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The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) 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 indications for use for the NXT system have not changed due to the addition of the NXT Bone Tips.

Device Description

The NXT Bone tips will attach to the Selector 24 kHz Neuro Short Handpiece (1523000M7) and will be controlled by the CUSA NXT console. Ultrasonic surgical aspirators facilitate the removal of cellular and other unwanted soft and hard (e.g. bone) tissue. These systems provide selective tissue disintegration with simultaneous irrigation and aspiration. The modification is intended to provide improved visualization due to the protruded abrasive cutting surface, concomitant with improved relief geometry to enable fine and precise shaving or cutting when fragmenting, emulsifying and aspirating hard tissue. There are two NXT Bone Tips. The Superior Forward Bone Tip has an abrasive surface that is oriented superiorly and distally at the distal end of the tip. The Superior Reverse Bone Tip has an abrasive surface that is oriented superiorly and proximally at the distal end of the tip.

The NXT Bone Tips consist of a titanium tip with a titanium nitride coating, silicone flue and an ultem shroud.

The NXT Bone Tips will be supplied sterile and are intended for single use.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Electromechanical Test (frequency, stroke, lateral movement, quiescent power)	Device meets specified frequency, stroke, lateral movement, and quiescent power limits.	Passed frequency, stroke, lateral movement, and quiescent power acceptance criteria.
Lateral Load Test (robustness under lateral load)	Performance of tips is not affected after application of lateral load.	Performance of the tips was not affected after the application of the lateral load.
Dry Flue Test (operation without irrigation for specified time)	Performance of tips is not affected when operated with no irrigation for specified time.	Performance of the tips was not affected when operated with no irrigation for the time specified.
Accelerated Stress Bone Cutting (effect of extended bone cutting)	No breakage of the abrasive surface occurs.	No breakage of the abrasive surface occurred.
Measurement of Thermal Rise During Ultrasonic Aspiration of Representative Tissue	Thermal rise in tissue field during tissue removal is less than stated product specification.	Thermal rise in tissue field during tissue removal was found to be less than stated in the product specification.
Biocompatibility	Materials have the same chemical formulations, manufacturing processes, and sterilization as predicate device.	Since the modified device uses materials that have the same chemical formulations, same manufacturing and same sterilization processes as in the predicate device, additional testing was not performed.

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

The document does not explicitly state sample sizes for each test in the non-clinical study. It describes the individual tests performed. The data provenance is internal to Integra Burlington MA, Inc., as these are non-clinical studies conducted to support a 510(k) submission. Therefore, it is retrospective as it was conducted prior to submission.

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

This information is not applicable. The study involves non-clinical performance and safety testing of a medical device, not evaluation of medical images or diagnoses requiring expert ground truth establishment. The "ground truth" here is objective physical and mechanical performance measurements against established engineering specifications.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert consensus on subjective evaluations. The non-clinical tests described involve objective measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing of a device's physical and mechanical performance, not its comparative effectiveness with human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable. The device described is a surgical instrument (ultrasonic surgical aspirator tips), not an algorithm or AI system. The tests evaluate the device's standalone physical and mechanical performance.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the defined engineering specifications and performance limits for the Integra™ CUSA NXT™ Bone Tips. These are established based on the safety and effectiveness requirements for similar devices and the intended function of the device (fragmentation, emulsification, and aspiration of tissue). For biocompatibility, the ground truth is established by the equivalence of materials, manufacturing, and sterilization processes to a predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. The document describes the testing of a medical device, not the training of an AI algorithm.

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

This information is not applicable, as there is no training set for an AI algorithm. The tests conducted are to verify the device's performance against predefined engineering and safety specifications.

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