(20 days)
The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician 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, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), 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.
The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.
Here's an analysis of the provided 510(k) summary regarding the SonoSite Edge™ Ultrasound System, structured to address your specific points:
Acceptance Criteria and Device Performance Study
The SonoSite Edge™ Ultrasound System is a general-purpose diagnostic ultrasound system. The provided document does not describe acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, acceptance is implicitly tied to demonstrating substantial equivalence to a previously cleared predicate device, the SonoSite Maxx Series Ultrasound System (K071134 / K082098), and compliance with various safety and performance standards.
The "study" proving the device meets its acceptance criteria is primarily a non-clinical safety and performance evaluation, as specified in the document, rather than a clinical effectiveness study with defined performance numbers.
Here's the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance and Evidence |
|---|---|
| Substantial Equivalence to Predicate Device (SonoSite Maxx Series Ultrasound System K071134 / K082098) | Demonstrated via comparison of technological characteristics and intended use. The SonoSite Edge and Maxx Series Ultrasound Systems "employ the same fundamental scientific technology." The intended uses for the SonoSite Edge System and its various transducers (C8x/8-5 MHz, C11x/8-5 MHz, D2x/2 MHz, C60x/5-2 MHz, HFL38x/13-6 MHz, HFL50x/15-6 MHz, ICTx/8-5 MHz, L25x/13-6 MHz, L38xi/10-5 MHz, L38x/10-5 MHz, P10x/8-4 MHz, P21x/5-1 MHz, SLAx/13-6 MHz, TEEx/8-3 MHz) are largely shown to be "P" (previously cleared by FDA) under the predicate device K071134 and K082098, with a few "N" (new indications) for certain transducer/application/mode combinations (e.g., L38xi/10-5 MHz for Abdominal, Intra-operative, Pediatric, Small Organ, Musculo-skeletal Conventional & Superficial, and Peripheral vessel applications). The FDA's 510(k) clearance letter explicitly states: "We have determined the device is substantially equivalent... to legally marketed predicate devices." |
| Compliance with Electrical, Thermal, Mechanical, and EMC Safety Standards | Evaluated, and the device "has been found to conform to all applicable mandatory medical device safety standards." (Specific standards referenced for the Maxx series, which is the predicate, include AAMI/ANSI/ISO 10993-1, 10993-5, 10993-12 for biocompatibility, and unspecified voluntary standards detailed in tables 1.1-1 and 1.1-2, though these tables are not provided in the excerpt). |
| Compliance with Cleaning/Disinfection Requirements | Evaluated. |
| Biocompatibility of Patient Contact Materials | Evaluated. "All patient contact materials are biocompatible." |
| Acoustic Output Compliance | Evaluated. |
| Quality Assurance (System & Software Verification, Hardware Verification, Clinical Validation, Human Factors Validation) | "Assurance of quality was established by employing the following elements of product development: System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation. Reports for these product development elements are referenced in Attachment 6." However, "The SonoSite Edge Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence." This means "Clinical Validation" in this context refers to demonstrating that the device performs as intended for its stated uses, implicitly equivalent to the predicate, rather than an independent clinical trial to establish new clinical efficacy or performance metrics. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/Not provided. The submission explicitly states: "The SonoSite Edge Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence." Therefore, there was no separate clinical "test set" in the context of generating new clinical performance data (like sensitivity/specificity) for this 510(k) submission. The evaluation was primarily non-clinical and a comparison to a predicate device's existing clearance.
- Data Provenance: Not applicable. As no new clinical studies were conducted for this submission, there is no new data provenance (country of origin, retrospective/prospective). The basis is primarily the regulatory clearance of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. Since no new clinical studies were performed requiring new ground truth establishment, this information is not provided. The clinical indications listed as "P" (previously cleared) rely on the ground truth established for the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication was performed for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance
- No. This is a submission for a general diagnostic ultrasound system, not an AI-enabled device. Therefore, no MRMC study or assessment of AI assistance was conducted or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This is a diagnostic ultrasound system, not an algorithm.
7. The Type of Ground Truth Used
- For the "P" (previously cleared) indications, the ground truth was established through the original clinical validations and regulatory clearances of the predicate device (SonoSite Maxx Series, K071134 and K082098). The specific type of ground truth (e.g., pathology, outcomes data) for the predicate device is not detailed in this particular summary.
- For the "N" (new) indications, specifically for the L38xi/10-5 MHz transducer, these are new combinations of application and mode on a new transducer for which the previous system (Edge) also had "N" indications for "B+M; B+PWD; B+CD" combined modes. The basis for these "new" indications still relies on the fundamental scientific technology being equivalent to the predicate, and safety/performance evaluations rather than novel clinical ground truth data.
8. The Sample Size for the Training Set
- Not applicable. This submission is for a diagnostic imaging device, not an AI/machine learning algorithm that requires a "training set." The system's development involved "System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation," but these are engineering and validation processes, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" in the machine learning sense, this question is not relevant.
§ 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.