Search Results
Found 1 results
510(k) Data Aggregation
(82 days)
INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP
The Integra CUSA NXT Inferior Forward Bone Tip is an accessory 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 Integra CUSA NXT Inferior Forward Bone Tip (Inferior Forward Bone Tip) will attach to the Selector 24 kHz Neuro Short Handpiece (1523000M7) and will be controlled by the CUSA NXT Ultrasonic Surgical Aspirator System (CUSA NXT System). The CUSA NXT System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. The device allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The system consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a single use tip, and a suction/irrigation system (manifold tubing and cooling water canister).
The Inferior Forward Bone Tip has an abrasive surface that is oriented inferiorly and distally at the distal end of the tip. This configuration facilitates the use of the system in procedures where it is necessary for practitioners to orient the surgical tip in the bottom dead center or inferior orientation.
The Inferior Forward Bone Tip consists of a titanium tip with a titanium nitride coating, silicone flue and an ultem shroud.
The Inferior Forward Bone Tip will be supplied sterile and is intended for single use.
The Integra CUSA NXT™ Inferior Forward Bone Tip is an accessory to an ultrasonic surgical aspirator system. The provided text outlines the performance criteria and the non-clinical tests conducted to demonstrate the device meets these criteria. No studies involving human readers or comparative effectiveness are described, as this is a device for surgical aspiration, not an AI or imaging diagnostic tool.
Here's the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| Electromechanical Test (measures frequency, stroke, lateral movement, and power) | Passed frequency, stroke, lateral movement, and quiescent power acceptance criteria. |
| Lateral Load Test (applies a lateral load on the vibrating tip to evaluate robustness) | Performance of the tips was not affected after the application of the lateral load. |
| Dry Flue Test (checks the effect of ultrasonically vibrating a surgical tip without the presence of irrigation) | Performance of the tips was not affected when operated with no irrigation for the time specified. |
| Accelerated Stress Bone Cutting (tests the effect of bone cutting for extended periods of time) | 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 was found to be less than stated in the product specification. |
| Biocompatibility | No additional testing performed, as materials, manufacturing, and sterilization are the same as the predicate device, implying satisfactory existing biocompatibility. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical bench testing. There is no test set of data in the context of imaging or AI analysis. The tests were performed on the device itself. Data provenance, country of origin, and retrospective/prospective status are not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical surgical device, and testing involves engineering and technical evaluations, not expert-derived ground truth from medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert reviews of data, which are not described here.
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 or imaging device. No MRMC study was conducted or is relevant to the device's function.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the physical device testing, the "ground truth" is established by engineering and performance specifications and direct measurement against those specifications, as well as comparison to the performance of the predicate device (K111741). For example, the thermal rise should be less than specified, and the tip should not break.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
Ask a specific question about this device
Page 1 of 1