(428 days)
The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK 360° Insulin Pump Configuration software facilitates the monitoring and programming of the pump settings.
The ACCU-CHEK Aviva Combo blood glucose system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. The ACCU-CHEK Aviva Combo blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Combo blood glucose monitoring system. The ACCU-CHEK Aviva Plus test strips are for use with the ACCU-CHEK Aviva Combo blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The ACCU-CHEK Aviva Combo meter can also be used to interface with, and remotely control, the ACCU-CHEK Spirit Combo insulin infusion pumps via radio frequency communication. The ACCU-CHEK Aviva Combo meter is also indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data.
For in vitro diagnostic use
The ACCU-CHEK Aviva Combo system is intended for single patient use and should not be shared.
The ACCU-CHEK Combo System includes:
- An ACCU-CHEK Spirit Combo insulin infusion pump and optional . accessory software (ACCU-CHEK 360° Insulin Pump Configuration software), and
- . An ACCU-CHEK Aviva Combo blood glucose monitor. Both devices utilize disposables that are already legally marketed.
The ACCU-CHEK Spirit Combo utilizes disposables that are already legally marketed:
- ACCU-CHEK FlexLink Plus .
- ACCU-CHEK Ultraflex ●
- ACCU-CHEK Tender .
- ACCU-CHEK Rapid-D .
- ACCU-CHEK 3.15 ml Plastic Cartridge .
The ACCU-CHEK Aviva Combo utilizes disposables that are already legally marketed:
- ACCU-CHEK Aviva Plus test strips .
- · ACCU-CHEK Aviva control solutions
The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiplepatient use.
Here's an analysis of the provided text to extract information about acceptance criteria and the supporting study for the ACCU-CHEK Combo System:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides specific performance criteria for the ACCU-CHEK Spirit Combo Insulin Pump. While it generally states that the ACCU-CHEK® Combo System performed equivalently to predicate devices, specific numerical acceptance criteria for the ACCU-CHEK Aviva Combo blood glucose monitor itself are not explicitly detailed in the provided text beyond general statements of accuracy.
| System/Component | Acceptance Criteria (Target) | Reported Device Performance (Result) |
|---|---|---|
| ACCU-CHEK Spirit Combo Insulin Pump | ||
| Delivery Rates: 1.0 I.U./h | Accuracy ± 5% | Accuracy ± 5% |
| Delivery Rates: 0.05 I.U./h | Accuracy ± 30% | Accuracy ± 30% |
| Occlusion bolus volume: U100 (at 1.0 IU/h feed rate) | ≤ 1.5 IU | ≤ 1.5 IU |
| Occlusion bolus delay time: U100 (at 1.0 IU/h) | ≤ 2 h | ≤ 2 h |
| Occlusion bolus delay time: U100 (at 0.05 IU/h) | ≤ 24 h | ≤ 24 h |
| ACCU-CHEK Aviva Combo blood glucose monitor | Accuracy (general) | Accurate blood glucose test results |
| Blood sample volume | (Not specified) | 0.6 µL |
| Test result time | (Not specified) | 5 seconds |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "Laboratory and Human Factors studies demonstrate that the ACCU-CHEK® Combo System performed in an equivalent manner to the predicate devices and is suitable for its intended use."
- Sample Size for Test Set: Not explicitly mentioned in the provided text for either laboratory or human factors studies.
- Data Provenance: Not specified whether the data was retrospective or prospective. The country of origin of the data is also not mentioned, although the submitting entity is Roche Diabetes Care, AG, based in Switzerland.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the given text.
4. Adjudication Method for the Test Set:
This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- MRMC Study Done: No. The document refers to "human factors studies" but does not describe them as MRMC studies to compare human readers with and without AI assistance. The device itself is an insulin pump and blood glucose monitor, not an AI-assisted diagnostic tool for interpretation by human readers.
- Effect Size: Not applicable, as no MRMC comparative effectiveness study of the described nature was mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- The ACCU-CHEK Combo System's components (insulin pump and blood glucose meter) inherently perform their functions in an "algorithm only" or standalone manner once activated, providing direct outputs (insulin delivery, glucose readings). The document implies that the "Laboratory studies" would form part of this standalone performance assessment for the pump's accuracy and the meter's accuracy, although specific details are limited. The "human factors studies" likely address human interaction with the device for usability and safety, rather than an "AI without human-in-the-loop" performance in a diagnostic sense.
7. The Type of Ground Truth Used:
For the ACCU-CHEK Spirit Combo Insulin Pump, the ground truth for accuracy of delivery rates, occlusion volume, and delay times would be established through laboratory measurements using precision instruments and calibrated test setups.
For the ACCU-CHEK Aviva Combo blood glucose monitor, "plasmalike results" are mentioned, suggesting a comparison of the device's glucose readings against a reference laboratory method (e.g., a highly accurate glucose analyzer).
8. The Sample Size for the Training Set:
This information is not provided in the given text. (Note: For medical devices like this, the concept of a "training set" in the machine learning sense isn't typically used. Instead, development and verification often involve extensive engineering testing and clinical validation.)
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the given text. (As mentioned above, the concept of a "training set" doesn't directly apply here in the AI context.)
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).