(150 days)
The BladderManager PCI 5000 and BladderScan BVI 5000 "project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder that is used to determine bladder volume non-invasively."
The BladderManager PCI 5000 is a portable, battery-powered ultrasound instrument designed for a patient to non-invasively monitor his or her bladder volume on an intermittent basis. The BladderScan BVI 5000 is similar, except that it is designed for use by the clinician with the added feature of a "docking cradle" containing an onboard computer that provides a hard copy printout of the scan images and the bladder volume.
The provided text describes the BladderManager PCI 5000 and the BladderScan BVI 5000 and their substantial equivalence to a predicate device (BladderScan BVI 2500). However, it does not explicitly state numerical acceptance criteria or detail a specific study proving those criteria are met for the new devices. Instead, it relies on demonstrating substantial equivalence to a previously cleared device.
While the document generally states safety and effectiveness, it doesn't provide the level of detail requested for a comprehensive acceptance criteria and study report.
Here's an attempt to extract and synthesize the information based on the provided text, while also highlighting what is not present:
1. A table of acceptance criteria and the reported device performance
No explicit numerical acceptance criteria are provided in the document. The performance is reported in terms of "substantial equivalence" to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device operates without significant adverse effects or complications. | "No significant adverse effects or complications were noted." (Both preliminary and clinical testing) |
| Effectiveness: Bladder volume measurements are comparable to the predicate device. | "demonstrated that the subject devices are substantially equivalent to the predicate device in terms of effectiveness." (Both preliminary and clinical testing) |
| Performance: Device functions as intended. | "All non-clinical testing demonstrated that the subject devices are substantially equivalent to the predicate device in terms of safety, effectiveness, and performance." |
2. Sample size used for the test set and the data provenance
- Preliminary Clinical Testing: "adult ambulatory volunteers."
- Sample Size: Not specified.
- Provenance: Not specified (e.g., country of origin). Likely prospective, as it's described as "preliminary clinical testing."
- Clinical Testing (BladderManager PCI 5000): "adult spinal cord diseased patients, as well as healthy volunteers."
- Sample Size: Not specified.
- Provenance: Performed at "three independent clinical sites." Geographical location not specified. Likely prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The document primarily focuses on comparison with a predicate device rather than establishing a new ground truth via expert consensus for this specific submission. The "ground truth" for the test set would effectively be the measurements obtained from the predicate device or a reference method of bladder volume measurement, but this is not explicitly detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified.
5. 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
Not applicable. This device is an ultrasonic bladder volume instrument, not an AI-assisted diagnostic tool for human readers. There is no mention of "human readers" or "AI assistance" in the context of improving diagnostic effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The devices (BladderManager PCI 5000 and BladderScan BVI 5000) are standalone ultrasonic instruments designed for direct measurement by a user (patient or clinician). The performance data refers to the accuracy and reliability of these devices compared to a predicate, not an algorithm's performance in isolation from the device operation. So, in a sense, the clinical testing assesses the device's standalone performance in measuring bladder volume.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document implies that the comparison was made against the measurements obtained from the predicate device (BladderScan BVI 2500), which would serve as the de-facto "ground truth" or reference for establishing substantial equivalence in terms of effectiveness/accuracy. There is no mention of other direct ground truth methods like catheterization for volume measurement, which is a common gold standard for bladder volume, but the reliance on substantial equivalence to the BVI 2500 suggests that the BVI 2500's accuracy/validity was previously accepted.
8. The sample size for the training set
Not applicable. These are medical devices, not machine learning algorithms that require a specific "training set" in the computational sense. The "development" or "design" of the device would involve engineering principles and calibration, not AI training data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the AI sense.
§ 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.