(62 days)
The XPS 3000 system with reciprocating adapter and suction cannlua is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.
The XPS 3000 system consists of a power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, rasps, and reciprocating cannulae.
Product: XPS 3000 System With Reciprocating Adapter And Suction Cannulae
Based on the provided FDA 510(k) summary (K010666), this document outlines the acceptance criteria and study information for the XPS 3000 System.
1. A table of acceptance criteria and the reported device performance
The provided document (K010666) is a 510(k) premarket notification for a medical device seeking substantial equivalence to a predicate device. It does not present specific quantitative acceptance criteria or detailed performance data from a dedicated study demonstrating how the device individually meets such criteria. Instead, the core of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device.
The study described is a substantially equivalent comparison.
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Operating Principle Equivalence: The new device operates using the same fundamental scientific principles as the predicate device. | The XPS 3000 system is stated to be "substantially equivalent in operating principle" to the predicate device, XPS / Powersculpt System (K992855). Both are described as systems with a power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, rasps, and reciprocating cannulae for tissue removal. |
| Technology Equivalence: The underlying technology used in the new device is the same or similar to that of the predicate device. | The XPS 3000 system is stated to be "substantially equivalent in... technology" to the predicate device. This implies they both utilize similar electromechanical components for tissue removal and fluid aspiration. |
| Overall Design Equivalence: The device's physical and functional design are comparable to the predicate. | The XPS 3000 system is stated to be "substantially equivalent in... overall design" to the predicate device. This suggests similar architecture, components, and interfaces. |
| Function Equivalence: The new device performs the same functions as the predicate device. | The XPS 3000 system is stated to be "substantially equivalent in... function" to the predicate device. Both are designed for removal of soft tissue and fluid during general surgical procedures, including suction lipoplasty. |
| Materials Equivalence: The materials used in the device are the same or similar, and do not raise new questions of safety or effectiveness, as those in the predicate device. | The XPS 3000 system is stated to be "substantially equivalent in... materials" to the predicate device. This indicates the use of comparable biocompatible and durable materials for the system's components. |
| Intended Use Equivalence: The new device is intended for the same medical purpose and indications as the predicate. | The XPS 3000 system's "Indications for Use" (removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring) are implied to be substantially equivalent to the predicate's indications. The 510(k) summary explicitly states "substantially equivalent in... intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The 510(k) summary does not describe a specific test set, its sample size, or data provenance in the way a clinical trial would. The "study" here is a comparison demonstrating substantial equivalence, not a performance study involving patient data or a specific test set of cases. The comparison is based on the technical specifications and intended use of the device against a known predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This type of information is generally found in clinical performance studies with diagnostic or AI devices, not in a substantial equivalence filing for a surgical tool where "ground truth" is a functional comparison, not an expert-annotated dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no described test set requiring expert adjudication for ground truth.
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. The XPS 3000 system is a surgical device for tissue removal, not an AI-assisted diagnostic or imaging interpretation tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The XPS 3000 system is a direct-use surgical tool, not an algorithm. Its performance is tied directly to its mechanical and electrical function, operated by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a 510(k) for a surgical device like the XPS 3000, "ground truth" relates to the established safety and effectiveness of the predicate device. The "ground truth" for the new device is its ability to perform its intended function safely and effectively, which in a 510(k) is demonstrated by its substantial equivalence to a device that has already met these criteria. This often involves:
- Bench testing: Verifying mechanical and electrical performance specifications.
- Biocompatibility testing: Ensuring materials are safe for human contact.
- Performance testing: Demonstrating the device can remove tissue and fluid as intended, often by comparing operational parameters (e.g., speed, torque, suction capabilities) to the predicate device.
- Prior clinical use history: The predicate device has a history of safe and effective use.
The document does not detail specific "ground truth" data types for the XPS 3000 but rather asserts its equivalence to the predicate, which would inherently have met these types of performance standards.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.