Search Results

Date Cleared

2019-02-01

(126 days)

Product Code

GGM

Regulation Number

864.8625

Type

Hepatology / Hepatic (HE)

Panel

Reference & Predicate Devices

K964052

Intended Use

HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.

Device Description

HemoTrol® WB is an assayed hemoglobin quality control material intended for professional use in the verification of the precision and accuracy of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® WB contains bovine red blood cells with hemoglobin lysates in MetHb and additional stabilizers. For daily quality control, three physiological relevant levels are available.

HemoTrol® WB solutions are filled in reclosable plastic primary containers. Each bottle contains 1.1 g of HemoTrol® WB solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (HemoTrol® WB) and focuses on establishing substantial equivalence to a predicate device. It describes performance data related to stability testing of the quality control material itself, rather than a clinical study evaluating the performance of an AI-powered diagnostic device in a patient population.

Therefore, the information required to answer your query about acceptance criteria and study proving a device meets acceptance criteria, specifically for an AI/diagnostic device, is not present in the provided text. The document describes:

Device: HemoTrol® WB (a quality control material for hemoglobin measurement, not an AI diagnostic device).
Purpose: To demonstrate substantial equivalence to a predicate quality control device (Eurotrol HemoTrol).
Performance Data: Focuses on stability of the quality control material (open-vial and closed-vial stability), not diagnostic performance metrics like sensitivity, specificity, or reader improvement in an MRMC study.

Here's a breakdown of why I cannot fulfill your request based on this document:

Acceptance Criteria for AI/Diagnostic Performance: The text does not mention any acceptance criteria for sensitivity, specificity, AUC, or other typical metrics for an AI or diagnostic device. The "acceptance criteria" presented here implicitly relate to demonstrating stability within acceptable ranges for a quality control material.
Study Proving Acceptance Criteria: The studies described ("Open Stability" and "Closed Stability") are designed to show how long the quality control material remains stable, not to evaluate the performance of an AI or diagnostic device against a ground truth in a clinical setting.
Sample Size (Test Set): Not applicable in the context of an AI/diagnostic test set. For stability testing, the sample size was "n=6" for open stability and "n=8" for closed stability.
Data Provenance: Not relevant for these stability tests. The "samples used were produced according the regular production process of HemoTrol® WB."
Experts for Ground Truth: Not applicable. Ground truth for stability is measurement against a known reference method for hemoglobin on specific analyzers (HemoCue® Hb 301 and HemoCue® Hb 801 systems).
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Study: Not performed, as this is a quality control material, not a diagnostic device for human interpretation.
Standalone (Algorithm Only) Performance: Not applicable.
Type of Ground Truth: For stability, the ground truth is the measured hemoglobin value on the specified HemoCue systems.
Training Set Sample Size: Not applicable, as this is not an AI/machine learning device requiring a training set.
Ground Truth for Training Set: Not applicable.

To answer your detailed questions, you would need a document that describes the clinical performance evaluation of an AI-powered diagnostic device in a patient population.

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K Number

K152553

Device Name

CueSee Hypoxic

Manufacturer

Date Cleared

2016-04-22

(227 days)

Product Code

JJS

Regulation Number

Type

Panel

EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM

Reference & Predicate Devices

k032453

Intended Use

CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers' performance of Oxygen partial pressure (pO2).

Device Description

CueSee® Hypoxic is prepared from a stroma-free bovine hemoglobin solution and provides the oxygen buffering characteristics of fresh whole blood. The concentrations of total hemoglobin and acid-base levels are within the normal physiological range. Tonometry with a predetermined level of oxygen balanced with nitrogen provides a distinct assay value for partial pressure of oxygen measurements. CueSee® Hypoxic contains no preservatives, viscosity adjusters or other additives that might adversely effect electrode measurements.

CueSee® Hypoxic provides one level in the critical low pO2 value range, each ampule holding 2.5 mL of solution.

CueSee® Hypoxic is packed in a carton box containing 5 ampules.

AI/ML Overview

The provided text describes the 510(k) submission for the CueSee® Hypoxic device, a quality control material for blood gas analyzers. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a diagnostic (e.g., accuracy, sensitivity, specificity for a medical condition).

Therefore, the document does not contain the information required to populate a table of acceptance criteria and device performance or describe a study for a diagnostic device in the sense of accuracy, sensitivity, or specificity. The "study" described is primarily about establishing stability and value assignment for a quality control material.

However, I can extract the relevant information regarding the product's characteristics and the tests performed to support its claims as a quality control material.

Here's what can be extracted and how it relates to the given prompt, with explanations for what is not present:

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

The document doesn't provide a typical "acceptance criteria" table for diagnostic performance (e.g., sensitivity, specificity, accuracy against a disease state). Instead, it discusses stability and value assignment as key performance aspects for a quality control material.

Characteristic	Acceptance Criteria (Implicit for QC Material)	Reported Device Performance (as a QC material)
Stability (Sealed Ampule)	Must maintain integrity and assigned values over time.	31 days at 2-8°C
Stability (Open Vial)	Must maintain integrity and assigned values for a short period after opening.	10 minutes
Value Assignment (pO2)	Values must be assignable and reproducible for monitoring blood gas analyzers.	Lot specific values determined by the mean of multiple determinations on randomly selected samples; Ranges assigned using pre-determined intervals.
Traceability	Values should be traceable to a recognized standard.	Traceable to NIST SRM: 2658a (for pO2)

Notes:

For a quality control material, the "performance" isn't about diagnosing a condition, but rather accurately reflecting a known concentration or value to allow verification of a diagnostic instrument.
The document implies that the device "meets" its purpose by demonstrating these characteristics, which are standard for quality control materials.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for specific tests (e.g., stability or value assignment). For value assignment, it mentions "multiple replicates of test samples" and "mean of multiple determinations performed on randomly selected samples from each lot," but no specific number.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's implied to be internal testing by the manufacturer (Eurotrol B.V., Netherlands).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of this document. For a quality control material, the "ground truth" (or assigned value) is established through rigorous internal testing against reference materials using validated methods, not typically by expert consensus in clinical interpretation.

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

Not applicable as the "ground truth" for a QC material's value assignment is based on metrology and analytical chemistry, not clinical 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-based diagnostic tool requiring human reader studies.

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

Not applicable. This is a physical quality control material, not an algorithm. Its "standalone performance" refers to its ability to yield consistent and accurate pO2 values when measured correctly. The document describes protocols for how these values are determined (section "12. Value Assignment").

7. The type of ground truth used:

For Value Assignment (pO2): Traceability to NIST SRM: 2658a (National Institute of Standards and Technology Standard Reference Material). This is a metrological ground truth derived from international standards, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not applicable. This is a quality control material, not an AI model or a device that requires "training."

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

Not applicable. As above, there's no "training set." The values of the QC material are established by direct measurement on a calibrated blood gas analyzer and traceable to a NIST Standard Reference Material.

Summary of Device and Study Focus:

The device, CueSee® Hypoxic, is a quality control material (Class I, reserved), not a diagnostic device that directly interprets patient data. Its primary purpose is to monitor the performance of blood gas analyzers for Oxygen partial pressure (pO2).

The "study" or evidence provided in the 510(k) summary focuses on demonstrating:

Its intended use as a quality control material for pO2.
Its composition and physical characteristics (e.g., bovine hemoglobin solution, 2.5 mL volume, liquid form).
Its stability (31 days un-opened, 10 minutes opened).
Its value assignment method (multiple replicates, mean determination, lot-specific values).
Its traceability to a recognized standard (NIST SRM 2658a for pO2).
Its substantial equivalence to a predicate device (RNA Medical® Brand QC 823 Range Blood Gas Electrolyte Metabolite Control) in terms of fundamental scientific technology, features, and characteristics, despite some differences (e.g., number of levels, analytes covered).

The provided text details the regulatory clearance for a quality control material, not an AI/diagnostic device that processes patient data and requires typical clinical performance metrics like sensitivity, specificity, or reader studies.

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K Number

K131595

Device Name

Manufacturer

Date Cleared

2013-07-26

(53 days)

Product Code

JJY

Regulation Number

Type

Panel

EUROTROL HEMATOCRIT CONTROL

Reference & Predicate Devices

k032453

Intended Use

Eurotrol GAS-ISE Hct QC is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i-STAT® POCT analyzer. It is intended that Eurotrol GAS-ISE Hct QC should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Eurotrol GAS-ISE Hct QC is for in vitro diagnostic use only.

Eurotrol GAS-ISE Hct LVM is an assayed aqueous blood gas, electrolyte and metabolite control material for professional use suitable for calibration of the Abbott i-STAT® POCT analyzer.

It is intended that Eurotrol GAS-ISE Hct LVM should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Eurotrol GAS-ISE Hct LVM is for in vitro diagnostic use only.

Device Description

Eurotrol GAS-ISE Hct QC quality controls are prepared using salts in an aqueous, physiologically buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provides distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and creatinine concentrations, within the reportable range of the Abbott i-STAT POCT analyzer.

Eurotrol GAS-ISE Hct QC is a non-hazardous aqueous solution that contains no biological materials.

Eurotrol GAS-ISE Hct QC provides three (3) physiological relevant levels, each ampule containing 2.5 mL of solution.

Eurotrol GAS-ISE Hct QC is packed in a carton box containing 10 ampules of a separate level.

Eurotrol GAS-ISE Hct LVM provides five (5) physiological relevant levels, each ampule containing 2.5 mL of solution. Eurotrol GAS-ISE Hct LVM quality controls are prepared using salts in an aqueous, physiologically buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provides five (5) distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and creatinine concentrations, within the reportable range of the Abbott i-STAT POCT analyzer.

Eurotrol GAS-ISE Hct LVM is a non-hazardous aqueous solution that contains no biological materials.

Eurotrol GAS-ISE Hct LVM provides five (5) physiological relevant levels, each ampule containing 2.5 mL of solution.

Eurotrol GAS-ISE Hct LVM is packed in a carton box containing a set of 5 ampules; one ampule of each level.

AI/ML Overview

The provided 510(k) summary (K131595) for Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM describes quality control materials for blood gas, electrolyte, and metabolite analysis. This submission focuses on the performance claims and stability of these control materials for use with the Abbott i-STAT® POCT analyzer.

Here's an analysis of the acceptance criteria and supporting study information, based on the provided document:

Acceptance Criteria and Reported Device Performance

The device itself is a quality control material, not a diagnostic device that produces patient-specific results. Therefore, the "device performance" in this context refers to the assigned values and ranges for the various analytes within the control material, and its stability.

The acceptance criteria are implicitly defined by the assigned value ranges for each analyte, which are developed to verify the precision and accuracy of the Abbott i-STAT® POCT analyzer. The reported device performance is specifically the mean and range provided for each analyte in the lot-specific value sheets.

For example, section {3} and {5} provide tables for Eurotrol GAS-ISE Hct QC (Lot 17401215, Level 1) with specific values and ranges for various analytes.

Analyte	Unit	Mean (X)	Range (R)
pH	1	6.973	6.893 - 7.054
pCO₂	mmHg	73.0	58.6 - 87.4
pO₂	mmHg	66	46 - 86
Na⁺	mmol/L, mEq/L	119	115 - 124
K⁺	mmol/L, mEq/L	2.7	2.3 - 3.1
iCa⁺⁺	mmol/L	1.40	1.29 - 1.51
Cl⁻	mmol/L, mEq/L	83	77 - 88
tCO₂	mmol/L, mEq/L	19	10 - 28
Glucose	mg/dL	303	257 - 349
Lactate	mmol/L	8.49	7.57 - 9.41
Urea	mmol/L	21.9	19.4 - 24.5
Creatinine	μmol/L	324	248 - 400

(Note: The tables in the input have some inconsistencies and overlapping information. The table above consolidates and clarifies based on the available data for 'Level 1' of the 'Eurotrol GAS-ISE Hct QC' found in {3} and {5}.)

Study Design and Evidence Pertaining to Acceptance Criteria

The studies described are primarily focused on value assignment, stability, and traceability of the control materials, rather than a clinical study evaluating diagnostic accuracy against a ground truth.

1. Sample size used for the test set and the data provenance:

Test Set Description: The "test set" in this context refers to the samples of the control materials from each lot that are analyzed to determine their assigned values and ranges.
Sample Size: "Multiple replicates of test samples" are measured. The exact number of replicates is not specified, but it's stated that values are determined by "the mean of multiple determinations performed on randomly selected samples from each lot." This implies multiple ampules from each production lot are tested multiple times.
Data Provenance: The studies are conducted by Eurotrol B.V., which is based in The Netherlands. The testing involves the Abbott i-STAT 300 System and various Abbott i-STAT cartridge types (CG4+, CG8+, EC8+, CHEM8+, Crea). The data is generated prospectively during the manufacturing and quality control process for each lot.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

No external experts are explicitly mentioned for establishing a "ground truth" in the typical sense of diagnostic imaging or clinical assessment.
The "ground truth" for these control materials is established by traceable reference materials and the performance of the specified analytical instruments. Section {13} meticulously lists the NIST Standard Reference Materials (SRMs) and other reference materials used for each analyte (e.g., NIST SRM 186 I/II, 185, 187, 191 and 192 for pH; NIST SRM 956b for Na+, K+, Ca++, Cl-).
The "experts" involved are likely the highly trained laboratory personnel at Eurotrol B.V. who perform the value assignment using validated methods and traceable standards. Their specific qualifications are not detailed in the summary.

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

No explicit adjudication method is described. The value assignment process involves taking the "mean of multiple determinations." This approach intrinsically averages out minor variations, but there isn't a stated independent review or adjudication process by multiple individuals or systems beyond the initial measurements.

4. 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 MRMC study was performed. This device is a quality control material for an in-vitro diagnostic device (Abbott i-STAT POCT analyzer), not an AI-based diagnostic tool for human interpretation. Therefore, the concept of "human readers improving with AI" is not applicable here.

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

This is not an algorithm-only device. It is a physical quality control material. However, the value assignment process (section {12}) for the control material is a "standalone" process in the sense that the control material is characterized independently of its ultimate use by individual operators, and these assigned values define its expected performance. The performance of the Abbott i-STAT analyzer itself with this control material is what's being verified.

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

The "ground truth" for the content of these control materials is established through traceability to internationally recognized reference materials (NIST SRMs) and other certified reference materials (Biomed DuoCal, Precipath U plus, Precinorm U plus, Hanna Instruments Conductivity Standards). This provides a highly accurate and standardized basis for the assigned values.

7. The sample size for the training set:

No specific "training set" in the context of machine learning is described. The concept of training data doesn't apply directly to this type of device. The control material itself is manufactured, and then its properties (assigned values and ranges) are determined.
However, the validation and establishment of the value assignment methodology would have relied on extensive testing and historical data for the Abbott i-STAT system, which could be considered analogous to a "training" phase for the manufacturer's internal processes. The summary mentions using "multiple cartridges of the latest available batches of the following cartridge types: CG4+, CG8+, EC8+, CHEM8+ and Crea" for value assignment, suggesting a broad basis for establishing the expected performance on the target analyzer.

8. How the ground truth for the training set was established:

As there is no "training set" in the machine learning sense, this question is not directly applicable. If we consider the "ground truth" for setting the manufacturing specifications and the value assignment methodology, it would again stem from traceability to reference materials, established analytical chemistry principles, and comprehensive statistical analysis of the performance on the Abbott i-STAT system over time.

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K Number

K121467

Device Name

Manufacturer

Date Cleared

2013-05-10

(358 days)

Product Code

GLK

Regulation Number

864.8625

Type

Hepatology / Hepatic (HE)

Panel

Reference & Predicate Devices

K061597,K955630

Intended Use

Eurotrol Hct Control is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. Eurotrol Hct Control is for in vitro diagnostic use only.

epoc® Hematocrit Verification Fluids is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit.

epoc® Hematocrit Verification Fluids is for in vitro diagnostic use only.

Device Description

Eurotrol Hct Control and epoc® Hematocrit Verification Fluids are assayed hematocrit reference materials, to verify the precision and accuracy of the epoc@ Blood Analysis System, manufactured by Epocal Inc., Ottawa, ON K1G3P5, Canada, as cleared by FDA, K061597. Eurotrol Hematocrit Control was designed to test the following analytes: Hematocrit.

Eurotrol Hot Control and epoc® Hematocrit Verification Fluids electrolyte solutions with conductivity at five levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the epoc Blood Analysis System.

Depending the sales unit, 10 ampules of the same level are packed in a carton box for Eurotrol Hct Control, or 5 ampule per level, are packed in a carton box for epoc®Hematocrit Verification Fluids. A product insert with Intended Use is inserted in each product box.

The assigned values of each batch are printed on a value sheet as available from the Epocal website: http://www.epocal.com/doc_library.html

AI/ML Overview

The provided text describes a 510(k) submission for "Eurotrol Hct Control and epoc® Hematocrit Verification Fluids," which are quality control materials for hematocrit measurements. This document is a premarket notification for a medical device that verifies the precision and accuracy of another device (the epoc Blood Analysis System). It is not a diagnostic device that performs a clinical diagnosis; thus, the concepts of sensitivity, specificity, human reader performance, MRMC studies, or training/test sets for AI models as typically applied to image-based diagnostic AI devices are not applicable here.

The "acceptance criteria" and "device performance" in this context refer to the characteristics and performance of the control fluid itself in demonstrating its suitability for verifying other devices.

Here's the breakdown based on the provided text, adapted for a quality control material:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a quality control material revolve around its ability to provide stable and accurate reference values. The "performance" is demonstrated by its inherent properties and its equivalence to a predicate device.

Characteristic	Acceptance Criteria (Implied / Comparator)	Reported Device Performance (New Device)
Number of Levels	Must have multiple levels to cover clinically significant ranges (Predicate has 5)	5 distinct Hct levels (conductivity), simulating clinically significant ranges of Hematocrit.
Analytes	Hematocrit (Conductivity)	Hematocrit (Conductivity)
Container	Suitable for stability and handling (Predicate: Clear glass ampules)	Clear glass ampules
Filling Volume	Sufficient for use (Predicate: 1.7 mL)	2.5 mL
Color	Clear, to avoid interference	Clear
Storage Temperature	Stable within a reasonable range (Predicate: 2 - 25°C/35 - 77°F)	2 - 30°C/35 - 86°F (Broader, which is an improvement)
Matrix/Materials	Stable aqueous solution without interfering substances	Prepared using pure chemicals in a physiologically buffered matrix. Aqueous buffered solution of water and electrolytes. This product contains no red cells and no human or biological materials.
Intended Use	To verify precision and accuracy of hematocrit measurement systems	To verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit.
Stability	Must maintain performance over time	12 months (Real-time evaluation of the products to support stability was conducted.)
Precision (QC fluid)	The QC fluid itself should provide consistent results	Precision testing was conducted. (Specific values for precision are not provided in the summary but were generated for the submission).
Accuracy (QC fluid)	The QC fluid should have assigned values that laboratories can use for reference	Assigned values of each batch are printed on a value sheet as available from the Epocal website (http://www.epocal.com/doc_library.html). (This demonstrates how users verify accuracy of their instrument against the QC fluid's known value.)

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

This is not applicable in the typical sense of a diagnostic device's test set for patient data. For this quality control material, the "test set" would refer to the samples of the QC fluid itself tested during its development and validation.

Test Samples: The document states "Tests were conducted to verify specific performance requirements: a) Real-time evaluation of the products to support stability. b) Test precision." The exact number of ampules or batches tested for these purposes is not specified in the summary but would have been part of the non-clinical testing data submitted to the FDA.
Data Provenance: The testing was conducted by Eurotrol B.V. in The Netherlands. This is a non-clinical, controlled laboratory setting, not patient data. It is inherently prospective testing of the manufactured QC material.

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

Not applicable. The ground truth for a quality control material is established by:

Its chemical formulation.
The highly precise and accurate methods used to assign values to each lot/batch in a reference laboratory setting (e.g., using reference methods and highly calibrated instruments).
Comparative testing against established predicate devices.

There are no "experts" in the sense of clinical reviewers establishing diagnoses as ground truth for this type of device.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or diagnostic decision-making involved that would require adjudication.

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

No. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially in the context of AI assistance. A quality control material does not involve human readers for diagnostic interpretation.

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

Not applicable. This device is a fluid, not an algorithm. Its "performance" is its chemical stability and its ability to act as a reliable reference standard for an analytical instrument.

7. The Type of Ground Truth Used

The ground truth for this quality control material is its precisely manufactured and characterized chemical composition and its assigned hematocrit values, which are determined by highly accurate reference measurement procedures. This is essentially a "reference standard" or "master value" derived from rigorous chemical and metrological characterization. Its primary evidence for substantial equivalence relies on comparison to a predicate device (RNA Medical QC 900 Hematocrit Control) that is already legally marketed and accepted as a reliable standard.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI models that require training sets of data.

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

Not applicable, as there is no training set for an AI model.

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K Number

K121468

Device Name

EUROTROL GAS-ISE METABOLITES

Manufacturer

Date Cleared

2012-06-22

(36 days)

Product Code

JJY

Regulation Number

Type

Panel

ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002

Reference & Predicate Devices

K032453

Intended Use

Eurotrol GAS-ISE Metabolites

Eurotrol GAS-ISE Metabolites is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoc® Blood Analysis System. Eurotrol GAS-ISE Metabolites was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactate, Urea, Creatinine and tCO2. Eurotrol GAS-ISE Metabolites is also developed to verify calibration, operating temperature and other performance characteristics.

epoc Calibration Verification Fluids

epoc Calibration Verification Fluids is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoc® Blood Analysis System.

epoc Calibration Verification Fluids was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactate, Urea, Creatinine and tCO2. epoc Calibration Verification Fluids is also developed to verify calibration, operating temperature and other performance characteristics.

Device Description

Eurotrol GAS-ISE Metabolites and epoc Calibration Fluids are assayed blood gas, electrolyte and metabolite reference materials, to venify the precision and accuracy of the epoc@ Blood Analysis System. Eurotrol GAS-ISE Metabolites and epoc Calibration Verification Fluids are filled in 3 mL clear glass ampules.

Eurotrol GAS-ISE Metabolites provides three different physiologically relevant levels. epoc Calibration Verification Fluids provides five different physiologically relevant levels.

10 ampules of the same level of Eurotrol GAS-ISE Metabolites are packed in a carton box. 5 ampules, 1 ampule per level, of epoc Calibration Fluids are packed in a carton box. A product insert with Intended Use is inserted in each product box of GAS-ISE Metabolites and epoc Calibration Verification Fluids.

AI/ML Overview

The provided 510(k) summary for Eurotrol B.V. GAS-ISE Metabolites and epoc Calibration Verification Fluids does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for diagnostic algorithms. Instead, it focuses on substantial equivalence to a predicate device and the traceability of its reference materials.

Here's an breakdown of the information that is available and a note on what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or device performance in quantifiable metrics (e.g., sensitivity, specificity, accuracy, precision ranges for device vs. ground truth). Instead, it describes the intended use of the devices as "to verify the precision and accuracy of the epoc® Blood Analysis System" by providing assayed blood gas, electrolyte, and metabolite material.

The performance described is primarily related to the traceability of the analytes to recognized reference materials, which serves as an indirect form of performance validation for calibration verification fluids.

Analyte	Reference Material
pH	NIST SRM: 186 I/II, 185, 187, 191 and 192
pCO2	NIST SRM: 1674b, 2625a, 2658a and 2659a
pO2	NIST SRM: 1674b, 2625a, 2658a and 2659a
Na+	NIST SRM 956b
K+	NIST SRM 956b
Ca++	NIST SRM 956b
Cl-	NIST SRM 956b
Glucose	NIST SRM 965c
Lactate	Biomed DuoCal Multi 10260
Urea	Precipath U plus 159955 + Precinorm U plus 157249
Creatinine	NIST SRM 967a

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

The document does not specify a "test set" in the context of evaluating an AI or diagnostic algorithm's performance on patient data. These devices are calibration verification fluids. For value assignment, the document states: "Multiple replicates of test samples are measured at the beginning and end of the production run on various analyzers for metabolites and on blood gas analyzers for blood gas and pH values." It also mentions "randomly selected samples from each lot."

Sample Size: Not explicitly stated as a number of "samples" or "replicates" for verification, but implies multiple measurements for "value assignment."
Data Provenance: Not applicable in the context of patient data. The provenance for the reference materials is stated as NIST (National Institute of Standards and Technology) and specific commercial products (Biomed DuoCal, Precipath U plus, Precinorm U plus). The study involves manufacturing and testing of the control fluids themselves.

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

This information is not applicable. The "ground truth" for these calibration fluids is established through traceability to certified reference materials (NIST SRMs), not by human expert consensus on clinical data. The value assignment process involves analytical measurements.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic algorithm evaluated on clinical cases requiring expert adjudication. The "value assignment" is based on instrumental measurements and takes the "mean of multiple determinations."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. These are calibration materials, not an AI or diagnostic device that assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is a control material, not an algorithm. Its performance is intrinsic to its chemical composition and its ability to provide stable, accurate values when measured by an analytical system.

7. The Type of Ground Truth Used

The ground truth for the analytes in the Eurotrol GAS-ISE Metabolites and epoc Calibration Verification Fluids is established through traceability to internationally recognized and certified reference materials (e.g., NIST Standard Reference Materials) and other commercial reference materials. This ensures the accuracy of the assigned values.

8. The Sample Size for the Training Set

Not applicable. These are calibration materials, not an AI algorithm that requires a "training set" of data.

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

Not applicable. There is no "training set" in the context of this device. The ground truth for the product's assigned values is established through metrological traceability to reference standards (as listed under point 1).

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K Number

K060215

Device Name

Manufacturer

Date Cleared

2006-03-24

(56 days)

Product Code

JJX

Regulation Number

Type

Panel