(271 days)
The DIP | U.S. Urine Analysis Test System consists of a smartphone application, a proprietary Color-Board, and Urinalysis Reagent Strips. It is intended for the semi-quantitative detection of the following analytes in urine: Glucose. Specific Gravity, Blood, pH and Protein, as well as the qualitative detection of Nitrite,
The DIP | U.S. Urine Analysis Test System is intended for prescription home-use only, with results provided directly to the physician. The results can be used to guide patient management and care, and aid in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function and endocrine disorders. Physician interpretation of the results should be made in conjunction with the patient's other clinical information to determine if further confirmatory tests or consultations are necessary. Patients do not have access to the results at any point in the process.
The DIP | U.S. Urine Analysis Test System consists of a smartphone application, a proprietary Color-Board, and Urinalysis Reagent Strips. It is intended for the semi-quantitative detection of the following analytes in urine: Glucose, Specific Gravity, Blood, pH and Protein, as well as the qualitative detection of Nitrite.
The DIP | U.S. Urine Analysis Test System is intended for prescription home-use only, with results provided directly to the physician. The results can be used to guide patient management and care, and aid in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function and endocrine disorders. Physician interpretation of the results should be made in conjunction with the patient's other clinical information to determine if further confirmatory tests or consultations are necessary. Patients do not have access to the results at any point in the process.
The device is provided as a kit that comprises a urine receptacle, an FDA-cleared urine test strip (ACON Mission Urinalysis Reagent Strips, 510K number K061559), a Color-Board, and a User Manual. The DIP | U.S. Urine Analysis Test System also consists of a smartphone application for use with a LG Nexus 5 device (running operating system Lollipop 5.0), and an image recognition algorithm running on the back-end.
The software component of the DIP | U.S. Urine Analysis Test System consists of both an application and a back-end server. The App instructs the patient how to accurately administer the test and conducts a number of algorithm processes. Once analyzed, the DIP | U.S. Urine Analysis Test System's software securely transmits the clinical results directly to the patient's Electronic Medical Records for review by the physician. As stated above, the patients do not have access to the results at any point during the testing process.
The provided text describes the acceptance criteria and study proving the device meets those criteria for the Healthy.io DIP | U.S. Urine Analysis Test System.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by the "percent exact match" and "±1 color block match" compared to the predicate device (ACON Mission U500 Urinalysis System). The exact numerical acceptance thresholds are not explicitly stated as strict percentages for all analytes, but the narrative implies "high-levels of accuracy" and specific target ranges are mentioned for certain analytes.
| Analyte | Acceptance Criteria (Implied) | Reported Device Performance (±1 Color Block % Agreement) | Reported Device Performance (Exact Match %) |
|---|---|---|---|
| Glucose | High agreement with predicate (implied 100% for ±1 block) | 100% (Study 2) | 89.6% (Study 2) |
| Specific Gravity | High agreement with predicate (implied 100% for ±1 block) | >99% (Study 1) | 63.4% (Study 1) |
| Blood | High agreement with predicate (implied 100% for ±1 block) | 100% (Study 2) | 91.4% (Study 2) |
| pH | High agreement with predicate (implied 100% for ±1 block) | >99% (Study 1) | 75.7% (Study 1) |
| Protein | High agreement with predicate (implied 100% for ±1 block) | >99% (Study 1) | 85% (Study 1) |
| Nitrite | High agreement with predicate (implied 100% for ±1 block) | >99% (Study 1) | 99% (Study 1) |
Additional Performance Metrics (from Analytical Performance Testing):
- Repeatability: 99.3% exact match
- Reproducibility: 98.5% exact match
- Linearity: At least 89.4% exact match and 100% ±1 color block accuracy.
- Illumination Study: 99.5% exact match
- Boundary Study: 99.5% exact match
2. Sample Sizes Used for the Test Set and Data Provenance
Two method comparison studies were conducted for the test set:
-
Study 1:
- Sample Size: 429 subjects, 500 total samples (including spiked samples). Only 284 results from LG Nexus 5 smartphones were used for performance data.
- Data Provenance: Two U.S. clinical sites. The studies involved lay-users in a simulated home-use environment. This indicates prospective data collection for the purpose of this validation.
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Study 2:
- Sample Size: 250 subjects, 289 total samples (including spiked samples).
- Data Provenance: One U.S.-based clinic. Similar to Study 1, this appears to be prospective data collection in a simulated home-use setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the comparison studies was established by "a laboratory professional using the predicate (ACON Mission U500 Urinalysis System)" measuring aliquots of the same samples. The specific number of laboratory professionals or their detailed qualifications (e.g., years of experience, specific certifications) are not explicitly stated in the provided text.
4. Adjudication Method for the Test Set
The text describes comparing the DIP system's results to those from a laboratory professional using the predicate device. It does not mention any formal adjudication method (e.g., 2+1, 3+1 consensus) for discrepancies between the device and the predicate. The predicate device's readings appear to be treated as the reference standard (ground truth).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This was not a MRMC comparative effectiveness study in the typical sense of evaluating human reader improvement with AI assistance. The study evaluates the performance of the device itself as used by a lay-user, compared to a predicate device operated by a laboratory professional. There is no mention of human readers interpreting images with and without AI assistance to measure improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance data presented, particularly the "Method Comparison Study," represents the device's performance with a human-in-the-loop (lay-user) interacting with the smartphone application and Color-Board. The device itself (including its image recognition algorithm on the back-end) performs the analysis of the test strip after the user interacts with it. The usability results (e.g., 99% success rate for lay users completing the test) address the human-in-the-loop aspect.
However, the "Analytical Performance Testing" (Precision, Interference, Limit of Detection, Linearity, Illumination, Boundary Studies) implicitly evaluates the algorithm's performance under controlled conditions with pre-determined reagent values or spiked samples, which can be seen as a form of standalone evaluation of the core analytical capability. For example, the Illumination Study and Boundary Study evaluate the device's (and thus the algorithm's) ability to measure accurately under varying external conditions. In these studies, the device measured against "predetermined reagent values," which serves as the ground truth for evaluating the algorithm's accuracy under those specific conditions.
7. The Type of Ground Truth Used
The primary ground truth used for the method comparison studies (clinical validation) was the readings obtained from the predicate device (ACON Mission U500 Urinalysis System) by a laboratory professional.
For the analytical performance studies (Precision, Interference, Limit of Detection, Linearity, Illumination, Boundary), the ground truth was based on validated spiked urine solutions at known concentrations or predetermined reagent values.
8. The Sample Size for the Training Set
The provided text does not explicitly state the sample size used for the training set for the image recognition algorithm. It focuses on the validation studies.
9. How the Ground Truth for the Training Set Was Established
The text does not describe how the ground truth for the training set was established. It only mentions that the device includes an "image recognition algorithm running on the back-end." It is standard practice for such algorithms to be trained on large datasets with established ground truth, but the details of this process are not provided in this specific document.
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.