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510(k) Data Aggregation
(422 days)
KetoSens Blood ß-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (beta-hydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood B-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.
The KetoSens Blood ß-Ketone Test Strips work with the KetoSens Blood ß-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the fingertip.
KetoSens Multi Blood p-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (beta-hydroxybutyrate) level in capillary whole blood from the fingertip and venous EDTA whole blood. KetoSens Multi Blood ß-Ketone Monitoring System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system should only be used with single-use, auto-disabling lancing devices.
The KetoSens Multi Blood p-Ketone Test Strips work with Blood ß-Ketone Meter to quantitatively measure Blood B-Ketone in capillary whole blood samples drawn from the fingertip and venous whole blood drawn in professional healthcare settings.
The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System consists of a meter, single use test strips, and control solutions with two different B-Ketone concentrations ("Control A" and "Control B" ranges).
The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System is based on an electrochemical biosensor technology (electrochemical). The System measures the Blood ß-Ketone level in whole blood samples using a small electrical current generated in the test strips.
This document focuses on the KetoSens Blood β-Ketone Monitoring System and its validation studies. It describes various performance tests conducted to ensure the device meets specified criteria, primarily focusing on accuracy, precision, and usability.
Here's an organized breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a single table labeled "Acceptance Criteria." However, acceptance criteria are implicitly stated within the "System Accuracy Test" and "Consumer Study" results, and "Repeatability Test" and "Intermediate Precision Test" conclusions.
| Test Type | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Repeatability (Precision) | Pooled SD of concentrations 1, 2 should be < 0.075 mmol/L. Pooled CV % of concentrations 3, 4, 5 should be < 5.0 %. | Passed. Pooled SD (concentration 1) = 0.027 mmol/L, (concentration 2) = 0.056 mmol/L. Pooled CV % (concentration 3) = 3.7%, (concentration 4) = 3.5%, (concentration 5) = 3.6%. |
| Intermediate Precision | Pooled SD for concentration interval 1 < 0.075 mmol/L. Pooled CV % for interval 2, 3 < 5.0 %. | Passed. Pooled SD (concentration 1) = 0.049 mmol/L. Pooled CV % (concentration 2) = 3.8%, (concentration 3) = 4.3%. |
| Linearity | High linear correlation (coefficient of determination r² > 0.95). | Passed. Total r² = 0.9985 across 3 strip lots. |
| System Accuracy (Capillary Blood) | At ketone < 1.5 mmol/L: 95% of results within ± 0.3 mmol/L. At ketone ≥ 1.5 mmol/L: 95% of results within ± 20 %. | Passed.> At ketone < 1.5 mmol/L: 170/171 (99.4%) within ± 0.3 mmol/L.> At ketone ≥ 1.5 mmol/L: 33/33 (100%) within ± 20 %. All 204 samples (100%) fell within specified ranges. |
| System Accuracy (Venous Blood) | At ketone < 1.5 mmol/L: 95% of results within ± 0.3 mmol/L. At ketone ≥ 1.5 mmol/L: 95% of results within ± 20 %. | Passed.> At ketone < 1.5 mmol/L: 169/169 (100%) within ± 0.3 mmol/L.> At ketone ≥ 1.5 mmol/L: 35/35 (100%) within ± 20 %. All 204 samples (100%) fell within specified ranges. |
| Consumer Study (Accuracy) | Capillary blood accuracy to satisfy system accuracy requirements (as defined above). | Passed.> General user tests: 185/185 (100%) within ± 0.3 mmol/L (for ketone < 1.5 mmol/L - implicitly applies given all results fell within).> Trained user tests: 185/185 (100%) within ± 0.3 mmol/L (for ketone < 1.5 mmol/L - implicitly applies). Also, 100% of general users could use the device correctly and obtain accurate results. |
| Point-of-Care (POC) Test (Accuracy) | Accuracy requirements met (as defined for system accuracy). | Passed.> Capillary: 124/124 (100%) within ± 0.3 mmol/L for < 1.5 mmol/L; 12/12 (100%) within ± 20% for ≥ 1.5 mmol/L.> Venous: 121/123 (98.4%) within ± 0.3 mmol/L for < 1.5 mmol/L; 13/13 (100%) within ± 20% for ≥ 1.5 mmol/L. |
| Hematocrit Effect | Hematocrit biases to be within acceptable limits (specific thresholds are detailed in the results section, generally showing low bias). | Passed. Biases were within specified ranges for different ketone intervals across 20-60% hematocrit. For example, -0.09 to 0.02 mmol/L at 0.0-0.8 mmol/L ketone, and percentage biases for higher concentrations (e.g., -15.02 to 8.73% at 5.5-6.5 mmol/L ketone). |
| Interference Test | No significant interference from listed substances. (Implicitly, results should not show significant bias). | Passed. Differences observed are mostly small, suggesting acceptable performance in the presence of various interferents. For example, Acetaminophen showed a -5.4% to -8.3% difference in the 2.0-3.5 mmol/L range, while many others were much smaller. Specific acceptance thresholds for interference are not explicitly provided in the summary, but the conclusion implies acceptance. |
| Altitude Test | No significant difference from reference equipment at high altitudes (up to 10,000 feet). | Passed. No systematic response to altitudes; not significantly affected by lack of atmospheric oxygen up to 10,000 feet (3,048m). |
| Operating Condition Test | Meters operate normally with less than 0.03 mmol/L or 20% bias from reference results. | Passed. Confirmed normal operation at 9 combined temperature-humidity conditions (10°C, 15°C, 30°, 40%, and 90% RH), with results showing bias less than 0.03 mmol/L or 20% from reference. |
2. Sample Size Used for the Test Set and Data Provenance
- System Accuracy Test (Capillary Blood): 204 samples.
- System Accuracy Test (Venous Blood): 204 samples.
- Repeatability Test: 300 measurements (N=300 for each of 5 concentration levels). This suggests a large number of readings rather than 300 unique samples.
- Intermediate Precision Test: 600 measurements (N=600 for each of 3 control levels).
- Consumer Study: 185 general users.
- Point-of-Care Test: 124 patients for capillary samples, 123 patients for venous samples.
- Hematocrit Effect Test: 5 different hematocrit levels, 5 different ketone intervals, measured using 30 meters and 3 lots of strips.
- Interference Test: 2 ketone concentrations, across 29 interferents, with 3 strip lots.
- Altitude Test: Not specified in terms of distinct sample numbers, but tested.
- Operating Condition Test: Not specified in terms of distinct sample numbers, but tested.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. However, based on the nature of clinical evaluation, consumer studies, and POC tests involving patient samples and human participants, these are typically prospective studies. The company, i-SENS, Inc., is based in Seoul, Korea, suggesting the studies likely took place there or in a similar regulatory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document mentions "trained staff" and "Health Care Professionals" (HCPs) in the context of comparative measurements.
- In the Consumer Study, results of general users are compared against "Rx Imola reference values" and "BKMS results obtained by trained staff."
- In the Point-of-Care Test, "Health care professionals" (six members) performed tests, and "The study staff operates the reference equipment and modify the KetoSens Multi BKMS results are compared against the reference values."
- The qualifications of these "trained staff" or "Health Care Professionals" are not explicitly defined (e.g., "radiologist with 10 years of experience"). Their role is to operate the reference equipment and/or the candidate device for comparison.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
The document does not describe an adjudication method for the test set in the context of expert review or consensus, as would be typical for image-based diagnostic AI. For a quantitative measurement device, the "ground truth" is typically established by comparative measurement to a highly accurate reference method. Discrepancies are usually managed through statistical analysis rather than an adjudication process among human readers.
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
This is not applicable as the device is a quantitative blood β-ketone monitoring system, not an AI-based diagnostic imaging tool that assists human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is a standalone quantitative measurement system. Its performance (accuracy, precision) is evaluated independently against a reference standard (Rx Imola equipment). The human user's role is to operate the device correctly, consistent with its "intended to be used for the quantitative measurement" function. The consumer study and POC test assess the usability for target users (self-testing or HCPs), but the core performance data in the system accuracy tests represent the device's measurement capabilities.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the quantitative measurement of β-ketone levels was established using a reference measurement procedure/equipment. Specifically:
- "The accuracy of KetoSens is evaluated with clinical evaluation using capillary and venous blood samples... and with the standard measurement."
- "KetoSens BKMS did not show significant difference with respect to the Rx Imola equipment, nor with different altitudes at all ketone concentrations."
- In the Consumer Study and POC test, results were compared against "Rx Imola reference values."
Therefore, the ground truth is comparative measurement to a recognized laboratory reference method/instrument (Rx Imola).
8. The Sample Size for the Training Set
The document describes performance evaluation (test set) studies but does not mention a 'training set' in the context of machine learning model development. This is because the KetoSens Blood β-Ketone Monitoring System is based on electrochemical biosensor technology, which relies on a chemical reaction to produce an electrical current proportional to the analyte, rather than an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
As the device does not employ an AI/ML algorithm requiring a 'training set,' this question is not applicable. The underlying principle is electrochemical, not data-driven machine learning.
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