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510(k) Data Aggregation
(111 days)
Mission CliniCheck Controls is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes: Acetaminophen, Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha-1 Anti-Trypsin, Alpha Fetoprotein, Alpha Hydroxybutyrate Dehydrogenase (α-HBDH), Amylase, Apolipoprotein A-1 (APO-A1), Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 Complement, C4 Complement, Calcium, Carbon Dioxide (CO2), Carcinoembryonic Antigen (CEA), Ceruloplasmin, Chloride, Cholesterol (Total), HDL- Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine, Digoxin, Gamma Glutamyltransferase (GGT), Glucose, Haptoglobin, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron, Iron-Binding Capacity, Total (TIBC), Iron-Binding Capacity, Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total, T4 Free, T4 Total, Thyroid Stimulating Hormone (TSH), Transferrin, Triglycerides, Urea Nitrogen, and Uric Acid on instruments listed in the expected values chart.
Mission CliniCheck Assayed Chemistry Control is a human serum based product containing constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. Two levels of Control are provided in a lyophilized form. Each level is packaged into a glass amber bottle containing 5mL of product. The product is packaged in single level boxes (12 x 5mL) or multiple level boxes (6 x 2 x 5mL) and stored at 2 - 8°C.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Mission CliniCheck Assayed Chemistry Control device:
Important Note: The provided document is a 510(k) summary for an Assayed Quality Control Material. This type of device is used to monitor the performance of laboratory tests, not to perform diagnostic tests directly on patients. Therefore, the "acceptance criteria" and "study" described are centered around the performance of the control material (its stability and value assignment) and its equivalence to a predicate control device, rather than the diagnostic accuracy or clinical utility of a medical device that generates results on patient samples. Many of the requested categories in your prompt (e.g., number of experts, adjudication, MRMC studies, standalone performance, training set) are typically relevant for AI/imaging diagnostic devices and are not applicable to the type of device described here.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Acceptance Criteria (Implied from testing methods) | Reported Device Performance |
|---|---|---|
| Value Assignment | Lot-to-lot variation determined by testing new lot vs. previous lot, normalized to a serum standard (NIST or OEM). Target values within a defined range. | Target values are obtained by testing 16 replicates (4 replicates over 4 days). The average of these 16 data points is the mean. The range is determined by multiplying the mean by ± 20%. All testing is performed alongside Original Equipment Manufacturer (OEM) material to verify values before accepting new ranges. |
| Shelf Life Stability | Supports a 2-year shelf life when stored at 2-8°C. | Accelerated (high temperature) stress test was conducted, and results support a 2-year shelf life when stored at 2-8°C. |
| Reconstituted Stability | Stable for up to 20 days at -20°C (frozen). | Testing showed reconstituted controls are stable for up to 20 days at -20°C. |
| In-use Stability (Refrigerated) | Stable for 7 days when stored at 2-8°C, with specific exceptions. | Values are stable for 7 days when stored at 2-8°C (tightly capped) with the following exceptions: Acid Phosphatase will be stable for 3 days, AST for 1 day, CK, LDH, T4 free and TSH for 6 days. (Note: The document implies these specific stabilities meet the acceptance criteria for those analytes). |
| Material Safety (Human Source) | Found negative for specific infectious agents. | All human source material was tested and found negative by FDA approved methods for HBsAg, HCV, and HIV-1/2. |
| Substantial Equivalence | Demonstrates substantial equivalence to the predicate device in composition, intended use, packaging, storage, and shelf life. | The conclusion states that based on the submitted results, the device "claims substantial equivalence to the predicate device in Composition... Intended use, Packaging, Storage, and Shelf life." This implies that the performance in the aforementioned areas was found to be comparable or equivalent to the predicate, as required for 510(k) clearance. |
Study Description:
The study proving the device meets the acceptance criteria is primarily an internal validation study and comparative analysis against a predicate device and known standards.
The key aspects of the study include:
- Value Assignment Study: This involves preparing a new lot of the control material and characterizing its analyte concentrations.
- Methodology: 16 replicates (4 replicates each over 4 days) are tested. The mean of these 16 data points establishes the target mean value. A range of ±20% of the mean defines the acceptable limits for control performance.
- Comparative Element: Testing is performed alongside OEM material to verify values. Lot-to-lot variation is determined by comparing the new lot to a previous lot, normalized to a serum standard (NIST or OEM).
- Stability Studies: These evaluate how the control material performs under different storage conditions and over time.
- Shelf Life: An accelerated (high temperature) stress test was conducted to project and support the 2-year shelf life.
- Reconstituted Stability: Testing determined stability for 20 days when frozen at -20°C.
- In-use Stability: Testing determined stability for 7 days when refrigerated at 2-8°C, with specific shorter stabilities noted for certain analytes.
- Safety Testing: All human source material was tested for infectious agents (HBsAg, HCV, HIV-1/2) using FDA-approved methods.
- Comparison to Predicate Device: A detailed comparison was made between the new device and the predicate device (K103364) across various attributes like name, 510(k) number, intended use, matrix, form, levels, storage, reconstituted stability, shelf life, and packaging. The key difference was the expanded list of analytes the new device is assayed for, indicating the device meets the performance for these additional analytes.
2. Sample Size used for the test set and the data provenance:
- Sample Size for Value Assignment (Test Set): 16 replicates were used for each analyte to establish the mean and range for value assignment.
- Data Provenance: The data is generated internally by Diamond Diagnostics, Inc., as part of their manufacturing and quality control processes. The document does not specify the country of origin for the data, but the company is located in Holliston, MA, USA, and the submission is to the FDA, implying studies conform to US regulatory standards. The studies conducted are prospective for the specific lot being validated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable to this type of device. The "ground truth" for a quality control material is established through precise analytical measurements using calibrated instruments and reference materials (like NIST standards) or comparison to existing validated OEM materials. It does not involve human expert interpretation in the way that, for example, a diagnostic imaging device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As described above, the "truth" for this control material is based on analytical measurements, not subjective human judgment requiring adjudication.
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. This is a quality control material, not an AI-powered diagnostic device involving human readers or interpretation of clinical cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm or AI-based device. Its "performance" is its intrinsic analytical characteristics and stability, which are measured directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the control material's analyte concentrations is established by:
- Analytical Measurement: Precise quantitative measurement of analytes using laboratory instrumentation.
- Reference Materials: Normalization to NIST (National Institute of Standards and Technology) comparable standards or Original Equipment Manufacturer (OEM) materials.
- Comparison to Predicate/Previous Lots: Ensuring consistency and comparability with previously validated lots and the predicate device.
8. The sample size for the training set:
Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in that context. The "value assignment" process involves establishing the characteristics of each new lot, which is analogous to a validation step for that specific lot, rather than training a model.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this device.
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(147 days)
The SMARTLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples. In addition, the analyzer can also measure sodium, chloride and calcium in dialysate samples.
The SMARTLYTE Sodium Assay is intended to measure sodium in whole blood, serum, plasma, pre-diluted urine and dialysate on the SMARTLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The SMARTLYTE Potassium Assay is intended to measure potassium in whole blood, serum, plasma, urine and dialysate. 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.
The SMARTLYTE Chloride Assay is intended to measure the level of chloride in whole blood, serum, plasma, urine and dialysate. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SMARTLYTE Calcium Assay is intended to measure ionized calcium levels in whole blood, plasma, serum, and dialysate. 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 SMARTLYTE Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, and serum. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
The SMARTLYTE Nat, K", CT, Ca*, Li Electrolyte Analyzer which can test serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials is identical to GEMLYTE Electrolyte Analyzer ( cleared under K082462) which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended . quality control material to be used daily.
Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them, based on your requested format:
Acceptance Criteria and Device Performance Study for SMARTLYTE Electrolyte Analyzer
The SMARTLYTE Electrolyte Analyzer is an automated, microprocessor-controlled device using ion-selective electrodes to measure sodium, potassium, chloride, calcium, and lithium in various sample types, including dialysate. The study aimed to demonstrate the substantial equivalence of the SMARTLYTE to its predicate device, the AVL 9180 (K961458), particularly for dialysate measurements, which represent a modification from previously cleared uses.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the predicate device's performance characteristics or defined in the "Reproducibility" section as maximum allowable CVs or SDs. The reported device performance is from the "Precision Dialysate" and "Dialysate Comparison" sections.
Note on Acceptance Criteria: The document primarily compares the SMARTLYTE's performance to the predicate device's expected values and establishes its own internal precision targets. For the method comparison, "good correlation to predicate with correlation coefficients typically greater than 0.99 and slope values between 0.96 and 1.04" serves as a key acceptance criterion for the clinical claims (correlation with a predicate device). For precision, specific CV/SD targets are given.
| Parameters | Matrix | Acceptance Criteria (Predicate/Target) | Reported Device Performance (SMARTLYTE) |
|---|---|---|---|
| Precision | |||
| Na+ | Dialysate | Within Run C.V. ≤ 1% Between Run C.V. ≤ 2% | Within Run C.V.: 0.32-0.47% Between Run C.V.: 0.32-0.54% |
| K+ | Dialysate | Within Run C.V. ≤ 2% Between Run C.V. ≤ 3% | Within Run C.V.: 0.28-0.87% Between Run C.V.: 0.88-1.27% |
| Cl- | Dialysate | Within Run C.V. ≤ 2% Between Run C.V. ≤ 3% | Within Run C.V.: 0.24-0.89% Between Run C.V.: 0.53-1.44% |
| Ca++ | Dialysate | Within Run SD ≤ 0.02 Between Run SD ≤ 0.06 | Within Run SD: 0.0087-0.0155 (CV not calculated in source) Between Run SD: 0.0076-0.0226 (CV not calculated in source) |
| Na+ | Urine | Within Run C.V. ≤ 5% Between Run C.V. ≤ 5% (Predicate: ≤ 7%) | (Not explicitly reported in this document for Urine; previously cleared K082462) |
| K+ | Urine | Within Run C.V. ≤ 5% Between Run C.V. ≤ 5% | (Not explicitly reported in this document for Urine; previously cleared K082462) |
| Cl- | Urine | Within Run C.V. ≤ 5% Between Run C.V. ≤ 5% | (Not explicitly reported in this document for Urine; previously cleared K082462) |
| Linearity | Dialysate | R-squared ≈ 0.99 (implied by "good correlation") | Sodium: 0.9995 Potassium: 0.9976 Chloride: 0.9998 Calcium: 0.9972 |
| Slope ≈ 1 (implied) | Sodium: 0.9806 Potassium: 1.0031 Chloride: 0.9996 Calcium: 0.9857 | ||
| Intercept ≈ 0 (implied) | Sodium: 2.53 Potassium: -0.37 Chloride: 1.60 Calcium: 0.06 | ||
| Method Comparison (to predicate AVL 9180) | Dialysate | R > 0.99, Slope 0.96-1.04 (Stated by manufacturer) | Sodium: R=0.9989, Slope=1.0183 Potassium: R=0.9996, Slope=0.9882 Chloride: R=0.9966, Slope=0.9825 Calcium: R=0.9956, Slope=1.0021 |
| Measuring Range | Dialysate | Na: 40-205 mEq/L K: 1.7-15 mEq/L Cl: 50-200 mEq/L Ca: 0.3-5.5 mmol/L (Predicate range) | Na: 40-200 mEq/L (Linearity confirmed: 24-205); Method comparison supported: 40-205 mEq/L K: 1.7-15 mEq/L (Linearity confirmed: 1.4-15.1); Method comparison supported: 1.7-11 mEq/L Cl: 50-200 mEq/L (Linearity confirmed: 40-202); Method comparison supported: 50-205 mEq/L Ca: 0.3-5.5 mmol/L (Linearity confirmed: 0.4-5.0); Method comparison supported: 0.3-5.5 mmol/L |
2. Sample Size Used for the Test Set and Data Provenance
- Precision (Dialysate):
- Within-run: 30 replicates for each of three dialysate samples (low, mid, high concentrations) per measurand.
- Between-run (Total precision): 40 replicates (4 groups of 10 replicates over 10 days) for each of three dialysate samples per measurand.
- Linearity (Dialysate):
- Sodium: 34 samples
- Potassium: 36 samples
- Chloride: 34 samples
- Calcium: 48 samples
- Method Comparison (Dialysate):
- Sodium: 43 samples
- Potassium: 56 samples
- Chloride: 51 samples
- Calcium: 43 samples
Data Provenance: The document implies these were prospective studies conducted to support the 510(k) submission for the specific device modifications. No explicit country of origin is stated for data collection, but given it's a US FDA submission, it's typically assumed to be North American or adhering to international standards accepted by the FDA. The samples were "dialysates collected" and some were "spiked or diluted" to span the measurement ranges, suggesting a mix of clinical and artificially prepared samples. Prior data for whole blood, serum, plasma, and urine were "previously cleared (K082462)".
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an in-vitro diagnostic device measuring analytes. The "ground truth" for the test set is established by the reference methods or the predicate device that the SMARTLYTE is compared against, not by human expert assessment of images or clinical cases. The reference for comparison would be the AVL 9180 predicate device.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1 for consensus among experts) are used in studies involving human interpretation or subjective assessments. This study evaluates the analytical performance of an IVD device against a predicate or defined analytical targets.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases with and without AI assistance to measure a change in human performance (e.g., diagnostic accuracy, reading time). The SMARTLYTE is an automated IVD device; it does not involve human readers interpreting output in the same way an imaging AI would.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described (precision, linearity, method comparison) represent standalone performance of the SMARTLYTE device. The device operates automatically to measure analyte concentrations. The "human-in-the-loop" aspect is limited to operating the device and collecting samples, not interpreting an AI's output to make a diagnosis.
7. The Type of Ground Truth Used
The "ground truth" for the performance studies can be defined as:
- Reference Intervals/Expected Values: For linearity studies, expected values based on known dilutions of stock solutions serve as the ground truth.
- Predicate Device Measurements: For the method comparison study, the measurements from the predicate device (AVL 9180) on the same dialysate samples served as the comparative ground truth.
- Internal Precision Targets: For the precision studies, the acceptance criteria (max CV/SD) are internal performance targets, and the reported values are measured against these.
8. The Sample Size for the Training Set
Not applicable. The SMARTLYTE Electrolyte Analyzer is an IVD device based on ion-selective electrode technology, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on its hardware, chemistry, and pre-programmed algorithms, which are calibrated and verified through analytical studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device's technology. The device uses established physical and chemical principles (ion-selective electrodes). Calibrations are performed using certified calibration fluids.
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(101 days)
The PROLYTE is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer (K070104).
The PROLYTE Electrolyte Analyzer is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, and Chloride found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.
This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of palients with electrolyte imbalance. These locations routinely conform to CLIA requlations, and conduct daily quality control programs.
The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, and chloride in whole blood, plasma, serum, and pre-diluted urine samples.
The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer. 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.
The PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
For In Vitro Diagnostic Use
The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium and chloride in serum, plasma, whole blood and pre-diluted urine samples. The PROLYTE analyzer is designed with the user in mind. It is fully automated with simple 'Yes' or 'No' commands for menu navigation. This simple interface ensures that the analyzer be easy to use for quick analysis, (one minute for most samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. The analyzer can be programmed to selfcalibrate using Mission Diagnostics Fluid Pack Na/K/Cl (510(k) 031159) at set intervals or on request. Sodium, potassium and chloride are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Mission Controls (510(k) 033063) are the recommended quality control material to be used daily.
Here's an analysis of the acceptance criteria and study details for the PROLYTE Electrolyte Analyzer, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the PROLYTE Electrolyte Analyzer are primarily focused on precision (within-run and total imprecision) and linearity. Another critical criterion for this 510(k) submission is substantial equivalence to its predicate device throughout its claimed measuring range, demonstrated through method comparison studies.
Here's the table summarizing these criteria and the reported performance from the provided document:
| Aspect | Analyte & Matrix | Acceptance Criteria (Performance Goal) | Reported Device Performance (Example Values - Note: Actual tables contain more detailed values, representative ones are presented here) | Pass/Fail |
|---|---|---|---|---|
| Precision | ||||
| Within-Run %CV | Serum/Blood: Na+ | ≤ 1% | Whole Blood: 0.60%, 0.58%, 0.91%Plasma: 0.95%, 0.55%, 0.63%Serum: 0.64%, 0.59%, 0.68% (all P) | Pass |
| Within-Run %CV | Serum/Blood: K+ | ≤ 2% | Whole Blood: 0.79%, 0.78%, 1.20%Plasma: 1.50%, 0.85%, 0.46%Serum: 0.66%, 0.70%, 0.85% (all P) | Pass |
| Within-Run %CV | Serum/Blood: Cl- | ≤ 2% | Whole Blood: 0.80%, 0.64%, 0.72%Plasma: 0.75%, 0.57%, 0.47%Serum: 1.47%, 0.67%, 1.25% (all P) | Pass |
| Within-Run %CV | Urine (1:10 dilution): Na+ | ≤ 2.5% | Urine: 0.54%, 0.68%, 0.55% (all P) | Pass |
| Within-Run %CV | Urine (1:10 dilution): K+ | ≤ 2.5% | Urine: 0.91%, 0.49%, 0.84% (all P) | Pass |
| Within-Run %CV | Urine (1:10 dilution): Cl- | ≤ 2.5% | Urine: 1.72%, 0.62%, 0.56% (all P) | Pass |
| Total %CV | Serum/Blood: Na+ | ≤ 2% | Whole Blood: 0.93%, 0.72%, 0.85%Plasma: 0.71%, 0.70%, 0.59%Serum: 0.76%, 0.88%, 1.03% (all P) | Pass |
| Total %CV | Serum/Blood: K+ | ≤ 2.5% | Whole Blood: 1.23%, 0.59%, 2.15%Plasma: 1.73%, 1.25%, 1.48%Serum: 0.91%, 0.80%, 1.19% (all P) | Pass |
| Total %CV | Serum/Blood: Cl- | ≤ 2.5% | Whole Blood: 1.30%, 1.13%, 1.09%Plasma: 1.25%, 0.83%, 0.81%Serum: 1.80%, 0.83%, 0.87% (all P) | Pass |
| Total %CV | Urine (1:10 dilution): Na+ | ≤ 5% | Urine: 3.82%, 1.02%, 1.48% (all P) | Pass |
| Total %CV | Urine (1:10 dilution): K+ | ≤ 5% | Urine: 1.57%, 1.06%, 0.91% (all P) | Pass |
| Total %CV | Urine (1:10 dilution): Cl- | ≤ 5% | Urine: 2.53%, 1.69%, 1.76% (all P) | Pass |
| Linearity | Na+, K+, Cl- across all matrices | R² > ~0.99 (Implicit in strong linear fit required for medical devices) | R² values for all analytes and matrices are very high, ranging from 0.9965 to 0.9997. (All P) | Pass |
| Method Comparison | Na+, K+, Cl- across all matrices | Strong correlation (R² > ~0.98) and slope near 1, intercept near 0, when compared to predicate device within reportable range to demonstrate substantial equivalence. | All R² values are between 0.9844 and 0.9995. Slopes are close to 1, and intercepts are close to 0, indicating strong agreement with the predicate. (All P) | Pass |
2. Sample Size and Data Provenance for the Test Set
- Precision Test Set Sample Sizes:
- Within-Run Imprecision: 30 replicates for each sample (low, mid, high concentrations) per analyte and matrix.
- Total Imprecision: 40 replicates (2 measurements daily for 10 days for serum, plasma, urine; 40 replicates on 2 instruments for whole blood).
- Linearity Test Set Sample Sizes:
- Whole Blood: 42 (Na+), 36 (K+), 42 (Cl-)
- Plasma: 42 (Na+), 54 (K+), 42 (Cl-)
- Serum: 33 (Na+), 33 (K+), 27 (Cl-)
- Urine: 40 (Na+), 36 (K+), 34 (Cl-)
- Method Comparison Test Set Sample Sizes:
- Whole Blood: 110 (Na+), 111 (K+), 108 (Cl-)
- Plasma: 101 (Na+), 104 (K+), 101 (Cl-)
- Serum: 103 (Na+), 100 (K+), 106 (Cl-)
- Urine: 102 (Na+), 105 (K+), 101 (Cl-)
- Data Provenance: The document does not specify the country of origin. It indicates that these are "non-clinical tests" and "clinical tests" referring to method comparisons with patient samples. The samples were either patient samples or spiked/diluted samples to cover the entire measuring range. This implies a prospective collection and testing approach for portions of the method comparison and possibly for precision and linearity.
3. Number of Experts and Qualifications for Ground Truth
- This device is an in vitro diagnostic (IVD) device (analyzing chemical analytes in body fluids) for which the "ground truth" is typically established by reference methods, calibrated standards, or a predicate device, not by human expert interpretation like in imaging.
- For the method comparison studies, the predicate device (original PROLYTE Electrolyte Analyzer K070104) served as the reference for ground truth. Therefore, the "experts" in this context would be the predicate device itself, which has been previously cleared by the FDA based on its own validation.
4. Adjudication Method for the Test Set
- No adjudication method (like 2+1 or 3+1 consensus) is applicable or mentioned. As an IVD device, measurements are quantitative and compared directly to either itself (for precision and linearity) or a predicate device (for method comparison), not to subjective expert interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done or is applicable. This is an IVD device providing quantitative measurements, not an AI imaging or diagnostic algorithm that assists human readers.
6. Standalone Algorithm Performance
- Yes, the entire study focuses on standalone performance of the PROLYTE Electrolyte Analyzer. The "algorithm" here refers to the instrument's internal measurement and processing capabilities. The non-clinical (precision and linearity) and clinical (method comparison) tests assess the device's inherent performance characteristics directly.
7. Type of Ground Truth Used
- For precision and linearity, the ground truth is established by the known concentrations of the analytes in the control materials and diluted stock solutions. These are internal reference points.
- For method comparison, the ground truth is established by the measurements obtained from the predicate device (original PROLYTE Electrolyte Analyzer K070104). This approach aims to demonstrate substantial equivalence, meaning the new device performs comparably to a device already cleared for market.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" in the context of machine learning. The device is an analyzer that uses ion-selective electrodes, and its "software" was rewritten, but its underlying measurement principles are the same as the predicate. The performance studies described are for validation/testing of the implemented system, not for training a model in the machine learning sense. The device is likely calibrated using standardized solutions, which could be considered an ongoing "training" or calibration process, but this is distinct from a one-time dataset for algorithm development.
9. How the Ground Truth for the Training Set Was Established
- As noted above, the concept of a training set as typically understood in machine learning is not directly applicable here. The device functions based on established electrochemical principles. The "calibration" of the device likely uses certified reference materials with known concentrations, ensuring accuracy. This would be part of the device's operational procedure rather than a study-specific training set.
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(239 days)
Diamond Calibrators for Medica ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na *, K , and Ci electrodes on the Poly-Chem and Randox Daytona instruments having the Medica ISE Module.
Diamond Calibrant A matrix consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a foil bag with a draw tube and covered in a corrugated box. Each foil bag contains 500 ml of solution.
Diamond Calibrant B matrix consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a plastic bottle with a cap. Each plastic bottle contains 125 ml of solution.
Here's a breakdown of the acceptance criteria and the study information for the Diamond Calibrators for Medica ISE Module, based on the provided text:
Acceptance Criteria and Reported Device Performance
The core acceptance criteria for these calibrators revolve around their ability to provide accurate calibration points for Na+, K+, and Cl- electrodes, effectively performing equivalently to the predicate device. The values for Calibrant A and B are explicitly stated:
| PN | ISE Module Calibrator | Na+ (mmol/L) | K+ (mmol/L) | Cl- (mmol/L) |
|---|---|---|---|---|
| ME-6370D | A | $140 \pm 2.0$ | $4.00 \pm 0.05$ | $125 \pm 2$ |
| ME-5410D | B | $70 \pm 1.5$ | $8.0 \pm 0.08$ | $41 \pm 1.5$ |
Reported Device Performance:
The summary states: "Results show equivalent performance for Na+, K+, and Cl calibration and precision. The devices show good correlation." This indicates that the Diamond Calibrators met the objective of providing calibration points within acceptable limits and demonstrating similar precision to the predicate device. While specific measured values are not provided in this summary, the declaration of "equivalent performance" and "good correlation" implies that the new device's output falls within the expected ranges and performs comparably to the predicate.
Study Details:
Based on the provided text, the study conducted is focused on demonstrating substantial equivalence to an existing predicate device rather than an independent standalone performance study or a comparative effectiveness study with human readers.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "Calibrators for Medica ISE Module were tested side by side with the predicate device on the Poly-Chem Dallrona Galleralyzer and Randox Daytona instruments." This implies multiple test runs or samples, but the exact number is not quantified.
- Data Provenance: Not explicitly stated. However, given it's a 510(k) submission from a US company (Holliston, MA), it's highly likely the testing was conducted in the US. The time frame (October 2009 submission) suggests prospective testing for this specific submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided as this is a chemical calibrator, not an imaging or diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for calibrators is their known chemical composition and the accuracy of the measurements they enable on an instrument.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for a chemical calibrator. The performance here is objectively measured by the instrument.
-
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is completely irrelevant for a chemical calibrator. The device described is not an AI-assisted diagnostic tool that aids human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm-only) performance study was not done in the context of AI. However, the study essentially functions as an instrument-based standalone performance study for the calibrators. The "algorithm" here is the chemical process and the instrument's measurement system. The calibrators themselves were tested "side by side with the predicate device on the Poly-Chem Dallrona Galleralyzer and Randox Daytona instruments." This represents the performance of the calibrators as measured by the instrument, without human intervention in the measurement process itself, beyond operating the analyzer.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the calibrators is their certified chemical concentrations (e.g., $140 \pm 2.0$ mmol/L for Na+ in Calibrant A). These are established through precise manufacturing and analytical chemistry methods. The "ground truth" during the comparison study would be the expected values on the instruments when calibrated correctly, as confirmed by the predicate device's performance.
-
The sample size for the training set:
- This is not applicable and not provided. This device is a chemical calibrator, not a machine learning algorithm that requires a "training set."
-
How the ground truth for the training set was established:
- This is not applicable as there is no "training set" for this type of device. The ground truth for the calibrators themselves is established through their precise formulation and analytical verification during manufacturing.
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(129 days)
Ask a specific question about this device
(131 days)
Mission Trinity R TM Control is intended to be used as an assayed quality control material for monitoring the precision and performance of the following analytes pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, and lactate on blood gas, electrolyte, and metabolite analyzers as well as tHb, %O2Hb, %O2Sat, %COHb, %MetHb, %O2Ct & %HHb on CO-Oximeter instrumentation. It is for in vitro diagnostics use and for the quantitative determination of the analytes listed on the Expected Values Chart.
Trinity R matrix consists of a buffered solution of electrolytes, glucose, lactate, dyes and preservative. It is equilibrated with specific levels of CO2, O2, and N2. It contains no human or biological materials. Trinity R is provided in three (3) distinct levels of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, % HbO2Sat, %COHb, %MetHb, %O2Ct & %HHb covering the significant range of the instrument performance. It is packaged in sealed glass ampules, each containing 1.8 ml of solution. Ampules are packaged in single level boxes (30 ampules of same level) or tri-level boxes (10 ampules of each level).
The provided text is a 510(k) Summary for the Mission Trinity R blood gas control device. It primarily focuses on demonstrating substantial equivalence to a predicate device (RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter Control) rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.
Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not explicitly available in the provided text.
The document states that Diamond Diagnostics, Inc. claims substantial equivalence for "Composition, Intended use, Packaging, Storage, and Shelf life" based on comparisons of these characteristics and analytes. It does not include a specific study design to prove performance against quantitative acceptance criteria for the device itself.
Here's a breakdown of what can be inferred or directly stated from the text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Missing. The document does not provide a table with quantitative acceptance criteria for device performance (e.g., accuracy, precision) for the analytes. It only lists the analytes and their intended use as quality control material.
- Implied Performance: The entire submission's purpose is to demonstrate that the Mission Trinity R control performs substantially equivalently to the predicate device. This implies that if the predicate device met performance standards, the Mission Trinity R is expected to meet similar, but not explicitly stated or quantified here, performance expectations.
2. Sample Size Used for the Test Set and Data Provenance:
- Missing. The document does not describe a "test set" in the context of device performance evaluation. It describes the product itself (30 ampules per box) but not the sample size used in a performance study.
- Data Provenance: Not applicable as no specific performance study data is presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Missing. Not applicable as no specific performance study with a test set requiring ground truth establishment is described. The "ground truth" for a quality control material would typically be its assigned target values, which are established by the manufacturer through rigorous characterization, but the details of this process are not in the document.
4. Adjudication Method for the Test Set:
- Missing. Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is more common for diagnostic imaging AI algorithms. The Mission Trinity R is a quality control material, not a diagnostic device requiring human reader interpretation, so an MRMC study is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. The device is a quality control material, not an algorithm. Its "performance" is about its stability, accuracy of its assigned values, and its ability to monitor other instruments.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Implied (for Quality Control Materials): For quality control materials, the "ground truth" for the assigned values is typically established through a robust process of multiple measurements on reference instruments, often traceably linked to international standards or reference materials. This process ensures the target values assigned to the control material are accurate. However, the details of how the expected values for Mission Trinity R were established are not provided in this summary.
8. The Sample Size for the Training Set:
- Missing/Not Applicable. As the Mission Trinity R is a physical quality control material and not an AI algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Missing/Not Applicable. No training set for an AI algorithm.
Summary of available information related to equivalence, which is the focus of this 510(k):
The document details the characteristics of the Mission Trinity R control and directly compares it to the predicate device, RNA Medical RA 525 Controls.
-
Similarities:
- Product Type: Assayed Blood Gas Control
- Intended Use: For in vitro diagnostics use for quality control of pH/Blood Gas analyzers, ISE analyzers, Metabolite analyzers, and CO-Oximeter Instrumentation.
- Matrix: Buffered Aqueous Solution
- Storage: 2-8°C
- Color: Red/purple solution
- Levels: Three (Levels 1, 2, 3)
- Analytes: pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, %COHb, %metHb, %O2Ct, %O2Sat, and %HHb.
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Differences:
- Preservative: Mission Trinity R has a preservative; Predicate does not.
- Package Size: Mission Trinity R is 30 x 1.8mL; Predicate is 30 x 2.5mL.
- Shelf Life: Mission Trinity R has 24 months; Predicate has 36 months.
The 510(k) process primarily relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. It does not always require new clinical studies with defined acceptance criteria for quantitative performance if substantial equivalence can be shown through other means (e.g., similar materials, design, intended use, and performance claims derived from the predicate).
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(163 days)
The GemLyte is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in whole blood, plasma and serum, and prediluted urine samples.
The GemLyte Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the GemLyte Electrolyte Analyzer. 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.
The GemLyte Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the GemLyte Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The GemLyte Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The GemLyte Calcium Assay is intended to measure the ionized calcium level in whole blood, plasma and serum. 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 GemLyte Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma and serum. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
The GemLyte is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood and prediluted urine samples. GemLyte analyzer is designed with the user in mind, it is fully automated with simple .Yes' or 'No' commands for menu navigation. This simple interface insures that not only will the analyzer be easy to use for quick analysis, (less than a minute for samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended quality control material to be used daily.
The provided text describes the 510(k) summary for the GemLyte Electrolyte Analyzer. Here's a breakdown of the acceptance criteria and the study information as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GemLyte Electrolyte Analyzer are primarily based on achieving performance similar to or within specified limits of the predicate device (AVL 9180 (K961458)) and meeting internal reproducibility guidelines. The reported device performance metrics are presented as "reproducibility" (precision) and "correlation" (agreement with predicate device).
Acceptance Criteria (Performance Specifications)
| Metric | Parameter | Matrix | Acceptance Criteria (Internal/Predicate Comparison) | Reported Device Performance (Achieved) |
|---|---|---|---|---|
| Reproducibility (Precision) | ||||
| Within-Run | Na+ | Blood/Plasma/Serum | C.V. ≤1% | C.V. ≤0.6% |
| K+ | Blood/Plasma/Serum | C.V. ≤1.5% | C.V. ≤1.5% | |
| Cl- | Blood/Plasma/Serum | C.V. ≤2% | C.V. ≤1% | |
| Ca++ | Blood/Plasma/Serum | SD ≤0.02 | SD ≤0.02 | |
| Li+ | Blood/Plasma/Serum | SD ≤0.03 | SD ≤0.04 (Note: This is slightly higher than the specified SD ≤0.03 in the "Reproducibility" table but within the "Summary of nonclinical tests" table. The text states "Results are within performance specifications.") | |
| Na+ | Urine | C.V. ≤5% | C.V. ≤ 5% | |
| K+ | Urine | C.V. ≤5% | C.V. ≤ 5% | |
| Cl- | Urine | C.V. ≤5% | C.V. ≤ 2% (Note: This is better than the specified C.V. ≤ 5% in the "Reproducibility" table but within the "Summary of nonclinical tests" table. The text states "Results are within performance specifications.") | |
| Between-Run | Na+ | Serum/Blood/Serum | C.V. ≤2% | C.V. ≤1.5% |
| K+ | Serum/Blood/Serum | C.V. ≤3% | C.V. ≤3% | |
| Cl- | Serum/Blood/Serum | C.V. ≤3% | C.V. ≤3% | |
| Ca++ | Serum/Blood/Serum | SD ≤0.06 | SD ≤0.06 | |
| Li+ | Serum/Blood/Serum | SD ≤0.09 | SD ≤0.09 | |
| Na+ | Urine | C.V. ≤5% | C.V. ≤4% | |
| K+ | Urine | C.V. ≤5% | C.V. ≤5% | |
| Cl- | Urine | C.V. ≤5% | C.V. ≤3% | |
| Linearity | All | All claimed range | Correlation coefficients > 0.99 (regression analysis) | All correlation coefficients were greater than 0.99. |
| Correlation to Predicate Device | All | All sample types | Correlation coefficients > 0.99 (regression analysis) | "Regression analysis show good correlation to predicate devices for all sample types, whole blood, plasma, serum and urine with correlation coefficients typically greater than 0.99." Specific R² values are provided in the tables above, all of which are ≥0.9687 (Chloride in Serum). |
2. Sample Size Used for the Test Set and Data Provenance
The test set for the correlation studies used the following sample sizes:
- Whole Blood: Sodium (n=128), Potassium (n=112), Chloride (n=123), Calcium (n=124), Lithium (n=123)
- Plasma: Sodium (n=105), Potassium (n=107), Chloride (n=115), Calcium (n=123), Lithium (n=115)
- Serum: Sodium (n=122), Potassium (n=127), Chloride (n=125), Calcium (n=120), Lithium (n=131)
- Urine (Spot): Sodium (n=118), Potassium (n=108), Chloride (n=118)
Data Provenance: The document does not explicitly state the country of origin. It indicates that samples were "collected for testing on the GemLyte as well as another predicate device, the AVL 9180." The language used (e.g., "mmol/L") is standard for clinical chemistry. The study appears to be prospective in nature, as it describes a setup for collecting and testing samples on two devices for comparison.
For precision (reproducibility) studies:
- Within-Run: 30 replicates for each sample type (blood, serum, urine).
- Between-Run: 2 runs per day with 2 replicates per run for 10 days for each sample type.
- Potassium (Whole Blood Specific): Multiple instruments (4) tested over a period of an hour due to instability.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (electrolyte analyzer) does not typically rely on "expert" interpretation for ground truth, unlike imaging or diagnostic AI. The "ground truth" for the correlation study is the measurement obtained from the predicate device (AVL 9180), which is an established, legally marketed device for the same purpose. The text states, "Clinical testing was conducted to demonstrate the correlation of Diagnostics GemLyte Analyzer to predicate devices operated by trained personnel." It clarifies that the comparison device was operated by "trained personnel," implying standard laboratory practice, but does not specify "experts" in the sense of clinical specialists like radiologists.
4. Adjudication Method for the Test Set
Not applicable. As explained above, the ground truth is established by the predicate device's readings, not by expert consensus or adjudication. The study design is a direct comparison of measurements between two devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an imaging or diagnostic AI device that involves human readers interpreting cases. It is an automated electrolyte analyzer.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies presented are standalone performance evaluations for the GemLyte Electrolyte Analyzer. The device is an automated system; its performance is measured directly (e.g., reproducibility, linearity) and compared against a predicate device's measurements, not against human performance in a diagnostic reading task.
7. Type of Ground Truth Used
The ground truth for the clinical correlation studies was the measurements obtained from the predicate device, AVL 9180. For within-run precision, the ground truth is implicitly the true stable concentration within the sample, with the device aiming to measure it consistently. For linearity, the ground truth was prepared standard solutions (dilutions from starting stock solutions).
8. Sample Size for the Training Set
The document does not specify a separate "training set" in the context of an AI/ML model for this device. The GemLyte Electrolyte Analyzer is based on ion-selective electrode (ISE) technology, not machine learning. Therefore, it does not typically involve a "training set" in the computational sense. The device is calibrated using internal calibration solutions and Diamond Diagnostics Fluid Pack (510(k) 013850) as described in the calibration section.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI/ML model, this question is not applicable in the typical sense.
For the device's internal calibration, the "ground truth" would be the known concentrations of the calibration solutions, which are presumably traceable to established standards. The text states:
- "The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request."
- "The GemLyte performs a 2-point calibration (3-point calibration if lithium) every 4 hours or software permits calibration on demand. A 1-point calibration is performed automatically with each measurement."
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(483 days)
The proLYTE Electrolyte Analyzer is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, and Chloride found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.
This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with electrolyte imbalance. These locations routinely conform to CLIA regulations, and conduct daily quality control programs.
For In Vitro Diagnostic Use
The proLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium and chloride in serum, plasma, whole blood and prediluted urine samples, proLYTE analyzer is designed with the user in mind, it is fully automated with simple 'Yes' or 'No' commands for menu navigation. This simple interface insures that not only will the analyzer be easy to use for quick analysis, (one minute for most samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. The analyzer an be programmed to self-calibrate using Mission Diagnostics ILyte 800 Fluid Pack Na/K/Cl (510(k) 031159) at set intervals or on request. Sodium, potassium and chloride are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Mission Controls (510(k) J33063) are the recommended quality control material to be used daily.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the proLYTE Electrolyte Analyzer:
1. Table of Acceptance Criteria and Reported Device Performance:
| Analyte | Sample Type | Acceptance Criteria (Within-Run Precision) | Reported Device Performance (Within-Run Precision) | Acceptance Criteria (Between-Run Precision) | Reported Device Performance (Between-Run Precision) | Linearity (Correlation Coefficient) |
|---|---|---|---|---|---|---|
| Na+ | Serum/Blood | C.V. ≤ 1% | "within performance specifications" | C.V. ≤ 2% | "within performance specifications" | > 0.99 |
| K+ | Serum/Blood | C.V. ≤ 2% | "within performance specifications" | C.V. ≤ 2.5% | "within performance specifications" | > 0.99 |
| Cl- | Serum/Blood | C.V. ≤ 2% | "within performance specifications" | C.V. ≤ 2.5% | "within performance specifications" | > 0.99 |
| Na+ | Urine (1:10 dil.) | C.V. ≤ 2.5% | "within performance specifications" | C.V. ≤ 2.5% | "within performance specifications" | > 0.99 |
| K+ | Urine (1:10 dil.) | C.V. ≤ 2.5% | "within performance specifications" | C.V. ≤ 2.5% | "within performance specifications" | > 0.99 |
| Cl- | Urine (1:10 dil.) | C.V. ≤ 2.5% | "within performance specifications" | C.V. ≤ 5% | "within performance specifications" | > 0.99 |
Note: The reported performance for precision states "within performance specifications." This indicates that the measured CV values were equal to or less than the specified acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Precision (within-run): Minimum of 30 replicates for each sample type (blood, serum, urine).
- Precision (between-run): 2 runs per day (AM & PM) with 2 replicates per run for 10 days for each sample type. This equates to 40 measurements per sample type (2 runs/day * 2 replicates/run * 10 days).
- Linearity: Minimum of 5 levels tested for each sample type.
- Clinical Testing (Correlation to Predicate Device): Not explicitly stated, but "All sample types, whole blood, plasma, serum and urine were collected for testing." The exact number of samples is not provided in this summary.
- Data Provenance: Not explicitly stated. The document doesn't mention the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for an in-vitro diagnostic, it's highly likely to be prospective data collected specifically for validation, but this isn't confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- None specified. For an electrolyte analyzer measuring quantitative values, the ground truth is typically established by reference methods or predicate devices, not by expert consensus in the same way an image analysis algorithm might use radiologists. The "ground truth" in this context is the actual concentration of the analytes as determined by a highly accurate and precise method. The clinical testing portion compares the proLYTE analyzer to "predicate devices operated by trained personnel," implying the predicate device serves as the reference for comparison.
4. Adjudication Method for the Test Set:
- Not applicable. As the device measures quantitative chemical analytes, there is no "adjudication" in the traditional sense of human readers disagreeing on an interpretation. The comparison is statistical (regression analysis) against reference measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study is typically for evaluating the diagnostic performance of human readers (e.g., radiologists) with and without AI assistance on a set of cases. This device is a quantitative analytical instrument, not an AI-assisted diagnostic tool for human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, this is a standalone device. The proLYTE Electrolyte Analyzer is an automated instrument that performs measurements directly. Its performance summarized in the document (precision, linearity, correlation) represents its standalone capability without human interpretation being part of the measurement process itself. Human operators introduce the sample and initiate the analysis, but the measurement and result generation are entirely automated.
7. The Type of Ground Truth Used:
- Reference measurements from predicate devices and/or highly accurate laboratory methods. For precision and linearity studies, the ground truth is often established by making known dilutions or using control materials with certified values. For clinical correlation, the ground truth is established by the measurements obtained from legally marketed predicate devices, which are assumed to be accurate and reliable. The summary states: "Clinical testing was conducted to demonstrate the correlation of Diamond Diagnostics proLYTE Analyzer to predicate devices operated by trained personnel."
8. The Sample Size for the Training Set:
- Not applicable. The proLYTE Electrolyte Analyzer is an electrochemical instrument based on ion-selective electrodes, not a machine learning or AI-driven system that requires a "training set" in the computational sense. Its "training" is inherent in its design, calibration, and manufacturing processes, not in learning from a dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no "training set" for this type of device. The accuracy and calibration are based on established scientific principles of electrochemistry and the use of known calibrant solutions.
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(118 days)
Mission Olympus AU ISE Calibrators are intended to provide calibration points for Na+, K+ and Cl- electrodes on the Olympus AU4xx and AU6xx instruments. For in-vitro diagnostics use.
Mission Olympus AU ISE Calibrators are intended to serve as a direct replacement to Olympus AU ISE Calibrators. They are aqueous solutions of salts & preservatives, containing NO human or animal materials, packaged in plastic bottles.
This is a 510(k) submission for in-vitro diagnostic calibrators, not an AI/ML device. Therefore, many of the typical acceptance criteria and study elements requested (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable.
Here's an interpretation of the provided information in the context of the requested structure:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Stability: Maintain performance over shelf life. | Accelerated (high temperature) stress testing supported stability. |
| Equivalence to Predicate Device: Perform comparably to the Olympus AU ISE Calibrators. | Side-by-side testing of Mission Olympus AU ISE Calibrators vs. Predicate (OEM) product on intended instruments demonstrated equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as this is a calibrator submission, not a study involving patient data. The "test set" here refers to the calibrator units and possibly instrument runs. The submission mentions testing across different instruments.
- Data Provenance: Not applicable in the sense of patient data. The provenance relates to the manufacturing and testing of the calibrator solutions and their evaluation on Olympus AU4xx and AU6xx instruments.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This concept is not applicable for this type of device (calibrators). Ground truth for calibrators is typically established through analytical methods and metrological traceability to reference materials, not through expert consensus on medical images or diagnostic outcomes.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication typically refers to resolving discrepancies among expert readers, which is not relevant for calibrator performance studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers in interpreting data (e.g., medical images). This submission is for physical calibrator solutions.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is not an algorithm, but a physical diagnostic calibrator. Its performance is inherent to the chemical composition and manufacturing, and its functional performance is assessed on the intended instruments.
7. The Type of Ground Truth Used
- The "ground truth" for calibrators relates to their assigned values for Na+, K+, and Cl- parameters, which are established through precise analytical methods, typically traceable to higher-order reference measurement procedures or certified reference materials. The submission implies that the 'ground truth' for comparison was the performance of the predicate (OEM) Olympus AU ISE Calibrators.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
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(84 days)
Mission Trinity B™ Controls are intended to be used as a quality control material for monitoring the performance of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, %COHb, %metHb & %HHb on Bayer instrumentation. For In Vitro Diagnostic Use
Trinity B is a specially formulated, three-level, aqueous material intended for use to monitor all analytes measured by the Bayer line of blood gas, electrolyte, metabolite and CO-Oximetry analyzers. Trinity B controls provide a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC as a part of their quality assurance program. Trinity B contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, chloride, ionized calcium, glucose, lactate and suitable concentrations of dyes to simulate clinically relevant values of hemoglobin, and hemoglobin derivatives: O2Hb, COHb, MetHb and HHB.
Here's the information regarding the acceptance criteria and study for the Mission Trinity B device, extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria or detailed performance data in a table format. It mentions "Tests were conducted to verify specific performance requirements" and that "side by side testing of Mission Trinity B vs. Predicate (OEM) product on intended instruments to o demonstrate equivalence" was performed.
| Criterion Type | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Stability | (Implied: Demonstrated stability over time under specified conditions) | "Accelerated (high temperature) stress test to support stability" was conducted. The specific results are not detailed, but the conclusion states "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence." |
| Equivalence | (Implied: Performance comparable to the predicate device for all specified analytes on intended instruments) | "Side by side testing of Mission Trinity B vs. Predicate (OEM) product on intended instruments to o demonstrate equivalence" was conducted. The conclusion states the device is substantially equivalent, implying this testing confirmed comparable performance. Specific data on individual analytes' equivalence is not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Side by side testing," suggesting that samples of both the Mission Trinity B and the predicate device were analyzed multiple times on the intended instruments.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a prospective comparison study conducted by the manufacturer, Diamond Diagnostics Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the device is a quality control material intended for instrument calibration/quality verification, not a diagnostic device that produces results requiring human expert interpretation for "ground truth." The "ground truth" for the performance of a quality control material such as this would be its known assayed values, and the performance is measured by how accurately and precisely the instruments measure these known values compared to the predicate control.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices or other interpretation-based systems, not for quality control materials for automated analyzers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The concept of "standalone performance" of an algorithm is not applicable in this context. Mission Trinity B is a chemical control solution, not an algorithm or a software-based device. Its "performance" is its stability and its ability to serve as a reliable reference material for analytical instruments. The testing involved instrument analysis of the control material, similar to a "standalone" chemical analysis.
7. The Type of Ground Truth Used
For a quality control material, the "ground truth" is its established assayed values for the analytes it contains. These values are determined through rigorous analytical methods (e.g., reference methods, highly precise laboratory techniques) by the manufacturer. The purpose of the study was to demonstrate that instruments measure these values comparably to how they measure the predicate control.
8. The Sample Size for the Training Set
This information is not applicable. Quality control materials like Mission Trinity B do not involve machine learning algorithms that require a "training set." The product is a chemical formulation.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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