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The Endoscopic Camera MC404/C3 is 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 MC404/C3 is a 1-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera MC404/C3 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 25 mm endofocus objective but may also be used with a 16 mm, 30 mmm or zoom (f = 13 to 28 mm) objective. The device is programmable by two head key bottons and offers focusing for both right-handed and left-handed users.

The provided text is a 510(k) summary for the Endoscopic Camera MC404/C3. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with specific acceptance criteria and detailed statistical analysis often seen with novel devices or AI/ML-based products.

Therefore, many of the requested categories for acceptance criteria and study details cannot be fully answered from this document. The document primarily confirms compliance with general safety and performance standards rather than specific clinical performance metrics.

Here's an analysis of what information is available from the provided text:

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

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

Not applicable. The "performance data" section refers to compliance with international and European standards for electrical safety, EMC, and general medical device requirements, not a clinical test set with human or patient data.

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. This was not a study requiring expert-established ground truth for a test set.

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

Not applicable. This was not a study requiring adjudication of a 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

No. This is a 2002 submission for an endoscopic camera, not an AI-based device. No MRMC study was performed or mentioned.

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

Not applicable. This is a medical device (endoscopic camera), not an algorithm or AI. Its core function is to provide an image for human interpretation.

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

Not applicable. The performance data relates to compliance with regulatory and safety standards, not diagnostic or clinical accuracy against a ground truth. The substantial equivalence argument relies on the predicate device's established use for "visualization of body cavities," implying that if the new device can also provide adequate visualization, it meets its intended purpose.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the study that proves the device meets the acceptance criteria (based on the provided text):

The "study" in this context is the submission and review process for substantial equivalence to a predicate device, along with verification of adherence to relevant safety and performance standards.

The primary "proof" that the Endoscopic Camera MC404/C3 meets its acceptance criteria (primarily its intended use as a visualization tool for endoscopic procedures) is based on:

• Substantial Equivalence: The device is deemed substantially equivalent to the Karl Storz Endovision XL Endoscopic Camera System (K974391). The submitter argues that both devices serve the same intended use (visualization of body cavities, hollow organs, and canals during endoscopic procedures when attached to standard endoscopes and displaying images on standard video monitors). The differences are noted as "limited to picture quality and handling convenience," implying these differences do not raise new questions of safety or effectiveness.
• Compliance with Standards: The device's performance is demonstrated through its compliance with recognized international and European standards for medical devices, specifically:
  • IEC 601-1 (general medical electrical equipment safety)
  • IEC 601-1-2 (electromagnetic compatibility for medical electrical equipment)
  • EN 55011 (industrial, scientific and medical (ISM) radio-frequency equipment)
  • Medical Device Directive 93/42/EEC (European regulatory compliance)
  • UL2601-1 (Underwriters Laboratories standard for medical electrical equipment, indicated as "will be tested in accordance with").

This type of submission assumes that if the device is substantially equivalent to a legally marketed predicate and meets fundamental safety and performance standards, it is safe and effective for its stated intended use. Specific clinical performance metrics, reader studies, or AI performance validations were not required for this type of device at the time of this 2002 submission.

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