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510(k) Data Aggregation
(18 days)
The i-STAT System is used by trained medical professionals for running clinical chemistry tests for sodium, potassium, chloride, urea nitrogen, glucose, hematocrit, calcium, blood-gases (PCO2, PO2) and blood pH, creatinine, lactic acid, and activated whole blood clotting time in a variety of test panels contained in the i-STAT test cartridges.
The i-STAT System is used in conjunction with disposable i-STAT cartridges for determination of a variety of parameters in whole blood.
The provided text is a 510(k) summary for the i-STAT System, primarily focusing on a software modification to address interference in the PCO2 test. It does not contain a typical study design or acceptance criteria for a new device's performance directly. Instead, it references prior substantial equivalence determinations and focuses on the modification.
Therefore, many of the requested categories cannot be filled based on the provided document.
Here's an analysis of what information can be extracted or inferred, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or a detailed performance table for this specific software modification. It mentions that the software modification was made "to diminish the interference on the PCO2 test caused by the drugs thiopental sodium and propofol." This implies that the previous performance in the presence of these drugs was unsatisfactory, and the modification aims to improve it, but no specific targets (e.g., % reduction in error, specific bias limits) are provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document for this modification. The implied criterion is to diminish interference from thiopental sodium and propofol on PCO2 test results. | The software has been modified to diminish the interference on the PCO2 test caused by the drugs thiopental sodium and propofol. No quantitative performance data is provided for this specific improvement. |
2. Sample Size Used for the Test Set and Data Provenance:
Not specified in the document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not specified in the document.
4. Adjudication Method for the Test Set:
Not specified in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This device is a clinical analyzer, not an imaging device typically evaluated with MRMC studies comparing human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The i-STAT System is a standalone clinical analyzer. The software modification described likely refers to an improvement in the algorithm that processes the PCO2 measurement from the sensor, without direct human-in-the-loop performance being a separate evaluation step. However, the document does not detail a specific standalone performance study for this modification. The device itself operates in a standalone manner.
7. The Type of Ground Truth Used:
Not specified in the document. For a clinical analyzer, ground truth would typically be established by a reference method (e.g., a laboratory-based blood gas analyzer) for the PCO2 measurement.
8. The Sample Size for the Training Set:
Not applicable/Not specified. This document describes a software modification to an existing device, not the training of a new AI model in the typical sense that would involve a "training set" with ground truth in the context of machine learning. The modification likely involved algorithm adjustments based on observed interference, rather than a large-scale machine learning training pipeline.
9. How the Ground Truth for the Training Set Was Established:
Not applicable/Not specified (as above).
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(49 days)
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(192 days)
The i-STAT Celite Activated Clotting Time (ACT) test cartridge is an in vitro diagnostic test used to monitor moderate- and high-level hevarin therapy through analysis of arterial and venous whole blood samples. The cartridge is to be used with the i-STAT System 200 model analyzer.
As part of the i-STAT System, the Celite ACT test cartridge is to be used by trained and certified health care professionals in accordance with a facility's policies and procedures.
The i-STAT Celite ACT test is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery, organ transplant and dialysis.
The i-STAT Celite ACT test is contained in a single test cartridge. In use, approximately 40 microliters of fresh whole blood are placed in the cartridge as described below. The cartridge is inserted into the thermally controlled i-STAT Model 200 Portable Clinical Analytical steps are performed automatically. Patient and user information may be entered into the analyzer via a keypad during the automated analysis cycle.
In the i-STAT ACT test the endpoint is indicated by the appearance of an electroactive marker generated by the thrombin-mediated conversion of a synthetic substrate included in the reagent. Detection of the marker indicates generation of thrombin and therefore complete activation of the coagulation cascade. The reported result is calculated from the time and rate of the substrate conversion and is given in seconds. The reported result correlates to the result of a traditional ACT in which the endpoint is indicated by physical clot formation.
The ACT cartridge is assembled from plastic components that provide the conduits for fluid handling and house the sensor chips. The coagulation test is identified to the user through the name and color code on the cartridge label and by the analyzer through features integral to the cartridge.
In the ACT cartridge the sensor comprises a gold film patterned on a silicon/silicon dioxide substrate.
During the test the blood sample is mixed with reagents which are coated on the cartridge cover in a segment of the sensor channel. The reagent layer includes an activating agent, a thrombin substrate, and inert matrix components. These reagents allow activation of the coagulation cascade and detection of clot formation.
Whole blood is introduced into the sample well of the cartridge at the sample port and the cartridge is closed and inserted into the analyzer. Insertion of the cartridge initiates a controlled and monitored sequence of steps in the instrument. These are:
- Electrical contact is made between the analyzer electronic input circuits and the cartridge. The analyzer identifies the type of cartridge being used and the tests contained in the cartridge.
- The dry chips and sensor channel are heated to 37C.
- The blood is then moved forward. Feedback from the fluid position sensor is used to allow controlled oscillation of the blood segment resulting in dissolution of the reagent layer.
- Following mixing, a count up time is displayed.
- During the course of testing, the position of the blood segment is actively controlled to maintain the length of the blood containing the reagent coincident with the endpoint detector.
- Calculation of sample clot time is performed and displayed.
The provided 510(k) summary describes the i-STAT Celite ACT test and its comparison to a predicate device, the Hemochron Systems Activated Clotting Time. The document focuses on demonstrating substantial equivalence, not on pre-defined acceptance criteria in the way AI/ML devices typically present them. However, we can extract performance metrics and the study design to infer the criteria being met.
Here's an analysis based on the provided text, structured to align with your request for acceptance criteria and study details:
Acceptance Criteria and Device Performance
The acceptance criteria here are implicitly derived from demonstrating substantial equivalence to the predicate device, the Hemochron Systems Activated Clotting Time. The study's goal was to show that the i-STAT Celite ACT test performs comparably to the predicate device in various clinical settings.
| Acceptance Criterion (Inferred from Predicate Equivalence) | Reported Device Performance (i-STAT Celite ACT vs. Hemochron ACT) |
|---|---|
| Linearity to Heparin Concentration: Device should respond linearly to heparin across its reportable range, similar to the predicate. | Responds linearly in the range of 50 to 1000 seconds. Average sensitivity across multiple donors is 77 seconds / U/ml heparin, "equivalent to the sensitivity of the Hemochron System Activated Celite Clotting Time test." |
| Within-Sample Reproducibility/Precision (whole blood): Imprecision should be comparable or better than the predicate device. | 5.6% within-sample reproducibility across the reportable range. (Predicate: 8.8%) |
| Imprecision (plasma controls - Level 1): Imprecision should be acceptable for plasma controls. | 221 ± 19 seconds (8.4% C.V.). (Predicate: 6.5% for whole blood controls) |
| Imprecision (plasma controls - Level 2): Imprecision should be acceptable for plasma controls. | 456 ± 22 seconds (4.8% C.V.). (Predicate: 5.3% for whole blood controls) |
| Clinical Correlation (Cardiac Catheterization/Bypass Procedures) - Sample Size (N): Adequate number of samples for comparison. | Site 1: 118; Site 2: 74; Site 3: 101 |
| Clinical Correlation (Cardiac Catheterization/Bypass Procedures) - Correlation Coefficient: High correlation between the two methods. | Site 1: 0.949; Site 2: 0.923; Site 3: 0.949 |
| Clinical Correlation (Cardiac Catheterization/Bypass Procedures) - Slope: Slope close to 1.0. | Site 1: 1.00; Site 2: 0.951; Site 3: 0.902 |
| Clinical Correlation (Cardiac Catheterization/Bypass Procedures) - Intercept: Intercept close to 0. | Site 1: 0; Site 2: 25; Site 3: 24 |
| Clinical Correlation (Cardiac Catheterization/Bypass Procedures) - Relative Standard Error of the Estimate (Syx %): Acceptable error between methods. | Site 1: 15.9%; Site 2: 15.7%; Site 3: 12.6% |
| Clinical Comparison (Hemodialysis/ECMO) - Mean Bias: Acceptable average bias between the methods. | Site 1: -24; Site 2: -24 |
| Insensitivity to Interfering Factors: | Not affected by hematocrit (20-70%), fibrinogen (100-500 mg/dL), or sample temperature (15-37°C). |
Note: The document does not explicitly state numerical "acceptance criteria" but presents performance data to demonstrate "substantial equivalence" to the predicate device, which is the regulatory standard for 510(k) clearance. The favorable comparisons above (e.g., better precision, high correlation) implicitly meet these unstated criteria.
Study Details:
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Sample sizes used for the test set and the data provenance:
- Cardiac Catheterization and Bypass Procedures:
- Site 1: 118 patient samples
- Site 2: 74 patient samples
- Site 3: 101 patient samples
- Hemodialysis and Extra-corporeal Membrane Oxygenation:
- Site 1: 52 patient samples
- Site 2: 14 patient samples
- Data Provenance: The studies were conducted at "three external sites" and "two sites" for different patient populations. The samples were "fresh whole blood samples" from patients undergoing the described procedures. The data is prospective in the sense that samples were collected and tested on both devices concurrently. Location (country of origin) is not explicitly stated but implies clinical sites within the same regulatory jurisdiction as the submission (likely USA).
- Cardiac Catheterization and Bypass Procedures:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the typical sense for an AI/ML device. For this in vitro diagnostic device, "ground truth" for the clinical studies was established by the predicate device (Hemochron® Systems Activated Clotting Time). The goal was to show correlation and agreement with an existing, legally marketed device, not to establish a new gold standard. Therefore, no "experts" for ground truth adjudication are described.
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Adjudication method for the test set:
- Not applicable as the "ground truth" was the measurement from the predicate device. The identical sample was tested on both the i-STAT device and the predicate device. Statistical comparisons (least squares regression, average bias) were then performed.
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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 in vitro diagnostic device, not an AI/ML medical imaging device that requires human reader interpretation. The device provides a quantitative measurement (Activated Clotting Time).
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance data presented (linearity, precision, clinical correlation) represents the performance of the i-STAT device itself in generating an ACT result, compared to the predicate device. The i-STAT system automatically performs the analytical steps and calculates the result, so this is a standalone performance assessment in its context.
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The type of ground truth used:
- For the clinical correlation studies, the "ground truth" was effectively the measurement obtained from the predicate device (Hemochron® Systems Activated Clotting Time). The internal studies for linearity and precision used established methods for determining heparin concentration and control material values.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its underlying principles are electrochemical detection and established chemical reactions, not machine learning from a dataset. The development likely involved internal validation and calibration using various samples, but this is not generally referred to as a "training set" for such a device.
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How the ground truth for the training set was established:
- Not applicable, as there is no traditional "training set" for this type of medical device. The "ground truth" for method development would be based on established analytical standards, reference methods, and gravimetric/volumetric preparations for control materials.
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(17 days)
The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood actifbase status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.
The i-STAT lactate test is contained in a single use cartridge. In use, two to three drops of blood are placed in the cartridge as described below. The cartridge is inserted into the thermally controlled i-STAT Model 200 Portable Clinical Analyzer and all analytical steps are performed automatically. Patient and user information may be entered into the analyzer via a keypad during the automated analysis cycle. The i-STAT System is an in vitro analytical system comprising a network of one or more portable clinical analyzers designed to be used at the point of patient care. The analyzers employ single-use test cartridges containing biosensor chips to perform diagnostic tests on whole blood. The system further comprises an infrared communications link from the analyzers to auxiliary information management devices such as printers, personal computers, laboratory information systems and hospital information systems. The i-STAT analyzers, as part of the i-STAT System, are intended for use by health-care professionals for the in vitro analysis of arterial, venous or capillary whole blood at the point of patient care. Tests with the i-STAT System are carried out in test cartridge. It houses the sensor array, aqueous calibrator, fluid channels, and a waste reservoir). Electrochemical sensors on biosensor chips are housed in cartridges in a variety of sensor test configurations appropriate to clinical needs. Test panels are identified by name and color code on the cartridge label. In addition, test panel configurations are encoded into the cartridge in a mechanical feature in the cartridge housing. An array of electrical pins in the analyzer recognizes the mechanical feature and automatically identifies the cartridge test panel type. In use, whole blood is introduced into the sample well of the cartridge at the sample port. After closure, the cartridge is inserted into the cartridge door of the analyzer. Insertion of the cartridge initiates a precisely controlled and monitored sequence of steps performed by the instrument without user intervention. These steps are: - Electrical contact is made between the analyzer electronic input circuits and the . The analyzer identifies the type of cartridge being used and the tests cartridge. contained in the cartridge. - Calibrator is positioned over the sensors. Each lactate test is calibrated with calibrator . fluid that contains a pre-determined amount of lactic acid. - Calibration measurements are made as the sensors generate signals mathematically . related to analytic concentrations. In the i-STAT lactate test the concentration of lactate is directly related to the appearance of hydrogen peroxide (measured by amperometrically) generated by lactic acid oxidase acting on lactic acid in the calibrator fluid or in the blood sample. - . Blood sample washes out the calibrator with the aid of an air bubble between the two. - . Blood sample is positioned over the sensors. - . Calculations of sample concentrations are performed and displayed. The displayed results are also stored in the analyzer memory and can be transmitted by infrared communication link to commercially available computers or printers. The lactate test cartridge is assembled from plastic components that provide the conduits for fluid handling and house the sensor chips. In the cartridge containing the test for lactate, the sensors comprise a patterned metallic layer, supported on a silicon/silicon dioxide substrate, coated with a thin membrane containing lactic acid oxidase.
Here's a breakdown of the acceptance criteria and the study details for the i-STAT Lactate test, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance for i-STAT Lactate Test
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a predicate device comparison study rather than explicitly stating acceptance criteria in advance. However, the "conclusions" section confirms that the device meets established standards by being substantially equivalent to the predicate. The performance comparisons provided serve as the basis for this determination.
| Acceptance Criterion (Inferred from Predicate Equivalence) | Reported i-STAT Lactate Performance |
|---|---|
| Linearity Range | 0.3 to 20 mmol/L |
| Imprecision (Normal Range) | 0.81 ± 0.03 mmol/L [3.3% c.v.] |
| Imprecision (Abnormal Range) | 6.35 ± 0.08 mmol/L [1.2% c.v.] |
| Correlation to Predicate Device (Blood) | Slope: 0.993, Intercept: 0.036, r: 0.998 (N=46) |
| Correlation to Standard Lab Instrument (Plasma) | Slope: 1.118, Intercept: -0.052, r: 0.998 (N=47) |
| Medical Allowable Error | Within standards accepted by the medical community (based on CAP Surveys) |
2. Sample Size and Data Provenance for Test Set
-
Sample Size (Test Set):
- Clinical Comparison - Blood: 46 patient samples
- Clinical Comparison - Plasma: 47 patient samples
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Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "patient samples" and "sites" (Site 1 for blood comparison, Site 2 for plasma comparison), implying clinical data rather than simulated. Without further detail, it's difficult to categorize definitively.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the clinical comparison. The "ground truth" was established by comparison to existing, cleared analytical devices (the predicate device and a standard laboratory instrument).
4. Adjudication Method for Test Set
No adjudication method is described. The comparison is directly between the i-STAT device and the reference devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed. This device is an in vitro diagnostic (IVD) for measuring a analyte; therefore, human reader improvement with AI assistance is not applicable.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance was done. The study evaluates the i-STAT Lactate test (the algorithm/device) directly against established methods without human interpretation of results influencing the primary analytical performance.
7. Type of Ground Truth Used
The ground truth for the clinical test set was established by comparison to existing, cleared analytical devices:
- Predicate Device: Stat Profile® Plus Ultra/Lactic acid test (for whole blood comparison).
- Standard Laboratory Instrument: (unspecified, but used for plasma comparison).
8. Sample Size for Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. The i-STAT Lactate test is an IVD device based on biosensor technology. Its performance is characterized through:
- Non-clinical studies: Calibration verification solutions (5 concentrations) and aqueous controls (N=120 for normal range, N=120 for abnormal range) were used to establish linearity and imprecision.
- Clinical studies: Blood and plasma samples from patients were used for comparison.
There is no mention of a "training set" in the sense of data used to train a predictive model.
9. How Ground Truth for Training Set was Established
As there is no explicit mention of a "training set" in the context of AI/ML, this question is not directly applicable. For the non-clinical studies (linearity, imprecision), the ground truth was established by using known concentrations of lactic acid in calibration verification solutions and aqueous controls.
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(48 days)
For the quantitative determination of Creatinine (Crea) in whole blood with the i-STAT analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Not Found
I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets said criteria. The document is an FDA 510(k) clearance letter for the i-STAT Creatinine Test, indicating its substantial equivalence to a legally marketed predicate device. It briefly mentions the intended use of the device: "For the quantitative determination of Creatinine (Crea) in whole blood with the i-STAT analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes." However, it does not provide any specific performance metrics, study details, or acceptance criteria.
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