(29 days)
The Ultrasound System SONIMAGE HS1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes. The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display or Dopler sound, offers a procedure applied to the human body for medical diagnosis or examination. The range of intended clinical applications is same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, musculoskeletal (soft tissue), peripheral vascular, and Cardiac.
The Ultrasound System SONIMAGE HS1 is a portable ultrasound system used for the purpose of diagnosing the human body, which visually represents the internal geometry, characteristics and dynamics of the human body, and transmits / receives ultrasound waves to obtain image data of the visual representation. This system provides ultrasound images in all its modes of B-mode, Mmode, Color Doppler-mode and PW Doppler-mode. It is also capable with Anatomical M-mode, CW Doppler-mode and CF/PW-TDI-mode with Sector transducer.
The provided document does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics for the device, KONICA MINOLTA Ultrasound System SONIMAGE HS1. The document is primarily a 510(k) clearance letter and a summary comparing the device to predicates.
However, based on the information provided, I can infer some aspects related to the "study" that proves the device meets (implied) acceptance criteria, primarily focusing on proving substantial equivalence to predicate devices.
Summary of the Document's Information Regarding Acceptance Criteria and Device Performance:
The document discusses that the device, Ultrasound System SONIMAGE HS1, is substantially equivalent to legally marketed predicate devices. This substantial equivalence forms the basis of its acceptance. The study supporting this is a non-clinical test and a comparison of technological characteristics to predicate devices.
Here's an attempt to structure the information based on your request, acknowledging that specific numerical acceptance criteria and performance data are largely absent for this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety/effectiveness. Specific numerical performance metrics that would typically be found in a clinical study report are not detailed here.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|
| Intended Use Equivalence: The device's intended use must be the same as or very similar to the predicate device(s). | The Indications for Use Statement is identical to the primary predicate device (K151060). The range of intended clinical applications is the same as the predicate device, such as small parts, abdomen, musculoskeletal (soft tissue), peripheral vascular, and cardiac. |
| Technological Characteristics Equivalence: The fundamental scientific technologies, operating principles, design, modes, and functions must be substantially similar to the predicate device(s). | Employs the same fundamental scientific technologies as the primary predicate device (K151060). Imaging hardware is identical to K151060. For new functions, other predicates (K061605) are referenced. Operating principle and designing are the same as predicate devices. The proposed system and predicates support the same operating modes and display format, and the same measurement functions. |
| Safety and Effectiveness Equivalence: The device must meet recognized safety standards and not raise new questions of safety or effectiveness. | Conforms to various recognized standards (AAMI/ANSI ES 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 10993-1, ISO 10993-5, ISO 10993-10, NEMA UD 2-2004, NEMA UD 3-2004) – same standards as the primary predicate device. Conforms to real-time display of thermal and mechanical output indices under Track 3. Biocompatibility of patient contact materials (including an acoustic standoff) evaluated under ISO 10993 and determined acceptable, achieving the same acceptance level as predicate systems. Risk Analysis performed per ISO14971:2007; risks reduced to an acceptable level. |
| Performance Verification: Specific performance aspects (e.g., geometric accuracy, Doppler accuracy) are typically verified. | Geometric accuracy in B-mode verified. Accuracy verification of position and velocity for Color Doppler-mode, PW/CW Doppler-mode, and TDI-mode performed. Accuracy of time for PW/CW Doppler-mode and ECG trace performed. These are described as "comprehensively tested as Bench-tests." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly states: "The clinical studies are not required to support substantial equivalence for these conventional ultrasound diagnostic equipment." This indicates that no separate "test set" of clinical patient data was used for a prospective or retrospective clinical study in the traditional sense for this 510(k) submission. The performance verification relied on non-clinical (bench) tests and comparison to existing, cleared predicate devices.
- Data Provenance: Not applicable as clinical data from patients were not used for proving substantial equivalence. The "data" primarily comes from engineering and bench testing, and comparisons to technical specifications and performance of legally marketed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Since no clinical "test set" with patient data was used, no experts were needed to establish ground truth for such a set.
- The "ground truth" for the non-clinical tests would be established by engineering specifications and reference standards used for the bench testing.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. The device is an ultrasound imaging system, not an AI-assisted diagnostic tool. No MRMC study was mentioned or implied.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This is not an AI algorithm. The performance verification refers to the ultrasound system itself and its imaging modes.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical performance tests mentioned ("geometric accuracy verification," "accuracy verification of the position and the velocity," "accuracy of time"), the ground truth would be based on physical phantom measurements, calibrated equipment, and engineering specifications.
- For the broader claim of substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices (K151060 and K061605) as previously cleared by the FDA.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set. The device is a conventional ultrasound imaging system.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
In conclusion, the "study" proving the device met "acceptance criteria" for its 510(k) clearance was a combination of:
- Demonstrating identical intended use to predicate devices.
- Showing substantial technological equivalence in terms of fundamental principles, hardware (where applicable), and core functions.
- Performing non-clinical bench testing to verify key performance parameters like geometric and Doppler accuracy against established engineering specifications and physical standards.
- Ensuring compliance with recognized safety and performance standards (e.g., electrical safety, EMC, biocompatibility).
- Conducting a risk analysis in accordance with ISO 14971.
This approach is typical for conventional medical imaging devices seeking 510(k) clearance, where clinical studies are often deemed unnecessary if substantial equivalence can be demonstrated through non-clinical data and comparison to legally marketed predicate 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.