(22 days)
The ALC method is an in vitro diagnostic test for the measurement of ethyl alcohol in serum on the Dimension Vista™ System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.
The ALP method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma the Dimension Vista™ System.
The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in serum, plasma, and urine on the Dimension Vista™ System.
The Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge is a device intended to measure ethyl alcohol in human serum. Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.
The Dimension Vista™ Alkaline phosphatase (ALP) Flex® reagent cartridge is a device intended to measure alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase are used primarily in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.
The Dimension Vista™ Calcium (CA) Flex® reagent cartridge is a device intended to measure the total calcium level in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge is a device intended to measure lactic acid in plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
The Dimension Vista™ Lithium (LI) Flex® reagent cartridge is a device intended to measure lithium in serum and plasma. Measurements of lithium are used to assure the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.
The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.
The provided text is a 510(k) Summary for in-vitro diagnostic test cartridges (Dimension Vista™ Flex® reagent cartridges) that measure various analytes like Ethyl Alcohol, Alkaline Phosphatase, Calcium, Lactic Acid, and Lithium. The key point of this submission is a packaging modification to allow these existing, previously cleared reagents to be used with the new Dade Behring Dimension Vista™ Integrated system.
Given that the core reagents and their underlying technology remain the same, and only the packaging is changing to adapt them to a new instrument, the information provided focuses on demonstrating that this packaging change does not negatively impact the performance or intended use of the devices compared to their predicate devices on the older Dimension® clinical chemistry systems.
Therefore, the "acceptance criteria" and "study" are not about demonstrating a new diagnostic capability or a new level of clinical performance for the analytes themselves, but rather about demonstrating substantial equivalence for the cartridges when used on the new Dimension Vista™ system. This means showing that the performance on the Dimension Vista™ system is comparable to the established performance on the Dimension® system for the same reagents.
Based on the provided text, the specific details requested in your prompt regarding acceptance criteria, study design, and ground truth for diagnostic device performance as one might expect for a new AI algorithm or a novel biomarker test are not directly applicable or explicitly stated, because the submission is for a packaging modification of existing, cleared assays.
However, I can infer the "acceptance criteria" for this type of submission to be equivalence in performance to the predicate device, and the "study" would likely be a comparative performance study between the new system and the predicate system using the same reagents.
Here's an interpretation based on the provided text, addressing your points where possible:
Acceptance Criteria and Study for Dimension Vista™ Flex® Reagent Cartridges (Packaging Modification)
The primary acceptance criteria for this 510(k) submission, which concerns a packaging modification for existing in-vitro diagnostic reagents, center on demonstrating that the modified cartridges perform equivalently when used on the new Dimension Vista™ system compared to their predicate versions on the Dimension® clinical chemistry systems.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a packaging modification and not a new diagnostic algorithm, the acceptance criteria would revolve around maintaining the performance characteristics (e.g., accuracy, precision, linearity) that were established and accepted for the predicate devices. The text does not provide a specific table of numerical acceptance criteria or reported performance metrics for each analyte. This kind of detailed performance data is typically found in the full 510(k) submission, not necessarily in the public summary.
However, the implied acceptance criterion is substantial equivalence in performance to the predicate devices. The "reported device performance" would be the demonstration that the assays, when run on the Vista system with the new packaging, yield comparable results to those obtained on the Dimension system with the original packaging.
Implied Acceptance Criteria for Substantial Equivalence:
| Performance Metric (Implied) | Acceptance Criteria (Implied) | Reported Device Performance (Inferred from "Substantial Equivalence") |
|---|---|---|
| Accuracy/Bias | Results on Dimension Vista™ are comparable to predicate Dimension® system. | Demonstrated to be substantially equivalent. |
| Precision | Reproducibility of results on Dimension Vista™ is comparable to predicate Dimension® system. | Demonstrated to be substantially equivalent. |
| Linearity/Range | The measuring range and linearity on Dimension Vista™ are comparable to predicate Dimension® system. | Demonstrated to be substantially equivalent. |
| Interference | Interference profiles on Dimension Vista™ are comparable to predicate Dimension® system. | Demonstrated to be substantially equivalent. |
| Intended Use | The intended use and clinical utility remain unchanged. | Confirmed. |
| Fundamental Technology | No alteration to the fundamental scientific technology of the devices. | Confirmed – "The reagents... are the same." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for any comparative testing or the data provenance (e.g., country of origin, retrospective/prospective). For in-vitro diagnostic devices, testing would typically involve patient samples (often spanning the clinical range of the analyte) and/or control materials.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable in the context of this 510(k) submission. This type of submission is for in-vitro diagnostic (IVD) reagents, which measure specific analytes in biological samples. The "ground truth" for chemical measurements is typically established through reference methods, calibrated standards, or comparative analysis with an established, cleared device (the predicate). It does not involve expert readers assessing images or clinical scenarios for a consensus.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like "2+1" or "3+1" are characteristic of studies involving human interpretation (e.g., radiology image reading), where multiple readers assess a case and a tie-breaking mechanism is needed. For IVD measurements, the comparison is typically quantitative, directly comparing instrument outputs or calculated values, not subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This question is not applicable. MRMC studies are specific to evaluating observer performance, particularly in medical imaging, and assessing the impact of a device (like AI assistance) on human interpretation. This 510(k) is for chemical reagents used on an automated analyzer, not a device intended to assist human readers in, for instance, interpreting images.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable in the sense of an "algorithm" being evaluated for diagnostic output that would otherwise require human interpretation. The devices are chemical reagents that interact with an automated analyzer to produce a quantitative measurement. The analyzer performs the "algorithm" for measuring the analyte. The "standalone performance" is essentially the analytical performance of the combined reagent-instrument system, which is what the comparison to the predicate device would demonstrate.
7. Type of Ground Truth Used
For this type of IVD device, the "ground truth" for the performance evaluation would typically be established by:
- Reference Methods: Highly accurate, standardized methods for measuring the target analyte.
- Certified Reference Materials: Materials with precisely known concentrations of the analyte.
- Comparison to Predicate Device: The performance of the new device (or the modified version) is compared directly to a legally marketed predicate device, which itself has established performance characteristics. This is the most likely "ground truth" used in this specific 510(k) for substantial equivalence.
8. Sample Size for the Training Set
This question is not applicable. These are chemical reagents for an in-vitro diagnostic device. There is no "training set" in the context of machine learning or AI algorithms as the terms are typically used for imaging or predictive diagnostics. The reagents are chemical formulations designed to react with analytes, and the instrument uses established analytical principles, not learned patterns from a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated in point 8.
§ 862.3040 Alcohol test system.
(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.