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The SELECTOR® Quantum Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

The SELECTOR® Ouantum Ultrasonic Aspirator System dissects and fragments soft tissue and leaves essential elastic structures such as nerves and blood vessels relatively undamaged. It is particularly useful for the ablation of unwanted tissue adjacent or attached to vital structures. The system consists of a Console, which provides control and display of aspiration, irrigation and ultrasonic power, and one or more Handpieces for selective tissue removal at the surgical site. The handpieces have a titanium tip and silicone irrigation flue. The tips are interchangeable which allows the surgeon to use the same handpiece for different applications. The required settings on the Console are selected by operation of up-down controls on the front panel. The Console provides power to the footswitch, which has two controls. One pedal provides proportional control of ultrasonic power, and the other the flow of irrigation fluid. An accessory Service Module may be used to provide a convenient source of suction and waste collection. A range of handpieces are connected to the console, both electrically and by a disposable sterile tubing kit which delivers sterile saline for irrigation, and removes aspirated waste matter. A special version of the Selector system will be available for use within an MRI suite. All handpieces may be sterilized by steam autoclaving or by Ethylene Oxide.

This 510(k) summary for the SELECTOR® Quantum Ultrasonic Surgical Aspirator System does not provide the detailed acceptance criteria and study results in the format requested, as it is a premarket notification for a medical device seeking substantial equivalence to existing devices rather than a report on a clinical trial with specific performance metrics.

However, I can extract information related to performance and safety, and how the device's characteristics compare to predicate devices. It focuses on the device's technical specifications and adherence to relevant standards rather than a study with specific performance numbers against defined acceptance criteria.

Here's an attempt to structure the available information regarding "acceptance criteria" and "device performance" based on the provided text, recognizing that these terms are interpreted within the context of a 510(k) submission for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically inferred from the technical specifications of the predicate devices and relevant performance standards. The "reported device performance" is demonstrated by the new device meeting or being comparable to these specifications and standards.

Study that Proves the Device Meets Acceptance Criteria:

The provided document describes a 510(k) submission, which is a regulatory pathway to demonstrate substantial equivalence to a predicate device, not necessarily a study proving specific numerical acceptance criteria. The "study" here is primarily a comparative analysis of technical specifications and adherence to standards, reinforced by performance testing.

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

• Test Set Sample Size: Not applicable in the context of this 510(k) summary. This document does not present a clinical trial or a test set of patient data. The "testing" referred to is engineering and performance verification of the device components and system.
• Data Provenance: Not applicable. There is no patient data or clinical trial data referenced in this summary. The data provenance relates to the technical specifications of the device and its predicate devices, as well as the standards it was tested against (e.g., ISO, CSA, EN, FCC).

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

• Number of Experts & Qualifications: Not applicable. This document does not describe a study involving expert assessment of a test set for ground truth establishment. The assessment is primarily technical and regulatory.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no test set in the clinical or data analysis sense requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses on device characteristics and technical equivalence.

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

• Standalone Performance Study: Not applicable. This device is an ultrasonic surgical aspirator, a physical medical instrument, not an algorithm or AI system. Its performance is tied to its mechanical and electrical characteristics and how it physically interacts with tissue under human control.

7. The Type of Ground Truth Used

• Type of Ground Truth: For this device, "ground truth" is established through engineering principles, adherence to recognized standards (e.g., electrical safety, sterilization, biocompatibility), and comparison of technical specifications (e.g., frequency, power, amplitude, vacuum) against predicate devices that have already been cleared for marketing. The ultimate "ground truth" for a 510(k) is the demonstration of substantial equivalence to an existing legally marketed device.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This summary does not involve machine learning or AI with a training set. The "training" in the context of a medical device would refer to the development and refinement process, which would be covered by design controls and verification/validation activities, not a distinct "training set" of data.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set in the context of AI/ML. The development and verification of the device's performance are based on engineering specifications, testing against known physical and biological principles, and comparison to the proven performance of predicate devices.

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