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The FreeStyle Freedom Lite Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program by quantitatively measuring glucose in fresh whole blood from the finger, upper arm and palm. The FreeStyle Freedom Lite Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. It is intended to be used by a single person and should not be shared. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly). The FreeStyle Lite Blood Glucose Test Strips are for use with the FreeStyle Freedom Lite Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, upper arm and palm.

The FreeStyle Freedom Lite Meter, in conjunction with the FreeStyle Lite Blood Glucose Test Strips works on the principal of coulometric biosensor technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrochemical mediation. The FreeStyle Freedom Lite Meter consists of the following major features: Strip Port, Buttons, Display Window. The device is prepared for use by inserting a FreeStyle Lite glucose test strip in the test strip port. Upon strip insertion, the meter will turn on automatically and perform a display check. The meter will then display the time, month and day. The apply blood message is displayed for the user to apply blood to the test strip until the meter begins the test. Blood detect will occur when the meter detects trigger current from the test strip, initiated when enough blood has covered the strip electrodes. Following the blood detect, the meter performs the glucose assay measurement.

The provide text is a 510(k) premarket notification for the FreeStyle Freedom Lite Blood Glucose Monitoring System, with a focus on incorporating cleaning and disinfection procedures.

Here's an analysis of the acceptance criteria and the study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on the modification of adding cleaning and disinfection procedures for the FreeStyle Freedom Lite Blood Glucose Monitoring System. The acceptance criteria for this specific modification would revolve around the device's ability to maintain its functionality and accuracy after repeated cleaning and disinfection cycles.

While the document details many characteristics of the device itself (measurement range, sample volume, etc.), it explicitly states the performance related to the modification which is the focus of this submission:

Note: The document does not provide a separate table of defined acceptance criteria for the performance of the glucose monitoring itself post-disinfection. Instead, it implies that the device remains "safe and effective for its intended use and technological characteristics" after undergoing these cycles, suggesting that the initial performance criteria for glucose measurement (e.g., accuracy against a reference method) are still met. The detailed performance characteristics like measurement range, sample volume, etc., are similarities to the predicate device and were likely established during the initial clearance or previous submissions.

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

The document describes disinfection and cleaning cycle testing for the device components themselves, not directly on patient samples to assess glucose accuracy after disinfection.

• Sample Size for Test Set:
  • For the meter: The testing was performed for 522 cleaning and 522 disinfection cycles. It is implied that a sufficient number of devices were tested to demonstrate this durability, but the exact number of physical meters tested is not specified.
  • For the lancing device: The testing was performed for 210 cleaning and 210 disinfection cycles. Similar to the meter, the exact number of lancing devices tested is not specified.
• Data Provenance: Not explicitly stated, but given this is a US FDA submission from Abbott Laboratories (headquartered in Alameda, CA, USA), the testing would typically be performed in-house or by a US-based contracted lab. The data is retrospective in the sense that the testing has already been completed and is being submitted to the FDA. It's not prospective in nature as part of a future clinical trial.

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

Not applicable for this type of testing. The "ground truth" here is the durability and continued functionality of the device components (meter and lancing device) after repeated exposure to cleaning and disinfection agents, not clinical diagnostic accuracy. The assessment would likely involve engineering evaluations, visual inspections, and continued functional testing (e.g., still powers on, buttons work, reads test strips accurately) by qualified technical personnel, rather than medical experts establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study that involves human interpretation or consensus directly on diagnostic outcomes. The "adjudication" would be based on predefined failure criteria for device functionality and integrity after the specified cleaning/disinfection cycles.

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

Not applicable. This submission is about the physical durability and functionality of a blood glucose meter system after cleaning/disinfection, not about the comparative effectiveness of human readers, with or without AI assistance, in interpreting results.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This device is a physical medical device (blood glucose meter and strips), not an AI algorithm. Its performance is intrinsic to its electrochemistry and hardware, demonstrated as a system ("algorithm" here would be the meter's internal processing of electrical signals).

7. Type of Ground Truth Used:

The ground truth for this specific submission (the modification) is the continued physical integrity and functional performance of the meter and lancing device after exposure to the specified cleaning and disinfection agents for a prescribed number of cycles. This would be established through a combination of:

• Engineering specifications and standards: Confirming the device still meets its original operating specifications (e.g., accuracy, display functionality, button responsiveness) after the cycles.
• Visual inspection: Assessing for material degradation, cracking, label fading, etc.
• Functional testing: Ensuring the device continues to successfully perform its core glucose measurement function (e.g., successful blood application, accurate reading of control solutions).

For the overall glucose measurement accuracy, the ground truth would be a laboratory reference method (e.g., YSI analyzer), likely established in prior submissions (like the predicate K092602) and implicitly maintained after the disinfection cycles.

8. Sample Size for the Training Set:

Not applicable. This device does not employ machine learning or AI that would require a "training set." Its operational principles are based on established coulometric biosensor technology.

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

Not applicable, as there is no training set for this device/submission.

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