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Intended Use: The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is intended for use in minimally invasive ligament or fascia release.

Indications for Use: The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is indicated for:

• · Carpal tunnel release in the wrist
• Cubital tunnel release in the elbow
• · Trigger finger release in the hand

MicroAire's SmartRelease Endoscopic Soft Tissue Release System is comprised of the following components: the SmartRelease Endoscope, the SmartRelease Handpiece, and the SmartRelease Standard and Onyx Blade Assemblies. The system includes a set of accessory Manual Surgical Instruments. The SmartRelease Handpiece, the SmartRelease Endoscope, and the Manual Surgical Instruments are reusable after cleaning and subsequent sterilization. The SmartRelease Blade Assemblies are gamma sterilized and intended for single-use only.

The provided text is a 510(k) summary for the MicroAire® SmartRelease® Endoscopic Soft Tissue Release System. This document focuses on demonstrating that the subject device is substantially equivalent to a previously cleared predicate device (K181819). The key aspect of this submission is the addition of a new indication for use: "Trigger finger release in the hand."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily related to proving that this new indication does not introduce new questions of safety or effectiveness, given that the device itself is identical to the cleared predicate.

Here's the analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to demonstrating safety and effectiveness for the new indication. Since the device itself is identical to the predicate, the performance data provided focuses on the usability and safety of the device for trigger finger release.

Note: The document explicitly states: "As the subject device is identical in construction, geometry, functionality, and Intended Use to its cleared predicate, previous testing provided in the cleared K181819 demonstrates that the SmartRelease Endoscopic Soft Tissue Release System is safe and effective for its Intended Use. Nothing has changed with the SmartRelease System to alter that conclusion." This indicates that the core mechanical and material performance criteria were already met by the predicate and are considered met by the subject device due to identity.

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

• Test Set Description: A "User Validation" study was performed.
• Sample Size: "Twenty users participated."
• Data Provenance: The study involved "cadaver labs," implying a laboratory setting. The country of origin is not specified but is likely the US, given the FDA submission. The study is prospective in nature, as it was conducted specifically to evaluate the new indication.

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

The document does not describe "ground truth experts" in the typical sense of diagnostic imaging (e.g., radiologists interpreting images). Instead, the user validation involved clinical use in cadavers. The "experts" in this context would be the "Twenty users" who participated, acting as the "intended user groups." Their qualifications are not explicitly stated, but they are described as "appropriate users for the subject device's new Indication for Use," implying they are surgeons or medical professionals who would perform trigger finger release procedures.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense of diagnostic assessment adjudication (e.g., 2+1, 3+1). The user validation study likely involved direct observation of performance and evaluation against pre-defined usability and safety criteria, rather than a consensus-based review of diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported. This type of study is typically done for AI-driven diagnostic devices to compare human performance with and without AI assistance. The SmartRelease device is a surgical instrument, not a diagnostic AI. The user validation was to confirm that the device itself can be safely and effectively used for the new indication, not to assess improvement in human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a way, the mechanical and material performance testing of the device can be considered "standalone" as it evaluates the device's inherent properties. The document states: "previous testing provided in the cleared K181819 demonstrates that the SmartRelease Endoscopic Soft Tissue Release System is safe and effective for its Intended Use." And "Nothing has changed with the SmartRelease System to alter that conclusion." This confirms that the device components and system function were tested independently of clinical use.

7. The Type of Ground Truth Used

For the user validation study, the "ground truth" was the demonstrated safe and effective use of the device in cadaveric models for trigger finger release, and meeting pre-defined user needs. This is assessed through observed performance and compliance with usability criteria, rather than a diagnostic "ground truth" like pathology or outcomes data.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This device is a mechanical surgical instrument, not an AI/machine learning algorithm that requires a training set.

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

Not applicable (as above).

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