FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The inui In-Home Urine Analysis Test System consists of the inui In-Home Urine Analysis Device and the inui Urine Analysis Mobile Application. The inui In-Home Urine Analysis Test System is intended for detecting the following parameters in urine: Protein, Glucose, Leukocytes, Nitrites, and Ketones. The test results provide information regarding the status of Urinary Tract Infections (UT), proteinuria, glucosuria, and ketonuria. These results can be used as an aid for monitoring kidney functions and metabolic disorders (e.g. diabetes mellitus), and can be used in the screening for Urinary Tract Infections (UTI).

The inui In-Home Urine Analysis Device is intended for use as a prescription home use device.

Device Description

The inui In-Home Urine Analysis Test System consists of inui In-Home Urine Analysis Device and the inui Urine Analysis Mobile Application. It is an in vitro diagnostic device comprised of a disposable test paddle, a urine collection cup, a gray background sheet, and a mobile application ("inui App"). The plastic "paddle" contains multiple chemistry test pads (CTPs) and 1 quick response (QR) barcode. CTPs contain pre-dried chemicals that react to specific substances in a urine sample. A color reaction occurs on the CTP based on the amount of substance in the urine sample. The color reaction is captured as an image using the mobile device camera and should only be read using the inui App. The results are reported as specified by the measurement range for each test. The QR Code is used for quality control purposes to track lot number, expiration date, and paddle use.

The inui In-Home Urine Analysis System reports semi-quantitative or qualitative results for each test parameters.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the inui In-Home Urine Analysis Test System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

General Acceptance Criteria from Analytical Performance:

Precision and Reproducibility: Proportion of agreement for each level and analyte tested to be above 95% to the expected values.
Limit of Detection (LOD) and Linearity: Established for each level and analyte.
Specificity and Interference Testing: Identification of interfering substances and their minimum concentration levels causing false positives/negatives. The device should produce an error message for substances introducing colors outside the analyte's normal range.

Clinical Performance Acceptance Criteria:

Clinical Accuracy (Method Comparison): Lay-user clinical test results should be comparable to those of professional users using the predicate device. Specific agreement percentages are implicitly set by the reported data in Table 5.
Usability: Lay users should be able to follow procedural steps to obtain successful test results with a specified performance percentage.
Lay-user Reproducibility: Lay-users should obtain the same results after repeated testing with a high reproducibility percentage.

1. Table of Acceptance Criteria and the Reported Device Performance

Parameter / Indication for Use	Acceptance Criteria (Implicit from Study Design)	Reported Device Performance
Analytical Performance
Precision & Reproducibility	>95% agreement to expected values for each level/analyte.	Achieved: "The proportion of agreement for each level and analyte tested met the established acceptance criteria and was found to be above 95% agreement to the expected values for both precision and reproducibility." (Page 7)
Limit of Detection (LOD)	Established for each level/analyte.	Achieved: LODs were determined, and a "Summary of the sensitivities are provided in Table 3." (Page 7)
Specificity / Interference	Identification of interfering substances, their levels, and a mechanism for handling abnormal urine colors (e.g., error message).	Achieved: "Thirty-nine potentially interfering exogenous and endogenous substances were evaluated." The device "produces an error message with no result (invalid) for any substance that introduces colors outside the range for that analyte." (Page 7-8) Acetoacetic Acid consistently produced an error message. Table 4 lists interfering substances and their levels. Other identified interferences include:

Protein: Albumin (>3000 mg/dL), Bilirubin (>10 mg/dL), Hemoglobin (>100 mg/dL), Chlorhexidine (>40 mg/dL), Riboflavin (>5 mg/dL), Hypochlorite (>375 mg/dL), Specific Gravity (>1.025).
Leukocyte: Human Leukocyte Esterase (>0.025 U/mL), Hemoglobin (>150 mg/dL), Albumin HSA (>3000 mg/dL), Bilirubin (>10 mg/dL), Sodium Chloride (>324 mg/dL), Hypochlorite (>375 mg/dL), Chlorhexidine (>60 mg/dL), Microbial Peroxidase (>0.65%), Riboflavin (>5 mg/dL), Sodium Acetate (>600 mg/dL), Sodium Bicarbonate (>630 mg/dL), Specific Gravity (>1.020), Urobilinogen (>4 mg/dL).
Nitrite: Sodium Nitrite (>5 mg/dL), Human Hemoglobin (>100 mg/dL), Hypochlorite (>375 mg/dL), Human Leukocyte (>0.0375 U/mL), Urobilinogen (>4 mg/dl), Sodium Bicarbonate (>945mg/dl), Sodium Acetate (>900 mg/dL), Hypochlorite (>375 mg/dL), Sodium Nitrite (>7.5 mg/dL).
Ketone: Lithium Acetoacetate (>40 mg/dL), Hypochlorite (>375 mg/dL), Sodium Nitrite (>7.5 mg/dL).
Glucose: D-(+)-Glucose (>500 mg/dL), Hypochlorite (>375 mg/dL), Bilirubin (invalid results at all conc), Lithium Acetoacetate (>80 mg/dL), Sodium Chloride (>486 mg/dL). (Pages 8-9) |
| Clinical Performance | | |
| Method Comparison (Lay User vs. Predicate) | Lay user results comparable to professional users with predicate device; high agreement percentages. An explicit threshold for each analyte/level is implied by the successful submission. | Achieved; "clinical test results that are comparable to those of a professional users".
Protein: Negative (83% exact, 100% within 1 block), Trace (75% exact, 100% within 1 block), Moderate (90% exact, 100% within 1 block), Large (100% exact, 100% within 1 block).
Glucose: Negative (100% exact, 100% within 1 block), Low (74% exact, 100% within 1 block), Moderate to Large (100% exact, 100% within 1 block).
Leukocyte: Negative (100% exact), Positive (97% exact).
Nitrite: Negative (96% exact), Positive (100% exact).
Ketone: Negative/Trace (99% exact, 100% within 1 block), Small (67% exact, 100% within 1 block), Moderate to Large (100% exact, 100% within 1 block). (Table 5, Page 10) |
| Usability | Lay users can follow all procedural steps to obtain a successful test result, with a high overall performance percentage. | Achieved: Overall performance of 88.9% (1st paddle), 86.7% (2nd paddle), and 91.1% (3rd paddle). (Page 10) |
| Lay-user Reproducibility | High reproducibility (e.g., 100%) for lay-user repeated testing. | Achieved: "reproducibility of the inui Device in the hands of the lay user was 100%." (Page 10) |

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Clinical Accuracy (Method Comparison): Two studies were conducted using 190 and 91 lay users, respectively.
- Usability Study: 45 lay users.
- Lay-User Reproducibility Study: 10 lay users.
Data Provenance: The document does not explicitly state the country of origin. It indicates that the clinical evaluation followed an "Investigational Review Board approved clinical protocol," suggesting prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the clinical accuracy study was established by comparing lay-user results from the inui device to results obtained from the predicate device, Siemens Multistix® 10SG, "by professional users."
The document does not specify the exact number of professional users or their specific qualifications (e.g., "radiologist with 10 years of experience"). It just refers to them as "professional users."

4. Adjudication Method for the Test Set

The document describes a direct comparison method where lay-user results from the inui device are compared against results from the predicate device read by professional users.
It does not mention an explicit adjudication method like "2+1" or "3+1" to resolve discrepancies between multiple professional readers or to establish a consensus ground truth beyond the professional reading of the predicate device. The professional reading of the predicate device serves as the reference.

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, an MRMC comparative effectiveness study involving AI assistance for human readers was not explicitly described.
The study focuses on the standalone performance of the inui system (which incorporates an app for image capture and analysis) when used by lay-users, against a predicate device read by professional users.
The system itself is the "AI assistance" in the sense that the mobile app performs the color analysis traditionally done visually. The comparison is between the inui system's performance by lay users and the predicate device's performance by professional users, not human readers with vs. without AI assistance.

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

Yes, in spirit, the core of the inui device's performance is essentially standalone algorithm performance within the context of a "lay-user-in-the-loop" setting.
The "inui App" performs the electronic color analysis via the mobile phone camera. The "lay user reproducibility study" and the "clinical accuracy study" demonstrate the device's (including the algorithm's) performance when operated by lay users. The comparison in the clinical accuracy study is effectively between the inui device's algorithm output (managed by lay users) and a predicate device's visual interpretation by professionals.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy (method comparison) study was established by comparison to a legally marketed predicate device (Siemens Multistix® 10SG device) assessed by professional users. This is a form of "reference method" ground truth.
For the analytical performance studies (Precision, LOD, Specificity), the ground truth was based on expected values and established protocols in accordance with CLSI guidelines.

8. The Sample Size for the Training Set

The document is a 510(k) summary, which focuses on validation data. It does not provide information on the sample size for the training set used to develop the inui device's mobile application algorithm.

9. How the Ground Truth for the Training Set Was Established

The document does not provide details on how the ground truth for the training set was established, as it pertains to the development process of the device which is typically not included in a 510(k) summary.

Acceptance Criteria and Reported Device Performance

§ 862.1340 Urinary glucose (nonquantitative) test system.