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The Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and from venous, arterial and neonatal whole blood, and for the quantitative measurement of ß-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous, arterial, and neonatal whole blood when used within 30 minutes after collection. The Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, autodisabling lancing devices.

The system should not be used for the diagnosis of or screening for diabetes.

The Freestyle Precision Pro Blood Glucose Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, and from venous, arterial. and neonatal whole blood. The Freestyle Precision Pro Blood B-Ketone Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantitatively measure ß-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous, arterial, and neonatal whole blood.

Freestyle Precision Pro Blood Glucose and ß-Ketone Monitoring System enables automatic transmission of stored data to a data management system using the docking station (optional). a data upload cable (optional), or wirelessly (optional) in a WiFi enabled facility when the meter and data management systems are properly configured.

The Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System is a microprocessor-controlled devices that algorithmically process electrical current from a (biosensor) test strip to compute a diabetic patient's blood glucose reading. The meter is fabricated from standard electronic components housed in an injection molded plastic case that offers easy test strip alignment and insertion, and a custom graphic liquid crystal display (LCD). The LCD will display menu prompts, icons, results, and data. The meter also includes a function key for turning the unit on/off and to select functions.

The meter requires 2 user replaceable standard AA cell batteries. The Freestyle Precision Pro meter is calibrated by scanning the lot specific bar code on the test strip foil label. An assay cannot be performed until the barcode information has been recorded.

The meter automatically stores the last 2,500 test results, which may be a combination of blood glucose or glucose control results. These results can be recalled and displayed again. Additionally, the meters can store up to 6,000 Operator IDs or 1,000 Quality Control tests.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K132511) does not explicitly state numerical acceptance criteria for blood glucose or β-ketone measurement accuracy. It primarily focuses on demonstrating substantial equivalence to a predicate device by extending the hematocrit range. The key performance characteristic mentioned is the acceptable performance over the hematocrit range of 15%-65%.

Important Note: The document mentions ISO 15197:2003 as a referenced standard, which does specify accuracy criteria for blood glucose monitoring systems. However, these specific criteria and how the device met them are not detailed in this 510(k) summary. The summary focuses on the change from the predicate (hematocrit range) and that the performance is "acceptable."

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The summary mentions "laboratory testing" and that "the performance of the meter and test strip was studied by healthcare professionals," but does not give a specific number of samples or patients.
• Data Provenance: Not explicitly stated. The document indicates "laboratory testing" and studies by "healthcare professionals," but does not specify the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned. The studies were conducted by "healthcare professionals," but their specific qualifications (e.g., specific medical specialty, years of experience) are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. The device is for quantitative blood glucose and β-ketone measurement, and the studies described focus on the analytical performance of the system itself against established methods (implied through substantial equivalence to the predicate) and across a new hematocrit range. There is no mention of human reader interpretation or AI assistance in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• Standalone Performance: Yes, this is inherently a standalone performance study. The FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System is a device designed to algorithmically process electrical current from a test strip to compute a blood glucose or β-ketone reading. The performance characteristics described are those of the device itself (meter and test strip) in measuring these analytes. There is no human interpretation component in the direct measurement of glucose/ketone levels by the device.

7. Type of Ground Truth Used

• Type of Ground Truth: Implied to be a reference method or predicate device comparison. The summary states, "The studies demonstrate that healthcare professionals can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements, which include the predicate device listed above." This suggests that the device's readings were compared against accepted laboratory reference methods for glucose and β-ketone, or directly against the predicate device (K130094) which itself would have been validated against reference methods.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a separate "training set" in the conventional AI sense. The "algorithm" within this device refers to the microprocessor's programmed processing of electrical currents from the biosensor, which is based on electrochemical principles, not learned from a dataset.

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

• Ground Truth for Training Set: Not applicable, as there is no training set in the AI sense for this device. The device's internal algorithms would be developed and calibrated based on chemical and electrical engineering principles, validated against known standards and reference methods during its design and development phases.

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The Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and from venous, arterial and neonatal whole blood, and for the quantitative measurement of B-ketone (beta-hydroxybutvrate) in fresh capillary whole blood from the finger and venous, arterial and neonatal whole blood when used within 30 minutes after collection. The Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.

The system should not be used for the diagnosis of or screening for diabetes.

The Freestyle Precision Pro Blood Glucose Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips and from venous, arterial and neonatal whole blood. The Freestyle Precision Pro Blood B-Ketone Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantitatively measure B-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous, arterial and neonatal whole blood.

Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System enables automatic transmission of stored data to a data management system using the docking station (optional), a data upload cable (optional), or wirelessly (optional) in a WiFi enabled facility when the meter and data management systems are properly configured.

The Freestyle Precision Pro Blood Glucose and ß-Ketone Monitoring System is a microprocessor-controlled devices that algorithmically process electrical current from a (biosensor) test strip to compute a diabetic patient's blood glucose reading. The meter is fabricated from standard electronic components housed in an injection molded plastic case that offers easy test strip alignment and insertion, and a custom graphic liquid crystal display (LCD). The LCD will display menu prompts, icons, results, and data. The meter also includes a function key for turning the unit on/off and to select functions.

The meter requires 2 user replaceable standard AA cell batteries. The Freestyle Precision Pro meter is calibrated by scanning the lot specific bar code on the test strip foil label. An assay cannot be performed until the barcode information has been recorded.

The meter automatically stores the last 2,500 test results, which may be a combination of blood glucose or glucose control results. These results can be recalled and displayed again. Additionally, the meters can store up to 6,000 Operator IDs or 1,000 Quality Control tests.

Here's an analysis of the acceptance criteria and study information for the Freestyle Precision Pro Blood Glucose and ß-Ketone Monitoring System, based on the provided text:

Important Note: The provided 510(k) summary is very high-level and does not contain detailed quantitative acceptance criteria or specific study results that would typically be found in a full performance study report. The document states that performance studies were conducted and the results were deemed "acceptable and comparable" to the predicate, but it does not provide the specific numerical acceptance thresholds or the exact performance metrics achieved.

Acceptance Criteria and Reported Device Performance

Summary of Acceptance Criteria: The primary acceptance criterion articulated in this summary is substantial equivalence to existing, legally marketed devices (specifically the Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System). This implies that the new device's performance, particularly in glucose and ketone measurement accuracy and precision, must be comparable to or better than the predicate's established performance, typically within predefined statistical limits. However, the exact numerical thresholds for "substantially equivalent" are not presented here.

Study Details

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

   • Sample Size: Not explicitly stated in the provided document. The summary mentions "laboratory and clinical settings" and "healthcare professionals" without specifying the number of samples or patients involved.
   • Data Provenance: The legal manufacturer is Abbott Diabetes Care Ltd. in Witney, UK. The studies were likely conducted in the UK or other regions where Abbott operates. The document does not specify a country of origin for the data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a new device, these would almost certainly be prospective studies specifically designed to demonstrate performance of the new device.

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

   • This information is not provided in the document. For blood glucose meters, ground truth is typically established using a highly accurate laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer or similar) rather than human experts.

3. Adjudication method for the test set:

   • Not applicable/Not provided. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments by multiple human readers (e.g., radiologists interpreting images) to establish a consensus ground truth. For a quantitative device like a blood glucose meter, ground truth is established by objective reference 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:

   • An MRMC study is not relevant here. This device is a standalone diagnostic instrument, not an AI-powered assistive tool for human readers in a diagnostic imaging context. There is no "human reader with AI assistance" component to evaluate.

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

   • Yes, this device is inherently a standalone (algorithm only) device in its core function of measuring glucose and ß-ketone. The performance studies described in the summary evaluate the accuracy and precision of the meter itself when operated by healthcare professionals. While a human handles the device, the core measurement and algorithmic processing are automated, making it a standalone performance assessment of the device's analytical capabilities.

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

   • The ground truth for quantitative blood tests like glucose and ß-ketone is typically established using a highly precise and accurate laboratory reference method, often an enzymatic reference method traceable to a recognized standard. The document doesn't explicitly state the reference method, but this is the standard practice for such devices.

7. The sample size for the training set:

   • This information is not applicable and not provided. Blood glucose meters do not typically involve "training sets" in the machine learning sense. Their algorithms are based on established electrochemical principles and signal processing, calibrated during manufacturing, rather than being "trained" on a large dataset of patient samples in the way an AI algorithm would be. Calibration data is used, but it's not a "training set" in the common understanding of AI/ML.

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

   • This information is not applicable. As explained above, these devices use calibration data, not a "training set" with ground truth established in the same way as for AI models. Calibration involves comparing the device's readings against known concentrations of analytes, usually using traceable reference standards, to ensure accuracy and linearity across the measurement range.

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