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Type

Panel

NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS

Reference & Predicate Devices

k061597,k090109,k093297,K001387,K024098

Intended Use

The Chloride test, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. Chloride measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of electrolyte and metabolic disorders.

The Creatinine test, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. Creatinine measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal diseases and in monitoring renal dialysis.

Device Description

The epoc Blood Analysis System is an in vitro analytical system comprising a network of one or more epoc Readers designed to be used at the point of care (POC). The readers accept an epoc single use test card containing a group of sensors that perform diagnostic testing on whole blood. The blood test results are transmitted wirelessly to an epoc Host, which displays and stores the test results. The epoc System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of whole blood. The test card panel configuration currently includes sensors for Sodium Na, Potassium K, Ionized Calcium iCa, pH, pCO2, pO2, Lactate, Glucose and Hematocrit Hct. This submission adds Chloride and Creatinine to this list of approved tests.

AI/ML Overview

This medical device (epoc System) is an in vitro analytical system that provides diagnostic testing for various analytes in whole blood. This submission adds Chloride and Creatinine tests to its existing capabilities.

Here’s a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied through the comparison with predicate devices and established standards like CLSI recommendations. The reported device performance is presented in various non-clinical and clinical studies.

Chloride Test

Acceptance Criteria / Performance Metric	Predicate Device (i-STAT™ Chloride) Target / Standard	epoc Chloride Test Performance
Intended Use	Diagnosis and treatment of electrolyte and metabolic disorders, including cystic fibrosis, diabetic acidosis, and hydration disorders.	Diagnosis and treatment of electrolyte and metabolic disorders.
Where Used	Hospital, point of care	Hospital, point of care
Sample Type	Venous, arterial, and capillary whole blood	Venous, arterial and capillary whole blood (heparinized or un-anticoagulated)
Reportable Range	65 - 140 mmol/L	65 - 140 mmol/L (supported by linearity study, Section 5.5.2)
Detection Principle	Ion selective membrane potentiometry	Ion selective membrane potentiometry
Sample Volume	100 μL	At least 92 μL
Aqueous Precision (Total %CV)	(Implicitly comparable to predicate)	Level 1: 0.5%, Level 3: 0.7% (Figure 5.3)
Clinical Site (various users, all sites, control fluids): Level 1: 0.7%, Level 2: 0.6%, Level 3: 0.9% (Figure 5.14)
Whole Blood Precision (Avg. SD W-R / CV% W-R)	(Implicitly comparable to predicate)	Syringe: Normal: 0.63 / 0.6%, Spiked: 0.86 / 0.7% (Figure 5.10)
Capillary: Normal: 0.70 / 0.7%, Spiked: 1.11 / 0.9% (Figure 5.10)
Method Comparison (vs. Predicate/Comparator)	(Expected high correlation, low bias)	vs. non-POC Systems: R² = 0.96, Mean Bias at 112 mM = -1.3 (Figure 5.5)
vs. Abbott i-STAT: R² = 0.98, Mean Bias at 112 mM = -1.0 (Figure 5.5)
Various Matrices vs. i-STAT: R² ranges from 0.97 to 0.99 for venous, arterial, capillary (Figure 5.15), Avg. Bias at decision levels from -0.9 to 0.0 (Figure 5.16)

Creatinine Test

Acceptance Criteria / Performance Metric	Predicate Device (Roche Cobas c 511/512 CREP2) Target / Standard	epoc Creatinine Test Performance
Intended Use	Quantitative determination of creatinine in human serum, plasma, and urine for diagnosis of renal diseases.	Diagnosis and treatment of certain renal diseases and in monitoring renal dialysis.
Where Used	Hospital, laboratory	Hospital, point of care
Sample Type	Serum, Plasma, Urine	Venous, arterial and capillary whole blood (heparinized or un-anticoagulated)
Reportable Range	0.03 - 30 mg/dL	0.3 - 15.0 mg/dL (supported by linearity study, Slope 1.00, Intercept 0.07, R² 0.99 for 0.25 - 15.5 mg/dL, Section 5.5.2)
Detection Principle	Enzymatic cascade reaction (creatininase, creatinase, sarcosine oxidase) leading to peroxidase-catalyzed chromogenic peroxide detection.	Enzymatic cascade reaction (creatininase, creatinase, sarcosine oxidase) leading to amperometric peroxide detection.
Sample Volume	2-5 μL	At least 92 μL
Aqueous Precision (Total %CV)	(Implicitly comparable to predicate)	Level 1: 4.9%, Level 3: 4.1% (Figure 5.3)
Clinical Site (various users, all sites, control fluids): Level 1: 6.8%, Level 2: 6.4%, Level 3: 6.3% (Figure 5.14)
Whole Blood Precision (Avg. SD W-R / CV% W-R)	(Implicitly comparable to predicate)	Syringe: Normal: 0.05 / 7.6%, Spiked: 0.06 / 3.9% (Figure 5.10)
Capillary: Normal: 0.04 / 6.8%, Spiked: 0.06 / 3.9% (Figure 5.10)
Method Comparison (vs. Predicate)	(Expected high correlation, low bias)	vs. Roche Cobas 6000: R² = 0.99, Mean Bias at 1.25 mg/dL = -0.06 (Figure 5.6)
Various Matrices vs. Roche Cobas: R² ranges from 0.99 for venous, arterial, capillary (Figure 5.15), Avg. Bias at decision levels from -0.04 to -0.08 (Figure 5.16)

2. Sample Sizes Used for the Test Set and Data Provenance

Chloride Test:

Method Comparison (Clinical Field Trials, Patient Samples):
- vs. non-POC Systems (Roche Cobas 6000, Siemens Advia): N = 96 (pooled venous samples, approximately equal numbers vs. each system). Data provenance not explicitly stated but implies clinical sites (hospitals).
- vs. Abbott i-STAT 300 (Predicate): N = 155 (patient samples, approximately equal numbers of venous, arterial, and capillary samples). Data provenance implies clinical sites (hospitals).
- Matrix Effects (Clinical Field Trials, Patient Samples):
  - Venous: N = 49
  - Arterial: N = 43
  - Capillary: N = 63
  - All: N = 155 (These are subsets of the Abbott i-STAT comparison data)
Blood Precision (Clinical Sites, End Users):
- Chloride Blood Precision Site 1: 4 users, 10-10 replicates each for normal/spiked syringe samples. Total N around 80.
- Chloride Blood Precision Site 2: 8 users for syringe, 4 users for capillary. 10-11 replicates each. Total N around 220.
- Overall Blood Precision Summary:
  - Normal Syringe: 120 tests (12 runs, 10 replicates)
  - Spiked Syringe: 119 tests (12 runs, 10 replicates)
  - Normal Capillary: 40 tests (4 runs, 10 replicates)
  - Spiked Capillary: 40 tests (4 runs, 10 replicates)
Anticoagulant Effect: 46 samples from a hospital, supplemented with 29 in-house samples.
Provenance: Clinical field trials at two hospitals (patient samples), and in-house studies (aqueous precision, linearity, detection limit, analytical specificity, some anticoagulant effect evaluation). The data is a mix of prospective (patient samples collected in clinical field trials) and retrospective (in-house studies using prepared samples).

Creatinine Test:

Method Comparison (Clinical Field Trials, Patient Samples):
- vs. Roche Cobas 6000 (Predicate): N = 144 (patient samples, approximately equal numbers of venous, arterial, and capillary samples). Data provenance implies clinical sites (hospitals).
- Matrix Effects (Clinical Field Trials, Patient Samples):
  - Venous: N = 53
  - Arterial: N = 42
  - Capillary: N = 49
  - All: N = 144 (These are subsets of the Roche Cobas comparison data)
Blood Precision (Clinical Sites, End Users):
- Creatinine Blood Precision (multiple sites, multiple users): Each user performed 9-10 replicates for normal/spiked syringe and capillary samples. Total N is around 118 for syringe (normal and spiked), and around 30 for capillary (normal and spiked).
- Overall Blood Precision Summary:
  - Normal Syringe: 118 tests (12 runs, 10 replicates)
  - Spiked Syringe: 118 tests (12 runs, 10 replicates)
  - Normal Capillary: 29 tests (3 runs, 10 replicates)
  - Spiked Capillary: 30 tests (3 runs, 10 replicates)
Anticoagulant Effect: 46 samples from a hospital, supplemented with 29 in-house samples.
Provenance: Clinical field trials at a hospital site (patient samples), and in-house studies (aqueous precision, linearity, detection limit, analytical specificity, some anticoagulant effect evaluation). The data is a mix of prospective (patient samples collected in clinical field trials) and retrospective (in-house studies using prepared samples).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth for the test set. Instead, the "ground truth" or reference values for the clinical method comparison studies were established by:

Predicate Devices: i-Stat™ Model 300 Portable Clinical Analyzer (for Chloride) and Roche Cobas c 511/512 CREP2 Creatinine Plus ver. 2 assay (for Creatinine). These are legally marketed devices that provide accepted reference measurements.
Comparative Instruments/Laboratory Methods: Other non-point-of-care systems (e.g., Roche Cobas 6000, Siemens Advia for Chloride) and a serum-based laboratory method (for Creatinine) at clinical sites.
Traceability: Both Chloride and Creatinine concentration values assigned to controls and calibrator fluids are traceable to NIST standards.

The expertise lies in the established and validated methodologies of these predicate and comparative devices/laboratory methods, rather than individual expert adjudication for each test case.

4. Adjudication Method for the Test Set

No explicit "adjudication method" in the sense of expert review for discrete cases (like 2+1, 3+1) is described. For in vitro diagnostic devices like this, the performance is typically evaluated by comparing the device's measurements against established reference methods (predicate devices or laboratory analyzers) which are considered the "ground truth." The statistical analysis (regression, bias, R²) serves as the method to determine agreement.

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

An MRMC study, particularly in the context of human readers and AI assistance, is not applicable to this device. This is an automated in vitro diagnostic system that directly measures analytes in blood. There are no "human readers" interpreting images or data that AI would assist. The device itself performs the analysis, and the studies assess its accuracy, precision, and agreement with reference methods.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies presented are essentially "standalone" performance evaluations of the device. The epoc Blood Analysis System is an automated system where the test card is inserted, blood is introduced, and analytical steps are performed automatically. The output is a direct measurement of analyte concentrations. The "human-in-the-loop" aspect primarily involves trained medical professionals collecting samples and operating the device, but not in interpreting raw data or making diagnostic decisions that the device's algorithm would assist. The performance data (precision, linearity, method comparison) reflects the device's inherent analytical capabilities.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for these studies is primarily:

Reference Method Comparison: Measurements from legally marketed and established predicate devices (i-Stat™ for Chloride, Roche Cobas for Creatinine) and other validated laboratory methods (e.g., Roche Cobas 6000, Siemens Advia).
Traceability to Standards: Calibration and control values are traceable to NIST (National Institute of Standards and Technology) standards (SRM 967 for Creatinine).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms as the primary component of the device's measurement principle. The device relies on electrochemical sensors (ion-selective membrane potentiometry for Chloride, enzymatic cascade with amperometric detection for Creatinine).

However, in the broader sense of device development and calibration:

In-house aqueous precision study: N=240 for Chloride (L1, L3) and N=239/241 for Creatinine (L1, L3) are mentioned (Figure 5.3). While these are presented as evaluation data, similar-sized or larger datasets would likely be used during initial development and calibration.
Linearity study: Involved nine blood samples prepared from two pools, evaluated against an in-house standard method.
The development and optimization of the enzymatic reactions and sensor response curves would involve extensive testing with many samples during the device's R&D phase, which functionally serves a "training" purpose for the device's internal calibration and algorithms. This specific data is not detailed as a distinct "training set" with a quantifiable size in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" with specific ground truth establishment isn't explicitly detailed in the context of an AI/ML device. For a sensor-based diagnostic device like this, the "ground truth" for calibrating and optimizing the sensors (analogous to training) would be established through:

NIST Traceability: Calibrator and control fluids are assigned values traceable to NIST standards. This is the ultimate ground truth for establishing the accuracy of the measurements.
Reference Laboratory Methods: During development, the device would have been extensively correlated with established laboratory methods to ensure its measurements align with accepted clinical standards.
Controlled Samples: Use of precisely prepared aqueous solutions, spiked blood samples, and pooled human serum with known concentrations, following guidelines like CLSI EP6-A and EP7-A2 for linearity, detection limits, and analytical specificity.

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K Number

K070068

Device Name

Manufacturer

NOVA BIOMEDICAL CORP.

Date Cleared

2007-05-07

(119 days)

Product Code

CGL,JJX

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The Nova StatSensor Creatinine Hospital Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.

Nova StatSensor Creatinine Test Strips are intended for use only with the StatSensor Creatinine Hospital Meter for quantitative tests. The Nova StatSensor Creatinine Hospital Meter is intended to quantitatively measure creatinine in whole blood. The Creatinine Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatSensor Creatinine Test Strips are for testing outside the body (in vitro diagnostic use only).

Nova StatSensor Creatinine Control Solutions are intended for use with the Nova StatSensor Creatinine Hospital Meter and Nova StatSensor Creatinine Test Strips as a quality control check to verify the accuracy of blood creatinine test results. There are three levels of controls, (Level 1, Level 2, and Level 3). These solutions will be offered for sale separately from the meter.

Nova StatSensor Creatinine Linearity Kit solutions are used to check the linearity of the Nova StatSensor Creatinine Hospital Meter System. There are five levels of Linearity Solutions, (Level 1, Level 2, Level 3, Level 4, and Level 5).

Device Description

Not Found

AI/ML Overview

Here's the analysis of the provided text regarding the Nova StatSensor Creatinine Hospital Meter, focusing on acceptance criteria and study details.

Important Note: The provided document is an FDA 510(k) clearance letter and an Indications for Use statement. It does not contain the detailed study write-up that would typically include acceptance criteria and specific performance data. Therefore, I can only extract information that is explicitly stated or can be reasonably inferred from this type of regulatory document. Many of the requested details (sample sizes, expert qualifications, adjudication methods, MRMC studies, training set details) are not present in this document.

Acceptance Criteria and Device Performance Study Analysis

Based on the provided documents (FDA 510(k) clearance letter K070068 and Indications for Use), the Nova StatSensor Creatinine Hospital Meter is cleared for marketing as it has been deemed "substantially equivalent" to legally marketed predicate devices. This indicates that the device met the performance requirements necessary to demonstrate this substantial equivalence. However, the exact numerical acceptance criteria and the detailed study design proving those criteria are not present in these documents.

Missing Information: A typical detailed study report would include specific numerical targets for accuracy, precision, linearity, etc., and the results obtained against those targets. This document only confirms that such testing must have occurred to achieve 510(k) clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (from predicate/general regulatory standards)	Reported Device Performance (as inferred from 510(k) clearance)
Accuracy / Bias	Must be demonstrably equivalent to a legally marketed predicate device for creatinine measurement in whole blood.	Deemed substantially equivalent to predicate devices; performs with acceptable accuracy for its intended use (quantitative measurement of creatinine in capillary, venous, and arterial whole blood, providing plasma equivalent results).
Precision	Must be within acceptable limits for a quantitative creatinine assay.	Achieved sufficient precision to demonstrate substantial equivalence.
Linearity	Must demonstrate linearity across the stated measurement range.	Linearity kit solutions are available, implying successful linearity testing across 5 levels.
Interfering Substances	(Not specified in document, but generally required) Minimal interference from common endogenous and exogenous substances.	Implied to be acceptable based on 510(k) clearance.
Reproducibility	(Not specified in document, but generally required) Consistent results across different operators, lots, and instruments.	Implied to be acceptable based on 510(k) clearance.
Calibrated to Plasma Equivalency	Must provide plasma equivalent results.	Explicitly stated: "The Creatinine Meter is calibrated to provide plasma equivalent results to laboratory methods."

(Note: The "Acceptance Criteria" column is inferred from the general requirements for 510(k) cleared IVD devices and the nature of the predicate determination. The "Reported Device Performance" column states what the FDA's clearance implies, rather than specific numerical outcomes, as these are not provided.)

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size (Test Set): Not specified in the provided documents.
Data Provenance: Not specified in the provided documents (e.g., country of origin, retrospective or prospective). Safety and effectiveness data, likely gathered prospectively from clinical or laboratory studies in the US or other regions, would have been submitted to the FDA as part of the 510(k) application.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
- For an in vitro diagnostic device measuring a chemical analyte like creatinine, the "ground truth" would typically be established by a reference method run by trained laboratory personnel in a CLIA-certified or equivalent laboratory, not necessarily "experts" in the sense of clinicians reviewing images, but rather highly skilled laboratory technicians and clinical chemists.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. This is generally not applicable in the same way for quantitative chemical assays as it would be for subjective interpretations (e.g., radiology reads). The "ground truth" for a chemical assay is typically a quantitative result from a reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC study is not applicable for this type of device. MRMC studies are used for devices that assist human interpretation of diagnostic images (e.g., radiologists interpreting X-rays or MRI scans). The Nova StatSensor Creatinine Hospital Meter is a quantitative assay device; it measures a biochemical marker directly, rather than assisting human readers in interpreting complex data.
Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed or is relevant for this device type.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance Study: Yes, the performance testing for an in vitro diagnostic device like this is inherently "standalone" in the sense that the device measures creatinine directly without human interpretive intervention. The performance characteristics (accuracy, precision, linearity, etc.) are evaluated based on the device's output compared to a reference method. There isn't an "algorithm" in the same sense as an AI image interpretation tool, but rather the electrochemical detection and calculation within the meter.

7. The Type of Ground Truth Used

Ground Truth Type:
- Reference laboratory method: For quantitative diagnostic devices like this, the ground truth is established by a highly accurate and precise reference method for creatinine measurement (e.g., enzymatic or HPLC-based methods) performed in a clinical laboratory.
- The document states, "The Creatinine Meter is calibrated to provide plasma equivalent results to laboratory methods," indicating that established laboratory methods serve as the standard for comparison.

8. The Sample Size for the Training Set

Sample Size (Training Set): Not specified in the provided documents.
- For a chemical assay device, "training set" doesn't apply in the same way as for machine learning algorithms. Instead, there would be internal development and verification studies using various samples to optimize the assay chemistry, electrode design, and instrument calibration before formal validation studies. The number of samples used in these internal studies is generally proprietary and not disclosed in regulatory summaries.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not specified.
- Similar to the test set, during the development and calibration phases, the ground truth would have been established using reference laboratory methods for creatinine measurement on various samples to guide the optimization and calibration of the Nova StatSensor system.

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K Number

K051968

Device Name

ABL8X7 FLEX

Manufacturer

RADIOMETER MEDICAL APS

Date Cleared

2006-10-16

(453 days)

Product Code

CGL

Regulation Number

Type

Panel

K041874,K043218,K002290,K973292

Reference & Predicate Devices

Intended Use

The ABL837 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood, plasma and serum for the parameter Creatinine measurements measurements measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Device Description

The ABL837 FLEX is an analyzer with the capability of measuring creatinine. The wet section of the ABL837 FLEX analyzer is structured as the wet section of the ABL800 FLEX and ABL800 FLEX with FLEXQ Module analyzers, but includes a measuring module comprising the measurement system for the creatinine parameter. This measuring system compissing electrodes, one of which measures creatine and the other of which measures creating and creatinine. The creatinine parameter value is determined as a difference measure of the output of these two new electrodes. The two electrodes are developed based on the concept of the existing Radiometer Medical ApS glucose and lactate electrodes. The sensors for measuring creatinine are electrochemical sensors.

AI/ML Overview

Here's an analysis of the provided text regarding the ABL837 FLEX device, focusing on the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly state numerical acceptance criteria for the ABL837 FLEX. Instead, it describes a "comparison test" against a predicate device and states that the ABL837 FLEX performed "equivalent" to that device.

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical criteria. The overarching acceptance criterion appears to be "equivalence" to the predicate device. The text mentions several performance aspects were tested.	Equivalent performance to the predicate device, i-STAT System Creatinine Test.

The device also demonstrated:LinearityPrecisionDetection limitsInterference (presumably acceptable levels) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified. It does not mention the country of origin of the data or whether the study was retrospective or prospective.

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 section is not applicable to this type of device and study. The ABL837 FLEX is an in vitro diagnostic device for measuring creatinine. Ground truth for such devices is typically established through reference methods, calibrated standards, or comparison to an established, legally marketed predicate device, rather than expert consensus on image interpretation or similar qualitative assessments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., medical imaging) where there might be disagreement among readers on a diagnosis or finding. For an objective measurement device like the ABL837 FLEX, performance is evaluated by comparing its output to a known standard or a predicate device.

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

No, an MRMC comparative effectiveness study was not done, and this type of study is not applicable here. MRMC studies are used to evaluate human reader performance, often in diagnostic imaging, and to assess the impact of AI assistance on that performance. The ABL837 FLEX is an automated analyzer, not an AI system assisting human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a "standalone" or algorithm-only performance assessment was done. The "Performance Test" section describes tests performed directly on the ABL837 FLEX analyzer (linearity, precision, detection limits, interference, and comparison to the predicate device). As a fully automated analyzer, its performance is inherently standalone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the comparison test was the i-STAT System Creatinine Test, which is a legally marketed predicate device (K973292). For linearity, precision, and detection limits, the ground truth would typically be established using calibrated reference materials or gold-standard laboratory methods. The document doesn't explicitly detail the specific gold standards used for these individual tests, but the overall claim of "equivalence" is relative to the i-STAT device.

8. The sample size for the training set

Not applicable/Not mentioned. This device does not use machine learning in a way that would typically involve a "training set" in the context of AI algorithms. It is an electrochemical sensor-based analyzer.

9. How the ground truth for the training set was established

Not applicable. As stated above, there is no mention of a training set for this type of device.

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K Number

K991727

Device Name

STAT PROFILE M7 ANALYZER

Manufacturer

NOVA BIOMEDICAL CORP.

Date Cleared

1999-07-16

(57 days)

Product Code

CGL,CDS,CEM,CGA,CGZ,CHL,GLY,JFP,JGS,JKS,JPI,KHP

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The Stat Profile Ultra M Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage in the quantitative determination of sodium, potassium, chloride, ionized calcium, creatinine, glucose, lactate, and BUN in serum, plasma and whole blood.; of pH, PCO2, PO2, oxygen saturation, hematocrit and hemoglobin in whole blood.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Stat Profile M 7 Analyzer" (later referred to as "Stat Profile Ultra M7 Analyzer"). It does not contain the detailed technical specifications, acceptance criteria, or study results that would typically describe the device's performance against specific metrics.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because it is not present in the provided text.

The document primarily focuses on:

Confirming substantial equivalence to a predicate device.
Outlining regulatory requirements and controls.
Stating the intended use and analytes the device measures.

To answer your questions, one would need to review the original 510(k) submission (K991727) or other technical documentation provided by Nova Biomedical for the Stat Profile Ultra M7 Analyzer.

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K Number

K973292

Device Name

I-STAT SYSTEM

Manufacturer

I-STAT CORP.

Date Cleared

1997-10-20

(48 days)

Product Code

CGL,CCL

Regulation Number

Type

Panel