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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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