(160 days)
The Mentor Ultrasound Assisted Tissue Removal System indications for use are the ultrasonic liquefication and aspiration of soft tissue.
The Mentor Ultrasound Assisted Tissue Removal System is indicated for use for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications.
The principles of operation and technology incorporated in the Mentor Tissue Removal System are equivalent to ultrasonic surgical aspirator systems which use ultrasonic energy to liquefy selected tissues. The Mentor TRS performs the functions of ultrasonic tissue liquefication, irrigation/infiltration and aspiration. The user interface consists of digital and bar displays of manually controlled parameters. The system is controlled by the handpiece mounted switches or by traditional footpedal controls. The handpiece contains a piezoelectric transducer and connects by cable to the control module. The handpiece converts the electrical signal into ultrasonic mechanical vibrations which are amplified by the titanium cannula. The cannula may be used by itself or together with a stainless steel sheath which provides a path for irrigation. The irrigation and aspiration functions may be performed simultaneously or independently. The Control Module/Ultrasonic Generator is designed to operate with the complete integrated Mentor Tissue Removal System or as a "stand alone" unit used in conjunction with existing aspiration and irrigation equipment.
This 510(k) summary (K970471) for the Mentor Ultrasound Assisted Tissue Removal System does not contain the specific acceptance criteria or a detailed study report proving the device meets acceptance criteria as typically expected for performance claims. The document focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.
Therefore, many of the requested details cannot be directly extracted from the provided text.
Based on the provided information, here's what can be stated:
-
Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the document. The submission focuses on establishing substantial equivalence to predicate devices, implying that its performance characteristics are presumed to be similar without explicitly stating new acceptance criteria or presenting a performance study.
-
Sample size used for the test set and the data provenance: Not applicable. There is no mention of a test set or associated data provenance in this submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for a test set is not discussed.
-
Adjudication method for the test set: Not applicable. There is no mention of a test set or adjudication.
-
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 device is an ultrasonic surgical aspirator, not an AI-assisted diagnostic or interpretative system.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical tool, not an algorithm. The "Control Module/Ultrasonic Generator is designed to operate with the complete integrated Mentor Tissue Removal System or as a 'stand alone' unit used in conjunction with existing aspiration and irrigation equipment," refers to its operational flexibility as a hardware component, not standalone algorithmic performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no specific performance study with ground truth is detailed.
-
The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
-
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Key takeaway from the document:
The submission for the Mentor Ultrasound Assisted Tissue Removal System (K970471) focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, specifically the Morwel Corporation Ultra-Safe Ultrasonic Aspiration System (K962525) and the Valleylab CUSA System (K910696). The argument for safety and effectiveness is based on the device's "principles of operation and technology incorporated... are equivalent to ultrasonic surgical aspirator systems" and are "similar to other surgical devices with suction, ultrasound and irrigation functions which FDA has found to be substantially equivalent to pre-amendment devices."
The FDA's letter concurs with the substantial equivalence finding, allowing the device to be marketed. This type of 510(k) submission typically relies on comparing features, indications for use, and technological characteristics to predicates rather than presenting de novo performance study results with predefined acceptance criteria.
N/A