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The ConMed Looking Glass System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, sinuscopic, plastic and as an accessory for microscopic surgery.

The Looking Glass™ 4K Integrated Visualization System (Looking Glass System, LG4K) is a combined system that provides image visualization to the user during minimally invasive surgical procedures. The system is comprised of a 4K monitor with a built-in camera control electronics and the Camera Head. The Camera Head is connected to the Looking Glass via Cable Connector Interface (CCI).

The Camera Head is a hand-held, sterilizable portion of the system which gets connected to the CCI via electrical cable. The Looking Glass System is designed to be used with Standard Eye-Cup Endoscopes. Additionally, the system can be used in conjunction with other light sources, e.g. Xenon or LED. The Camera Head is offered in non-sterile configuration and requires sterilization prior to use via Autoclave Method.

The provided text is a 510(k) summary for the ConMed Looking Glass™ 4K Integrated Visualization System. It describes the device, its intended use, and how it is substantially equivalent to a predicate device. However, this document does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria, particularly in the context of an AI/ML-driven device.

This 510(k) is for an endoscopic visualization system, which is essentially an upgraded camera and monitor for surgical procedures. It's not an AI/ML device that performs diagnostic or prognostic tasks, nor does it involve human readers interpreting images with or without AI assistance. Therefore, many of your questions (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to the information provided in this document.

The "Performance Testing" section broadly states that tests were conducted to demonstrate the device performs as intended and meets specifications. It lists general categories like "System Testing" (Verification, Validation), "Standard Compliance" (EMC, Electrical Safety, Endoscopic Equipment Safety), and "Risk analysis." It also mentions software verification and validation activities per IEC 62304. However, it does not provide:

• Specific acceptance criteria values (e.g., minimum resolution, color accuracy, latency thresholds).
• Reported device performance values against those criteria.
• Details about the methodology of these tests, such as the sample size of tested units, data provenance, or the nature of "ground truth" (which would simply be engineering specifications for hardware performance, not clinical ground truth as with diagnostic AI).
• Information about human expert involvement in establishing ground truth for performance, as this is a hardware system, not an image interpretation system.
• Any mention of AI/ML components, training sets, or comparative effectiveness studies involving human readers.

In summary, based only on the provided text, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I answer questions related to AI/ML device validation. The document indicates the device is a hardware upgrade to an existing visualization system, not an AI/ML diagnostic tool.

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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.

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The IVS is used in providing illumination for endoscopic procedures and transmitting an image from an endoscope to a viewing monitor, which is integral to the system.

The Integrated Visualization System is comprised of a light source, CCD camera, and 10.4" flat panel monitor, all housed in a single unit weighing approximately seven pounds. It has an immersible camera head with minimum illumination requirements of 1 lux. The light source uses 24 watts and outputs a color temperature of 5460°K.

This 510(k) notification describes an "Integrated Visualization System" which is a light source, camera, and a monitor in one unit. This device is a medical apparatus designed to provide illumination and image transmission for endoscopic procedures. It is not an AI/ML device, and thus the requested information (acceptance criteria, study details, expert involvement, ground truth, training data, etc.) is not applicable in the context of AI/ML device evaluation. The document focuses on performance specifications (like light output, camera illumination requirements) and comparisons to predicate devices in terms of its technical function, not its diagnostic accuracy or AI performance.

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