(57 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Qualitative: Safe and effective for indicated uses (carpal tunnel, cubital tunnel, plantar fascia, gastrocnemius aponeurosis recession). | The device was found to be "safe and effective when used according to the instructions for use" and "meets the documented User Needs for the device." |
| Comparative: As safe and effective as the predicate device. | "All testing demonstrated that the SMARTRELEASE® Endoscopic Soft Tissue Release System is as safe and effective as the predicate device." |
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.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.