(11 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (includes infertility monitoring of follicle development), Abdominal, Pediatric, Small Organ, Cardiac (Adult), Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial). Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans.
The mycolor 202 scanner (marketed under the name SonoAce PICO) is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color-Flow Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The mycolor 202 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The mycolor 202 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Seven different models of transducers are available and only one can be connected. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The mycolor 202 uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using BPD (Biparietal Diameter), HC (Head Circumference), OFD (Occipital Frontal Diameter), FL (Femur Length), AC (Abdominal Circumference), FTA (Fetal Trunk Area), APTD (Anterior Posterior Thoracic Diameter), TTD (Transverse Thoracic Diameter), TAD (Transverse Abdominal Diameter), CRL (Crown Rump Length). GS (Gestational Sac), APD (Anterior-Posterior Abdominal Diameter), AF1 (Amniotic Fluid Index), APD (Anterior-Posterior Abdominal Diameter), Cerebellum, CLAV(Clavicle), CM (Cisterna Magna), Ear, FIB (Fibular), Foot, HUM (Humerus), IOD (Inner Ocular Distance), LV (Lateral Ventricle). Mid Cerebral Artery. MP (Middle Phalanx), NF (Nuchal Fold), OOD (Outer Ocular Distance), RAD (Radius Length), TIB (Tibia), ULNA (Ulna Length), Umbilical Artery, YS- Yolk Sac, Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, ICA/CCA ratio. Volume flow). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method, which has its images flow from the right to the left on the monitor. The mycolor 202 supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
The provided document is a 510(k) Premarket Notification for the mycolor 202 Ultrasound System, dated May 30, 2003. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than a detailed performance study with acceptance criteria in the context of AI/ML.
Therefore, many of the requested elements (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth for test/training sets, and training set sample size) are not applicable or not detailed in this type of submission. This document is a regulatory filing for a traditional, non-AI ultrasound system.
However, based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
This document does not present "acceptance criteria" and "reported device performance" in the way one would typically expect for an AI/ML device (e.g., target specificity, sensitivity, or AUC values). Instead, it focuses on the device's technical specifications and adherence to safety and regulatory standards, and its substantial equivalence to predicate devices for specific clinical applications and modes of operation.
The key "acceptance criteria" implicitly addressed are:
| Acceptance Criteria Category | Reported Device Performance (or Compliance) |
|---|---|
| Intended Use Equivalence | The mycolor 202 has the same clinical uses as predicate devices (SA9900 (K002185) and SA8000 (K013627)). |
| Technical Equivalence | Operates identically to predicate devices (piezoelectric material, sound wave reflection, display of B-mode, M-mode, Spectral Doppler, Color Doppler, Power Doppler, or 3D images). |
| Acoustic Output Limits | ISPTA: 720 mW/cm2; MI: 1.9 (same limits as predicate Track 3 devices). |
| Safety Standards | Compliant with EN 60601-1 (IEC 601-1), UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157:1992, EN 60601-1-2 (IEC 60601-1-2), and European Medical Device Directive (TUV certified). |
| Transducer Compatibility | Specific transducers (C2-4ES, C3-7ED, HC2-5ED, HL5-9ED, EC4-9ES, EC4-9/10ED) are listed as compatible and intended for various applications and modes (B, M, PWD, CWD, Color Doppler*). |
| Measurement Functions | Provides ability to measure anatomical structures (e.g., BPD, HC, FL, AC) and calculate expected date of delivery, cardiac analysis, and vascular analysis. |
| Image Management | Supports Cine function (up to 256 sequential images), real-time zoom, DICOM 3.0 compatible output for remote viewing, and patient history management. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. This is a regulatory submission for a conventional ultrasound device based on substantial equivalence, not an AI/ML performance study utilizing test datasets.
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 provided as this is not an AI/ML study involving ground truth experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as this is not an AI/ML study involving expert 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed for this submission. This device is a diagnostic ultrasound system and does not incorporate AI for assistance to human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not performed. This is a hardware and software system for direct human operation, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
"Ground truth" in the context of an AI/ML algorithm's performance is not applicable to this submission. The "truth" here is related to the device's ability to accurately acquire and display ultrasound data, perform measurements, and conform to safety and technical standards as expected of a diagnostic ultrasound system. Compliance with established safety standards and verification of technical specifications serve as the "ground truth" for this type of device.
8. The sample size for the training set
This information is not provided as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device that requires a training set and associated ground truth.
§ 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.