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The Elite Biomedical Solutions Dose Request Cord is an accessory for a syringe pump and may be used in the same environment as the corresponding pump. The healthcare worker connects the device to the pump. The patient uses the switch on the cable to signal the syringe pump to deliver medication consistent with the parameters entered into the pump by the healthcare worker. The Elite Biomedical Solutions Dose Request Cord is a non-sterile, reusable device intended for multi-patient use in adult and adolescent (over 12 years of age) population.

Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris PCA Pump Model 8120 syringe infusion pump. Elite Biomedical Solutions does not manufacture the pump. The Dose Request Cord is an accessory for the pump and is available as a replacement part. The Dose Request Cord contains a handpiece with integral cable which plugs into the mating connector on the BD Alaris PCA Pump to allow the patient to request medication within the parameters entered into the syringe/infusion pump by the healthcare provider and the designed limits on the pumps. The Elite Biomedical Solutions Dose Request Cord has the same type of construction and technological characteristics as the predicate device, which is also a replacement bolus cable. Both the subject and predicate device are equivalent to the accessories supplied with the original pump. The Dose Request Cords are passive devices that contain no powered electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device.

The provided document describes the Elite Biomedical Solutions Dose Request Cord, an accessory for a syringe pump. The submission focuses on demonstrating substantial equivalence to a predicate device, the American IV Patient Pendant Bolus Cable (K120209), rather than presenting a study where a device's performance is measured against specific acceptance criteria in the context of improving human reader performance with AI.

Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML device submissions) are not applicable or cannot be extracted from this document.

However, I can provide information based on the available performance data for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

This document describes non-clinical performance testing for a medical device accessory (a cable), not an AI/ML diagnostic system. Therefore, concepts like "test set" in the context of clinical data are not directly applicable.

• Sample Size for Test Set: Not specified in terms of patient data. The non-clinical testing likely involved a specific number of manufactured units of the Dose Request Cord, though this number is not detailed in the summary.
• Data Provenance: The data is from non-clinical laboratory testing performed by Elite Biomedical Solutions to verify the device's functional and safety characteristics. Country of origin for the testing is not specified but is implicitly tied to the submitter (Elite Biomedical Solutions, Cincinnati, Ohio, USA). This testing is prospective as it was performed specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" for this device is its physical integrity and functional performance (e.g., button press accurately signals the pump, cable withstands a pull test, electrical insulation is sufficient). This is established through engineering and laboratory testing against established specifications and standards, not through expert consensus on medical images or patient outcomes.

4. Adjudication Method

Not applicable. This is not an AI/ML diagnostic device requiring adjudication of clinical data. Testing involved objective measurements and validations against predetermined engineering and functional specifications.

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

No. This is a physical medical device accessory (cable), not an AI-powered diagnostic tool. Therefore, an MRMC study and the concept of human readers improving with or without AI assistance are not applicable.

6. Standalone Performance

Yes, in the sense of the device's intrinsic function. Non-clinical performance testing was conducted on the Dose Request Cord itself (and in conjunction with the compatible pump to verify its signaling function). The testing demonstrated that the device "performs as intended." The performance involves:

• Delivering a dose when the activation button is pressed.
• Not delivering a dose when the button is not pressed.
• Meeting construction, operational, cleaning, disinfection, and safety specifications.
• The accuracy of the dose itself being determined by the associated syringe infusion pump, confirming the cable's role as an accurate signaling accessory rather than a dosing mechanism.

7. Type of Ground Truth Used

The ground truth used for non-clinical testing comprises:

• Engineering Specifications: Design documents detailing required electrical, mechanical, and safety characteristics (e.g., cable length, operating voltage, double insulation).
• Functional Requirements: Specifications for how the device should operate (e.g., button press triggers signal, no signal when button not pressed).
• Test Standards: Compliance with relevant industry and regulatory standards for medical device accessories (e.g., IPX water intrusion, cleaning/disinfection validation methods).

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth for such a set.

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