(201 days)
The AU5 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.
Ultrasound Imaging System
Here's an analysis of the provided text regarding the acceptance criteria and study for the AUS Biosound Esaote ultrasound imaging system:
Based on the provided document, there is no specific acceptance criteria table or detailed study proving the device meets particular performance metrics beyond substantial equivalence to a predicate device.
The document is a "Safety and Effectiveness Summary" submitted for 510(k) clearance, which is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, the AU4 Esaote (K#944485). The FDA's letter explicitly states, "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to legally marketed predicate devices."
Therefore, most of the requested information cannot be extracted directly from this document, as a 510(k) submission generally does not require the same level of detailed performance study as, for example, a PMA application or a clinical trial for a novel device.
However, I can extract information related to the device comparison and the regulatory context.
Analysis of Acceptance Criteria and Study Data
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: Not explicitly stated as specific performance thresholds (e.g., sensitivity, specificity, accuracy percentages). The primary "acceptance criterion" for 510(k) clearance in this context is substantial equivalence to the predicate device (AU4 Esaote).
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Reported Device Performance: Instead of performance metrics, the document provides a "Comparison Chart for Substantial Equivalence" outlining technical and functional characteristics. The "performance" is implicitly deemed equivalent if these characteristics are similar or improved without raising new safety/effectiveness concerns.
General Characteristics Predicate Device (AU4, K#944485) Proposed Device (AU5) "Acceptance" (Implicit) Transducer Type Annular Array, Mechanical Sector, Linear, Convex, Phased Array Annular Array, Mechanical Sector, Linear, Convex, Phased Array Equivalent 2D Freq MHz 2.5/15 2.5/15 Equivalent PW Freq MHz 2.25/10 2.25/10 Equivalent CW Freq MHz 2.25/5.0 2.25/5.0 Equivalent Imaging Modes Real-time/2D, M Mode, PW Doppler, CW Doppler, CFM Doppler, Power Doppler Real-time/2D, M Mode, PW Doppler, CW Doppler, CFM Doppler, Power Doppler Equivalent Probes MHz (Annular array) 2.5, 3.5, 7.5, 10, 13 2.5, 3.5, 7.5, 10, 13 Equivalent ... (many other items) ... ... Equivalent or Improved (e.g., Monitor size, DSM) Monitor size (inches) 12 14 Improved DSM (Dicom storage module) No Yes New Feature
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable/not mentioned. This type of 510(k) submission generally relies on technical comparisons and, potentially, internal verification and validation testing rather than large-scale clinical test sets with patient data.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/not mentioned for clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/not mentioned. No clinical test set requiring expert ground truth establishment is described in the provided summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/not mentioned.
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
- No MRMC study discussed. This device is an ultrasound imaging system, not an AI-powered diagnostic tool, and the document predates widespread AI in medical imaging.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an imaging system, not an algorithm, and is intended for human-in-the-loop operation (a physician using it for diagnostic imaging).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/not mentioned as no clinical ground truth for performance evaluation of a test set is described. The "ground truth" for demonstrating substantial equivalence is the existing performance and safety profile of the predicate device.
8. The sample size for the training set
- Not applicable. This is an imaging hardware system, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of what the document does provide:
- Device Name: AUS Biosound Esaote AU5 Ultrasound Imaging System
- Predicate Device: AU4 Esaote (K#944485)
- Intended Use: "by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications."
- Method of demonstrating "effectiveness": Primarily through comparison of technical specifications and features to a legally marketed predicate device, showing substantial equivalence. Improved features such as a larger monitor and a Dicom storage module (DSM) are highlighted.
- Regulatory Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This clearance is contingent on a post-clearance special report regarding acoustic output measurements based on production line devices.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.