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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

This is a 510(k) premarket notification for the BK Medical Ultrasound Scanner System bk2300, which is an ultrasound device. The information provided is typical for a 510(k) submission, focusing on establishing substantial equivalence to a legally marketed predicate device rather than detailing specific clinical study results for novel performance claims.

Based on the provided document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily related to safety and performance specifications that demonstrate equivalence to predicate devices, rather than specific diagnostic accuracy metrics for AI. Since this is an ultrasound system, the performance is about its various imaging modes, clinical applications, and safety.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly describe a "test set" in the context of a clinical performance study using patient data for specific diagnostic claims for AI. For an ultrasound system, "testing" primarily refers to technical verification and validation, and acoustic output measurements.

• The section on Acoustic Output Reporting states it's "made according to the standards required by 'Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 9, 2008'". These standards define measurement procedures and reporting requirements, but not a patient-based test set size.
• The document also notes that "All transducers in this submission have previous been cleared," simplifying the current submission to changes to the system rather than the transducers themselves.
• Data Provenance: Not applicable in the context of a clinical test set for AI, as this submission focuses on the safety and functional equivalence of an ultrasound system, not AI performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This FDA 510(k) submission is for a general diagnostic ultrasound system (bk2300) and its various transducers. It does not describe an AI/CADe (Computer-Aided Detection/Diagnosis) system that requires expert-established ground truth on a clinical test set. The "performance" claims are about physical parameters and safety limits, not diagnostic accuracy in interpreting images.

4. Adjudication Method for the Test Set

Not applicable. As there is no clinical test set for diagnostic performance evaluation or AI, no adjudication method would have been used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This submission is for an ultrasound imaging system, not an AI or CADe product. MRMC studies are typically used for evaluating the effectiveness of AI/CADe systems in improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm being submitted for standalone performance evaluation. It is a diagnostic ultrasound system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance claims (e.g., acoustic output, electrical safety, biocompatibility, measurement capabilities) is established through adherence to recognized national and international standards (e.g., IEC, ISO, AIUM/NEMA standards) and technical specifications. It's not clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy for AI.

8. The Sample Size for the Training Set

Not applicable. This submission does not describe an AI system, therefore, there is no training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI algorithm or training set, this information is not relevant to this submission.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical technical verification and validation study. This involves:

• Acoustic Output Measurements: The system controlling acoustic output (same as predicate Pro Focus 2202) was verified to ensure that the device's acoustic output remains below regulatory limits (Ispta ≤ 720 mW/cm² and MI ≤ 1.9, TI ≤ 6.0). This is done through standard phantom and hydrophone measurements as per AIUM/NEMA UD-2 and UD-3.
• Safety Testing: The device was tested by a recognized Certified Body to confirm compliance with a comprehensive set of safety standards, including IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic equipment specific safety), ISO 14971 (risk management), IEC 62304 (software lifecycle), and IEC 62359 (field characterization). These tests ensure thermal, mechanical, and electrical safety, as well as software integrity.
• Biocompatibility Testing: Patient contact materials were assessed for biocompatibility according to EN ISO 10993-1.
• Clinical Measurements and Calculations: The accuracy of clinical measurements and calculations is stated to be "described and accuracies are provided in the User Information," indicating that these were verified against established performance benchmarks, although specific metrics are not in the 510(k) summary itself.
• Technological Equivalence Comparison: The core of the 510(k) submission relies on demonstrating that the bk2300 system, including its new optional RF wireless function and the addition of Elastography (for some transducers compared to the oldest reference device, though it's present in the direct predicate), has "the same major technological characteristics" and intended use as the previously cleared predicate device (bk2300, K143298) or the reference device (ProFocus 2202, K132346). This comparison inherently "proves" that the device meets acceptance criteria by establishing its substantial equivalence to a device already deemed safe and effective by the FDA.

In essence, the "study" is a collection of engineering and regulatory compliance tests rather than a clinical trial assessing diagnostic performance.

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