(224 days)
UF-Check™ is intended for use in the quality control of Sysmex UF-100™ automated urine analyzer. The Sysmex UF-100 is a in vitro medical device for use in urinalysis in clinical laboratories to replace microscopic review of normal and abnormal specimens and to flag specimens containing certain abnormalities.
UF-Check is a suspension of particles representing red blood cells, white blood cells, epithelial cells, casts, and bacteria in a liquid medium. Sysmex UF-Check is supplied in glass bottles containing 47 ml volumes. Three bottles - one of each level- are packaged in one box.
Here's a breakdown of the provided text in relation to your request about acceptance criteria and a study proving device fitness.
It's important to note that the provided text is a 510(k) Summary for a medical device control solution, not a diagnostic device that analyzes patient data. Therefore, many of your requested items, particularly those related to "ground truth," "expert consensus," "training sets," and "human-in-the-loop," don't directly apply in the context of this control device. Controls are used to verify the performance of an analyzer, not to diagnose patients.
However, I will extract what information is present and explain why other parts are not applicable.
Acceptance Criteria and Device Performance
The provided document describes a control solution (UF-Check™) for an automated urine analyzer (Sysmex UF-100™). The "performance" of this control solution would be its ability to consistently produce expected values when run on the analyzer and to remain stable over time.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Consistency within a single run (Within Run Precision) | "Results were consistent and gave acceptable performance." (No specific numerical range provided in this summary, but implies the variability within a single run met pre-defined acceptable limits). |
| Consistency across different manufacturing lots (Within Lot Precision) | "Results were consistent and gave acceptable performance." (Implies that the variation between batches of the control solution was within acceptable limits). |
| Stability over its intended shelf life (Long Term Stability) | "Results were consistent and gave acceptable performance." and "Study results show UF-Check to be consistently reproducible and stable for the entire product dating." (Confirms the control maintains its integrity and performance characteristics throughout its stated shelf life). |
| Ability to challenge key analyzer functions | "UF-Check performs like a five-part differential control which when run in the QC mode gives values for the measurement of parameters. When run in the QC mode, all systems are checked for performance such as correct addition of dye, correct particle sizing, and correct enumeration of elements." (Implies the control effectively tests the critical functions of the Sysmex UF-100™ analyzer). |
| Safety and Effectiveness | "UF-Check is a safe and effective urinalysis control when used as instructed in the product package insert." (General conclusion of the studies). |
Study Details (Based on the Provided Text)
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Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the summary. The text mentions "Studies were performed" (plural), but does not quantify the number of runs, samples, or lots included in these studies for Within Run Precision, Within Lot Precision, and Long Term Stability.
- Data Provenance: Not explicitly stated. Given it's a 510(k) summary filed by Sysmex Corporation in Long Grove, IL, it's highly probable the studies were conducted internally or through collaborators within the US or by Sysmex's global R&D. The data is retrospective in the sense that the studies were completed before the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in this context. For a control solution, "ground truth" is typically established by the manufacturer through rigorous analytical characterization methods using reference instruments and gravimetric/volumetric precision measurements during the manufacturing process. The "experts" would be the scientists and engineers involved in developing and characterizing the control, but not in the sense of clinical experts interpreting diagnostic results.
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Adjudication method for the test set:
- Not Applicable. Adjudication is usually for subjective interpretations of diagnostic results. For a control solution, performance is measured against pre-defined analytical specifications and expected ranges.
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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:
- Not Applicable. This is a control solution, not an AI-powered diagnostic device. There are no "human readers" interpreting the control's results in a diagnostic fashion, nor is there AI performing diagnoses. The human interaction is usually limited to loading the control onto the analyzer and reviewing the quantitative results generated by the analyzer for quality control purposes.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. Again, this is a control solution, not an algorithm or diagnostic device. The "standalone" performance for the control would be its intrinsic characteristics and stability, which are what the precision and stability studies assessed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Analytical Characterization / Manufacturing Specifications. As explained in point 2, the "truth" for a control solution is its meticulously defined composition and the analytical values ("assayed control") it is designed to produce within specific ranges on the target analyzer. This is established through the manufacturer's internal quality assurance and scientific methods during the development and production of the control.
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The sample size for the training set:
- Not Applicable. Control solutions do not have "training sets" in the machine learning sense. Their "performance" is inherent to their chemical and physical composition and manufacturing process, validated through analytical studies.
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How the ground truth for the training set was established:
- Not Applicable. No training set.
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).