(165 days)
The Deltec Cozmo™ Insulin Infusion Pump (Model 1700) is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes.
The Deltec Cozmo™ 3-ml Cartridge is designed for use with the Deltec Cozmo™ Insulin Infusion Pump for Continuous Subcutaneous Insulin Infusion (CSII).
The Deltec Cozmo™ Treatment Assistant™ PC Communications System is designed for use with Deltec Cozmo™ Insulin Infusion Pump as a tool in optimizing diabetes management. It allows communications between the pump and a computer for accessing data stored in pump memory, and programming the pump.
The Deltec Cozmo™ Insulin Infusion Pump is a small, ambulatory, battery-powered, microprocessor controlled, external insulin syringe pump. Key features of the pump include: backlit liquid crystal display (LCD), 4-key keypad, separate audio bolus button, AAA-battery power source, waterproof, audible alarm option, vibratory alarm option, real time clock, belt-clip and interface, various basal and bolus delivery rates, stored memory, PC-downloading and programming capability, IR windows, 3-ml cartridge, cartridge cap and child-proof cartridge cap.
The Deltec Cozmo™ 3-ml Cartridge is a syringe style reservoir and is a proprietary design for use specifically with the Deltec Cozmo™ Insulin Infusion Pump. It is not compatible with other pumps. The 3-ml Cartridge is made of three separate pieces: barrel, plunger and rod. The barrel has an integral luer fitting on one end, volume markings, and a raised ring at the opposite end of the luer fitting that acts as a stop for the plunger. The plunger is conical in shape with a double o-ring seal design. The plunger and rod are detachable with a snap-fit design. The rod is removed from the plunger prior to cartridge insertion into the pump.
The Deltec Cozmo™ Treatment Assistant™ PC Communications System is a software program, which allows communications between a personal computer (PC) and an infusion pump. It allows for downloading of information from the pump to a PC and for programming of the pump via a PC. The "connection" between the pump and the PC is via infra-red (IR) windows on the back of the pump and the computer's IR port. A standard off-the-shelf IR cable connector for the PC may also be used if the user's computer does not have an integral IR port.
The provided text is for a 510(k) premarket notification for the Deltec Cozmo™ Insulin Infusion Pump and Accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing specific acceptance criteria and detailed study performance as would be seen in a clinical trial or a novel device submission. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement is not explicitly detailed in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) summary focuses on demonstrating functional similarity and safety through various types of testing, but it does not present a table of quantitative acceptance criteria for device performance (e.g., accuracy of insulin delivery within specific tolerances) and then report measured performance against those criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The document refers to "Functional Testing" which included "software validation, verification of software controlled programming functions, and software related to proper pump operation" for the pump and the PC Communications System, along with "In-vitro testing and biocompatibility testing" for the 3-ml Cartridge.
- Sample Size: The specific sample sizes for these tests are not disclosed.
- Data Provenance: The tests are described as "in-vitro testing" and "functional testing," implying they were conducted in a lab environment. The document does not mention human subject testing or data from specific countries of origin in this context. It's retrospective in the sense that the testing was completed before the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Given the nature of functional and in-vitro testing for an insulin pump, the "ground truth" would typically be established based on engineering specifications, regulatory standards, and established scientific principles for measuring device performance (e.g., fluid delivery accuracy, software functionality, material biocompatibility). These evaluations would be performed by qualified engineers, testers, and scientists, but the number and specific qualifications are not detailed here.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where independent reviewers assess outcomes. For functional and in-vitro testing, the assessment typically involves comparing test results against pre-defined specifications and pass/fail criteria, which is a different process than multi-expert adjudication.
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
- MRMC Study: No MRMC comparative effectiveness study was conducted or described.
- AI vs. Human Assistance: This device is an insulin infusion pump and associated software, not an AI-powered diagnostic or assistive technology for human 'readers'. Therefore, the concept of human readers improving with AI assistance is not applicable to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: The core components being tested are the insulin pump's mechanical and software functions, and the PC communication system's software functionality. These are inherently "standalone" in the sense that the device's accuracy and function are tested independently of a human user's direct intervention in that specific test setting (though the ultimate use involves human interaction).
- Details: The document states "Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified," and "In-vitro testing and biocompatibility testing was performed on the Deltec Cozmo™ 3-ml Cartridge." These represent standalone evaluations of the device components. However, specific performance metrics from these standalone tests are not provided.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc)
The "ground truth" for the various tests mentioned would be based on:
- Engineering Specifications/Standards: For functional testing (e.g., insulin delivery rates, alarm accuracy).
- Software Requirements Specifications: For software validation and verification.
- Biocompatibility Standards: For the cartridge (e.g., ISO 10993 series).
- Material Specifications: For the cartridge components.
The document does not refer to expert consensus from healthcare professionals, pathology, or outcomes data to establish ground truth for these tests. Clinical studies were "not deemed necessary."
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a mechanical/software medical device, not a machine learning or AI algorithm that requires a "training set" in the context of supervised learning to develop its functionality. Its design and operation are based on explicit programming and engineering principles rather than learned patterns from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of AI/ML for this device. The functionality of the pump and its software is designed and validated against engineering specifications and regulatory requirements.
§ 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).