(238 days)
MD-6000P Bladder Scanner is intended to measure the urine volume in human bladder.
The device is intended to be used in medical and nursing care institutions. It should be operated by trained professionals. The device is not intended for use on pregnant women. It cannot be used on wounded skin.
MD-6000P Bladder Scanner is a hand-held device which utilizes ultrasonic distance measuring principle to calculate urine volume in the bladder.
The device takes mechanical sector scan by 2.5MHz ultrasonic waves and recognizes the reflected waves of the front and back walls of bladder to get the area of bladder section; then it makes 12 scans at an interval of 15° and calculates the urine volume in human bladder with volume integral algorithm.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| Measurement accuracy of ±15% or ±15ml within the measurement range of 20-999ml (for 100-999ml range) | Met the requirements of ±15% |
| Measurement accuracy of ±15% or ±15ml within the measurement range of 20-999ml (for 20-100ml range) | Met the requirements of ±15ml |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench testing for accuracy using a phantom and a water sac. It does not specify a "test set" in the context of human subjects or a clinical study.
- Test Set Sample Size: Not explicitly stated as a number of measurements, but refers to "scan on the phantom" and "scan on the test object of water sac with known volume." This implies a series of measurements were performed.
- Data Provenance: The document does not provide information on data provenance (e.g., country of origin, retrospective/prospective) for these bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The ground truth for the bench tests was established by "nominal value" for the phantom and "known volume" for the water sac.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Ground truth was based on physical properties (nominal value, known volume) rather than expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document states: "The MD-6000P Bladder Scanner, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: The accuracy reported (±15% or ±15ml) is from bench testing of the device's measurement capabilities. This can be considered a standalone performance assessment in the sense that it evaluates the device's ability to measure a known volume without a human interpreter influencing the measurement outcome. However, it's not "algorithm-only" performance in the context of AI, as this is a physical measurement device.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the bench testing, the ground truth was based on:
- Nominal value (for the phantom in the 100-999ml range).
- Known volume (for the water sac in the 20-100ml range).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The document describes a medical device (bladder scanner) that utilizes ultrasonic distance measuring principles and a volume integral algorithm. It does not mention any machine learning or AI components that would require a "training set" in the conventional sense. The "algorithm" here refers to a deterministic calculation method, not a learned model.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set or a machine learning algorithm.
§ 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.