(77 days)
VITROS Chemistry Products K* DT Slides quantitatively measure potassium (K+) concentration in serum and plasma using VITROS DT60 and DT60 II Chemistry Systems. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases or conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only, VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems. For in vitro diagnostic use only.
The VITROS Chemistry Products K* DT Slide assay is performed using the VITROS Chemistry Products K DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/DT60 II Chemistry Systems. The VITROS K+ DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry' for measurement of potassium ions. All reactions necessary for a single quantitative measurement of potassium take place within the multi-layered analytical element of a VITROS Chemistry Products K DT Slide. The slide consists of two ionselective electrodes, each containing valinomycin (an ionophore for potassium), a reference layer, and a silver layer and a silver chloride layer coated on a polyester support. VITROS Chemistry Products K+ DT Slides use ion-selective electrodes for potentiometric measurements of ionic potassium. Ionic potassium determinations are made by simultaneously depositing 10 uL each of a reference fluid and a sample fluid on separate halves of the VITROS Chemistry Products K+ DT Slide. The electrode receiving the reference fluid is identified as the reference electrode. A paper bridge connects the reference electrode and the indicator electrode, which receives the sample fluid. A stable liquid junction between the two fluids is formed in the paper bridge. The potassium ions in the tested reference and sample fluids migrate to the silver/ silver chloride lavers and establish equilibrium. After an incubation period, the electrometer in the VITROS Chemistry System measures the potential difference between the reference and indicator electrodes. Each electrode responds to the activity of potassium ions in the respective fluids to produce a potential for the concentration cell. The VITROS DT60/DT6011 Chemistry System's microprocessor uses this measurement and the stored calibration parameters to determine the concentration value of the potassium ion in the sample fluid. The test result is reported in millimoles per liter (mmol/ L). VITROS Chemistry Products DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. The VITROS DT60 / DT60 II Chemistry System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
The provided text describes a 510(k) submission for a modified medical device, the VITROS Chemistry Products K+ DT Slides, and its associated calibrator kit. The submission aims to demonstrate substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria or a detailed study report with performance metrics, sample sizes, expert qualifications, or ground truth establishment methods.
The key information regarding performance is limited to a general statement that "Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured potassium values spanning the assay range." This indicates that a comparative study was performed, but the specifics are not provided in this summary.
Therefore, I cannot fulfill all parts of your request with the given input. I will extract what information is present and indicate where information is missing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: Not explicitly stated in the provided summary. The summary states that "Equivalence was demonstrated" and that the "performance of the VITROS Chemistry Products K+ DT Slides (modified)... is substantially equivalent to the cleared predicate device." This implies that the 'acceptance criteria' are likely related to demonstrating similar performance characteristics (e.g., accuracy, precision, linearity, limits of detection) to the predicate device, but the specific numerical targets or statistical methods for demonstrating equivalence are not detailed.
Reported Device Performance: Specific performance data (e.g., accuracy, precision, correlation coefficients, bias) are NOT provided in this summary. The summary only makes a general declaration of substantial equivalence.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Not explicitly stated (implied to be similar performance to predicate device across assay range) | The performance of the modified VITROS Chemistry Products K+ DT Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device. |
| Accuracy | Not specified | Not reported |
| Precision | Not specified | Not reported |
| Assay Range | Not specified | Equivalence demonstrated with samples spanning the assay range. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The text mentions "patient and quality control samples," but no number is given.
- Data Provenance: Not specified. The country of origin and whether the data was retrospective or prospective are not mentioned.
3. Number of Experts and Qualifications for Ground Truth Establishment
- Number of Experts: Not applicable/Not specified. For a device measuring a quantitative chemical analyte (potassium concentration), ground truth is typically established through reference methods, calibrated instruments, or certified reference materials, rather than expert consensus on images or clinical assessments. The summary does not mention any human experts being involved in establishing the ground truth for the test set.
4. Adjudication Method
- Adjudication Method: Not applicable/Not specified. As ground truth for chemical analytes is typically established by objective measurement rather than expert judgment, an adjudication method for expert disagreement is not relevant and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This type of study is relevant for imaging devices or diagnostic aids where human readers interpret results, and the AI's impact on their performance is evaluated. The VITROS Chemistry Products K+ DT Slides measure potassium concentration directly, so a human-in-the-loop scenario with AI assistance is not applicable.
- Effect Size of Human Reader Improvement: Not applicable.
6. Standalone Performance Study
- Standalone Performance Study: Yes, implicitly. The entire submission is about demonstrating that the "algorithm only" (the modified slide's measurement system) performs substantially equivalently to the predicate device. The performance of the modified VITROS K+ DT Slides (the "algorithm") was evaluated against the predicate device using patient and quality control samples.
- The study assessed the performance of the modified device in its intended function (quantitatively measuring potassium concentration).
7. Type of Ground Truth Used
- Type of Ground Truth: Implied by comparison to predicate device. The ground truth for potassium concentration levels would typically be established by a well-accepted, highly accurate reference method or by the predicate device itself, which is considered a legally marketed and understood method. The text refers to "measured potassium values spanning the assay range," suggesting that comparison was made against established values for those samples.
8. Sample Size for the Training Set
- Training Set Sample Size: Not specified. The summary does not provide information about a training set. This is common for this type of device where a direct substitution of a component (manufacturing process change for the ISE baseweb) is being made, and the intent is to show the modified device performs comparably to the predicate device, rather than training an AI model.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable/Not specified. A training set for an AI model is not described or alluded to in this summary.
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.