(24 days)
The BladderScan® Prime system is an ultrasound device intended to be used for measuring the urine in the bladder non-invasively.
The BladderScan" Prime system instrument provides noninvasive measurement of urinary bladder volume. The instrument calculates the bladder volume using patented NeuralHarmonics technology, which is easy to use and comfortable for the patient. Volume measurements made with NeuralHarmonics are accurate than those from conventional two-dimensional ultrasound as they are based on a more complex, three-dimensional image of the bladder.
Bladder volume, mode (male, female and small child), directional aiming with real-time feedback, battery status and usage rate indicators are displayed on the LCD display. The system also includes a battery charger for custom, user-replaceable lithium-ion batteries included with the system,
The provided text is a 510(k) summary for the BladderScan® Prime System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (BladderScan® BVI 9400), rather than outlining a standalone clinical study with detailed acceptance criteria and performance data for a new device's accuracy against a ground truth.
Therefore, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an accuracy study (e.g., against a ground truth). It primarily details the technological characteristics, intended use, and safety standards compliance to show equivalence.
However, it does provide one quantitative metric which can be interpreted as an acceptance criterion for measurement accuracy based on the predicate device's performance.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate) | Reported Device Performance (BladderScan® Prime) |
|---|---|
| Measurement Accuracy: ± 15% ± 15mL | Measurement Accuracy: ± 15% ± 15mL |
| Measurement Range: 0 to 999 mL | Measurement Range: 0 to 999 mL |
Note: The document states that the proposed device (BladderScan® Prime) intends to meet the same accuracy and range specifications as the predicate. It does not provide new, independent study results to prove this for the BladderScan® Prime specifically. It relies on the assertion that "The BladderScan® Prime system and BladderScan® BVI 9400 system are both Track 1 devices that employ the same fundamental technology." implying similar performance.
Missing Information (not found in the provided text):
- 2. Sample size used for the test set and the data provenance: Not mentioned. The document primarily discusses comparisons of technical specifications and safety standards, not a specific clinical test set for accuracy.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as a clinical accuracy study with ground truth establishment is not described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 ultrasound system for measuring bladder volume, not an AI-assisted diagnostic imaging device for human reader improvement studies.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is an algorithm for calculating bladder volume from ultrasound data. Its performance is stated to be "± 15% ± 15mL", but no specific study demonstrating this standalone performance for the Prime system is detailed. It is inherited from the predicate.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not detailed. For bladder volume measurement, the gold standard for ground truth often involves catheterization or direct measurement during surgery, but no such method is described for validating the new device. The document implies that the "NeuralHarmonics technology" provides a more complex, three-dimensional image of the bladder, leading to more accurate volume measurements, but it doesn't describe the validation process.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device in the modern sense that learns from a training set. It's an ultrasound device applying a specific calculation algorithm.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.