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The CADD-Legacy™ pump is suitable for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space infusion.

The CADD-Legacy™ 1 Model 6400 ambulatory infusion pump is similar in design, function, and intended use to Deltec's CADD-1 " Ambulatory Infusion Pump and the CADD-Prizm® VIP Model 6100 Ambulatory Infusion System . The Model 6400 pump provides measured drug therapy for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space delivery to patients in hospital or outpatient settings. The pump is capable of storing one delivery application. The delivery application resident in the Model 6400 pump and the subject of this 510(k) Notification is the continuous delivery application.

The provided text describes the 510(k) submission for the CADD-Legacy™ 1 Model 6400 Ambulatory Infusion System. However, it does not include detailed acceptance criteria or a study designed to explicitly prove the device meets specific performance criteria in the way modern AI/ML device submissions typically do (e.g., using metrics like sensitivity, specificity, AUC).

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices (CADD-1® Ambulatory Infusion Pump and CADD-Prizm® VIP Model 6100 Ambulatory Infusion System) as per FDA 510(k) requirements from 1998. The "study" for this type of device at that time primarily involved functional testing and a comparison to already approved devices.

Here's an analysis based on the provided text, highlighting where information is absent due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

Missing specific quantitative acceptance criteria: The document does not provide specific numerical acceptance criteria (e.g., "infusion accuracy within X%," "flow rate deviation within Y ml/hr") that would typically be found in detailed engineering specifications or test reports. The assessment relies on a broader "functional equivalence" and the successful completion of internal functional testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not explicitly stated for performance testing. The "Functional Testing" section mentions "test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified." This implies internal testing was conducted, but details on the number of units tested or specific test cases are not provided.
• Data Provenance: Not applicable in the context of this 510(k) as the "studies" primarily consisted of functional/software testing and comparison to predicate devices, not clinical data collection from patient populations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is an ambulatory infusion pump, not an AI/ML-based diagnostic or prognostic tool that would require expert-established ground truth from medical images or patient records. The "ground truth" for functional testing would be the engineering specifications and expected operational behavior of the pump.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. As noted above, this kind of adjudication is relevant for expert-driven ground truth establishment in clinical studies, which were not conducted for this 510(k) due to it being a functional device rather than a diagnostic AI/ML system.

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

• No. An MRMC study is not relevant for this device. This is a standalone medical device (an infusion pump), not an AI-assisted diagnostic tool that would be used by human "readers" (e.g., radiologists interpreting images).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, in a sense. The "Functional Testing" described the testing of the pump's software-controlled functions and proper operation. This is inherently a standalone performance assessment of the device's functionality. The clinical studies were "not deemed necessary," further indicating the focus was on the device's inherent functional performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the "Functional Testing" would have been the device's design specifications, engineering requirements, and pre-established expected performance parameters for infusion delivery (e.g., flow rates, volumes, alarm conditions). This is based on engineering standards and the known behavior of similar predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The device is a hardware-based infusion pump with embedded software, not a machine learning algorithm trained on data.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for this type of device.

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