(261 days)
The Mission® U500 Urine Analyzer is intended for use in conjunction with the Mission® Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Billirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection Nitrite. The instrument is intended for prescription, for in vitro diagnostic use only. Mission Urinalysis Reagent Strips are available in different test configurations and the measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.
The Mission® U500 Urine Analyzer is a semi-automated reflectance photometer in conjunction with Mission Urinalysis Reagent Strips (originally cleared under K061559) that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. The analyzer throughput is 500 tests per hour and the measuring cycle is 7 seconds per test. The analyzer stores up to 2,000 patient records and prints the results in Conventional, SI, or Arbitrary units using an integrated internal or external printer.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Mission® U500 Urine Analyzer:
Acceptance Criteria and Device Performance for Mission® U500 Urine Analyzer
The provided document describes the Mission® U500 Urine Analyzer and its substantial equivalence to a predicate device (ACON U120 Urine Analyzer). While explicit "acceptance criteria" are not presented as a standalone table with numerical targets, the document implicitly defines acceptance based on demonstrating substantial equivalence to the predicate device through analytical and clinical performance.
The "reported device performance" is primarily articulated through the comparison to the predicate device and the conclusion that the new device is "substantially equivalent."
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Analyte | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Overall | Demonstrate performance (sensitivity, range, reproducibility, etc.) comparable to the predicate device. | Evaluated through analytical sensitivity and detection range, reproducibility, interfering substances, temperature flex, humidity flex, voltage flex, and reagent strip stability. (Specific quantitative results not provided in this summary, but the conclusion states these studies demonstrate substantial equivalence). |
| Clinical Performance | ||
| Overall | Clinical results (percent positive agreement, percent negative agreement, percent agreement on and between color blocks) should be comparable to the predicate device when used by intended users. | A method comparison study was conducted between the Mission® U500 Urine Analyzer and the ACON U120 Urine Analyzer. Results for percent positive agreement, percent negative agreement, and percent agreement on and between color blocks indicate that "the intended users were able to obtain comparable testing results." (Specific quantitative results not provided in this summary, but the conclusion states these studies demonstrate substantial equivalence). |
| Technological Characteristics | ||
| Intended Use | Identical to predicate device. | Same |
| Testing Specimen | Identical to predicate device. | Same |
| Detection | Identical to predicate device. | Photosensitive diode (Same) |
| Methodology | Identical to predicate device. | Reflectance Photometer (Same) |
| Wavelength | Identical to predicate device. | 525 nm and 635 nm (nominal) (Same) |
| Operation Cond. | Identical to predicate device. | 0-40°C (32-104°F); ≤85% Relative Humidity (non-condensing) (Same) |
| Strips Used | Mission® Urinalysis Reagent Strips (Same as predicate). | Mission® Urinalysis Reagent Strips (Same) |
| Incubation Time | Identical to predicate device. | 1 minute (Same) |
| Calibration | Automatic (Same as predicate). | Automatic (Same) |
| Power Source | Identical to predicate device. | 100-240 VAC, 50-60 Hz (Same) |
| Data Transfer | Identical to predicate device. | Standard RS232C Port (Same) |
| Capabilities | Internal printer, external printer port, barcode reader (all same as predicate except for integration of internal printer). | Internal printer (included), 25 Pin Parallel External Printer Port connector (included), Barcode Reader (optional) (Similar, internal printer is explicitly included). |
| Languages | Identical to predicate device. | English (default), Spanish, French (others as installed) (Same) |
| Throughput | Improved over predicate device. | 500 tests/hour (Predicate: Single Test Mode: 40 tests/hour, Continuous Test Mode: 120 tests/hour) |
| Measuring Cycle | Improved over predicate device. | 7 seconds/test (Predicate: 20 seconds/test) |
| Memory | Improved over predicate device. | 2,000 results (Predicate: Last 500 results) |
| Waste Diposal | Improved over predicate device. | Up to 150 strips (Predicate: Manually at each test) |
| Dimensions | Different (larger) than predicate device. | 14"(L) x 10.8"(W) x 7.7"(H) (35.5 x 27.4 x 19.5)cm (Predicate: 10.7"(L) x 10.4"(W) x 5.8"(H) (27.1 x 26.5 x 14.8) cm) |
| Display Dim. | Different (larger) than predicate device. | 4.5"(W) x 3.5" (H) (11.5 × 9.0) cm (Predicate: 4.2"(W) x 1.1"(H) (10.6 x 2.8) cm) |
| Weight | Different (heavier) than predicate device. | 8.82 lbs (4.0 kg) (Predicate: 5.73 lbs (2.6 kg)) |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "Clinical study data are presented for the percent positive agreement, percent negative agreement, and percent agreement on and between color blocks," which implies a set of clinical samples were used.
- Data Provenance: The studies were conducted "in-house and in a clinical setting." The document does not specify the country of origin for the clinical data. It also doesn't explicitly state whether the data was retrospective or prospective, though "clinical performance testing" typically implies prospective collection for such comparison studies.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- For this type of device (urine chemistry analyzer reading reagent strips), the "ground truth" would typically refer to a consensus reading by trained, certified clinical laboratory personnel or medical professionals, or possibly reference methods of laboratory analysis, rather than "experts" in the sense of radiologists.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with or without AI assistance. This device is an automated analyzer, not an AI-assisted diagnostic tool for human readers. The clinical study compares the device's performance to a predicate device's performance.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance: Yes, the entire study effectively serves as a standalone performance evaluation of the "algorithm" (the automated reflectance photometer) as it compares the new device's readings to those of a predicate automated device. The device itself is the algorithm, interpreting the color changes on reagent strips. The "Analytical Performance Testing" and "Clinical Performance Testing" sections describe this.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the clinical comparison was based on comparison to the predicate device (ACON U120 Urine Analyzer). The document states: "Clinical performance of the Mission® U500 Urine Analyzer was evaluated in a method comparison study between the Mission® U500 Urine Analyzer and ACON U120 Urine Analyzer predicate device." For the analytical performance, it would involve known concentrations/values of analytes in controlled samples.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable in the context of this device. This device is a reflectance photometer, which relies on a fixed optical and chemical-reaction principle, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its calibration is "Automatic," implying an internal, fixed calibration procedure rather than a learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable for the reasons stated above (not an AI/ML algorithm requiring a training set). The calibration of such a device would be established using certified reference materials or standardized solutions with known analyte concentrations.
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.