(90 days)
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.
| Characteristic | Acceptance Criteria (Predicate Device K970471) | Reported Device Performance (Mentor TRS Solid Probe) |
|---|---|---|
| Operating Frequency | 27 kHz | 27 kHz |
| Amplitude (maximum) | 130 µ peak-to-peak | 130 µ peak-to-peak |
| Attachment Method | Threaded screw fit | Threaded screw fit |
| Material | Titanium 6Al-4V | Titanium 6Al-4V |
| Outside diameter (O.D.) | 3 mm, 4 mm, 5 mm | 3 mm, 4 mm, 5 mm |
| Length | 4 to 45 cm | 4 to 45 cm |
| Inner diameter (I.D.) | 1.98 mm, 2.26 mm, 2.54 mm | Not Applicable (as it's a solid probe) |
| Tip Shape | Bullet and spherical | Spherical |
| Sterilization Method | Steam autoclave | Steam autoclave |
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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