(136 days)
MD-6000 Bladder Scanner is a portable battery-operated ultrasonic equipment of pulse reflection. It is intended to measure the volume of bladder filled with urine.
The MD-6000 is intended to be used only by qualified medical professionals. Contraindications for the MD-6000 are fetal use and use on pregnant patients.
MD-6000 Bladder Scanner is a portable battery-operated ultrasonic equipment of pulse reflection. It utilizes ultrasonic distance measuring principle to calculate the bladder volume.
It makes mechanical sector scan by 2.5MHz ultrasonic wave and recognizes the reflected wave of the front and back wall of bladder to get the area information of bladder section. It calculates the volume of bladder by volume integral algorithm on the basis of the area information of 12 reference planes which are changed automatically with an interval of 15°.
MD-6000 Bladder Scanner has a Pre-Scan function, which shows the real-time B mode image for sectional plane of bladder. The Pre-Scan function helps a user to locate the bladder easily and get more accurate results.
Built-in thermal printer provides convenience of printing data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: MD-6000 Bladder Scanner
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Measuring Range | 20-999 ml |
| Measuring Accuracy | ±15% |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 10 volunteers.
- Data Provenance: Not explicitly stated whether the data was retrospective or prospective. The study mentions "collected and evaluated" and "validation to the measuring accuracy of bladder volume to 10 volunteers," which suggests a prospective collection for this specific validation. The country of origin is implied to be China, as the submitter, MEDA Co., Ltd., is located in Tianjin, P.R. China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: "Professional doctors" were entrusted to make clinical effectiveness tests. The exact number of doctors is not specified, nor are their specific qualifications (e.g., years of experience or specialty).
4. Adjudication Method for the Test Set:
- The document does not describe a specific adjudication method like 2+1 or 3+1 for establishing ground truth from multiple experts. It states that "professional doctors" conducted clinical effectiveness tests, and a comparison was made between the device's measurement and the actual volume of excreted urine. This implies a direct comparison rather than an expert consensus adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or reported in this summary. The device's primary function described is measuring bladder volume, not assisting human interpretation of complex medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, a standalone performance evaluation was done. The "validation to the measuring accuracy of bladder volume to 10 volunteers" involved comparing the device's measurement directly to the "actual volume of excreted urine." This assesses the device's performance in isolation.
7. The Type of Ground Truth Used:
- The ground truth for the device's accuracy validation was "actual volume of excreted urine." This is a direct, objective measurement rather than an expert consensus or pathology report.
8. The Sample Size for the Training Set:
- The document does not specify a sample size for a training set. The descriptions focus on the validation study. Ultrasonic bladder scanners typically rely on algorithms derived from physical principles (ultrasonic distance measuring principle, volume integral algorithm) rather than learning from a large training dataset in the same way modern AI algorithms do.
9. How the Ground Truth for the Training Set Was Established:
- As a training set is not explicitly mentioned (or likely not applicable in the modern sense of AI/ML for this type of device based on the description), there is no information on how its ground truth was established. The device utilizes "ultrasonic distance measuring principle to calculate the bladder volume" and a "volume integral algorithm," which are pre-determined mathematical models rather than learned from a training set with ground truth labels.
§ 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.