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The SONALIS® system and transducers are intended for diagnostic ultrasound imaging of the human body. The clinical application is trans-rectal imaging. Typical examination using the SONALIS® Platform system: Prostate and Rectal wall studies.

The SONALIS® is a real time, two-dimensional, diagnostic system that produces high quality images. The system currently supports imaging applications for trans-aectorl ultrasound imaging. The system consists of:

• . system console,
• . keyboard.
• . ultrasound probe,
• . ultrasound probe connector,
• . power cord,
• high resolution LCD monitor to display the image,
• System Operating Manual ●
• B&W graphic printer .

The provided text is a 510(k) summary for the SONALIS® Ultrasound System from Best NOMOS, dated November 24, 2009, with an FDA acceptance date of February 19, 2010.

Based on the information provided, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

No explicit "acceptance criteria" table with performance metrics (e.g., sensitivity, specificity, accuracy) is present in the provided document. The submission is a 510(k) for a medical device that operates identically to a predicate device. Therefore, the primary acceptance criterion is substantial equivalence to the predicate device (Sonalis Ultrasound System, K043189).

The "reported device performance" in this context is the assertion that the device functions identically to the predicate device and is compliant with relevant safety standards.

• Intended Use
• Design
• Technological Characteristics |
  | Compliance with Safety Standards | Compliant to:
• UL60601-1 (2003), 1st Edition Medical Electrical Equipment, Part 1, General Requirements for Safety
• IEC 60601-1 (1988), 2nd Edition, Medical Electrical Equipment, Part 1: General Requirements for Safety +A1(91) + A2(95)
• IEC 60601-2 (2001), 2nd Edition Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic compatibility
• IEC 60601-2-37 (2001), 1st Edition Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment +A1(2004) |
  | Biocompatibility | Tested in accordance with the testing requirements of the ISO 10993 Recognized Standards and found to be safe for its intended use. |
  | No new questions concerning safety or effectiveness compared to the predicate device | Stated directly in the Conclusion: "The Sonalis Ultrasound System introduces no new questions concerning the safety or effectiveness and is thus substantially equivalent to the predicate device." |
  | Intended Use: Diagnostic ultrasound imaging of the human body, specifically trans-rectal imaging (Prostate and Rectal wall studies). | The intended use matches the predicate device and is explicitly stated: "The SONALIS® system and transducers are intended for diagnostic ultrasound imaging of the human body. The clinical application is trans-rectal imaging. Typical examination using the SONALIS® Platform system: Prostate and Rectal wall studies." |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a specific "test set" for performance evaluation, nor does it mention any clinical studies involving patient data. This is characteristic of a 510(k) submission for a device demonstrating substantial equivalence, especially when the changes from the predicate are minor and do not affect performance. The proof of meeting acceptance criteria is based on the claim of identical operation and compliance with standards, not new clinical data.

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)

No information is provided regarding experts to establish ground truth because no specific clinical test set requiring expert interpretation is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is described, as no clinical 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

No MRMC study was done, as this is a diagnostic ultrasound system, not an AI-based interpretation device. It is a hardware device for imaging.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The SONALIS® is a diagnostic ultrasound imaging system, not an algorithm, and it explicitly requires human operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

No ground truth is described because no clinical performance study involving patient data was conducted or reported in this 510(k) summary. The "ground" for approval is the technical equivalence to a previously cleared device and compliance with safety standards.

8. The sample size for the training set

No training set is mentioned. This device is an imaging system, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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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.

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