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The OVS 1 Video System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The OVS1 Video System is indicated for use with a compatible Olive Medical Camera Head and other accessory devices including an endoscope, optical coupler, and light cable

The OVS I Video System is a Camera Control Unit with integrated LED Light Source and Video Display for use in a surgical environment to view endoscopic images when interfaced with the Olive Medical TCK I HD Camera Head, an endoscope, a light cable, and other accessory devices.

The Olive Medical OVS1 Video System is a surgical video system that includes a Camera Control Unit with an integrated LED Light Source and Video Display. It is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body.

Here's an analysis of the provided information regarding its acceptance criteria and the study proving it meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided documentation does not explicitly list quantitative acceptance criteria in the typical sense (e.g., minimum resolution, specific light output intensity). Instead, the acceptance criteria are implicitly defined by demonstrating substantial equivalence to existing predicate devices. The "reported device performance" is a comparative qualitative assessment against these predicates, highlighting similarities in technology and function.

Note: The document states "Output resolution unknown. Vertical lines of input listed" for Tele Pack X, implying the 494 lines is an input spec, not necessarily output resolution.

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

The document explicitly states: "No comparison of clinical performance data was used for demonstration of substantial equivalence." This means there was no "test set" in the context of clinical data for performance evaluation. The substantial equivalence was based on comparison of technological characteristics and non-clinical safety testing against predicates.

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

N/A. As no clinical performance data was used, there was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set:

N/A. No clinical test set.

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:

N/A. This device is an endoscopic video system, not an AI-powered diagnostic tool. No MRMC study was performed, and the concept of "human readers improving with AI" is not applicable here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

N/A. This device is hardware for visualization, not a standalone algorithm.

7. The type of ground truth used:

N/A. As no clinical performance data was used, no ground truth was established for a clinical test set. The "ground truth" for demonstrating substantial equivalence was effectively the established safety and performance records of the predicate devices and compliance with relevant electrical and EMC standards.

8. The Sample Size for the Training Set:

N/A. This device is not an AI/ML algorithm that requires a training set.

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

N/A. No training set was used.

Summary of the Study Proving Device Meets Acceptance Criteria:

The Olive Medical OVS1 Video System demonstrates it meets acceptance criteria (which are defined implicitly by substantial equivalence) through a non-clinical comparative study and safety testing:

• Comparative Assessment: The primary "study" was a detailed comparison of the OVS1 Video System's technological characteristics (display, light source, control unit, resolution) and intended use against several legally marketed predicate devices (Tele Pack X, Image 1 Video Imaging System, InnerVue Diagnostic Scope System, Flexible Video Endoscope, LED Light Source, Lightsource or Illuminator). The study concluded that the OVS1 is "substantially equivalent" because its technology and design are similar, its indications for use are similar, and differences do not negatively affect performance, function, or intended use.
• Non-Clinical Testing: The device underwent compliance testing with recognized international standards for medical electrical equipment:
  • ISO 60601-1: General requirements for basic safety and essential performance.
  • ISO 60601-1-2: Electromagnetic compatibility (EMC) requirements and tests.

These non-clinical tests and the detailed comparative analysis against predicate devices established that the OVS1 Video System is as safe and effective as the already-marketed devices, thus meeting the requirements for its 510(k) clearance. No clinical trials or human performance studies were conducted or required to demonstrate substantial equivalence for this type of device.

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