(84 days)
The Sonalis system and transducers are intended for diagnostic ultrasound imaging of the human body. The clinical application is trans-rectal imaging. Typical examinations using the Sonalis Platform system: Prostate and rectal wall studies.
The Sonalis System is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The device consists of two parts: the system console and the transducer. The console contains the user interface, a display, system electronics and optional peripherals (printers). The removable transducers are connected to the system using standard technology. The Sonalis system uses standard transducer technology and supports linear and curved linear arrays. The Sonalis system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.
The provided text is a 510(k) Summary for the KOH-3189 Sonalis Ultrasound System. The document focuses on establishing substantial equivalence to a predicate device (Sonada ultrasound system) rather than detailing specific acceptance criteria and a study to prove meeting those criteria.
Here's an analysis of the information, addressing your points where possible, and noting where information is explicitly not provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria or specific quantitative performance metrics like sensitivity, specificity, or accuracy. The basis for clearance is substantial equivalence to a predicate device. The "performance" claimed is that the device "operates identically to the predicate device" in its fundamental mechanism of action and intended use.
The closest to acceptance criteria are references to meeting various standards:
- UL 2601-1 Safety Requirements for Medical Equipment
- CSA C22.2 No 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD 2 Standard for Real-Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment.
- AIUM/NEMA UD 3 Standard for Real-Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment.
- IEC 1157 Declaration of Acoustic Power.
- IEC60601-1-2
- IEC60601-2-37
And a statement that "Both systems [Sonalis and predicate] have acoustic output levels below the applicable FDA limits." However, specific numerical limits or measured performance against these limits are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission is for a general-purpose diagnostic ultrasound system, not an AI or image analysis device that would typically involve a "test set" of patient data for performance evaluation in the way you're asking. The evaluation is based on technical specifications and comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable, as no test set requiring expert ground truth is described.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes a traditional ultrasound imaging system, not an AI-assisted device. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant or performed.
6. If a Standalone Study Was Done
No. The submission is based on substantial equivalence, meaning its performance is compared to an existing, cleared device, not typically a standalone performance study as would be done for a novel technology or AI. The FDA letter does mention a postclearance special report requested to contain "complete information, including acoustic output measurements based on production line devices," but this is a post-market requirement for validation, not a pre-market standalone performance study for clinical efficacy.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" in this context is the safety and effectiveness of the predicate device, and the demonstration that the new device is functionally equivalent and meets the same standards. There isn't a clinical "ground truth" derived from patient outcomes or pathology related to the diagnostic performance of the device itself described in this document.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
Summary of Device Acceptance Rationale (based on the provided text):
The Sonalis Ultrasound System was accepted based on substantial equivalence to a previously cleared predicate device, the Sonada ultrasound system (K993092). The key arguments for substantial equivalence presented are:
- Intended Use: Both systems are intended for diagnostic ultrasound imaging of the human body, specifically mentioning trans-rectal imaging and prostate/rectal wall studies for the Sonalis system (with additional specific transducers listed for Small Organ and Peripheral Vascular imaging).
- Technological Characteristics: Both operate identically, using piezoelectric material in transducers to transmit and receive sound waves, converting them into 2D images.
- Safety & Effectiveness:
- Similar technologies for imaging and signal processing.
- Acoustic output levels are below applicable FDA limits for both.
- Manufactured from materials evaluated and found safe.
- Designed to meet various international and national safety and performance standards (UL, CSA, AIUM/NEMA, IEC).
The FDA's clearance letter confirms this substantial equivalence determination, with a specific condition for a post-market special report on acoustic output measurements from production units.
§ 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.