(80 days)
The Yellow IRIS is used by a competent human operator to produce a complete urinalysis profile, including chemistry, sediment microscopy and specific gravity determinations.
It is capable of detecting and reporting all types of formed urine sediment elements and of quantitating such elements, when desired, based on observed proportion of total particulate count.
The Yellow IRIS is intended to replace the conventional intensive manipulatively manual complete urinalysis procedure as well as the abbreviated.
The Yellow IRIS urinalysis workstation, an already existing commercial in-vitro diagnostic device
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Performance Metric | Acceptance Criteria (Implied) | Reported Performance (Yellow IRIS vs. Urine Test Strips) |
|---|---|---|
| Sensitivity: Microscopic detection of Red Blood Cells (hematuria) | Improved sensitivity over existing methods | 37.9% greater sensitivity |
| Sensitivity: Microscopic detection of White Blood Cells (pyuria or leukocyturia) | Improved sensitivity over existing methods | 80.8% greater sensitivity |
| Sensitivity: Microscopic detection of Bacteria (bacteriuria) | Improved sensitivity over existing methods | 555.5% greater sensitivity |
| Detection of abnormal compositions of RBCs, WBCs, and/or bacteria (compared to 3-part dipstick) | Improved detection over existing methods | 29.4% more specimens detected |
| Detection of abnormal compositions of RBCs, WBCs, and/or bacteria (compared to 6-part dipstick) | Improved detection over existing methods | 13.4% more specimens detected |
Explanation of Acceptance Criteria: The document implies that the acceptance criterion for the Yellow IRIS urinalysis workstation was to demonstrate increased sensitivity in the detection of abnormal microscopic content compared to traditional urine test strips and popular screening algorithms. While specific numerical targets are not explicitly stated as "acceptance criteria," the reported performance metrics clearly aimed to prove superiority in sensitivity.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: More than 18,000 abnormal urine specimens.
- Data Provenance: The study was carried out among more than 100 clinical laboratories. This suggests a multi-site, potentially nationwide or regional, collection effort. The data appears to be retrospective, as it describes "comparisons of detection...by dipstick screening and by visual observation of flow microscopy using The Yellow IRIS" in a population of specimens where both methods were already in use for "complete routine urinalysis."
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 used or their specific qualifications for establishing ground truth. However, it mentions "visual observation of flow microscopy using The Yellow IRIS" which implies that trained laboratory personnel or medical professionals were performing the visual assessments. Given it's a urinalysis workstation, these would typically be clinical laboratory scientists, medical technologists, or pathologists. Specific experience (e.g., "radiologist with 10 years of experience") is not provided.
4. Adjudication Method for the Test Set
The document does not provide details on any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set. The comparison is described as "comparative measures...carried out among more than 100 clinical laboratories," suggesting that the performance of each method (dipstick vs. Yellow IRIS) was assessed against each other, rather than against a single, independently adjudicated "gold standard" truth for each specimen.
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
- This document describes a comparison between a device (Yellow IRIS) and traditional methods (urine test strips), not a study explicitly evaluating human reader improvement with AI assistance. The Yellow IRIS is described as an "urinalysis workstation" that utilizes "flow microscopy" for visual observation, which could involve an automated component for image capture and analysis, but it is still overseen by a "competent human operator."
- Therefore, an MRMC comparative effectiveness study as typically defined in the context of AI assistance to human readers was not explicitly conducted or reported here. The device itself (Yellow IRIS) is being compared to the existing standard of care, not human performance with and without the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document explicitly states that "The Yellow IRIS is used by a competent human operator to produce a complete urinalysis profile, including chemistry, sediment microscopy and specific gravity determinations." This indicates that the device operates with a human-in-the-loop, and therefore, a standalone (algorithm only) performance study was not conducted or reported.
7. The Type of Ground Truth Used
The ground truth for the comparison was essentially the visual observation of flow microscopy using The Yellow IRIS itself, compared against the results from urine test strips. It's a comparison between two different diagnostic methods rather than against a completely independent "gold standard" such as pathology or outcomes data. The document states its goal is to show increased sensitivity of the Yellow IRIS compared to dipstick screening.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. The description focuses solely on the performance comparison study. This implies that if there was any machine learning or algorithm development, the details of its training and validation are not included in this summary.
9. How the Ground Truth for the Training Set Was Established
Since no information is provided about a training set, there is no information on how its ground truth might have been established.
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AUG 25 :097
Supplement to K972141 June 17, 1997 (Amended on August 22, 1997)
Device Name: The Yellow IRIS urinalysis workstation
K. 510(k) summary statement
This submission supports the position of increased sensitivity in the detection of abnormal microscopic content using The Yellow IRIS urinalysis workstation, an already existing commercial in-vitro diagnostic device, compared to what can be obtained both by individual surrogate measures carried out on unne test strips and combinations of their measures in popular screening algorithms.
It reports a study which comprises compansons of detection of microscopic abnormalities in a population of more than 18,000 abnormal unine specimens by dipstick screening and by visual observation of flow microscopy using The Yellow IRIS. The comparative measures were carried out among more than 100 clinical laboratories, in which both unine test strips and The Yellow IRIS are used to perform a complete routine unnalysis.
The Yellow IRIS shows 37.9%, 80.8%, and 555.5% greater sensitivity in the microscopic detection of abnormal numbers of red blood cells, (hematuria), white blood cells, (pyuna or leukocyturia) and bacteria (bacteriuria) in unne than does chemical detection by surrogate measures using urine test strips. The Yellow IRIS also finds 29.4% and 13.4% more specimens which contain abnormal compositions of red blood cells and/or white blood cells and/or bacteria content than does a three part and six-part dipstick screening algorithm, respectively.
372-01
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
President International Remote AUG 25 1997 Imaging System, Inc. 9162 Eton Avenue Chatsworth, California 91311 Re : K972141 Trade Name: The Yellow IRIS Urinalysis Workstation Requlatory Class: I Product Code: KQO Dated: June 3, 1997 Received: June 6, 1997
Dear Mr. Deindoerfer:
Mr. Fred H. Deindoerfer
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Supplement to K972141 June 17, 1997
The Yellow IRIS urinalysis workstation Device Name:
- J. Indications for use
The Yellow IRIS is used by a competent human operator to produce a complete urinalysis profile, including chemistry, sediment microscopy and specific gravity determinations.
It is capable of detecting and reporting all types of formed urine sediment elements and of quantitating such elements, when desired, based on observed proportion of total particulate count.
The Yellow IRIS is intended to replace the conventional intensive manipulatively manual complete urinalysis procedure as well as the abbreviated.
Peter E. Madin
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number -
§ 862.2900 Automated urinalysis system.
(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(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.