(183 days)
The OneTouch® Ultra® Family of Systems are intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra Family of Systems are intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.
The OneTouch Ultra Family of Blood Glucose Monitoring System is specifically indicated for use on the finger, arm or palm.
The OneTouch Family of Systems consists of the OneTouch Ultra, InDuo and UltraSmart Meters, OneTouch Ultra Test Strips, OneTouch Ultra Control Solution, UltraSoft Lancing Device, UltraClear Cap and UltraSoft Lancets. The OneTouch Ultra meter, when used with the OneTouch Ultra Blood Glucose Test Strips, quantitatively measures glucose in capillary whole blood. The OneTouch Ultra Control Solution verifies the performance of the OneTouch Ultra Blood Glucose Test Strips.
The provided document is a 510(k) summary for the OneTouch® Ultra® Family of Blood Glucose Monitoring Systems. It describes the device, its intended use, and its comparison to predicate devices. However, this document does not contain specific acceptance criteria, detailed study results, sample sizes for test and training sets, information on ground truth establishment, expert qualifications, adjudication methods, or MRMC study results.
The submission revolves around expanding the intended use to include palm testing and other incremental changes, stating "Clinical testing demonstrated that palm and finger glucose measurements are equivalent during the steady state." This is the only mention of a study proving performance, and it lacks the detailed information requested.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be extracted:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | "Clinical testing demonstrated that palm and finger glucose measurements are equivalent during the steady state." (No quantitative metrics provided) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: 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)
- Number of Experts: Not applicable, as the "clinical testing" mentioned is comparing glucose measurements, not expert interpretations of medical images or data.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not specified. The study described is measuring glucose levels, not requiring adjudication of interpretations.
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
- No, an MRMC study was not done. The device is a glucose monitoring system, not an AI-based diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies a standalone (device-only) clinical testing was conducted to compare palm and finger glucose measurements. The "performance characteristics of the device systems" are stated to have "no change," suggesting the core blood glucose measurement algorithm was tested. However, no specific details of this "standalone" testing are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" would likely be laboratory-analyzed blood glucose levels (a reference method), against which the device's measurements from finger and palm were compared. This is not explicitly stated but is standard practice for blood glucose meter validation.
8. The sample size for the training set
- Not specified. The document primarily focuses on the modification of intended use and clinical testing related to that, not on detailed algorithm development or training data for a new algorithm.
9. How the ground truth for the training set was established
- Not specified. (Likely established using a laboratory reference method if training data were used for algorithm development/calibration).
§ 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.