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Olympus Endoscopic System for Lumbar Hernia Discectomy and its ancillary equipment are intended for visualizing lumbar disc, lumbar herniated disc material and lumbar paravertebral tissue, and aiding in search and removal of vertebral bone and nucleus material.

The Olympus Endoscopic System for Lumbar Hernia Discectorny and Accessories consist of the following components:

• Initial Placement Instruments (Guide Needle, Dilators, Mandolin, Flexible Sheath, Pusher, Side Sheath)
• Olympus XELSPAS Series Manual Surgical Hand Instruments
• Telescope to view operative site
• Light Guide Adaptor an adaptor to be used with commercially available light systems to provide illumination
• Surgical Holder Adaptor an adaptor to be used to attach the endoscope to Olympus surgical holder device (510(k) K960068)

This 510(k) premarket notification describes the Olympus Endoscopic System for Lumbar Hernia Discectomy. It is important to note that this document is a 510(k) summary for substantial equivalence to existing devices, not a study describing the acceptance criteria and a study proving the device meets those criteria from an AI/performance perspective.

Therefore, I cannot directly provide information on acceptance criteria for device performance as typically understood in a clinical study validating a diagnostic or AI-driven device (e.g., sensitivity, specificity, accuracy). This document focuses on demonstrating physical and intended use equivalence to predicate devices already on the market.

However, I can extract information related to the device description and its intended use, which would form the basis for any performance evaluation, if one were conducted.

Here's an analysis based on the provided text, but it will largely indicate what isn't present in terms of AI/performance acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria for device performance (e.g., diagnostic accuracy, sensitivity, specificity, or performance metrics for identifying herniations) because it's a 510(k) for substantial equivalence, not a performance study of a novel diagnostic or AI device. The "performance" being evaluated here is primarily functional equivalence to predicate devices.

The device's intended performance is:

• Visualizing: Lumbar disc, lumbar herniated disc material, and lumbar paravertebral tissue.
• Aiding in: Search and removal of vertebral bone and nucleus material.

The document implicitly "reports" that the device meets these intended uses by claiming substantial equivalence in technological characteristics, design, and materials to legally marketed predicate devices.

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

Not applicable. This is not a study evaluating diagnostic performance on a test set of data (e.g., images for AI). It's a regulatory submission for a surgical endoscopic system based on equivalence to existing technology. If clinical testing was done to demonstrate functional equivalence (e.g., visualization quality during surgery), this document does not detail it.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is not a study evaluating diagnostic performance using ground truth established by experts.

4. Adjudication Method

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This submission concerns a physical surgical endoscopic system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant or described.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is an endoscopic system, not an algorithm.

7. Type of Ground Truth Used

Not applicable in the context of diagnostic performance or AI. The "ground truth" for this submission is that the predicate devices are legally marketed and perform their intended function. The Olympus system is deemed "substantially equivalent" to this established "truth."

8. Sample Size for the Training Set

Not applicable. There is no AI model being trained discussed in this document.

9. How Ground Truth for the Training Set Was Established

Not applicable.

Summary regarding the device and the submission:

The Olympus Endoscopic System for Lumbar Hernia Discectomy is described as:

• Intended Use: Visualizing lumbar disc, lumbar herniated disc material, and lumbar paravertebral tissue, and aiding in search and removal of vertebral bone and nucleus material.
• Components: Guide Needle, Dilators, Mandolin, Flexible Sheath, Pusher, Side Sheath, Olympus XELSPAS Series Manual Surgical Hand Instruments, Telescope, Light Guide Adaptor, Surgical Holder Adaptor.
• Substantial Equivalence Claim: The device is claimed to be substantially equivalent to Sofamor Danek's MED MicroEndoscopic Discectomy System, Sofamor Danek's INCL Endoscopic System (K955471), Rigid Arthroscope (K950501), and MICRO-ENDO Instruments (K950130), as well as another Olympus Endoscope (K951354) in optical characteristics and design. The materials of manufacture are standard medical products and identical to those cleared in legally marketed Olympus devices.

In conclusion, based on the provided 510(k) summary, there is no discussion of acceptance criteria for diagnostic/AI performance or a study demonstrating the device meets such criteria. The document focuses on demonstrating that the physical device is functionally and technologically equivalent to other legally marketed predicate devices for its intended surgical visualization and assistance purposes.

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