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The Concert Medical Hands-Free Syringe (HFS) is indicated for general fluid irrigation/infiltration.

The Concert Medical Hands-Free Syringe (HFS) is an infiltration pump used to infuse fluids (such as regional anesthetics) into the body. The HFS consists of a sterile, single-use plastic syringe (20 mL capacity) fitted with a custom plunger, a reusable motor housing, and a reusable foot pedal. The user fills the syringe with the fluid of choice, then locks the filled syringe into the motor housing, where the specially designed syringe plunger rack mates with the custom plunger housing gear. The male luer fitting of a sterile, single-use needle set (not supplied by Concert Medical) is attached to the standard female luer fitting on the HFS syringe. The foot pedal connector is plugged into the receptacle on the motor housing, then the foot pedal is placed in a convenient location on the floor. The motor housing contains non-replaceable AAA batteries, which power a small DC motor which in turn controls the movement of the syringe plunger. The foot pedal consists of a color-coded rubber bar; when the user applies light foot pressure to the appropriate half of the foot pedal (green = infuse; yellow = aspirate), the motor activates the plunger movement mechanism to move the plunger forward (infuse) or backward (aspirate). The motor control is designed to deliver fluid at a maximum flow rate of 0.5 mL/sec. The motor is designed with an overpressure safety feature, which causes the plunger movement to stop if the pressure in the syringe exceeds 15 psi regardless of whether the "infuse" portion of the foot pedal is depressed. The motor housing has three LED indicator lights for real-time display of the syringe plunger action: a green light illuminates when the syringe is infusing, a yellow light illuminates when the syringe is aspirating, and a red light illuminates if the plunger movement has stopped because the 15 psi pressure limit has been reached. The foot pedal control provides the user with two-handed control of the needle placement without the need for a second person to manipulate the syringe plunger for infusion or aspiration.

Here's an analysis of the acceptance criteria and study information for the Concert Medical Hands-Free Syringe (HFS) based on the provided document:

This document does not describe an AI/ML device, therefore many of the requested fields (multi-reader multi-case study, standalone performance, training set details, ground truth for training) are not applicable. The device is a physical medical device (an infiltration pump).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table with specific acceptance criteria values alongside their corresponding reported performance values for each test. Instead, it offers a general statement that the device "met pre-determined acceptance criteria."

However, we can infer some criteria and performance from the "Device Description" and "Non-Clinical Performance Testing" sections:

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

The document does not specify the sample size for the non-clinical performance testing. It also does not mention data provenance in terms of country of origin or whether the study was retrospective or prospective, as these are typically considerations for clinical data, which is not described here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable as the "test set" here refers to physical performance testing of a medical device, not a diagnostic or AI/ML algorithm requiring expert-established ground truth from data. No experts were involved in establishing "ground truth" for pressure, flow rate, or electrical safety tests.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. Adjudication methods are typically used for reconciling disagreements among human readers or for establishing consensus ground truth in studies involving human interpretation, not for physical device performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that impact human reader performance. The Concert Medical HFS is a physical medical device (an infiltration pump), not a diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone study was not done. This concept applies to AI/ML algorithms, not physical devices. The device's performance is inherently linked to its physical operation, which is what was tested.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" would be established by:

• Measurement against objective physical standards: For flow rate, pressure, and electrical safety, the "ground truth" is derived from direct measurements using calibrated instruments and comparison to predefined engineering specifications and regulatory limits (e.g., 15 psi pressure limit, 0.5 mL/sec flow rate).
• Functional verification: For foot pedal and syringe plunger control, the "ground truth" is simply whether the device functions as designed (e.g., foot pedal depression leads to infusion/aspiration).

8. The Sample Size for the Training Set

This question is not applicable. The Concert Medical Hands-Free Syringe is a physical device, not an AI/ML system. Therefore, there is no "training set" in the context of machine learning.

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

This question is not applicable for the same reason as point 8.

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