(245 days)
The FreeStyle Freedom™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.
The FreeStyle Freedom™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
The FreeStyle Freedom™ monitor utilizes coulometric biosensor technology found in the FreeStyle Freedom test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Freedom BGMS measures glucose electrochemically. The glucose biosensor is capable of recognizing the glucose present in whole blood by virtue of the glucose specificity of the enzyme glucose dehydrogenase (GDH) present on the glucose test strip.
The provided text is a 510(k) summary for a blood glucose monitoring system. It primarily focuses on the substantial equivalence of the FreeStyle Freedom system to a predicate device, rather than providing detailed acceptance criteria and a comprehensive study report with the specific metrics requested.
Therefore, much of the requested information cannot be extracted directly from the provided document.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document states, "The performance of the FreeStyle Freedom Blood Glucose Monitoring System was evaluated in laboratory studies as well as accuracy and lay user clinical studies. Data from the clinical studies demonstrates that lay users can obtain results from the FreeStyle Freedom Blood Glucose Monitoring System that correlate well with the laboratory reference glucose values."
However, specific numerical acceptance criteria (e.g., accuracy percentages, bias thresholds) and the corresponding reported performance values are not provided in this summary. It concludes generally that the performance "is substantially equivalent to the performance of the predicate devices for blood glucose testing and suitable for its intended use."
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|
| Likely related to accuracy/precision against laboratory reference values (e.g., ISO 15197 standards would typically apply for BGMs). | Document states "correlate well with the laboratory reference glucose values." No specific metrics provided. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "accuracy and lay user clinical studies" and "clinical testing" but does not provide any details about the sample size for these studies or the test set.
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document refers to "laboratory reference glucose values" as the comparator for the device's performance. However, it does not specify the number or qualifications of experts involved in establishing these laboratory reference values.
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for establishing ground truth, as it primarily relies on "laboratory reference glucose values."
- Adjudication method: Not applicable/Not specified for this type of device and study description.
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 device is a blood glucose monitoring system, not an AI-assisted diagnostic tool for image interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this type of device and was not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone blood glucose meter that provides a numerical reading. Its performance is inherently "standalone" in the sense that the algorithm (biosensor technology) directly provides the glucose measurement. The clinical studies evaluate how well these results compare to laboratory methods when used by lay users.
- Standalone Performance: Yes (the device measures glucose concentration directly). The "lay user clinical studies" evaluate its performance when used by humans in a real-world scenario, but the core measurement is a standalone algorithmic result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for evaluating the device's performance was "laboratory reference glucose values." This typically refers to measurements obtained using a highly accurate and precise laboratory analyzer (e.g., a YSI analyzer) in a controlled setting.
- Type of Ground Truth: Laboratory reference glucose values.
8. The sample size for the training set
The document does not mention a "training set" as this is a traditional medical device (biosensor) and not explicitly an AI/machine learning model in the contemporary sense that would require distinct training/validation/test sets for algorithm development. The performance studies described are for validation/testing of the final device.
- Sample Size (Training Set): Not applicable/Not specified.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for AI/ML model development, this information is not applicable. The ground truth for performance evaluation was "laboratory reference glucose values" as noted in question 7.
§ 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.