(304 days)
The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that are 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 Extended Length Tip (ELT) has been designed to be used with the 35kHz Handpiece of the CUSA Selector and CUSA NXT Ultrasonic surgical aspirators. 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 design of the 35 kHz Fine tip that is currently used with the 35kHz Handpiece has been modified to increase the working length of the device and reduce the bend angle. This will allow the device to be used in procedures where the surgeon requires a longer tip. The distal end of the ELT will have a flat annulus and two pre-aspiration holes. The ELT will be supplied sterile and is intended for single use.
The provided text describes a 510(k) summary for the Integra™ CUSA NXTTM Extended Length Tip, an accessory to ultrasonic surgical aspirator systems. The summary includes non-clinical tests to demonstrate substantial equivalence to predicate devices, focusing on the device's physical and performance characteristics rather than clinical diagnostic performance. Therefore, many of the requested fields related to diagnostic studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance) are not applicable to this submission.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by demonstrating that the new tip performs "the same" as or "less" than the predicate device in terms of potential adverse effects (like heating) while maintaining equivalent functional performance (like tissue removal rate).
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electromechanical | Same frequency, stroke, lateral movement, and fragmentation power as the predicate device (35 kHz Fine Tip). Implies similar heating potential. | The modified tip has the same stroke, and therefore the same fragmentation power, as the predicate device (35 kHz Fine Tip). This indicates similar heating potential. Performance for frequency and lateral movement was also confirmed to be the same. |
| Acoustic Power Transfer | Equivalent or less acoustic power transfer in liquid compared to the predicate device (35 kHz Fine Tip, K021989). Implies reduced heating potential. | The modified tip has less acoustic power transfer in liquid as the predicate device (35 kHz Fine Tip, K021989). This indicates reduced heating potential. |
| Tissue Removal Rate & Power Usage | Equivalent tissue removal rate and power used during tissue removal as the predicate device (35 kHz Fine Tip, K021989). | The modified tip and predicate device (35 kHz Fine Tip, K021989) remove tissue at an equivalent rate, using equivalent power. |
| Thermal Rise During Aspiration | Equivalent or less thermal rise in the tissue field during tissue removal compared to the predicate device (35 kHz Fine Tip, K021989). | Thermal rise in tissue field during tissue removal was found to be less for the new tip than the predicate device (35 kHz Fine Tip, K021989). |
| Biocompatibility | Materials used should have the same chemical formulations, manufacturing, and sterilization processes as the predicate device, or additional testing performed. | 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, but test results on the predicate device material were included. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable. This was a non-clinical, benchtop study comparing the performance characteristics of the new tip against a predicate device, not a study involving patient data or a test set in the traditional sense of a diagnostic device.
- Data provenance: Not applicable. The tests were performed in a lab setting by the manufacturer (Integra Burlington MA, Inc.).
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)
- Not applicable. This was a non-clinical, benchtop study. No expert review of patient data was involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This was a non-clinical, benchtop study. No adjudication of patient cases was involved.
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
- Not applicable. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" equivalent in this context is the performance of the legally marketed predicate device (35 kHz Fine Tip, K021989). The study's goal was to demonstrate that the new device is substantially equivalent to this predicate in terms of safety and performance.
8. The sample size for the training set
- Not applicable. This is a non-clinical submission for a surgical instrument accessory, not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set or associated ground truth was established for this submission.
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