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The Armand Endoscope Holder is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 14.6mm to 15.8mm during diagnostic and therapeutic procedures.

The Armand Endoscope Holder is a manually operated surgical device. It is composed of surgical grade stainless steel and anodized aluminum. The holder consists of a table clamp, adjustable stainless steel rods, and an endoscope clamp. The endoscope clamp is designed to hold endoscopes in diameter from 14.6mm to 15.8mm. The device uses a single knob clamp assembly to hold the endoscope and a single knob to tighten and lock the stainless steel rods into the desired position.

The provided 510(k) submission (K050051) for the Armand Endoscope Holder does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in the way typically expected for performance claims in medical imaging or diagnostic AI devices.

This submission is for a manually operated surgical device (an endoscope holder). Its equivalence is based on its technological characteristics (materials, description, application, and function) to predicate devices, not on performance metrics derived from a clinical or analytical study with ground truth and statistical analysis.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, experts, adjudication, MRMC, standalone performance, and ground truth establishment cannot be found in this document because they are not relevant to the type of device and the pathway chosen (substantial equivalence based on technological characteristics).

Here's why and what can be extracted:

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

   • Acceptance Criteria: Not explicitly stated as performance metrics. The underlying acceptance criterion for this type of device is "substantial equivalence" to predicate devices in materials and function.
   • Reported Device Performance: The document only describes the device's physical attributes and intended function (holding endoscopes of a specific diameter). It doesn't report performance metrics like accuracy, sensitivity, or specificity, as these are not applicable to an endoscope holder.

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

   • Not applicable. There was no "test set" in the context of performance evaluation for this device. The evaluation was based on a comparison of design and intended use specifications to predicate devices.

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. No ground truth establishment was performed, as it's not relevant for a mechanical device like an endoscope holder.

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

   • Not applicable. No test set requiring adjudication.

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 a mechanical endoscope holder, not an AI or imaging device.

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

   • Not applicable. This device is a mechanical endoscope holder, not an algorithm.

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

   • Not applicable. No ground truth used.

8. The sample size for the training set:

   • Not applicable. No training set was used.

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

   • Not applicable. No ground truth for a training set.

Summary based on the provided document:

The K050051 submission for the Armand Endoscope Holder is a 510(k) premarket notification for a Class II medical device. The basis for substantial equivalence is a comparison of its technological characteristics and intended use to legally marketed predicate devices, the Neuroview® Instrument Holder (K992006) and the KSEA Endoscope Holder (K990334).

The relevant "acceptance criteria" here are that the device's design, materials (surgical grade stainless steel and anodized aluminum), and function (holding rigid and flexible endoscopes from 14.6mm to 15.8mm in diameter) are sufficiently similar to the predicates to ensure safety and effectiveness for its intended use. The "study" proving this is implicitly the comparison described in the "Technological Characteristics" and "Substantial Equivalence" sections, affirming its similarity to previously cleared devices.

No performance study, clinical trial, or AI-specific evaluation was conducted or required for this type of device and regulatory pathway.

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