Search Results

Device-Specific Indications for Use/Intended Use: This device is intended for use as part of the AirDrive system to facilitate diagnostic and image guided procedures including under fluoroscopy, X-ray, CT, MR, other imaging procedures, and other procedures involving transfer of a patient.

System Indications for Use/Intended Use: The Qfix® Symphony Patient Transport System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI; and external beam radiation therapy treatment with electrons, photons; and other procedures requiring transfer of a patient. The Symphony is designed to interface with other positioning devices, such as couchtops, inserts, thermoplastic masks, and positioning pads.

Qfix has made a modification to its previously cleared Symphony Patient Transport System (cleared in K160627). This modification introduces a new transfer device variant compatible with the Symphony Patient Transport System – the Iris AirShuttle is designed to be used with an AirDrive source, such as the AirDrive Trolley or AirDrive Caddie, to provide a solution for a complete patient transport system. With the Iris AirShuttle, the system is capable of being used in multimodal imaging and treatment environments, including interventional radiology procedures and workflows involving fluoroscopy, angiography, and magnetic resonance imaging. To facilitate these workflows, user configurable accessory rails have been added to the design, allowing easy transfer of essential railmounted equipment with the patient. Additionally, the Iris AirShuttle allows for patient transfer on soft and hard surfaces. Device pads have been included in the modification to maximize patient comfort while minimizing the distance between the patient and the spine coil of MR machines for optimal image quality. Alternative integrated transfer handles have also been included to allow for transfers with or without air power and without installation of the removable transfer handles. Qfix intends to market the subject device for use with the AirDrive Trolley and the AirDrive Caddie. This creates an improved efficient workflow while reducing the risk of injuries related to manually lifting patients for transport in various treatment environments, including multimodal imaging and treatment workflows involving fluoroscopy, angiography, and magnetic resonance imaging.

The Iris AirShuttle is a modification to the previously cleared Symphony Patient Transport System (K160627). It's designed to be used with an AirDrive source (like an AirDrive Trolley or Caddie) to facilitate patient transfer in various medical environments, including multimodal imaging (fluoroscopy, X-ray, CT, MR, angiography) and external beam radiation therapy.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify explicit sample sizes for the "test set" in terms of patient data or a particular number of units tested for all performance aspects.
• The studies were described as "bench testing and analysis," "analysis of mechanical components," "verification of MRI compatibility," and "radiographic property analysis."
• "Usability studies" were conducted, but the number of participants or duration is not stated.
• Data Provenance: The studies were conducted by the manufacturer (Qfix) as part of their verification and validation processes. No mention of data provenance in terms of country of origin or retrospective/prospective clinical data is relevant, as no clinical studies were performed.

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

• This information is not provided as no clinical studies were performed that would typically require expert ground truth establishment for a test set. The performance validation relies on engineering and physical testing, and usability assessments. The intended users are healthcare professionals, but they weren't necessarily establishing ground truth for a diagnostic task.

4. Adjudication Method for the Test Set

• This information is not applicable as no clinical studies were performed that would involve adjudication of a test set.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical or animal studies were completed to support the subject device and substantial equivalence argument." Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.

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

• Not applicable. The Iris AirShuttle is a patient transport device, not an AI or algorithm-based device. Its performance is assessed through physical, mechanical, and usability testing, not algorithmic performance.

7. The Type of Ground Truth Used

• For the physical and functional aspects of the device, the "ground truth" was established by engineering specifications, recognized physical standards (e.g., ASTM F2503-20 for MR compatibility, ISO 14971:2019 for risk management), and validated mechanical test methods.
• For usability, "ground truth" typically comes from user feedback and observations during usability studies, measured against predefined usability criteria.

8. The Sample Size for the Training Set

• Not applicable. The Iris AirShuttle is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense.

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

• Not applicable. As a physical device, there is no training set. Design and manufacturing adhere to established engineering principles, material science, and quality system regulations (e.g., CFR 21 Part 820) and standards (e.g., ISO 14971), which form the basis for its development and "ground truth" adherence to specifications.

Ask a specific question about this device