Search Results
Found 1 results
510(k) Data Aggregation
(18 days)
MAS Liquid Urinalysis Control Level 1, Level 2, and Level 3 is a human urine based quality control material used in routine urinalysis testing performed in clinical laboratories, The product is formulated to contain Protein, Glucose Ketones, Bilirubin, Blood (hemoglobin), Nitrite, Urobilinogen, Leukocyte Esterase, Sodium, Potassium, Red Cells, White Cells, Crystals, Microalbumin, and Creatinine. The product insert contains assay values for these constituents as well as physical characteristics including pH, Appearance, Color, Specific Gravity, and Osmolality.
MAS Liguid Urinalysis Control Level 1, Level 2, and Level 3 is used by the Clinician as a guality control sample with known qualitative and semi-quantitative values for each of the listed constituents, physical characteristics and assay methodologies. This allows the Clinician to monitor and control the quality of the laboratory urinalysis testing results.
MAS Liquid Urinalysis Control Level 1, Level 2, and Level 3 is a human urine based quality control material used in routine urinalysis testing performed in clinical laboratories. The product is formulated to contain Protein, Glucose Ketones, Bilirubin, Blood (hemoglobin), Nitrite, Urobilinogen, Leukocyte Esterase, Sodium, Potassium, Red Cells, White Cells, Crystals, Microalbumin, and Creatinine. The product insert contains assay values for these constituents as well as physical characteristics including pH, Appearance, Color, Specific Gravity, and Osmolality.
Please note: The provided text is a 510(k) clearance letter and an accompanying "Indications for Use" statement for a urinalysis control material. It describes the purpose and content of the control and confirms its substantial equivalence to previously marketed devices. However, this document does not contain any information about a study proving device performance against specific acceptance criteria for AI or a diagnostic algorithm.
Therefore, I cannot fulfill most of your request as it pertains to AI-based device performance studies. The information below is limited to what can be inferred or stated from the provided document in relation to a laboratory control device.
Based on the provided document, the following information can be extracted or inferred:
The document describes the MAS Liquid Urinalysis Control Levels 1, 2, and 3, which is a human urine-based quality control material for routine urinalysis testing. Its purpose is to allow clinicians to monitor and control the quality of laboratory urinalysis testing results.
Since this is a quality control material and not a diagnostic device or an AI algorithm, the concepts of "acceptance criteria" and "device performance" in the context of sensitivity, specificity, or algorithm accuracy as you've requested for an AI device, do not directly apply in the same way. Instead, for a control material, "performance" would relate to its stability, accuracy of its assigned values, and its ability to challenge the assay within acceptable ranges.
The document does not describe or reference any study that would meet your criteria for proving device performance in the context of an AI or diagnostic algorithm study.
Here's an attempt to answer your questions based on the nature of the device (a quality control material) and the information available, noting where the information is absent due to the document type:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred for a QC material) | Reported Device Performance (Inferred/Not Applicable) |
|---|---|
| Purity/Composition: Formulated to contain specified constituents. | The device "is formulated to contain Protein, Glucose, Ketones, Bilirubin, Blood (hemoglobin), Nitrite, Urobilinogen, Leukocyte Esterase, Sodium, Potassium, Red Cells, White Cells, Crystals, Microalbumin, and Creatinine." It also has physical characteristics including pH, Appearance, Color, Specific Gravity, and Osmolality. (This describes its composition, not a performance metric like accuracy or precision). |
| Assigned Values: Product insert contains assay values for constituents and physical characteristics. | The product insert "contains assay values for these constituents as well as physical characteristics." (This states that values exist, but does not provide actual performance data or how precisely the control material matches those values over time or across batches). |
| Substantial Equivalence: Demonstrated equivalence to a legally marketed predicate device. | The FDA determined the device is "substantially equivalent" to devices marketed prior to May 28, 1976. (This refers to regulatory equivalence, not statistical performance metrics against a clinical gold standard for the device itself). |
| Stability: (Expected for a QC material, but not explicitly stated as an acceptance criterion in this document) | Not stated within this document. |
| Reproducibility/Precision: (Expected for a QC material, but not explicitly stated as an acceptance criterion in this document) | Not stated within this document. |
| Accuracy of Values: (Expected for a QC material, but not explicitly stated as an acceptance criterion in this document, nor data provided) | Not stated within this document. The document mentions it's a "quality control sample with known qualitative and semi-quantitative values," but doesn't provide data to validate the accuracy of these 'known' values or the precision with which they are maintained over time. This information would typically be found in the manufacturer's internal validation reports or product insert, which is not fully included here. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Information not provided. This document does not describe a clinical study or a test set in the context of evaluating an AI or diagnostic algorithm. It's a regulatory clearance for a laboratory control material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Information not provided. As above, this document does not refer to a test set for a diagnostic algorithm where expert ground truth would be established. For a QC material, "known values" are typically established through rigorous analytical methods and calibration, not expert consensus on cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Information not provided.
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:
- Not applicable / Information not provided. This device is a quality control material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Information not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a quality control material, the "ground truth" would be its assigned values for each constituent and physical characteristic. These values are typically established through a combination of highly precise analytical methods, calibration against reference materials, and inter-laboratory studies, rather than expert consensus on patient cases or pathology. The document indicates the product insert "contains assay values," suggesting these are the reference points.
8. The sample size for the training set:
- Not applicable / Information not provided. No training set for an algorithm is discussed in this document.
9. How the ground truth for the training set was established:
- Not applicable / Information not provided.
In summary: The provided document is a 510(k) clearance letter for a laboratory quality control material. It confirms the device's substantial equivalence and describes its intended use and composition. It does not present information about a study evaluating the performance of an AI or diagnostic algorithm, and therefore, most of your questions cannot be answered based on this text.
Ask a specific question about this device
Page 1 of 1