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The CADD® -Solis Ambulatory Infusion Pump, Model 2110, Version 3.0, is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled demand doses.

The CADD™-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis VIP Ambulatory Infusion Pump, CADD®-Solis Ambulatory Infusion Pump, or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The CADD™-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD™-Solis Medication Safety Software - Administrator to the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The CADD® -Solis Ambulatory Infusion Pump, Model 2110, Version 3.0 ("CADD"-Solis Version 3.0 Pump") has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump, Version 1.0 (K072144) and CADD -Solis VIP Ambulatory Infusion Pump, Version 2.0 (K111275). The user activates CADD® Solis Version 3.0 Pump via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory.

The CADD®-Solis Version 3.0 Pump consists of components, such as the user interface, sensors, communication ports, power ports, structural (housing) components, electronics, pumping mechanism, watchdog timer, pump battery and circuitry, real time clock, onboard memory, and pump log. The CADD® Solis Version 3.0 Pump exterior surface components include the pump housing, LCD lens, labels, and keypad, and the materials of construction for these components are widely used in the medical industry. The CADD -Solis Version 3.0 Pump is designed to be used with a CADD® Infusion Disposable, such as Medication Cassette Reservoir.

The CADD™-Solis Medication Safety Software System consists of the Administrator and the Point of Care software applications. This software allows the user to create therapy-based protocol libraries to be used with the CADD®-Solis Ambulatory Infusion Pump, or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The provided text describes the CADD®-Solis Ambulatory Infusion Pump, Model 2110, Version 3.0, and the CADD™-Solis Medication Safety Software, Version 3.1. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study with reported performance metrics.

Here's a breakdown of the requested information based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" or provide "reported device performance" against those criteria in a table format. Instead, it relies on demonstrating equivalence through design verification, software validation, and human-factors engineering studies, concluding that "All testing met pre-established specifications."

Instead of a typical acceptance criteria table for a diagnostic device, the document presents a comparison table between the new device and predicate devices for various characteristics and infusion specifications. This table essentially defines the design and functional characteristics that were evaluated for equivalence.

Since direct "acceptance criteria" and "reported performance" like sensitivity/specificity for a medical device are not specified for this infusion pump and software, I cannot create that table. However, I can infer from the comparison tables that the acceptance for this 510(k) submission primarily involved demonstrating that the new device's characteristics and performance are comparable to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of a clinical study or a dataset for evaluating an AI algorithm. The testing described is "design verification and software validation testing" and "human-factors engineering studies."

• Sample Size: Not applicable/not provided for a "test set" in the context of clinical performance evaluation. The testing would have involved engineering and software quality assurance methods.
• Data Provenance: Not applicable/not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is typically relevant for studies validating diagnostic algorithms or interpretations. For an infusion pump and its associated software, "ground truth" would be established through engineering specifications, regulatory standards, and functional testing protocols rather than expert consensus on medical findings.

• Number of Experts: Not applicable/not provided.
• Qualifications of Experts: Not applicable/not provided.

4. Adjudication Method

This is also typically relevant for studies involving human interpretation. For design verification and software validation of an infusion pump and software, adjudication methods (like 2+1, 3+1) are not typically used. Testing outcomes are usually determined by passing or failing pre-defined engineering and functional requirements.

• Adjudication Method: Not applicable/not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. The document explicitly states: "Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the CADD®-Solis Version 3.0 Pump. CADD™ Solis Medication Safety Software-Administrator and POC."
• Effect Size with AI vs. without AI assistance: Not applicable, as there was no MRMC study and the devices are an infusion pump and its safety software, not an AI diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: Yes, in a sense, as design verification and software validation would assess the device's inherent performance capabilities without direct human-in-the-loop performance measurement against a clinical outcome. However, this is not in the context of an "algorithm" in the way it's usually asked for AI diagnostic devices. The performance testing was of the "algorithm" of the pump's operating system and the software's functionality. The "Testing Conclusion" states: "All testing met pre-established specifications, and successfully demonstrated that the devices performed as intended."

7. Type of Ground Truth Used

The "ground truth" for this type of device would be based on:

• Engineering Specifications: Pre-defined functional requirements and performance parameters for mechanical, electronic, and software components.
• Regulatory Standards: Compliance with relevant national and international medical device standards.
• Functional Testing Protocols: Measured outputs and behaviors of the pump and software across various operating conditions.

8. Sample Size for the Training Set

This product is not described as an AI/ML device that requires a "training set" in the conventional sense (e.g., for image classification or prediction tasks). Therefore:

• Sample Size for Training Set: Not applicable/not provided.

9. How Ground Truth for the Training Set was Established

As this is not an AI/ML device requiring a training set with medical "ground truth":

• How Ground Truth for Training Set was Established: Not applicable/not provided.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The study described is a combination of:

• Design Verification and Software Validation Testing: This rigorously evaluated the CADD®-Solis Version 3.0 Pump and the CADD™-Solis Medication Safety Software-Administrator and Point of Care against pre-established engineering specifications and software requirements. This type of testing ensures that the device and software function as intended and meet all design inputs.
• Human-Factors Engineering Studies: These studies assessed the usability and user interface of the device and software, ensuring that they can be operated safely and effectively by users.
• Substantial Equivalence Comparison: The submission primarily relies on demonstrating that the new devices are substantially equivalent to previously cleared predicate devices (CADD®-Solis Ambulatory Infusion Pump, Models 2100/2110 Version 1.0, and CADD®-Solis VIP Ambulatory Infusion Pump, Model 2120 Version 2.0; and CADD™-Solis Medication Safety Software Versions 1.2 and 2.0). The detailed comparison tables (pages 4-8 and 9-10 of the original document) highlight the similarities in intended use, technological characteristics, and performance features between the new and predicate devices.

The "Testing Conclusion" states: "All testing met pre-established specifications, and successfully demonstrated that the devices performed as intended. The testing results allowed for a conclusion to be made that the CADD® -Solis Version 3.0 Pump, and CADD™ Solis Medication Safety Software-Administrator and POC were as safe and effective as the predicate devices."

This indicates that the "acceptance criteria" were essentially the fulfillment of all design and software requirements and the demonstration of substantial equivalence to predicate devices through comprehensive non-clinical testing. No clinical studies were deemed necessary.

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