(162 days)
The U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System is 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 U-RIGHT TD-4238 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The kit of U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring Systems consist of Glucose Meter, Test Strips, 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 U-RIGHT TD-4238 and TD-4246 Blood Glucose Monitoring Systems:
The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than outright proving performance against specific acceptance criteria with a detailed study report. Therefore, much of the requested information regarding specific study details (sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, ground truth for training data) is not explicitly stated within the provided document.
However, I can extract what is present and highlight what is missing based on your request.
Acceptance Criteria and Reported Device Performance
The core claim here is substantial equivalence to the predicate device, not meeting predefined acceptance criteria for a novel device. The document states:
"A comparison of system accuracy performance demonstrated that the U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System and the currently marketed FORA G30/TD-4241 Blood Glucose Monitoring System are substantially equivalent."
And, "U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System have the same performance characteristics as the predicate device."
Since the specific acceptance criteria and performance of the predicate device are not detailed here, it's impossible to create a table of acceptance criteria vs. specific reported device performance. The implication is that the new device meets the same performance characteristics as the predicate.
Missing Information: Specific numerical acceptance criteria (e.g., accuracy percentages, bias limits) and the detailed results of the U-RIGHT TD-4238/TD-4246 systems against those criteria.
Study Details
Here's a breakdown of the study details based on the provided text, and identification of missing information:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as specific numerical targets for the U-RIGHT devices. The acceptance criterion is "substantial equivalence" to the predicate device (FORA G30/TD-4241). Implied acceptance is that the device demonstrates "the same performance characteristics" as the predicate.
- Reported Device Performance: Not explicitly enumerated in a table. The document only states that performance "demonstrated" substantial equivalence and "have the same performance characteristics" as the predicate device.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Studies for medical devices of this type are typically prospective, but this is not confirmed here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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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:
- MRMC Study: Not applicable/not mentioned. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves "human readers." Its purpose is direct measurement.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The general performance characteristics (accuracy) of the U-RIGHT system itself would have been tested in a "standalone" fashion to demonstrate equivalence to the predicate. The statement "Software verification and validation testing confirmed that the performance, safety and effectiveness of the U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System are equivalent to the predicate device" implies standalone testing of the system as a whole. However, explicit details of this testing are absent.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For blood glucose meters, the "ground truth" is typically established by laboratory reference methods (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer, or similar, which are highly accurate and precise methods for measuring glucose in blood samples). This is not explicitly stated but is the standard for such devices.
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The sample size for the training set:
- Sample Size (Training Set): Not specified. The document indicates a "modification in the software of the glucose meter," which might imply some level of software development and possibly associated data for the software. However, it does not detail a separate "training set" in the context of an AI/machine learning model, which is typically what that term refers to. Given this is an electrochemical biosensor, the "training" may be more akin to calibration and optimization data rather than an AI training set.
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How the ground truth for the training set was established:
- Ground Truth (Training Set): Not specified. (See point 8 regarding the nature of "training" for this type of device).
Summary of what is explicitly stated:
- Device Type: Blood Glucose Monitoring System.
- Comparison: Substantial equivalence to FORA G30/TD-4241 Blood Glucose Monitoring System (K090187).
- Performance Claim: The new devices "have the same performance characteristics" as the predicate and "demonstrated that they are substantially equivalent."
- Technology: Electrochemical biosensor technology using glucose oxidase.
- Key changes from predicate: Software modification, physical appearance modification, labeling change.
- Software V&V: Software verification and validation confirmed performance, safety, and effectiveness are equivalent to the predicate.
Key Missing Information (as per your request, and typical information found in detailed study reports):
- Detailed numerical acceptance criteria.
- Specific accuracy, precision, or bias results for the U-RIGHT devices.
- Exact sample sizes for any performance evaluation studies.
- Details on expert involvement or adjudication.
- Any mention of separate "training" and "test" sets in the context of advanced algorithms, although this might not be relevant for a non-AI electrochemical biosensor.
- The exact reference method used as ground truth.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.