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MD-320W Ultrasound Biomicroscope is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes.

The device is intended to be used in hospitalmology clinics. The operators should be trained professionals and have basic capabilities for PC operation.

It is not allowed to use UBM on patients with eye trauma, inflammation or infection.

MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It consists of AC-DC power adapter, main unit, 50MHz sector scan probe, footswitch, USB cable and two user-selectable APPs:

MD3XUBM.AP1-C V1.0 APP (included in MD3XUBM-C V1.0) runs on the windows operating system of the PC and allows the user to control probe scanning, image acquisition and display via the PC user interface.

MD3XUBM.AP1-S V1.0 APP (included in MD3XUBM-S V1.0) runs on the operating system of the legally marketed MD-2300S Ultrasonic A/B Scanner for Ophthalmology (K152318) and allows the user to control probe scanning, image acquisition and display via the MD-2300S user interface.

Under the excitation of electric pulse, the 50MHz ultrasound transducer emits ultrasonic pulse into eye and receives reflective echo from the surfaces of different tissue, thus forming real-time two-dimensional image of eye tissue.

This FDA 510(k) summary for the MD-320W Ultrasound Biomicroscope details its substantial equivalence to a predicate device but does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria. The provided text focuses on comparing the new device's technological characteristics and intended use to a predicate device (VuPad Ophthalmic Ultrasound System), highlighting non-clinical testing for safety, EMC, and acoustic output.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
• Whether a standalone performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any specific performance study.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document only states that "The software and essential performance have passed verification and validation, and the results comply with the related requirements as per the FDA Guidance document 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in June 27, 2019." This is a general statement about compliance with guidance and does not provide specific performance metrics or study details.

In summary, the provided text describes regulatory approval based on substantial equivalence to a predicate device, focusing on technical specifications and general safety/EMC testing, rather than detailed performance study data against specific acceptance criteria.

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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

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.

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