(89 days)
The SONOCA 180/190 is an instrument intended for selected ultrasound dissection and fragmenting of tissue at the operation site during multi-medical discipline surgery including: General Surgery, Neuro, Thoracic, Urology, and Gastro-intestinal modalities.
SONOCA 180 & 190 is a desktop unit that controls ultrasonic handpieces used in general surgery, vascular surgery, and dermatological surgery.
general bargery, vacual carget case; technologically derived from the Sonoca 300 family of units (K992026) with the same general modules (hardware and software).
During the use of this ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue and is a supplementary tool for the selective dissection of human tissue.
The provided text describes the regulatory filing for the Sonoca 180/190 ultrasonic surgical instrument, focusing on its substantial equivalence to a predicate device (Sonoca 300). However, the document does not contain the detailed performance study information typically found in an AI/Software as a Medical Device (SaMD) submission. The performance data section refers to compliance with general safety and electromagnetic compatibility standards for the device itself (hardware and software controls for error detection), not to the clinical performance of an AI algorithm in the way a diagnostic AI would be evaluated.
Therefore, many of the requested items cannot be answered from the provided text.
Here's what can be extracted and what cannot:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety of Information Technology Equipment (IEC 950) | Complies with IEC 950 |
| Electromagnetic Compatibility (CISPR 22, class A) | Complies with CISPR 22, class A |
| Electromagnetic Compatibility (IEC-801-2, IEC-801-3) | Complies with IEC-801-2, IEC-801-3 |
| General Electrical Safety for medical devices (IEEE 1003.1) | Complies with IEEE 1003.1 |
| Electrical Safety for medical devices using RF-power (IEC 601-1) | Complies with IEC 601-1 |
| Ultrasonic surgical devices (IEC 601-2-2) | Complies with IEC 601-2-2 |
| General Electrical Safety (DIN EN 61847) | Complies with DIN EN 61847 |
| Overall Performance Claim | "The subject and predicate devices both use similar software controls to detect errors." |
| "The device and the predicate device share the same conformance to performance standards and both function as Ultrasonic Dissectors." |
Study Details (Information Not Available in the Provided Text for AI/SaMD Context)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document focuses on regulatory compliance of a hardware device with software controls, not an AI algorithm evaluated on a test set of data.
-
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):
- Not applicable/Not provided. This is not an AI/diagnostic device that generates specific outputs requiring expert adjudication for ground truth.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No adjudication of AI output against expert ground truth is described.
-
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/Not provided. This is a surgical instrument, not an AI-assisted diagnostic tool for human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. "Standalone" performance in the context of AI refers to the algorithm's diagnostic accuracy without human involvement. This document describes a surgical instrument, not an AI algorithm with such a function. The "software controls to detect errors" are part of the device's basic functionality, not an AI a standalone AI.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided. No ground truth in the context of AI performance evaluation is mentioned. The "ground truth" for this device's performance would be its adherence to established safety and functional standards.
-
The sample size for the training set:
- Not applicable/Not provided. This device is not described as having an AI component that undergoes a training phase with a dataset.
-
How the ground truth for the training set was established:
- Not applicable/Not provided. As there's no mention of a training set for an AI component, this information is not relevant or provided.
Summary of Device and Performance Context:
The Sonoca 180/190 is an ultrasonic surgical instrument. Its "performance data" refers to its compliance with a list of regulatory and safety standards (e.g., IEC, CISPR, IEEE, DIN EN) and its functional equivalence to a predicate device (Sonoca 300) in terms of using "similar software controls to detect errors" and functioning as an ultrasonic dissector. This is a traditional medical device submission, not an AI/SaMD submission, which is why the requested details about AI performance studies are missing.
N/A