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The Mentor Contour Genesis System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications. It is also indicated for the liquefication and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.

The Mentor Contour Genesis System consists of the following components: ultrasonic generator, infiltrator, aspirator, ultrasonic handpiece, foot pedal(s), cannulae and cannulae sheaths, system cart, irrigation tubing set, infiltration tubing set, and aspiration tubing set.

The provided text describes a 510(k) premarket notification for the Mentor® Contour Genesis System, a device for ultrasound-assisted lipoplasty. It references a clinical study conducted to demonstrate substantial equivalence to a predicate device. However, the document does not present specific acceptance criteria in a table format with reported device performance against those criteria. It also doesn't detail the study information in the structured way requested.

Based on the information provided, here's what can be extracted and inferred, along with the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative or tabular format. Instead, it compares the new device (UAL) to a predicate device (SAL) based on safety and effectiveness measures.

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

• Sample Size for Test Set:
  • Total subjects enrolled: 366
  • UAL patients (test group): 180
  • SAL patients (control group): 186
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a clinical study comparing two treatments for a 510(k) submission, it is highly likely to be a prospective study. The country of origin is not specified, but typically for FDA submissions, studies are often conducted in the US or follow international clinical trial standards.

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

• The document mentions "a masked reviewer" assessed body contour measurements.
• It does not specify the number of experts (beyond "a masked reviewer"), their qualifications (e.g., radiologist with X years of experience), or how they established the 'ground truth' for other measures like satisfaction or self-esteem (which are patient-reported outcomes).

4. Adjudication Method for the Test Set:

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For patient-reported outcomes like satisfaction and self-esteem, adjudication is typically not applicable as the patient's report is the primary data. For body contour measurements, "a masked reviewer" implies a single assessment, not a consensus or adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• This study was a clinical comparative effectiveness study, but specifically comparing device performance (UAL vs. SAL lipoplasty), not a multi-reader multi-case study comparing human readers with and without AI assistance.
• Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable to this document as it's not an AI device.

6. Standalone (Algorithm Only) Performance:

• This is not an AI device, so standalone algorithm performance is not applicable. The study evaluates the performance of a medical device (Mentor® Contour Genesis System) used by a surgeon.

7. Type of Ground Truth Used:

• Primary Safety Measures: Adverse events (patient-reported and/or clinician-observed).
• Secondary Effectiveness Measures:
  • Patient-reported overall satisfaction.
  • Patient-reported feelings towards each body area treated.
  • Patient-reported self-esteem (using Rosenberg Self-Esteem scale and Body Esteem scale).
  • Body contour measurements as assessed by a masked reviewer.

8. Sample Size for the Training Set:

• The document describes a clinical study to compare the device, which serves as the test set for demonstrating equivalence. It does not mention a separate training set for the device itself. This device is a physical medical system (ultrasonic generator, handpiece, etc.), not a machine learning algorithm that requires a training set.

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

• As this is not an AI/ML device, a separate training set and its associated ground truth establishment are not applicable.

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The Mentor Ultrasound-Assisted Tissue Removal System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications.

The Mentor Ultrasound-Assisted Tissue Removal System (TRS) consists of the following components: ultrasonic generator, infiltrator, aspirator, ultrasonic handpiece, foot pedal(s), hollow cannulae and cannulae sheaths, system cart, irrigation tubing set, infiltration tubing set, and aspiration tubing set. The purpose of this 510(k) notification is to add a solid probe as an accessory to the Mentor TRS. The solid probe is composed of Titanium 6Al-4V and will be available in three diameters (3 mm, 4 mm, and 5 mm) in lengths of 4 cm to 45 cm. The probe is connected to the handpiece with a threaded screw-fit. The tip has a spherical shape.

The provided document is a 510(k) premarket notification for a medical device accessory (Mentor® Solid Probe) and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a clinical trial report or a more comprehensive validation study. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

However, based on the information provided, we can infer the "acceptance criteria" and "device performance" in terms of substantial equivalence to the predicate device.

Here's an attempt to answer your request based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" are implicitly that the new device's characteristics are either identical to or do not raise new questions of safety and effectiveness compared to the predicate device. The "reported device performance" is the direct comparison of the new device's specifications to those of the predicate.

The document also states: "The Mentor solid probe is also substantially equivalent to other solid probes currently on the market, such as the solid probe used with the SMEI Sculpture ultrasonic aspiration system which received clearance under 510(k) K971609. Both are made of solid titanium and are used in the same manner for the same intended use. The Mentor solid probe has a spherical tip, while the SMEI Sculpture probe does not." This implies that the broad characteristics and intended use align with another predicate for solid probes.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of clinical or performance data for the solid probe. The "test" here refers to a comparison of the device's technical specifications to those of a predicate device. Therefore, there is no sample size for a test set, nor specific data provenance (e.g., country of origin, retrospective/prospective) as there wasn't a study involving human subjects or collected data for the new accessory's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This 510(k) submission is for an accessory based on substantial equivalence to predicate devices, not a study requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There was no test set or adjudication process described for the solid probe accessory. The FDA reviewed the submission based on the provided technical specifications and comparison to predicate devices.

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-assisted device, and no MRMC study was conducted or described in the provided document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical probe, an accessory, and does not involve algorithms or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the typical sense of clinical studies. The "ground truth" for this 510(k) submission is the specifications and performance of the legally marketed predicate devices, to which the new device (solid probe) is compared to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not involve training sets.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device and does not involve training sets or associated ground truth establishment.

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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method for the test set: Not applicable. There is no mention of a test set or adjudication.

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 device is an ultrasonic surgical aspirator, not an AI-assisted diagnostic or interpretative system.

6. 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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no specific performance study with ground truth is detailed.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.

9. 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.

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