was comparison to a predicate device (Unotech AccuTest™ hCG-Urine).
- For the sensitivity and specificity testing, the ground truth was known, manufactured concentrations of hCG in urine samples.
8. The Sample Size for the Training Set
The document does not mention a separate training set. This is typical for traditional diagnostic test kits that are developed through chemical and biological experimentation and validation, rather than machine learning algorithms which require training data. The "studies" described are validation studies.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this question is not applicable.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.