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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

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.

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when used with a fiberoptic endoscope, this device can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.

The MYELOTEC VIDEO GUIDED CATHETER (VGC) consists of a flexible double lumen catheter, steering handle and associated ports for access to the lumens. The catheter has a built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. Each lumen is one (1) mm in diameter. The design allows the use of a flexible fiber optic endoscope for visual examination of the area and surrounding tissues at the distal end of the catheter. This visual examination then allows the physician to diagnose the potential causes of neural distress and pain.

The port on the second lumen allows the injection of saline to expand the space and expose the source of distress for viewing and treatment. The port also facilitates the connection of syringes to deliver physician selected therapeutic agents as appropriate to their diagnosis.

The provided text is a 510(k) notification summary for the MYELOTEC VIDEO GUIDED CATHETER II. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications for the device.

Therefore, I cannot provide the requested information from the given text.

The document mainly includes:

• Contact information and submission date
• Device name, classification, and predicate device
• Description and intended uses of the device
• New indications for use
• A comparison table between the MYELOTEC VGC and the RACZ Tun-L-Kath, highlighting differences in attributes like length, lumen diameter, number of lumens, endoscope capability, and steerability.
• An FDA letter confirming the review and substantial equivalence determination.
• An enclosure reiterating the intended use/indications.

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The Myeloscope is intended to be used by physicians for the illumination and The Mydlescope is intenthe epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.

The Myelotec Myeloscope is a flexible fiberoptic system that includes a video guided catheter that allows steering of the fiberoptic scope. The fiberoptic scope is a reusable device that is supplied non-sterile with instructions for cleaning, sterilization and re-use. The video guided catheter is a sterile, disposable device.

The provided document is a 510(k) premarket notification letter from the FDA for a device called Myeloscope. It does not contain acceptance criteria or a detailed study proving the device meets acceptance criteria.

The 510(k) summary only briefly mentions some performance and safety testing. Therefore, I cannot complete the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted from the text:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set or the data provenance. It only mentions "performance testing of the video guided catheter."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not mentioned in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not mentioned in the document.

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
No MRMC study was mentioned. The device described is a physical scope, not an AI system for image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not specified. The performance testing appears to be functional and safety testing of the device itself (e.g., flexibility, biocompatibility), not related to diagnostic accuracy against a ground truth for disease.

8. The sample size for the training set
Not applicable. No training set is mentioned as this is a physical device subject to performance and safety testing, not an AI/ML model that requires training.

9. How the ground truth for the training set was established
Not applicable (see point 8).

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