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FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in the FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System consists of Glucose meter, Test Strips, Two levels of Control solution, A commercially available (510(k) cleared) lancing device and sterile Lancets, User Manual, and Storage Pack.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the provided text does not explicitly state specific acceptance criteria (e.g., accuracy percentages or error ranges) for the glucose monitoring system, nor does it present detailed performance data in a table format.

Instead, the document primarily focuses on establishing substantial equivalence to a predicate device and broadly states that the new models "have the same performance characteristics as the predicate device" and that a "comparison of system accuracy performance demonstrated that... [the new models] are substantially equivalent." It also mentions that "a mechanical resistance test showed that the model TD-4253 meet the requirement of EN ISO 15197."

Without specific numerical acceptance criteria from the text, a table cannot be fully constructed.

What we can infer about "acceptance criteria" from the text:

• Substantial Equivalence: The primary "acceptance criterion" appears to be demonstrating substantial equivalence in performance to an existing, legally marketed predicate device (K082482). This implies that if the predicate device met certain performance standards, the new device must meet or exceed those to be considered substantially equivalent.
• Mechanical Resistance: For model TD-4253, meeting the requirements of EN ISO 15197 for mechanical resistance is an acceptance criterion.
• Software Verification & Validation: The software's performance, safety, and effectiveness being equivalent to the predicate device is an acceptance criterion.

Reported Device Performance (as stated in the document):

• "The FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring Systems have the same performance characteristics as the predicate device."
• "A comparison of system accuracy performance demonstrated that the FORA TD-4251 //U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System... and the currently marketed FORA TD-4251/ URIGHT TD-4252 / URIGHT TD-4254 Blood Glucose Monitoring System are substantially equivalent."
• "A mechanical resistance test showed that the model TD-4253 meet the requirement of EN ISO 15197."
• "Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System... are equivalent to the predicate device."

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

The provided text does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "A comparison of system accuracy performance" and "Software verification and validation testing," without providing details on the number of subjects, samples, or how the data was collected for these tests.

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

The document does not mention the use of experts or their qualifications for establishing ground truth for any test set. The nature of a blood glucose monitoring system typically relies on a laboratory reference method (e.g., YSI analyzer) as the ground truth, rather than expert consensus on interpretive tasks.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method like 2+1 or 3+1. This is expected given that the device measures a quantitative value (blood glucose) and typically compares it against a reference standard, not against human interpretation that might require adjudication.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Blood glucose monitoring systems are standalone diagnostic devices for quantitative measurement, and their evaluation typically does not involve comparing human readers with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance assessment was implicitly done. The document states:

• "A comparison of system accuracy performance demonstrated that the FORA TD-4251 //U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System... and the currently marketed FORA TD-4251/ URIGHT TD-4252 / URIGHT TD-4254 Blood Glucose Monitoring System are substantially equivalent."
• "Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System... are equivalent to the predicate device."

While explicit results are not detailed, these statements confirm that the device's performance was evaluated on its own ("standalone") and compared against a predicate, implying its ability to accurately measure glucose without a human in the loop for the measurement itself (though a human interprets the result).

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, for blood glucose monitoring systems, the standard ground truth is typically a laboratory reference method, such as a YSI glucose analyzer, which provides a highly accurate and precise measurement of blood glucose.

8. Sample Size for the Training Set

The provided text does not mention a training set or its sample size. This is likely because the device is a re-submission of a modified existing device, and the changes are primarily in software and physical appearance, rather than a completely new algorithm requiring a separate training and validation paradigm in the context of this 510(k) summary. For a de novo AI/ML device, this information would be crucial.

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

As no training set is mentioned, information on how its ground truth was established is not provided in the document.

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