(128 days)
The Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley are general purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vasculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gvn and Urology.
The P11 Portable Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. The P1 Portable Diagnostic Ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.
The P11 EXPERT Portable Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This P11 Expert Portable system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.
The P12 Trolley Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. The P12 Trolley Digital Color Doppler Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.
The P12 Expert Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. The system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.
The P25 Trolley Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.
The P25 Expert Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.
This document describes the 510(k) premarket notification for the MEDISONO Color Doppler Ultrasound System, comprising models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the device's conformance to established industry standards and substantial equivalence to legally marketed predicate devices. The reported device performance is indicated by its ability to meet these standards and achieve the same intended uses as the predicates.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Acoustic Output Standards | Conforms to NEMA UD 2: 2004 and NEMA UD3: 2004 |
| Electrical Safety Standards | Conforms to IEC 60601-1:2012 A(2), IEC 60601-1-1, IEC 60601-1-2:2007, IEC 60601-2-37:2007 |
| Biocompatibility Standards | Conforms to ISO 10993-5:2009 and ISO 10993-10:2010 |
| Technology Characteristics | Similar to predicate devices |
| Intended Use | Same as predicate devices |
| Design Principle | Same as predicate devices |
| Electrical Classification | Same as predicate devices |
| Accuracy | Same as predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical testing is not required." This indicates that no separate "test set" in the sense of patient data was used for a clinical study to prove efficacy, but rather, performance was established through non-clinical testing and comparison to predicate devices. Therefore, there is no information on sample size or data provenance from a new clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Since clinical testing was not required and no new "test set" from patient data was analyzed by experts for ground truth, this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
As no clinical test set requiring expert adjudication was conducted, this information is not applicable and not provided.
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
The document does not mention any MRMC comparative effectiveness study, nor does it describe any "AI" or human-in-the-loop performance evaluation. The device is a diagnostic ultrasound system, which typically involves direct use by a qualified physician, not an AI assistance evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a diagnostic ultrasound system, not an AI algorithm. Its performance is inherent to its imaging capabilities, which are evaluated through technical standards and comparison to predicate devices, not as a standalone algorithm without human interaction.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" implicitly refers to the established specifications and performance parameters as defined by the mentioned standards (NEMA, IEC, ISO). For the substantial equivalence determination, the "ground truth" is the established safety and effectiveness of the legally marketed predicate devices.
8. The Sample Size for the Training Set
As this is not an AI/machine learning device, there is no concept of a "training set" for an algorithm. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, this information is not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The device's acceptance is based on demonstrating substantial equivalence to existing legally marketed predicate devices. The study proving this involved:
- Non-clinical testing: The device was tested to ensure it conforms to applicable acoustic output, electrical safety, and biocompatibility medical device standards. These standards (NEMA UD 2: 2004, NEMA UD3: 2004, IEC 60601-1:2012 A(2), IEC 60601-1-1, IEC 60601-1-2:2007, IEC 60601-2-37:2007, ISO 10993-5:2009, and ISO 10993-10:2010) represent the acceptance criteria for the technical performance and safety aspects of the device.
- Comparison to Predicate Devices: The submission highlights that the Medisono Color Doppler Ultrasound System (P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley models) incorporates the "same fundamental technology" as its respective predicate devices (Sonoscape S6, S8 Exp Portable, S11, S12, S20, and S22 ultrasound systems). It asserts that the subject device has similar technology characteristics, the same intended use, same design principle, same electrical classification, and same accuracy as the predicate devices. The conclusion drawn is that "There are no differences between the devices that affect the usage, safety and effectiveness, thus no new question is raised regarding the safety and effectiveness."
In essence, the "study" is a demonstration of conformance to regulatory standards and a thorough comparison to already cleared devices, rather than a novel clinical trial.
§ 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.