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CamAPS FX is a mobile app intended for managing glucose levels in people with type 1 diabetes, aged 2 years and over, using a hybrid closed loop approach (automated basal insulin delivery with manual bolusing for meals). Additional age and other restrictions may apply depending on the chosen continuous glucose monitor and insulin pump.

CamAPS FX requires an insulin pump and a continuous glucose monitor (CGM) to fulfil its intended use. The list of supported insulin pumps and CGMs is provided in the User Manual.

CamAPS FX is indicated for use in pregnancy complicated by type 1 diabetes provided that the linked continuous glucose monitoring system is suitable for use in pregnancy.

CamAPS FX is for prescription use only.

CamAPS FX is a mobile app.

This FDA 510(k) clearance letter (K232603) for the CamAPS FX device does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a more comprehensive summary of safety and effectiveness.

The document primarily focuses on the regulatory clearance of the device, stating that it is substantially equivalent to legally marketed predicate devices and outlining the indications for use. It details regulatory compliance aspects such as general controls, special controls, the Quality System regulation, and reporting requirements.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, one would need access to the full 510(k) submission, including the performance data and clinical study summaries.

Based on the provided text, the answer to all your questions about acceptance criteria and the study that proves the device meets them would be: "Information not available in the provided document."

The document mentions:

• Device Name: CamAPS FX
• Regulation Number/Name: 21 CFR 862.1356, Interoperable automated glycemic controller
• Regulatory Class: Class II
• Indications for Use: Managing glucose levels in people with type 1 diabetes, aged 2 years and over, using a hybrid closed loop approach (automated basal insulin delivery with manual bolusing for meals). Also indicated for use in pregnancy complicated by type 1 diabetes, provided the linked CGM is suitable. Requires an insulin pump and CGM. Prescription use only.

However, it does not provide any details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case comparative effectiveness study results or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How training set ground truth was established.

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