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The Endoscopic cameras VP-1000C ( Med Cam 100) and VP-3000A /Med Cam 300) are intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.

The Endoscopic camera VP-1000C ( Med Cam 100) is a 1-CCD camera, the VP-3000A (Med Cam 300) is a 3-Chip camera; both consist of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic cameras VP-1000C (Med Cam 100) and VP-3000A (Med Cam 300) take the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera heads are supplied with an standard objective with the focal length 18, 25, 30 or 40mm. A Zoom objective can be used too. The devices allow focussing for both right-handed and left-handed users.

The provided text is a 510(k) summary for an endoscopic camera, not a study report demonstrating the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics cannot be extracted from this document.

Here's an analysis based on the available information:

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

This document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics in relation to such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance testing against predefined criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not describe a clinical or performance study with a test set. The claim of substantial equivalence is based on design and technological characteristics, not on a study with a sample size of patients or images.

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 applicable. There is no mention of a test set with ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No test set or adjudication method is described.

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 endoscopic camera, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. This device is a hardware component (endoscopic camera) and does not involve a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. Ground truth is not relevant in the context of demonstrating substantial equivalence for an endoscopic camera in this document.

8. The sample size for the training set:

Not applicable. This document does not describe any machine learning or AI component requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no training set mentioned.

Summary of what the document does state regarding performance/equivalence:

Acceptance Criteria (Implied by Substantial Equivalence):

The implied acceptance criteria for this 510(k) submission are that the devices (VP-1000C/Med Cam 100 and VP-3000A/Med Cam 300) are "substantially equivalent" to predicate devices already on the market. This means they should pose the "same type of questions about safety and effectiveness" and have "no diminished safety or effectiveness" compared to predicates.

Reported Device Performance (as presented for substantial equivalence):

The document states that the new devices are "similar in design and technological characteristics" to their respective predicate devices (World of Medicine Lemke GmbH's Endoscopic Camera MC404/C3 for VP-1000C and Endoscopic Camera TC804/C4 for VP-3000A).

The key performance claims supporting substantial equivalence are:

• Intended Use: Identical – "permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor."
• Design: Both are camera systems consisting of a camera control unit (CCU), camera head, objectives, cables, and adapters.
• Functionality: Both take images through standard endoscopes and display them on standard video monitors.
• Differences: Described as "minor and limited to picture quality and handling convenience," implying that these differences do not negatively impact safety or fundamental effectiveness for the intended use.
• Standards Compliance: The devices "will comply with the International Standard IEC 60601-1-2, IEC 60601-1-2, IEC 60601-2-18 and will conform to the Medical Device Directive 93/42/EEC." (Note: IEC 60601-1-2 is listed twice; likely a typo in the original text, usually refers to General Requirements for Safety and Essential Performance and Electromagnetic Disturbances).

In essence, the "study" demonstrating the device meets acceptance criteria is a demonstration of substantial equivalence through comparison of design, intended use, and technical specifications with legally marketed predicate devices, rather than a clinical trial or performance study with quantified metrics.

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