(104 days)
The VitaScan LT (aka. Scanmaster) is a B-mode ultrasonic instrument which projects ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder which is used to determine bladder volume non-invasively, on an intermittent basis. Bladder scanning measures ultrasonic reflections within a patient's body and differentiates the urinary bladder from the surrounding tissues. The intended use of the device, as defined by FDA guidance documents, is for Abdominal (adult and pediatric) applications.
VitaScan LT is applicable in many clinical areas to determine bladder volume, time for bladder emptying and detection of post void residual volume (PVR).
The VitaScan LT (aka. Scanmaster) is a hand held, B mode ultrasound scanner with a USB interface to a personal computer. This software controlled ultrasound system is used to acquire and display representations of the bladder, from which the bladder volume can be calculated. The system is intended to non-invasively monitor bladder volume on an intermittent basis which may be used to assist in the determination of time for bladder emptying and for the detection of post void residual volume (PVR).
The VitaScan LT (aka. Scanmaster) is a Track 1 System and meets the FDA's preammendment acoustic output limits for "fetal imaging and other" applications.
The VitaScan LT (aka. Scanmaster) is a 2.3 MHz mechanical sector scanner which operates only in the B mode to locate the bladder and automatically calculate the bladder volume. The ultrasonic power transmitted by the system is not user adjustable. Bladder Volume, Patient ID, Patient Name, Gender, Age and Hospital Name are displayed and stored on the personal computer application program provided with the VitaScan LT (aka. Scanmaster), which is connected to, and receives power through, the USB port of the personal computer.
VitaScan LT (aka. Scanmaster) is applied to the patient's abdomen, immediately superior to the patient's symphysis pubis with an ultrasound gel interface. The transducer collects cross-sectional images of the bladder from up to 24 scan planes and transmits the image information to the personal computer via the USB connection. Using this information, the VitaScan LT application program constructs a finite element model of the bladder and automatically computers the volume of the bladder via volumetric integration.
Here's a breakdown of the acceptance criteria and study information for the VitaScan LT (aka. Scanmaster) device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria for bladder volume measurement accuracy. Instead, it relies on demonstrating substantial equivalence to predicate devices which are already on the market and presumed to meet established standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate bladder scanners (Vesiscan, BladderScan™ BVI 6100, BVI 9400) regarding safety, effectiveness, and performance in non-invasive bladder volume measurement. | "All nonclinical testing demonstrated the subject device to be substantially equivalent to the predicate devices in terms of safety, effectiveness and performance." |
| "Clinical testing...demonstrated that the subject device is substantially equivalent to the predicate devices in terms of safety and effectiveness." | |
| "All testing demonstrated the VitaScan LT (aka. Scanmaster) is as safe, as effective, and performs as well as the legally marketed predicate devices." | |
| Accurate bladder volume calculation. | The device "automatically calculate the bladder volume" and "constructs a finite element model of the bladder and automatically computes the volume of the bladder via volumetric integration." Confirmation of operation and accuracy can be done using an optional phantom. |
| Compliance with acoustic output limits. | "The VitaScan LT (aka. Scanmaster) is a Track 1 System and meets the FDA's preammendment acoustic output limits for 'fetal imaging and other' applications." |
| Safety based on non-clinical and clinical testing. | "Non-clinical testing included acoustic output testing; thermal, mechanical and electrical safety testing; electromagnetic emissions and immunity testing; biocompatibility testing." |
| "No adverse effects or complications were noted" during clinical testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "Clinical testing of the subject device was performed on healthy volunteers." However, no specific number of volunteers (sample size) is provided.
- Data Provenance: The document does not specify the country of origin. The study was prospective as it involved "healthy volunteers" undergoing clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a ground truth for the clinical test set. The evaluation seems to be focused on comparing the device's performance to predicate devices and verifying safety and effectiveness, rather than establishing a new ground truth with expert consensus. The "ground truth" for non-clinical testing appears to be a "known volume contained within an optional phantom."
4. Adjudication Method for the Test Set
No adjudication method is mentioned or implied, as the study does not describe a process for reviewers to resolve disagreements on case interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not conducted. The device is a standalone system for volume calculation, not an AI-assisted tool meant to improve human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The device "automatically calculate the bladder volume" and "constructs a finite element model of the bladder and automatically computers the volume of the bladder via volumetric integration." This is an algorithm-only performance. The clinical testing likely validated the accuracy of this automated calculation.
7. The Type of Ground Truth Used
- For non-clinical testing: "a known volume contained within an optional phantom."
- For clinical testing: The document does not explicitly state how ground truth for bladder volume was established in "healthy volunteers." Given the nature of a bladder scanner, the implied ground truth would be comparison to a highly accurate reference method for bladder volume (e.g., catheterization or another validated imaging modality, though these are not specified). The core comparison is against predicate devices, implying their established performance serves as a benchmark rather than an independent "ground truth" for each subject.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This suggests the device's algorithm may have been developed using internal data not disclosed in this summary, or that it uses a model that doesn't explicitly refer to a "training set" in the context of this regulatory submission. Bladder scanners often rely on established physical principles and geometric models rather than large image-based machine learning training sets in the same way modern AI systems do.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided, no information on how its ground truth was established is available.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.