(64 days)
Health Buddy with Device Connect [Glucose Meter] is indicated for use in non-clinical settings to collect and transmit historical blood glucose meter data to healthcare professionals to help support effective management of diabetes patients.
Health Buddy with Device Connect is intended to be a communication tool to enable healthcare providers to receive patient blood glucose information. The product is intended to be used in conjunction with Health Hero Network Online Service, a communication tool to enable healthcare providers to educate, motivate, and receive patient information. Health Buddy with Device Connect and the Health Hero Network Online Service are not intended to provide automated treatment decisions, nor to be used as a substitute for a healthcare professional's judgment. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
Health Buddy with Device Connect [Glucose Meter] is indicated for use in non-clinical settings to collect and transmit historical blood glucose meter data to healthcare professionals to help support effective management of diabetes patients.
The provided text describes a 510(k) submission for the Health Buddy® with Device Connect [Glucose Meter], a device intended to collect and transmit historical blood glucose meter data to healthcare professionals. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets acceptance criteria, or details regarding device performance metrics.
The document is a US FDA 510(k) summary and the accompanying FDA clearance letter, which focuses on:
- Device Description and Intended Use: Explains what the device does (collects and transmits blood glucose data) and its purpose (to help healthcare professionals manage diabetes patients).
- Substantial Equivalence: States that the device is substantially equivalent to legally marketed predicate devices (LifeScan ONE TOUCH Profile Diabetes Tracking System and LifeScan IN TOUCH Diabetes Management Software). This is the primary basis for 510(k) clearance, rather than a de novo performance study against pre-defined acceptance criteria.
- Regulatory Classification: Identifies it as a Class II device under 21 CFR §862.1345 (Glucose Test System).
- Administrative Details: Contact information, dates, and FDA correspondence.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The 510(k) clearance is based on substantial equivalence, not a direct comparison against explicit performance acceptance criteria in the provided document.
- Sample size used for the test set and the data provenance: Not available. No "test set" in the context of a performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone performance study: Not mentioned.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is a regulatory submission for substantial equivalence clearance, not a clinical or performance study report that would contain the requested details on acceptance criteria and performance data.
§ 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.