(164 days)
The portable CD4, CD4/20 infusion devices have been designed only for use in subcutaneous infusion of prescribed liquid medicines.
This infusion device has been manufactured since 1978 and has, during all this time, proved to be highly reliable in terms of sturdiness, reliability, accuracy and easy operation. Moreover, it does not require particular maintenance work. Microjet CD4 is a portable, battery-operated infusion device for use with 5 ml and 10 ml syringes (20 ml syringes are used with model CD4/20). A special micromotor actuates mechanical members that transform the motor rotary motion into the pusher linear motion which, in turn, causes the syringe piston to advance. The infusion device operating features enable to make infusions with varying amounts of medicine and different infusion times. During infusion, the motor is controlled by a special electronic circuit with regular pulses; therefore, infusion is carried out by delivering small amounts of medicine repeated with the passing of time.
The provided text describes a 510(k) summary for the Microjet CD4, CD4/20 Ambulatory Infusion Pump. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device for market clearance.
Therefore, most of the requested information regarding AI/ML device performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not present in the provided document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device's characteristics and compares them to a predicate device, but it does not specify quantitative acceptance criteria or performance metrics in the way one would for an AI/ML system (e.g., sensitivity, specificity, AUC).
Instead, the "performance" is implicitly deemed acceptable by demonstrating substantial equivalence to a legally marketed predicate device. The characteristics compared are:
| Characteristic | Cadd-Legacy 1 (Predicate) | Microjet CD4, CD4/20 (New Device) |
|---|---|---|
| Intended Use | Intravenous, Intra-arterial, Subcutaneous, Intraperitoneal, Epidural, Intrathecal | Subcutaneous only |
| Physical characteristics: | ||
| Power Source | 2 AA alkaline batteries, AC Adapter | 9 volt Alkaline battery |
| Size | 4.4 x 3.8 x 1.6 in (112x 95x41 mm) | 170 x 70 x 20 mm |
| Weight | 13.8 oz (392 grams) | Approximately 220 g (including alkaline battery) |
| Capacity | 10 ml | Disposable 5 ml or 10 ml syringes (CD4/20 model accommodates 20 ml syringes) |
| Warranty | 1 year | SAME |
The "study" that proves the device meets acceptance criteria is described as "bench, EMC, and user testing," which concluded that the new device is "as safe and effective as the predicate device" and has "few technological differences."
Missing Information (Relevant to AI/ML Performance):
- Specific quantitative acceptance criteria (e.g., accuracy, precision, recall) for AI/ML performance.
- Reported device performance against such criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "bench, EMC, and user testing" but does not quantify the number of units or users involved in these tests.
- Data Provenance: Not specified, other than it being part of internal testing by CANÈ S.r.l. (Italy).
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this type of device submission. Ground truth, in this context, would relate to the physical and functional performance of the infusion pump itself, not diagnostic interpretations by experts.
4. Adjudication method for the test set:
- Not applicable.
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:
- Not applicable. This is not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a standalone medical device (infusion pump), not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device would be established through engineering specifications, laboratory measurements for accuracy and reliability, and possibly usability assessments during user testing. The document refers to "bench, EMC, and user testing data" to support its claims of safety and effectiveness, implying these physical and functional validations served as the basis for comparison.
8. The sample size for the training set:
- Not applicable. This device does not use an AI/ML training set.
9. How the ground truth for the training set was established:
- Not applicable. This device does not use an AI/ML training set.
§ 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).