(232 days)
For introduction of instrumentation through a portal for surgical procedure.
This device is intended to puncture the tissue for making the path of surgical instrument in the orthopedic surgery. It is consisted with cannula and trocar. This device is single-use.This device has 3 types. (Threaded type, Smooth type, All smooth type)
The provided text is a 510(k) Pre-Market Notification for a medical device called the "JOINIX Cannular System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's clinical efficacy or diagnostic accuracy through extensive clinical trials.
As such, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning clinical performance (e.g., diagnostic accuracy, human reader improvement with AI assistance, MRMC studies, or detailed ground truth establishment for clinical data).
The "Performance data" section (Section 6) and "Predicate device comparison table" (Section 7) describe bench testing only, focusing on the device's physical properties, biocompatibility, and functional equivalence to a predicate device for its intended mechanical purpose (introduction of instrumentation through a portal for surgical procedure).
Here's why the requested information cannot be extracted from this document:
- No Clinical Study: The document explicitly states "Bench test were performed." and lists mechanical and biocompatibility tests. There is no mention of a clinical study involving human subjects or real-world data collection for performance evaluation in a diagnostic or clinical decision-making context.
- Device Type: The JOINIX Cannular System is an arthroscope, a surgical instrument used to create a portal. Its performance is assessed on its mechanical properties, material safety (biocompatibility), and functionality as a conduit, not on its ability to interpret medical images, make diagnoses, or assist human experts in complex tasks that would require accuracy metrics (like sensitivity, specificity, or AUC).
- 510(k) Scope: A 510(k) submission primarily aims to show that a new device is "substantially equivalent" to a legally marketed device (predicate device). This often relies on comparative performance against the predicate in bench tests or, if applicable, comparisons of design, materials, and intended use, rather than de novo clinical outcome studies demonstrating superiority or specific accuracy thresholds in a clinical setting.
Therefore, I cannot provide a table of acceptance criteria for clinical performance, details on test set sample sizes, expert qualifications for ground truth, MRMC studies, or training set details because this document pertains to a mechanical surgical instrument and its bench test performance for 510(k) clearance, not a diagnostic or AI-driven device requiring clinical performance validation.
§ 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.