(266 days)
The ACCU-CHEK® Smart Pix enables persons with diabetes or healthcare professionals to send stored data from their compatible ACCU-CHEK blood glucose monitor and/or Disetronic/ACCU-CHEK Insulin infusion pump to a compatible computer as a set of reports or data stream.
The ACCU-CHEK Smart Pix is intended to help monitor and clinically manage individuals with diabetes.
Accessory to ACCU-CHEK® brand meters and/or Disetronic/ACCU-CHEK insulin infusion pump that enables the persons with diabetes or healthcare professionals to send stored data to a compatible computer.
The provided 510(k) summary for the ACCU-CHEK® Smart Pix Device does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
This document is a 510(k) premarket notification, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study. The focus of this type of submission is on comparing the new device's features, intended use, and technology to an existing device, and showing that any differences do not raise new questions of safety or effectiveness.
Therefore, many of the requested elements for describing an acceptance criteria study (like sample size, ground truth, expert qualifications, etc.) are not present in this type of regulatory document for this specific device.
However, based on the information provided, we can infer some "acceptance criteria" related to functional equivalence and report the described features:
Acceptance Criteria and Reported Device "Performance" (Functional Equivalence)
Since this is a 510(k) for a data transfer device, the "performance" is primarily functional equivalence to the predicate device in terms of data handling and reporting capabilities, rather than clinical efficacy or accuracy of measurements.
| Acceptance Criteria Category (Inferred) | Specific "Criteria" (Inferred from Similarity Claims) | Reported Device Performance (ACCU-CHEK® Smart Pix) |
|---|---|---|
| Connectivity | Able to connect to and download information from ACCU-CHEK brand blood glucose monitors. | The ACCU-CHEK® Smart Pix connects to and downloads information stored on ACCU-CHEK brand blood glucose monitors. It also connects to Disetronic/ACCU-CHEK insulin infusion pumps. |
| Warnings & Precautions | Maintain "for in vitro diagnostic use only" warning. | Maintains "for in vitro diagnostic use only" warning. |
| State Messaging | Provide feedback to the consumer through a combination of LED flashes. | Provides feedback to the consumer through a combination of LED flashes. |
| Reports & Data Processing | Create reports and graphs using basic statistical calculations of historic data stored in connected devices. | Creates reports and graphs using basic statistical calculations of the historic data stored in the devices they can connect to. It sends data to a compatible computer as a set of reports or a data stream. |
| Intended Use | Enable persons with diabetes or healthcare professionals to send stored data from compatible ACCU-CHEK devices to a compatible computer, intended to help monitor and clinically manage individuals with diabetes. | The ACCU-CHEK® Smart Pix enables persons with diabetes or healthcare professionals to send stored data from their compatible ACCU-CHEK blood glucose monitor and/or Disetronic/ACCU-CHEK Insulin infusion pump to a compatible computer as a set of reports or data stream. It is intended to help monitor and clinically manage individuals with diabetes. (This is identical to the predicate's intended use in function, though the method of transfer differs). |
| Physical Characteristics (Differences) | While not an "acceptance criterion" in the traditional sense, the device's physical differences (power, weight, size, operating conditions) were evaluated and accepted. | Power supply: USB port (Predicate: AC adapter) |
| Weight: 90 g (Predicate: 205 g) | ||
| Size: 104 x 74 x 38 mm (Predicate: 137 x 113 x 41 mm) | ||
| Ambient conditions: Service temperature: 5 - 40 C; Storage temperature: -25 - 70 C; Humidity: 9.6 - 98% Rh (Predicate: Operating temperature: 0-50 C; Storage temperature: -25 - 65 C; Humidity: 0 – 95% Rh) |
Unavailable Information from the Provided Document:
- Sample size used for the test set and the data provenance: Not applicable or provided. The submission focuses on functional equivalence and design differences rather than performance testing against a "test set" of clinical data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth for clinical performance is not discussed for this device.
- Adjudication method for the test set: Not applicable or provided.
- 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: Not applicable. This is not an AI-assisted diagnostic or interpretative device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a data transfer accessory, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or provided.
- The sample size for the training set: Not applicable or provided. This device does not involve machine learning or a "training set."
- How the ground truth for the training set was established: Not applicable or provided.
Conclusion:
The provided 510(k) summary for the ACCU-CHEK® Smart Pix Device demonstrates its substantial equivalence to a predicate device by comparing their features, intended uses, and technical specifications. It highlights similarities in functions like data connectivity, reporting, and basic statistical calculations. The "study" referenced implicitly is the detailed comparison of the new device's design and functionality against the predicate, asserting that the new design (e.g., USB power, smaller size) does not alter the fundamental mechanism or intended use, thus not raising new questions of safety or effectiveness. As such, quantitative performance acceptance criteria and associated clinical studies with ground truth are not part of this specific submission type for this kind of device.
§ 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.