(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, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.
The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, 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 SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging and system feature selections. 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, bionsy, 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 carotid 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 system includes a variety of accessories including a mobile docking system, external monitor, bar code reader, digital video disk recorder, printer, VCR, and biopsy/needle guide kits. The system includes USB host support for peripherals such as input devices and storage devices include wired and wired and wireless devices such as keyboard, mouse, remote. Storage devices include wired and wireless devices such as memory sticks, hard drives, CDs, 802.11 devices. The SonoSite Maxx Series Ultrasound System 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 text describes the SonoSite Maxx™ Series Ultrasound System and its various transducers, along with their intended uses and compliance with regulatory standards. It does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically found in a performance study section.
Therefore, most of the requested information cannot be extracted from the given text. The document is primarily a 510(k) Summary of Safety and Effectiveness for the SonoSite Maxx™ Series Ultrasound System, focusing on its description, intended uses, and substantial equivalence to predicate devices, along with compliance with recognized standards.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be answered from the text. The document lists acoustic output limits as therapeutic safety limits, not as performance acceptance criteria for clinical efficacy. It does not provide detailed performance metrics for specific medical imaging tasks or a comparison against predefined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from the text. The document does not describe any clinical or technical performance studies that would involve a "test set" in the context of algorithm or device performance evaluation.
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)
- Cannot be answered from the text. No "test set" and corresponding ground truth establishment is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered from the text. No "test set" is mentioned.
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
- Cannot be answered from the text. This document is for an ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be answered from the text. This document is for an ultrasound system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be answered from the text. No ground truth for performance evaluation is mentioned.
8. The sample size for the training set
- Cannot be answered from the text. This information is relevant for AI/ML device submissions, which this is not.
9. How the ground truth for the training set was established
- Cannot be answered from the text. This information is relevant for AI/ML device submissions, which this is not.
Information that can be extracted related to device specifications and safety limits:
Acoustic Output Limits (acting as safety limits, not performance acceptance criteria):
| Parameter | General Use Max/Range | Ophthalmic Use Max/Range |
|---|---|---|
| ISPTA (d) | 720 mW/cm² (Maximum) | 50 mW/cm² (Maximum) |
| Tis/Tlb/Tlc | 0.0 - 4.0 (Range) | 0.0 - 1.0 (Range) |
| Mechanical Index (MI) | 1.9 (Maximum) | 0.23 (Maximum) |
| ISPPA (d) | 0 - 700 W/cm² (Range) | Not specified |
The document states these limits are "the same as predicate Track 3 devices," indicating that meeting these safety limits is part of demonstrating substantial equivalence to previously cleared devices. Compliance with these limits is typically verified through engineering testing and measurements, not a clinical study to establish performance against acceptance criteria. The document explicitly states that the determination of substantial equivalence is granted "on the condition that prior to shipping the first device, you submit a postclearance special report... including acoustic output measurements based on production line devices."
§ 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.