Search Results
Found 1 results
510(k) Data Aggregation
(111 days)
Control-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.
Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 6 years of age and greater.
Control-IQ technology is intended for single patient use and requires a prescription.
Control-IO technology is indicated for use with NovoLog or Humalog U-100 insulin.
The Control-IQ technology, is an interoperable automated glycemic controller. This is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated divcemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining qlycemic control.
The provided text is a 510(k) summary for Tandem Diabetes Care's Control-IQ technology. While it states that a clinical study was performed, it does not provide any specific acceptance criteria or detailed results of that study (e.g., specific metrics like mean glucose, time in range, or hypoglycemia rates). It only generically states that it "demonstrates that the device is safe and effective in the population evaluated (ages ≥ 6 and ≤ 13 years old)."
Therefore, I cannot fulfill all parts of your request with the given information. However, I can extract what is provided.
Here's a summary based on the provided text, highlighting the missing information:
Description of Acceptance Criteria and Proving Study
The provided 510(k) summary for the Control-IQ technology indicates that a clinical study was performed to assess the efficacy and safety of the device. However, the document does not explicitly state the specific acceptance criteria used for this study, nor does it provide detailed performance metrics or results from the study. It only makes a general statement about the device being safe and effective.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|
| Specific quantitative thresholds for glucose control, hypoglycemia, or other clinical outcomes were not provided in the document. | Specific quantitative results from the clinical study (e.g., mean HbA1c, time in range, standard deviation of glucose) were not provided in the document. |
| Safety endpoints (e.g., severe hypoglycemia, DKA rates) were not explicitly defined with thresholds. | General statement: "The study demonstrates that the device is safe and effective in the population evaluated (ages ≥ 6 and ≤ 13 years old)." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions a "randomized controlled trial" but does not specify the sample size of participants in this trial.
- Data Provenance: The document does not specify the country of origin of the data. It implies the study was prospective ("randomized controlled trial").
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Not applicable for this type of device. The "ground truth" for glycemic control in a clinical study is typically established by objective physiological measurements (e.g., CGM readings, lab glucose values) rather than expert review of images or medical records.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. Adjudication methods are typically used when there's subjective interpretation involved, such as in image-based diagnostics. For a glycemic control device, the primary "data" are objective glucose measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not relevant for this type of device (automated glycemic controller). These studies are typically used for diagnostic devices that involve human interpretation of medical images or other data. This device is an automated system designed to manage glucose levels directly.
6. Standalone Performance Study
- Yes, implicitly. The clinical study performed on the Control-IQ technology assessed the device's performance (efficacy and safety) as an automated system. While it interacts with an iCGM and an ACE pump, the "Control-IQ technology" itself is the algorithm and software component being evaluated for its standalone ability to manage glucose. The study evaluated its performance, not how it assists a human to perform a task.
7. Type of Ground Truth Used
- The ground truth for evaluating an automated glycemic controller in a clinical study would be based on physiological measurements such as:
- Continuous Glucose Monitoring (CGM) data
- Laboratory-confirmed blood glucose values
- Clinical outcomes data (e.g., episodes of hypoglycemia/hyperglycemia, hospitalizations, DKA events).
- The document does not explicitly state the specific ground truth metrics used, but these are standard for such studies.
8. Sample Size for the Training Set
- Not provided. The document does not mention the sample size or details of any training set used for developing or training the Control-IQ algorithm. It only refers to a "Clinical study" for validation.
9. How the Ground Truth for the Training Set Was Established
- Not provided. Since details about a training set are not mentioned, how its ground truth was established is also not available in this document.
Ask a specific question about this device
Page 1 of 1