(79 days)
The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic
Fetal - OB/GYN
Abdominal
Pediatric
Small Organ (breast, thyroid, testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Peripheral Vessel
The SonoSite SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.
This is an FDA 510(k) premarket notification for the FUJIFILM SonoSite, Inc. SonoSite SII Ultrasound System. The document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance metrics for a novel AI device.
Therefore, the information you're requesting regarding acceptance criteria, study details, sample sizes, expert qualifications, and comparison with human readers is not directly available in this type of regulatory submission for a standard ultrasound system. This document is a clearance for a medical device that does not appear to involve AI/ML components for diagnostic interpretation that would necessitate such detailed performance studies.
However, I can extract information relevant to the device's characteristics and how its substantial equivalence was determined based on what is provided:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table of specific acceptance criteria in numerical performance metrics typically seen with AI devices (e.g., sensitivity, specificity, AUC). Instead, substantial equivalence is claimed based on similar technological characteristics, intended uses, and compliance with recognized safety and performance standards to the predicate devices.
Here's a summary of the characteristics of the SonoSite SII Ultrasound System as reported in the submission, compared to its predicates (K162045 SonoSite SII Ultrasound System and K162045 SonoSite Edge II Ultrasound System):
| Feature | SonoSite SII Ultrasound System (This submission) | SonoSite SII Ultrasound System (K162045 - Predicate) | SonoSite Edge II Ultrasound System (K162045 - Predicate) |
|---|---|---|---|
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body | Diagnostic ultrasound imaging or fluid flow analysis of the human body | Diagnostic ultrasound imaging or fluid flow analysis of the human body |
| Indications for Use (Key Applications) | Ophthalmic, Fetal - OB/GYN, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral Vessel, Needle guidance | Ophthalmic, Fetal - OB/GYN, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral Vessel, Needle guidance | Ophthalmic, Fetal - OB/GYN, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel, Needle guidance |
| Transducer Types | Linear Array, Curved Linear Array, Intracavitary, Phased Array | Linear Array, Curved Linear Array, Intracavitary, Phased Array | Linear Array, Curved Linear Array, Intracavitary, Phased Array, Trans-esophageal |
| Transducer Frequency | 1.0 — 15.0 MHz | 1.0 – 15.0 MHz | 1.0 – 15.0 MHz |
| Global Maximum Outputs/Worst Case Setting | Ispta.3: 598.9 (HFL50x), TI Type: TIB (rP19x), TI Value: 4.98 (rP19x), MI: 1.7 (rP19x), Ipa.3@MI Max: 776 (L38xi) | Ispta.3: 420.2 (L38xi), TI Type: TIC (rC60xi), TI Value: 3.05 (rC60xi), MI: 1.7 (rP19x), Ipa.3@MI Max: 776 (L38xi) | Ispta.3: 598.9 (HFL50x), TI Type: TIB (rP19x), TI Value: 4.98 (rP19x), MI: 1.7 (rP19x), Ipa.3@MI Max: 776 (L38xi) |
| Modes of Operation (Key differences) | Includes PW Doppler (available on all except P11x), CW Doppler (available on P10x and rP19x), Tissue Doppler Imaging (TDI) | No PW or CW Doppler listed for K162045 SII. Modes listed: B-mode Grayscale, THI, M-mode, Color M-Mode, Color Power Doppler, Zoom, Combination Modes, SonoHD2 Noise Reduction, SonoMB/MBe, Compounding, Velocity Color Doppler. | Includes PW and CW Doppler, Tissue Doppler Imaging (TDI) |
| ECG Feature | 3-lead ECG input, or ECG Slave Cable | Not available | 3-lead ECG input, or ECG Slave Cable |
| DICOM Version | DICOM 3.0 Store, Print, Modality Worklist, Perform Procedure Step (PPS), Storage Commitment (NEMA PS3.15 2011) | DICOM 3.0 Store, Print, Modality Worklist, Perform Procedure Step (PPS), Storage Commitment (NEMA PS3.15 2003) | DICOM 3.0 Store, Print, Modality Worklist, Perform Procedure Step (PPS), Storage Commitment (NEMA PS3.15 2011) |
| Product Safety Certification | AAMI/ANSI ES60601-1:2005 (R2012), IEC 60601-2-37 Ed. 2.1:2015, CAN/CSA C22.2 No. 60601-1:08, NEMA UD2-2004, IEC 62359 (2017 - although form states 2015 for 60601-2-37 and 2017 for 62359 in standard listing) | AAMI/ANSI ES60601-1:2005 (R2012), IEC 60601-2-37: 2007, CAN/CSA C22.2 No. 60601-1:08, NEMA UD2-2004, IEC 62359:2010 | AAMI/ANSI ES60601-1:2005 (R2012), IEC 60601-2-37 Ed. 2.1 :2015, CAN/CSA C22.2 No. 60601-1:08, NEMA UD2-2004, IEC 62359:2017 |
Acceptance Criteria for Substantial Equivalence (General, inferred from 510(k) process):
- Identical Intended Use: The device must have the same intended use as a legally marketed predicate device.
- Similar Technological Characteristics: The device must have similar technological characteristics to the predicate, or if there are differences, these differences must not raise new questions of safety or effectiveness.
- Equivalent Safety and Effectiveness: The device must be as safe and effective as the predicate device. This is often demonstrated through adherence to recognized standards for electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, and acoustic output.
- Compliance with Standards: Conformance to relevant national and international medical device safety and performance standards (e.g., ISO, IEC, NEMA UD).
Reported Performance (Relevant to ultrasound system functionality, not AI-specific):
The performance of the device is assessed against the established standards and its predicate's performance. The submission states: "The SonoSite SII Ultrasound System and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and conform to applicable electromedical device safety standards."
New "N" indications for specific transducers (found in Tables 1.3-1 to 1.3-14) for Pulsed Wave Doppler (PWD), and in some cases, Color Doppler modes show the scope of the device's capabilities are being expanded or specifically detailed for certain transducers.
2. Sample size used for the test set and the data provenance:
The document explicitly states: "The SonoSite SII Ultrasound System, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."
Therefore, there is no test set sample size or data provenance related to clinical performance metrics for this device as it is not an AI/ML device requiring such validation for regulatory clearance. The assessment is based on technical, safety, and performance characteristic comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical study or test set with ground truth established by experts was conducted or required for this 510(k) submission.
4. Adjudication method for the test set:
Not applicable, as no clinical study or test set requiring adjudication was conducted or required for this 510(k) submission.
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, as this device is a general-purpose ultrasound system and does not appear to incorporate AI assistance for diagnostic interpretation. Hence, no MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a medical imaging device as opposed to an AI algorithm.
7. The type of ground truth used:
Not applicable, as no clinical study requiring ground truth for clinical decision or diagnostic performance was conducted. The "ground truth" in this context refers to compliance with performance and safety standards, and equivalence to predicate devices, rather than diagnostic accuracy.
8. The sample size for the training set:
Not applicable, as this is a traditional ultrasound system and not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, for the same reason as above.
§ 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.