Search Results

The SurgView™ Integrated Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.

The SurgView™ Integrated Imaging System is a video endoscope/arthroscope imaging system consisting of the following components:

1. A Light Source/Display/Image Capture device that includes a monitor, image processor, Xenon light source, camera unit, and a camera hand piece with integrated fiberoptic cable.
2. A semi-rigid Fiberoptic Scope designed for one time use, in a variety of diameters, lengths, and viewing angles.
3. Supplemental Instruments that can be used interchangeably throughout the procedure. They include a cannula, trocar, obturator, and cannula plug.
4. Procedural Kit that contains a variety of sterile items used to aid in the procedure.

Here's a summary of the acceptance criteria and study information for the "SurgView™ Integrated Visualization System" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary, does not detail specific performance acceptance criteria or report a direct comparison of the device's performance against such criteria using quantitative metrics (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on:

• Similarities in intended use, design, and materials, physical characteristics and geometry.
• Compliance with recognized electrical safety and electromagnetic compatibility (EMC) standards.

Therefore, instead of a direct performance table, the "acceptance criteria" are implied to be adherence to the design and safety characteristics of the predicate devices.

Missing Information: It's important to note that this 510(k) summary does not provide specific quantitative performance metrics (e.g., resolution, light intensity, image fidelity) for the device, nor does it explicitly state acceptance thresholds for such metrics. The acceptance is based on demonstrating equivalence, primarily through non-clinical testing and adherence to standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. The document states, "Clinical testing was not used to establish substantial equivalence to predicate devices." The evaluation was based on non-clinical testing and comparison to predicate devices, which typically does not involve a "test set" in the sense of clinical data.
• Data Provenance: Not applicable, as clinical testing was not performed for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. No clinical test set was used, and thus no ground truth established by experts in this context.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. The device is a visualization system (arthroscope/endoscope) and there is no mention of artificial intelligence (AI) or an MRMC study in the provided text.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. The device is not an AI algorithm; it's a visualization system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not applicable for performance evaluation against a specific clinical ground truth. The "ground truth" for the submission is the established safety and performance of the listed predicate devices, and the device's compliance with relevant electrical and EMC standards.

8. The Sample Size for the Training Set

• Not applicable. The device is not an AI algorithm that undergoes training.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. The device is not an AI algorithm, and therefore there is no training set or associated ground truth establishment.

Ask a specific question about this device