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The 37cm iQ Large tip and sleeve sets, when used with the appropriate Sonopet iQ handpiece, are intended for use in surgical procedures where fragmentation, emulsification, and aspiration of tissue is desirable.
The 37cm iQ Large tip and sleeve sets intended for soft tissue may be used in surgical procedures including gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

The Sonopet iQ Ultrasonic Aspirator System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, emulsifies fragments and removes unwanted tissue. The system consists of a console to provide control and power functions, a surgical handpiece to provide ultrasonic mechanical energy (25kHz), sixteen (16) tips with irrigation sleeves and a cassette for irrigation and suction. Users may choose from three different styles of foot pedals. The sixteen tips and sleeves consist of a soft tissue family and a hard tissue family.
The Sonopet iQ 37cm iQ Large (5500-25S-601) is the subject device of this submission and is an extension to the family of Sonopet iQ soft tissue tips and sleeves which are commercially available in the United States. The Sonopet iQ 37cm iQ Large is a single use device that forms part of the Sonopet iQ Ultrasonic Aspirator System.

This document is a 510(k) premarket notification for the Stryker Sonopet iQ 37cm iQ Large ultrasonic surgical aspirator. It describes the device, its intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All pre-defined acceptance criteria for the above tests have been met." However, it does not provide specific quantitative acceptance criteria or detailed reported performance for each test. It only lists the categories of non-clinical testing performed.

2. Sample Size for the Test Set and Data Provenance:

The document does not provide details on the sample size used for the test set for any of the non-clinical tests. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective) for these tests. All testing appears to be non-clinical, implying laboratory-based or simulated environments, rather than human clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. Given that the testing is non-clinical (engineering, simulated use), the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists interpreting images) is not directly applicable here. "Ground truth" for engineering tests would typically be established by validated measurement techniques, standards, or specifications defined by engineers/designers.

4. Adjudication Method for the Test Set:

This information is not provided as it's not relevant to non-clinical engineering and performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments.

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 comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required for this traditional 510(k)." The device is an ultrasonic surgical aspirator, not an AI-assisted diagnostic tool for human readers.

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

The device is a physical surgical instrument, not an algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable. The performance evaluated related to the physical characteristics and function of the device in a surgical context, specifically its fragmentation, emulsification, and aspiration capabilities. The "Simulated Use Validations" would assess the device's performance in a simulated surgical environment.

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

For the non-clinical tests listed (Sterilization, Biocompatibility, EMC/Electrical Safety, Design Verification, Human Factors, Simulated Use), the "ground truth" would be established by:

• Sterilization and Package Integrity: Industry standards (e.g., ISO standards), validated sterilization cycles, and package testing specifications.
• Biocompatibility: ISO 10993 series of standards and associated tests.
• EMC and Electrical Safety: IEC 60601 series of standards.
• Design Verification: Engineering specifications, design requirements, and validated test methods.
• Human Factors and Usability: Usability standards (e.g., IEC 62366) and defined user tasks with performance metrics.
• Simulated Use Validations: Performance specifications (e.g., tissue fragmentation rate, aspiration efficiency) evaluated against realistic simulated tissue or models.

The document does not detail specific ground truth criteria for each test but indicates they were "pre-defined acceptance criteria."

8. The Sample Size for the Training Set:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as point 8.

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