(24 days)
LYSONIX 2000/3000 Systems are indicated for the liquefaction and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery Applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.
is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation / aspiration unit is provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.
The provided FDA 510(k) summary for the Misonix Inc. LYSONIX 2000/3000 Ultrasonic Surgical Aspirator Systems focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and performance data from a clinical study.
Therefore, much of the requested information regarding acceptance criteria, specific device performance metrics, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document. The 510(k) process for this device relies on proving that the new device is as safe and effective as existing legally marketed devices, often through comparison of design, materials, and operating parameters, and adherence to voluntary standards.
Here's an attempt to answer what can be extracted from the document, along with explanations for what is not available due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated as acceptance criteria for specific performance metrics in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to voluntary safety standards.
- Acceptance Criteria (Implied/General): The device is substantially equivalent to legally marketed predicate devices regarding design, materials, operating parameters, and intended use. It also meets voluntary safety and EMC standards.
- Reported Device Performance:
- Intended Use: Liquefaction and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery Applications. Also indicated for the liquefaction and aspiration of localized subcutaneous fatty deposits for aesthetic body contouring.
- Operating Parameters: Generates a 22.5 kHz electrical signal, piezoelectric crystals vibrate at the same frequency, and a titanium tip amplifies the vibration. Irrigation/aspiration unit provided.
- Safety/EMC: Designed and tested to pass UL 2601-1, EN 60601-1, EN 60601-1-2 (for LySonix 2000/3000), and FCC Part 18 EMC Requirements.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/not provided. The submission does not describe a clinical "test set" in the context of performance metrics that would require a defined sample size (e.g., number of patients, images, or cases). Instead, it relies on comparison to predicate devices and adherence to engineering standards.
- Data Provenance: The document does not describe specific clinical data provenances (e.g., country of origin, retrospective/prospective) because it's not a clinical efficacy study involving patient data endpoints.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/not provided. Ground truth establishment by experts for a test set is not part of this 510(k) submission, as it's not a study evaluating diagnostic or treatment outcomes against a gold standard in a clinical population.
4. Adjudication method for the test set
- Not applicable/not provided. Adjudication methods are relevant for studies comparing interpretations or outcomes, which is not the focus of this 510(k) submission.
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
- No. This device is an ultrasonic surgical aspirator, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical instrument and does not feature algorithms that would perform "standalone" operations without human interaction in a diagnostic or interpretive sense. The document explicitly states: "This device does not contain software."
7. The type of ground truth used
- Not applicable/not provided for clinical outcomes. The "ground truth" in this context refers to the established safety and effectiveness of the predicate devices and the adherence of the new device to recognized voluntary safety and electromagnetic compatibility (EMC) standards. There is no mention of pathology, outcomes data, or expert consensus being used to establish ground truth for performance metrics of the device itself beyond its design and intended function as a surgical tool.
8. The sample size for the training set
- Not applicable/not provided. There is no "training set" in the context of an algorithm or machine learning for this type of device submission.
9. How the ground truth for the training set was established
- Not applicable/not provided. As there is no training set mentioned, this question is not relevant.
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.