(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.
The MicroMaxx™ High-Resolution Ultrasound System (C3 Series) is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler or in a combination of these modes. The System has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect data for M-mode and Doppler measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The system includes the ability to measure the intima-media thickness (IMT) of the carolid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient. The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance. The MicroMaxx™ High-Resolution Ultrasound System (C3 Series) is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.
The provided document is a 510(k) Premarket Notification for the Sonosite MicroMaxx High-Resolution Ultrasound System (C3 Series) and its associated transducers. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, quantitative acceptance criteria through a study with a dedicated test set and ground truth.
Therefore, the information typically requested in your prompt regarding acceptance criteria, specific study designs (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance), and details about training sets and ground truth methodologies for AI/ML devices is not applicable to this 510(k) submission for a diagnostic ultrasound system.
This document focuses on demonstrating that the new device has the same intended use and similar technological characteristics as predicate devices, and that any differences do not raise new questions of safety or effectiveness.
However, I can extract the relevant information presented in the document pertaining to the device's characteristics and its compliance with recognized standards, which serve as a form of "acceptance criteria" for regulatory clearance based on substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance:
Since this is a 510(k) submission for an ultrasound system, the "acceptance criteria" are not reported as performance metrics like accuracy, sensitivity, or specificity against a clinical ground truth, but rather as compliance with regulatory standards and alignment with the capabilities of predicate devices. The "reported device performance" is essentially the device's specifications and features.
| Acceptance Criteria (Regulatory Compliance / Predicate Equivalence) | Reported Device Performance (Device Specifications) |
|---|---|
| Intended Use: Device performs diagnostic ultrasound imaging or fluid flow analysis for various clinical applications as specified by FDA guidance documents. | Clinical Applications Supported: Ophthalmic, Fetal (OB/GYN), Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel. (Tables 4.3-1 to 4.3-8 and section 5 of the 510(k) Summary). |
| Imaging Modes: Device supports standard diagnostic ultrasound imaging modes. | Supported Modes: 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, Velocity Color Doppler, or combinations thereof. Electrocardiography (ECG) display feature for M-mode and Doppler measurements. (Section 4 of 510(k) Summary) |
| Measurement Capabilities: Device provides standard measurement capabilities. | Measurement Capabilities: Anatomical structures and fetal biometry. Intima-media thickness (IMT) of the carotid artery. (Section 4 of 510(k) Summary) |
| Connectivity and Data Handling: Device integrates with standard medical imaging and communication systems. | Connectivity: Digital Imaging and Communications (DICOM) capabilities, general computer communication capabilities for acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support for HIPAA compliance. (Section 4 of 510(k) Summary) |
| Frequency Range of Transducers: Capable of operating within a specified frequency range. | Frequency Range: 2.0 - 12.0 MHz. (Section 4 of 510(k) Summary) |
| Transducer Types Supported: Compatible with various transducer types. | Transducer Types: Linear array, Curved array, Intracavitary array, Phased array, Static probes. Specific cleared transducers listed include: D2/2 2.0 MHz Dual Element Circular Array; C60e/5-2 5.0-2.0 MHz Curved Array; HFL38/13-6 13.0-6.0 MHz Linear Array; SLA/13-6 13.0-6.0 MHz Linear Array; LAP/12-5 12.0-5.0 MHz Linear Array Laparoscopic; L38e/10-5 10.0-5.0 MHz Linear Array; TEE/8-3 8.0-3.0 MHz Trans-esophageal Echocardiography; SLT/10-5 10.0-5.0 MHz Linear Array; P10/8-4 8.0-4.0 MHz Phased Array; P17/5-1 5.0-1.0 MHz Phased Array. (Page 1 of the letter & Section 4 of 510(k) Summary) |
| Regulatory Standards Compliance: Device complies with relevant FDA-recognized consensus standards and miscellaneous design standards for medical electrical equipment, safety, biological evaluation, acoustic output, and electromagnetic compatibility. | Compliance List (Examples): AAMI/ANSI/ISO 10993-1, AIUM Medical Ultrasound Safety, ANSI/AAMI EC53, EN 980 A1, IEC 60601-1 (and amendments), IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-25, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004, ASTM D5276-98, ASTM D999-96, CISPR 11, EN 60529, JIS standards, RTCA/DO160D, UL 60601-1, UL 94, EN ISO 13485, EN ISO 14971, ACR-NEMA DICOM version 3.0 - 2003. (Section 4 of 510(k) Summary) |
| Acoustic Output Limits: Device's acoustic output remains within specified safe limits. | Acoustic Output Limits (Non-Ophthalmic): ISPTA(d) max=720 mW/cm², Tis/Tlb/Tlc range=0.0-4.0, Mechanical Index (MI) max=1.9, ISPPA(d) range=0-700 W/cm². |
| Acoustic Output Limits (Ophthalmic): ISPTA(d) max=50 mW/cm², Tls/Tlb/Tic range=0.0-1.0, Mechanical Index (MI) max=0.23. These limits are stated to be the same as predicate Track 3 devices. (Section 6 of 510(k) Summary) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This 510(k) submission does not describe a clinical study in the typical sense with a "test set" of images or patient data for performance evaluation against a ground truth. Instead, it demonstrates substantial equivalence to predicate devices, which means it fulfills the same intended uses with similar technological characteristics without raising new questions of safety or effectiveness.
- The document primarily references engineering and safety standards compliance.
- Data provenance for clinical performance is not applicable or provided.
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)
- Not applicable. This submission doesn't detail a study involving expert-established ground truth for performance evaluation of a new algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This submission doesn't detail a study with adjudicated ground truth.
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
- Not applicable. This is not an AI/ML device and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a diagnostic ultrasound system, not an algorithm being evaluated for standalone performance. Its performance is inherent to the imaging technology and operator use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The clearance is based on substantial equivalence, not a direct clinical performance study with a specific ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning model development.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/ML model.
In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a diagnostic ultrasound system. It focuses on comparing the device's intended use and technical specifications with existing, legally marketed predicate devices, and on compliance with recognized safety and performance standards. It does not contain information about clinical performance studies with specific acceptance criteria, test sets, or ground truth methodologies that would be typical for an AI/ML device or a novel clinical diagnostic tool requiring such rigorous validation.
§ 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.