(142 days)
The Pearl™ Diabetes Management System is intended for continuous, subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.
The Pearl™ Diabetes Management System is a continuous, programmable insulin delivery system. It consists of a controller, a single use pump body and an infusion set adapter. The controller unit has a user interface to program delivery parameters for basal and bolus insulin delivery. It attaches to the pump body. The pump body provides the drive mechanism and battery power and holds the pre-filled insulin cartridges. The infusion set adapter is the conduit from the insulin cartridge to the final delivery tubing.
The document provided does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets those criteria.
However, based on the available text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document mentions several tests performed, but it does not list specific quantitative acceptance criteria or detailed results. It generally states that the system "performs reliably and delivers insulin as intended" and "design verification testing confirmed that no new questions of safety or effectiveness were identified."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Insulin delivery accuracy | "The system performs reliably and delivers insulin as intended." |
| Altitude and altitude shock resistance | Verified and found acceptable (no specific metrics provided). |
| Free fall resistance | Verified and found acceptable (no specific metrics provided). |
| Liquid ingress protection | Verified and found acceptable (no specific metrics provided). |
| Positive and negative elevation performance | Verified and found acceptable (no specific metrics provided). |
| System occlusion detection/performance | Verified and found acceptable (no specific metrics provided). |
| Software validation | Verified and found acceptable (no specific metrics provided). |
| Overall safety and effectiveness | "No new questions of safety or effectiveness were identified." |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified. The document only states "the major tests that were performed on the Pearl Pump System to support the modifications." It does not provide the number of devices or data points used in these tests.
- Data Provenance: Not specified. It does not mention the country of origin or if the study was retrospective or prospective. Given it is a device modification, the testing would typically be internal "design verification testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the "Pearl™ Diabetes Management System" is an insulin infusion pump, a hardware device, not an AI/ML-based diagnostic or prognostic tool that would require expert-established ground truth for a test set in the same manner. The "ground truth" for this device would be its physical and software performance against engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable for this type of medical device as it's not a diagnostic system requiring human expert adjudication of results.
5. 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:
This is not applicable. The Pearl™ Diabetes Management System is an insulin pump, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable in the context of AI/ML algorithm performance. The device itself (the pump) operates in a standalone manner to deliver insulin based on programmed parameters, but this is not an "algorithm-only" performance study in the AI sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance would be derived from engineering specifications, established performance standards (e.g., for accuracy, occlusion detection), and regulatory requirements for insulin infusion pumps. The document explicitly mentions "assure conformance to the requirements for its intended use" and "design verification testing confirmed that no new questions of safety or effectiveness were identified."
8. The sample size for the training set:
This is not applicable. The Pearl™ Diabetes Management System is not an AI/ML device that uses a "training set" in the conventional machine learning sense. Its functionality is based on pre-programmed logic and mechanical engineering, not learned from data.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above for question #8.
§ 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).