(120 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Blade Assembly Actuation (proper deployment/retraction) | All test results demonstrated the MicroAire SMARTRELEASE Soft Tissue Release System can perform its intended use safely and effectively, including Blade Assembly Actuation. |
| Horizontal Deflection (within acceptable limits for stability) | All test results demonstrated the MicroAire SMARTRELEASE Soft Tissue Release System can perform its intended use safely and effectively, including Horizontal Deflection performance. |
| Vertical Deflection (within acceptable limits for stability) | All test results demonstrated the MicroAire SMARTRELEASE Soft Tissue Release System can perform its intended use safely and effectively, including Vertical Deflection performance. |
| Blade Sharpness (sufficient for cutting ligament/fascia) | All test results demonstrated the MicroAire SMARTRELEASE Soft Tissue Release System can perform its intended use safely and effectively, including Blade Sharpness. |
| Blade Piercing (sufficient for initial penetration) | All test results demonstrated the MicroAire SMARTRELEASE Soft Tissue Release System can perform its intended use safely and effectively, including Blade Piercing. |
| Performance in Cadaver Study (surgical efficacy and safety) | The system was evaluated by multiple surgeons per the instructions for use during a cadaver study. All test results demonstrated the system can perform its intended use safely and effectively. |
| Package and Distribution Testing (maintaining integrity) | The SMARTRELEASE® Endoscopic Soft Tissue Release System passed package and distribution testing. |
| Biocompatibility Testing (safety for human contact) | The SMARTRELEASE® Endoscopic Soft Tissue Release System passed applicable biocompatibility testing. |
| Sterilization Tray (meeting ANSI AAMI ST 77:2003 requirements) | The sterilization tray meets the requirements set forth in ANSI AAMI ST 77:2003. |
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.
§ 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.