Search Results
Found 1 results
510(k) Data Aggregation
(187 days)
The J-Scope System is an endoscopic device intended to be used by physicians for introduction of fluids to assist in visualization of intra-articular structures for arthroscopic diagnosis, as well as for surgical procedures using a second J-Scope or other arthroscopic device. It is indicated for use in the shoulder, hip, wrist, ankle, knee, and elbow joints.
The J-Scope Tissue Visualization & Assessment Mini-Cannula Kit is a single-use, disposable small diameter, 14-gauge needle mini-cannula device which, when coupled with the J-Scope semi-rigid or flexible Arthroscope, provides convenient and precise arthroscopic visualization of both major and minor joints. The micro-invasive design of the system allows the procedure to be performed comfortably with the patient under local anesthesia.
This 510(k) submission (K122411) for the J-Scope Tissue Visualization & Assessment Mini-Cannula Kit and J-Scope Tissue Visualization & Assessment Arthroscope does not contain information about clinical studies with acceptance criteria, human reader performance, or AI assistance.
The submission focuses on establishing substantial equivalence to a predicate device (Henke Sass Wolf Arthroscope, K080560) based on design, materials, and performance standards testing.
Therefore, most of the requested information regarding acceptance criteria derived from clinical studies, human reader performance, and AI assistance cannot be extracted from the provided text.
Here is a breakdown of what can be inferred or is explicitly stated:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (J-Scope System) |
|---|---|
| Biocompatibility | Conformance with ISO 10993: Biological Evaluation of Medical Devices. (Implies meeting the safety requirements for patient contact). |
| Electrical Safety | Conformance with IEC 60601-2-18 - Medical Electrical Equipment - Particular requirements for the safety of endoscopic equipment, and EN60601-2-18. (Implies meeting electrical safety and performance requirements for endoscopic devices). |
| Sterilization | Conformance with ISO 11135-1:2007. Sterilization of Health Care Products-Ethylene Oxide, reference 7.1, Product Adoption and Process Equivalency for Ethylene Oxide Sterilization. (Implies that the device can be effectively sterilized and maintains sterility). |
| Shelf Life | Expiration Dating tests were performed. (Implies that the device maintains its function and sterility for its stated shelf life). |
| Component Validation | System component validation testing was performed. (Implies that individual components and their interaction meet specified functional requirements). |
| Substantial Equivalence | "The technological differences between the HSW Arthroscope and the J-Scope System do not raise any new questions of safety or effectiveness and testing demonstrates that the J-Scope is as safe and effective as the predicate devices." (The ultimate acceptance criterion for 510(k) clearance is demonstrating that the device is as safe and effective as a legally marketed predicate device. This is the overarching "performance" demonstrated through the described testing.) |
2. Sample size used for the test set and the data provenance
- The submission does not describe a clinical test set with a sample size for evaluating clinical performance. The testing mentioned refers to engineering and regulatory compliance testing (e.g., biocompatibility, electrical safety, sterilization).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no mention of a test set requiring expert-established ground truth for clinical performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no mention of a clinical test set that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an arthroscope, a physical medical device for visualization and surgical procedures, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The J-Scope is a physical device that is inherently human-in-the-loop, requiring a physician for its operation and interpretation of what is viewed through it. It is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The submission focuses on device safety and performance criteria evaluated through engineering and regulatory standards rather than clinical outcomes or diagnostic accuracy. "Ground truth" in this context would likely refer to established engineering standards and specifications.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set described.
Ask a specific question about this device
Page 1 of 1