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510(k) Data Aggregation
(266 days)
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of ionized calcium and hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings.
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in capillary whole blood in point of care or clinical laboratory settings.
Ionized calcium measurements are used in the diagnosis, monitoring, and treatment of conditions including, but not limited to, parathyroid disease, a variety of bone disease, chronic renal disease, tetany, and disturbances related to surgical and intensive care.
Hematocrit measurements can aid in the determination of normal or abnormal total red cell volume status that can be associated with conditions including anemia, erythrocytosis, and blood loss related to trauma and surgery.
The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System and contains test reagents to measure hematocrit (Hct) in arterial, venous or capillary whole blood and to measure ionized calcium (iCa) in arterial and venous whole blood.
The i-STAT 1 System is an in vitro diagnostic (IVD) medical device intended for the quantitative determination of various clinical chemistry tests contained within i-STAT cartridges using whole blood. The i-STAT 1 System consists of a portable blood analyzer (i-STAT 1 analyzer), single-use disposable test cartridges (i-STAT cartridges), liquid quality control and calibration verification materials, and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator and i-STAT 1 Printer). The i-STAT 1 System, including the i-STAT CG8+ cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.
The i-STAT CG8+ cartridge contains the required sensors, a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within cartridge. The i-STAT cartridge format allows all the tests in the cartridge to be performed simultaneously. All the test steps and fluid movement occur within the i-STAT CG8+ cartridges require two to three drops of whole blood which are applied to the cartridge using a transfer device by the trained user before the cartridge is placed within the analyzer.
The i-STAT 1 analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the i-STAT CG8+ cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).
The provided text describes the analytical performance studies for the i-STAT CG8+ cartridge with the i-STAT 1 System, a device for in vitro quantification of ionized calcium (iCa) and hematocrit (Hct). This submission sought to demonstrate substantial equivalence to a predicate device (i-STAT CHEM8+ cartridge with the i-STAT 1 System, K191360).
Here's an analysis of the acceptance criteria and study details based on the provided information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined acceptance criteria (e.g., target ranges for precision, linearity, or bias). Instead, it presents the results of various analytical performance studies. The conclusion states that the studies demonstrate substantial equivalence to the predicate device, implying that the reported performance metrics met the internal or regulatory thresholds for such a claim.
However, we can infer performance targets for some aspects by comparing the reported results to general expectations for such devices or by looking at the predicate device's characteristics mentioned (though the predicate's detailed performance is not provided in this document).
For the purpose of this request, I will present the reported performance values. The "Acceptance Criteria" column will reflect the general expectation of "demonstrating substantial equivalence" or meeting regulatory standards for the tested parameter, as specific numerical acceptance criteria are not provided in the document.
| Test Parameter | Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance (i-STAT CG8+ cartridge with i-STAT 1 System) |
|---|---|---|
| Precision (Aqueous Materials) - 20 Days | Performance demonstrating substantial equivalence to predicate. | iCa (mmol/L): Overall Within-Laboratory SD typically < 0.015 mmol/L, %CV < 0.8%. Hct (%PCV): Overall Within-Laboratory SD typically < 0.5%, %CV < 2%. (See Table 2 for full details) |
| Precision (Aqueous Materials) - Multi-site/Operator | Performance demonstrating substantial equivalence to predicate. | iCa (mmol/L): Overall SD typically < 0.02 mmol/L, %CV < 1%. Hct (%PCV): Overall SD typically < 0.5%, %CV < 3.5%. (See Table 3 for full details) |
| Precision (Whole Blood) | Performance demonstrating substantial equivalence to predicate. | iCa (mmol/L): SD typically < 0.022 mmol/L, %CV < 1.3%. Hct (%PCV): SD typically < 2.2%, %CV < 5.6%. (See Table 4 for full details) |
| Linearity (iCa) | Linear response over reportable range, demonstrating substantial equivalence. | Reportable Range: 0.25 - 2.50 mmol/L Range Tested: 0.204 - 2.832 mmol/L Slope: 1.016, Intercept: 0.019, R: 0.9981 (See Table 5) |
| Linearity (Hct) | Linear response over reportable range, demonstrating substantial equivalence. | Reportable Range: 15 - 75 %PCV Range Tested: 12.7 - 78.3 %PCV Slope: 1.031, Intercept: -0.592, R: 0.9992 (See Table 5) |
| Limit of Quantitation (LoQ) | LoQ at or below the lower limit of the reportable range. | iCa: Determined LoQ 0.15 mmol/L (Lower limit: 0.25 mmol/L) Hct: Determined LoQ 13 %PCV (Lower limit: 15 %PCV). (See Table 6) |
| Limit of Blank (LoB) | LoB consistent with low-end measurement expectations. | iCa: LoB 0.119 mmol/L Hct: LoB 0 %PCV (See Table 7) |
| Limit of Detection (LoD) | LoD consistent with low-end measurement expectations. | iCa: LoD 0.125 mmol/L Hct: LoD 0.4 %PCV (See Table 7) |
| Analytical Specificity (Interference) | Interference properties demonstrate substantial equivalence to predicate, with known interferences identified. | Various substances tested. Identified interferences for iCa: Bromide (dose-response needed), Lactate (≥6 mmol/L), Leflunomide (≥0.345 mmol/L), Magnesium (≥3.5 mmol/L), Nithiodote (≥5.3 mmol/L), Teriflunomide (≥0.049 mmol/L), Thiocyanate (≥0.898 mmol/L). Identified interferences for Hct: Bromide (dose-response needed), Total Protein (≥9.5 g/dL). (See Table 8) |
| Method Comparison (iCa) | Strong correlation and low bias against comparative method, demonstrating substantial equivalence. | Comparative Method: i-STAT CHEM8+ N: 343 Slope: 1.02, Intercept: -0.02, r: 0.99 Bias at MDLs: -0.009 to 0.003 mmol/L (See Table 9) |
| Method Comparison (Hct) | Strong correlation and low bias against comparative method, demonstrating substantial equivalence. | Comparative Method: i-STAT CHEM8+ / Epoc Blood Analysis System N: 535 Slope: 1.000, Intercept: -1.00, r: 0.98 Bias at MDLs: -1.0 %PCV (See Table 10) |
| Method Comparison (Capillary Hct only) | Strong correlation and low bias against comparative method, demonstrating substantial equivalence for capillary samples. | N: 208 Slope: 1.000, Intercept: 0.00, r: 0.97 Range: 18-73 %PCV Bias at MDLs (Native): 0.0 %PCV. (See Tables 11 & 12) |
| Matrix Equivalence (iCa) | Strong correlation between non-anticoagulated and anticoagulated samples. | N: 298 r: 0.99, Slope: 1.00, Intercept: 0.01 (See Table 13) |
| Matrix Equivalence (Hct) | Strong correlation between non-anticoagulated and anticoagulated samples. | N: 293 r: 0.99, Slope: 1.000, Intercept: 0.00 (See Table 13) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision (Aqueous Materials) - 20 Days: N=80-82 for iCa and Hct (number of measurements). Data provenance: Not specified, but likely internal lab data based on CLSI guidelines.
- Precision (Aqueous Materials) - Multi-site/Operator: N=90-97 for iCa and Hct (number of measurements). Data provenance: Three (3) sites, 2 operators per site. Not specified if within the US or international, or retrospective/prospective.
- Precision (Whole Blood): Sample sizes vary by analyte and range:
- iCa Venous: N=5-95
- iCa Arterial: N=0-92
- Hct Venous: N=7-88
- Hct Arterial: N=2-104
- Hct Capillary: N=17-109
- Data provenance: "collected across multiple point of care sites." Not specified if within the US or international, or retrospective/prospective, but implied prospective for the study as specimens were "collected with lithium heparin."
- Linearity/Assay Reportable Range: Sample not explicitly sized by patient count, but rather by varying analyte levels created from whole blood samples. Data provenance: Whole blood samples.
- Limit of Quantitation (LoQ): Whole blood samples (altered to low analyte level).
- Limit of Blank (LoB) & Detection (LoD): Whole blood samples (altered to blank/low levels).
- Analytical Specificity (Interference): Whole blood samples.
- Method Comparison:
- iCa Method Comparison: N=343 (pooled venous and arterial whole blood specimens).
- Hct Method Comparison (pooled): N=535 (venous, arterial, and capillary whole blood specimens).
- Hct Method Comparison (capillary only): N=208 (capillary whole blood specimens, native and contrived). N=193 for native only.
- Data provenance: "Lithium heparin venous and arterial whole blood specimens collected across multiple point of care sites." "Capillary whole blood specimens collected from skin puncture... across multiple point of care sites." Implied prospective collection for the study. Not specified if within the US or international.
- Matrix Equivalence: N=298 for iCa, N=293 for Hct. Data provenance: "non-anticoagulated venous and arterial whole blood specimens." Implied prospective collection for the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is an in vitro diagnostic (IVD) instrument that provides quantitative measurements. The "ground truth" for these types of devices is established by a comparative method (often a laboratory reference method or another FDA-cleared device) rather than expert consensus on interpretations. The document explicitly mentions:
- iCa and Hct Method Comparison: The i-STAT CG8+ cartridge on the i-STAT 1 analyzer was compared against "a comparative method." For iCa, the predicate device i-STAT CHEM8+ was used as the comparative method. For Hct, the i-STAT CHEM8+ and Epoc Blood Analysis System were used as comparative methods.
- Traceability: iCa is traceable to NIST SRM956. Hct is traceable to CLSI H07-A3 procedure for determining packed cell volume by the microhematocrit method.
Therefore, no human experts were directly involved in establishing the ground truth for these quantitative measurements in terms of interpretation, as it's an analytical performance study against established analytical methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers interpret medical images or clinical findings and discrepancies need to be resolved. This study focuses on the analytical performance of a quantitative measurement device, where the ground truth is established by a "comparative method" or recognized reference standards, not by human interpretation 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 an analytical performance study for an IVD device, not a multi-reader multi-case clinical study involving human readers and AI assistance for interpretation. The device itself performs the measurement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this entire submission revolves around the standalone analytical performance of the i-STAT CG8+ cartridge with the i-STAT 1 System. The "algorithm" (the device's internal measurement and calculation processes) generates quantitative results without human interpretation as part of its core function, although trained medical professionals operate the device. All the precision, linearity, detection limit, interference, and method comparison studies are evaluations of this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this quantitative measurement device is established through:
- Comparative Reference Methods: For method comparison studies, existing FDA-cleared or well-established laboratory methods (i-STAT CHEM8+ and Epoc Blood Analysis System) serve as the comparative ground truth.
- Certified Reference Materials/Standardized Procedures: Traceability to NIST SRM956 for iCa and CLSI H07-A3 for Hct indicates the use of recognized reference materials and standardized procedures for calibration and accuracy verification, which forms the basis for the ground truth in analytical measurements.
8. The sample size for the training set
The document does not explicitly describe a "training set" in the context of machine learning. This is an IVD device, and its development typically involves internal R&D, calibration, and verification rather than a dedicated machine learning "training set" as understood in AI/ML systems. All the presented studies are for validation of the finalized product.
9. How the ground truth for the training set was established
As there's no explicitly defined "training set" for a machine learning algorithm in the provided document, this question is not fully applicable. The development and internal validation of such a device generally rely on established metrological principles, using reference materials, spiked samples, and comparison to established methods to ensure accuracy and precision during its design and optimization phases.
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