(46 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 Doppler 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 for general purposes. The system provides ultrasound imaging information such as 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/CW Doppler-mode. The optional items are available, such as a Pole Cart with storage basket, a power extension unit, and a foot switch with dual pedals. This system conforms to Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment (Track 3). Transducers have their own characteristic applications, and are brought into contact with the body surface.
The Konica Minolta Ultrasound System SONIMAGE HS1 and its transducers are medical devices intended for diagnostic ultrasound imaging and fluid flow analysis of the human body. The system is substantially equivalent to legally marketed predicate devices (K142197 and K061605).
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific numerical performance acceptance criteria in the traditional sense of an original device evaluation. Instead, the "acceptance criteria" are implied by conformity to established standards and proven equivalence to predicate devices, particularly regarding safety and technological characteristics.
| Acceptance Criteria Category | Description | Reported Device Performance / Compliance |
|---|---|---|
| Intended Use | The device's intended clinical applications should be consistent with predicate devices and suitable for diagnostic ultrasound imaging (small parts, abdomen, musculoskeletal, peripheral vascular, cardiac). Contraindications: Eyeball examination, direct contact to central nerves and cardiac systems. | The range of intended clinical applications is the same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, musculoskeletal (soft tissue), peripheral vascular, and Cardiac. The additional intended use for Cardiac is the same as K061605. The system is contraindicated for eyeball examination or any other examination that may require the passage of an ultrasound beam through an eyeball. The system is NOT designed for use in direct contact to central nerves and cardiac systems. Only to be used by fully qualified and certified medical personnel. |
| Technological Characteristics | The device should employ fundamental scientific technologies, operating principles, and design features that are substantially similar to predicate devices. This includes imaging modes (B-mode, M-mode, Color Doppler-mode, PW/CW Doppler-mode) and display formats. | The proposed Ultrasound System SONIMAGE HS1 employs the same fundamental scientific technologies as the primary predicate device (K142197). The operating principle and designing (transmits ultrasonic energy, processes echoes for display, laptop shape, battery operation) are the same as the predicate devices. The proposed system and predicate devices support the same operating modes and display format, and same measurement functions. |
| Non-clinical Performance Testing | Verification of geometric accuracy in B-mode and accuracy of position/velocity for Color and PW/CW Doppler-mode, and time for PW/CW Doppler-mode. | Comprehensively tested as Bench-tests for geometric accuracy in B-mode, accuracy of position and velocity for Color and PW/CW Doppler-mode, and time for PW/CW Doppler-mode, except quantitative Doppler sensitivity. The systems do not have quantitative claims of sensitivity regarding Color Doppler-mode and PW/CW Doppler-mode. |
| Safety | Compliance with relevant electrical safety, electromagnetic compatibility, and medical device standards. Real-time display of thermal and mechanical output indices. | The system is in conformance with the standards described (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), which are same or equivalent standards to those of the predicate device. Both systems conform to real-time display of thermal and mechanical output indices under Track 3. |
| Biocompatibility | Patient contact materials should be evaluated for biocompatibility. | The patient contact materials of the human body surface are evaluated under ISO 10993 and determined as acceptable for these usage. Both systems achieve the same acceptance level for biocompatibility. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that non-clinical tests (Bench-tests) were performed. It does not specify a "test set" in terms of patient data or studies. The evaluation is based on comparing engineering and performance specifications to predicate devices and adherence to international standards. Therefore, information regarding sample size, data provenance, or retrospective/prospective nature of a clinical test set is not applicable as per the provided text for this determination of substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as there was no clinical test set described that required expert-established ground truth. The evaluation was based on engineering and performance comparisons.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there was no clinical test set described requiring adjudication.
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
This information is not applicable. This submission is for an ultrasound system, not an AI-powered diagnostic device, and it does not mention any MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is an ultrasound imaging system, not an algorithm being evaluated in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The device's performance was demonstrated through non-clinical bench testing and comparison to legally marketed predicate devices, not through a clinical study that would require a ground truth for diagnostic accuracy.
8. The sample size for the training set
This information is not applicable. This submission is for an ultrasound system, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As no training set for an algorithm was used, no ground truth needed to be established for it.
§ 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.