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510(k) Data Aggregation
(82 days)
INTEGRA BURLINGTON MA, INC.
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.
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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.
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(63 days)
INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI
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.
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.
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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