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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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The SMARTRELEASE® Endoscopic Soft Tissue Release System is indicated for use in minimally invasive ligament or fascia release:

• Carpal tunnel release in the wrist
• Cubital tunnel release in the elbow ●
• Plantar fascia release in the foot
• Gastrocnemius aponeurosis recession in the leg .

MicroAire's SMARTRELEASE® Endoscopic Soft Tissue Release System is comprised of the following components: the SMARTRELEASE® Endoscope, the SMARTRELEASE® Handpiece, the SMARTRELEASE® Standard and Onyx Blade Assemblies. The system includes a set of 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.

This FDA 510(k) summary (K211297) describes the SMARTRELEASE® Endoscopic Soft Tissue Release System. However, it does not contain the detailed information necessary to fully address all aspects of your request, particularly regarding specific acceptance criteria metrics and a rigorous comparative effectiveness study with AI assistance. This document primarily focuses on establishing substantial equivalence to a predicate device for marketing clearance, not on a detailed performance study with AI.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions a "User Design Validation" and states that the "product meets the documented User Needs for the device" and "confirms that the device is safe and effective." However, it does not provide specific, quantifiable acceptance criteria or detailed performance metrics from this validation. It only states a qualitative finding of safety and effectiveness.

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

• Sample Size: The "User Design Validation" involved 15 orthopedic and foot-specialist surgeons. The study was conducted on cadaver studies for plantar fascia and gastrocnemius releases.
• Data Provenance: The study appears to be prospective as it involved a validation study specifically designed for this submission. The country of origin of the data is not explicitly stated, but given it's an FDA submission for a US company, it's likely primarily US-based.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: 15 orthopedic and foot-specialist surgeons participated in the user design validation. The document implies these surgeons were the "users" evaluating the device's performance, effectively serving to establish the practical "ground truth" of its usability and effectiveness in a simulated surgical environment.
• Qualifications: "Orthopedic and foot-specialist surgeons." Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method for the test set. The validation seems to have been a direct assessment by the 15 surgeons, without mention of a separate panel or formal adjudication process for disagreements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done (and effect size of human reader improvement with AI):

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a surgical instrument, not an AI-based diagnostic or assistive device. Therefore, there is no discussion of human readers, AI assistance, or an effect size for human improvement with AI.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

• Not applicable. This device is a surgical instrument, not an algorithm or AI system. Its performance inherently involves a human operator (the surgeon).

7. The Type of Ground Truth Used:

• The "ground truth" in this context is the user-reported safety and effectiveness in a cadaveric setting, as assessed by the 15 participating surgeons during the "User Design Validation." It's based on their practical experience and evaluation of the device's performance in simulated procedures. This is a form of expert assessment/consensus on practical utility and function rather than, for example, pathological confirmation of a diagnosis.

8. The Sample Size for the Training Set:

• Not applicable. This document describes a medical device (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. As above, there is no training set for a device of this type.

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The MicroAire SMARTRELEASE® Endoscopic Soft Tissue Release System is indicated for use in minimally invasive ligament or fascia release:

• Carpal tunnel release in the wrist
• Cubital tunnel release in the elbow

MicroAire's SMARTRELEASE® Endoscopic Soft Tissue Release System is comprised of four (4) components: The SMARTRELEASE® Endoscope, the SMARTRELEASE® Handpiece, the SMARTRELEASE® Standard and Low Profile Blade Assemblies and the SMARTRELEASE® Sterilization Tray. In addition, the system includes a set of FDA Class 1 Manual Surgical Instruments. The SMARTRELEASE® Handpiece, the SMARTRELEASE® Endoscope, and the Manual Surgical Instruments are re-usable after cleaning and subsequent sterilization in the SMARTRELEASE® Sterilization Tray. The SMARTRELEASE® Blade Assemblies are gamma sterilized, single-use devices.

The provided text describes the MicroAire SMARTRELEASE® Endoscopic Soft Tissue Release System and its 510(k) summary, which outlines the device's technical characteristics, intended use, and comparison to predicate devices, along with a summary of supporting data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a tabular format with corresponding reported performance metrics. Instead, it generally states that the device "passed" various tests or "demonstrated" the intended use safely and effectively.

Based on the "Summary of Supporting Data," the following functional tests were performed. The acceptance criteria for these would implicitly be successful completion and performance as intended.

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

• Test Set Sample Size: The document mentions a "cadaver study" where the system was "evaluated by multiple surgeons." However, it does not specify the number of cadavers used or any other quantitative sample size for the functional tests.
• Data Provenance: The document does not explicitly state the country of origin of the data. The study appears to be prospective in the sense that MicroAire conducted these tests specifically to support their 510(k) submission.

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

• Number of Experts: The document states the cadaver study was evaluated by "multiple surgeons." A specific number is not provided.
• Qualifications of Experts: The experts are identified as "surgeons," which implies they are medically qualified to assess surgical device performance. No specific details on their years of experience or sub-specialty (e.g., orthopedic surgeons, hand surgeons) are provided.

4. Adjudication Method for the Test Set:

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the cadaver study or other functional tests. It simply states that "multiple surgeons" evaluated the system, implying a consensus or individual assessment against predetermined criteria.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study appears to be focused on demonstrating the safety and effectiveness of the device itself rather than comparing human reader performance with and without AI assistance. The device is a surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• This question is not applicable to the device described. The MicroAire SMARTRELEASE® Endoscopic Soft Tissue Release System is a physical surgical instrument system, not an algorithm or software-only device. Therefore, a standalone performance study without human involvement is not relevant in this context. The functional tests and cadaver study describe the direct performance of the physical device components.

7. Type of Ground Truth Used:

• For the cadaver study, the ground truth was established by expert assessment/consensus (the evaluation by "multiple surgeons") regarding the device's ability to perform its intended use safely and effectively in a simulated surgical environment (cadavers).
• For the functional tests (Blade Assembly Actuation, Horizontal and Vertical Deflection, Blade Sharpness, Blade Piercing, etc.), the ground truth would have been based on engineering specifications and performance standards.

8. Sample Size for the Training Set:

• This question is not applicable as the device is a physical surgical instrument and not an AI/machine learning algorithm that requires a training set.

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

• This question is not applicable for the same reason as point 8.

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