Search Results

The XPRESSE Assist Device is a syringe assist device intended for use in the administration of sterile materials under aseptic conditions in accordance with the best judgment of the clinician.

The XPRESSE Assist Device is a non-sterile, air/gas-powered device that is used to assist the clinician in dispensing the contents of a prefilled piston syringe into the body. The clinician connects the XPRESSE Assist Device to the desired syringe, and uses the foot pedal to activate the XPRESSE Assist Device. When activated by the foot pedal, the XPRESSE Assist Device allows flow of compressed air/gas, which pushes the syringe plunger forward, dispensing the syringe contents. The XPRESSE Assist Device is compatible with standard glass or plastic barrel syringes.

The XPRESSE Assist Device includes the following components:

• a controller to provide regulated, compressed air/gas to a syringe (syringe not a part of this device),
• a foot switch connecting to the control unit for clinician activation of the system, and
• a disposable adaptor and tubing unit, with integral plastic tube connecting the controller to the desired syringe.

The controller includes an electrically-powered LED display to indicate system pressure settings and to allow activation/inactivation of the foot pedal. Pressure is adjustable by the clinician from 0 to 100 psi using the controller knob located on the front face plate of the controller. The XPRESSE Assist Device is compatible with either a compressed air canister (45-gram CO2) or facility compressed air.

Here's an analysis of the provided 510(k) summary regarding the XPRESSE Assist Device, focusing on acceptance criteria and supporting studies:

This summary is for a medical device that assists in administering materials via a syringe (a hardware device), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested criteria (e.g., number of experts for ground truth, sample size for training data, MRMC studies) are not applicable to this type of submission. The device falls under Class II with product code FMF (Piston Syringe).

The core of its clearance is establishing substantial equivalence to predicate devices, focusing on safety and performance as a hardware accessory.

Acceptance Criteria and Reported Device Performance

Given that this is a hardware device focused on assisting manual injection, the "acceptance criteria" are interpreted as compliance with relevant medical device standards and demonstrating performance equivalent or superior to the predicate devices in terms of force application and control.

Study Information

1. Sample size used for the test set and the data provenance:

   • The document does not specify a "test set" in the context of diagnostic or predictive AI. The testing described is performance testing for a hardware device.
   • The "test data" referred to are from verification and validation (V&V) activities, including electrical, EMC, shelf life, environmental, and shipping tests, and demonstrations of force application.
   • Provenance: This is not explicitly stated. Typically, such V&V testing would be conducted in a laboratory or engineering environment.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is a hardware device. Ground truth, in the AI/SaMD sense, is not relevant here. The "ground truth" for the device's function is its ability to apply force in a controlled manner, which is evaluated through engineering and performance testing against specifications and standards, not through expert consensus on images or clinical data.

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

   • Not applicable. This is a hardware device. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic AI, neither of which applies here.

4. 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. This is a hardware device. MRMC studies are used for evaluating diagnostic performance, particularly with AI assistance for human readers, which is not relevant to this product.

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

   • Not applicable. This device is an assist device and inherently designed to be used with a human clinician. It is not an algorithm, and the concept of "standalone" performance for an algorithm doesn't apply. Its function is to aid the human in an existing task.

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

   • Not applicable in the AI/SaMD sense. The "ground truth" for this device's performance is its adherence to engineering specifications, safety standards, and its ability to consistently apply force as measured by instruments. The claim of "more uniform manner and with less overall pressure, allowing greater control" would have been substantiated by measurable physical parameters (e.g., pressure sensors, force gauges, consistency metrics), rather than clinical outcomes or expert consensus on clinical data.

7. The sample size for the training set:

   • Not applicable. This is a hardware device, not an AI/machine learning model. There is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.

Ask a specific question about this device