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The XPS/PowerSculpt System with reciprocating adapter and suction cannula is indicated for the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.

The Power Control Unit, handpiece and principle of operation remain essentially the same as described in K984363. The standard blades that are used for tissue debridement and aspiration will be replaced by suction cannulae equivalent in design to predicate suction lipoplasty cannulae. Lastly, a removable adapter, similar to the adapter cleared for rasping in K983025, will be provided to translate the rotary action of the handpiece to a reciprocating action. The resulting reciprocation will facilitate the movement of the cannula through the adipose tissue.

The provided documents are a 510(k) notification and related FDA correspondence for the Xomed XPS/PowerSculpt System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with specific acceptance criteria and detailed performance metrics as expected for a typical AI/ML device submission.

Therefore, the requested information regarding acceptance criteria, specific study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment is not available in these documents.

The documents focus on the device's design, intended use, and comparison to legally marketed predicate devices to establish substantial equivalence based on technological characteristics and safety/effectiveness.

Here's what can be extracted and why the other information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable / Not Available. The 510(k) submission for the XPS/PowerSculpt System does not present specific acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that would be evaluated in a study with a test set. This type of evaluation is more common for diagnostic or AI/ML-driven devices.
• The FDA's substantial equivalence determination is based on the device having the same intended use and similar technological characteristics as predicate devices, without raising new questions of safety or effectiveness. The "performance" assessment is comparative, not based on meeting predefined numerical thresholds.

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

• Not Available. The document does not describe a "test set" in the context of a performance study with human subjects or retrospective data for evaluating accuracy. The device is a surgical system for tissue removal. The "test" it undergoes is primarily verification and validation of its mechanical and electrical components, alongside comparative analysis with existing devices.

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

• Not Applicable / Not Available. This device is a surgical instrument, not a diagnostic tool requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

• Not Applicable / Not Available. No test set or ground truth adjudication process is described.

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

• Not Applicable / Not Available. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. The XPS/PowerSculpt System is a surgical tool; therefore, this type of study is not relevant to its 510(k) submission.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable / Not Available. This device is a mechanical surgical system, not an algorithm or AI model.

7. Type of Ground Truth Used

• Not Applicable / Not Available. As mentioned, the device is a surgical instrument. "Ground truth" in the context of diagnostic accuracy is not relevant here. The "truth" for this device would relate to its ability to perform its intended mechanical function safely and effectively, which is assessed through engineering tests and comparison to predicates.

8. Sample Size for the Training Set

• Not Applicable / Not Available. This device is a surgical instrument, not an AI/ML model that requires a training set.

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

• Not Applicable / Not Available. Again, not an AI/ML model.

Summary of what the documents do provide related to equivalence:

• Device Name: XPS/PowerSculpt System
• Intended Use: For the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.
• Predicate Devices:
  • MicroAire PAD-100 "Power Aspiration Device" (K981922)
  • NuMED Power Cannula (510k unknown)
  • Various aspiration cannulae from Wells Johnson Company (K832520)
• Substantial Equivalence Rationale: The XPS/PowerSculpt System is considered substantially equivalent because it has the "same intended use and the same technological characteristics" as the predicate devices. Specifically, it consists of a console, handpiece, and disposable cannulae. An adapter converts rotary action to reciprocating action, simulating the manual motion of a surgeon using a standard aspiration cannula, reducing manual effort, and facilitating penetration of adipose tissue. The "end result and performance" are claimed to be equivalent to the predicate devices.

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