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MTM301 Blood Glucose and Ketone Monitoring System: MTM301 Blood Glucose and Ketone Monitoring System is comprised of the MTM301 Blood Glucose and Ketone Meter, the MTM301 Blood Glucose Test Strips, and the MTM301 Blood Ketone test strips.

The MTM301 Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood drawn from fingertips. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.

The MTM301 Blood Glucose and Ketone Monitoring System consists of the MTM301 Blood Glucose and Ketone Meter, MTM301 Blood Glucose test strips, MTM301 Blood Ketone test strips, MTM301 Glucose Control Solution (Level 1, Level 2), and MTM301 ketone control solution (Level 1 and Level 2). The system is for self-testing of blood glucose and blood ketone. The MTM301 Blood Glucose test strips, MTM301 Blood Ketone test strips, MTM301 Glucose Control Solution, and MTM301 ketone control solution are purchased separately.
The glucose test strips utilized in the MTM301 Blood Glucose and Ketone Monitoring System are the same as the BGM009 glucose test strips previously cleared in K170267 ; The ketone test strips are the same as the KET-1 Blood Ketone test strips, previously cleared in K182593.

Here's a summary of the acceptance criteria and study information for the MTM301 Blood Glucose and Ketone Monitoring System, based on the provided FDA 510(k) Summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria (e.g., specific accuracy percentages for glucose ranges). Instead, it states that "Results demonstrate substantial equivalence to the predicate system" for various tests. The predicate system is the Nova Max Plus Blood Glucose and β-Ketone Monitoring System (K091547).

However, the "Non-Clinical Testing" and "Clinical Testing" sections indicate the types of studies performed to demonstrate this substantial equivalence.

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

The document does not explicitly state the numerical sample size for the test set used in the accuracy studies (clinical testing) or for the individual non-clinical tests.

• Data Provenance: The submitter is Apex Biotechnology Corp. in Hsinchu, Taiwan. The document does not explicitly state the country of origin of the clinical data or whether it was retrospective or prospective, but clinical studies are generally prospective for device clearance.

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

This information is not provided in the document. For glucose and ketone monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer) performed by trained laboratory personnel, rather than experts in the sense of radiologists.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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. The MTM301 Blood Glucose and Ketone Monitoring System is a self-testing in vitro diagnostic device, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

Yes, the device operates as a standalone system. The clinical accuracy studies evaluate the algorithm's performance in measuring glucose and ketone in capillary whole blood. The system is intended for "self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home," indicating its standalone operational nature without professional human interpretation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used, but for blood glucose and ketone monitoring systems, the ground truth is typically established using laboratory reference methods (e.g., a YSI analyzer for glucose, or a high-performance liquid chromatography (HPLC) method for ketones) on venous blood samples, against which the capillary blood measurements from the device are compared. This constitutes a highly accurate, quantitative ground truth.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" sample size. For in vitro diagnostic devices like blood glucose meters, the development process typically involves internal calibration, optimization, and verification using various samples, but these are not usually referred to as a "training set" in the same way as machine learning models. The "clinical testing" described would be more analogous to an independent "test set" for performance evaluation.

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

As noted above, the document does not refer to a "training set" in the context of establishing ground truth for machine learning. The ground truth for development and testing would generally follow standard laboratory reference methods.

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