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The Karl Storz Trans-Nasal Esophagoscopes are designed to be used by qualified surgeons and physicians and are indicated for endoscopic access and examination of the nasal sinuses, larynx, esophagus and gastro-esophageal junction and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The Karl Storz Trans-Nasal Esophagoscopes are manually operated surgical devices, flexible fiberoptic telescopes that utilize fiber-optic technology. The body contact portions of the Kall Storz Trans-Nasal Esophagoscopes are manufactured using medical grade polyurethane.

This 510(k) summary (K051972) is for the Karl Storz Trans-Nasal Esophagoscopes. This document is a Summary of Safety and Effectiveness, which typically summarizes information from a 510(k) submission, including a declaration of substantial equivalence to a predicate device. It does not describe a clinical study or performance data against specific acceptance criteria in the way one would for a novel AI/ML device or a device requiring significant clinical validation.

Here's an analysis based on the provided text, and why most of your requested points cannot be answered from this document:

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

This document does not contain a table of acceptance criteria or performance data for the Karl Storz Trans-Nasal Esophagoscopes. The 510(k) relies on establishing substantial equivalence to existing predicate devices rather than proving performance against novel acceptance criteria.

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. No test set or associated data is described, as the submission focuses on substantial equivalence.

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 or expert involvement for a test set is described.

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

Not applicable. No test set or adjudication is mentioned.

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 manually operated flexible fiberoptic endoscope, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm-only device.

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

Not applicable. The concept of "ground truth" as it relates to clinical performance studies is not relevant to this 510(k) submission. The device's "truth" or acceptability is based on its similarity to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a training set.

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

Not applicable. This device does not involve machine learning or ground truth for a training set.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "acceptance criteria" in a 510(k) of this nature are inherently tied to demonstrating substantial equivalence to a predicate device, rather than meeting specific quantifiable performance metrics.

Substantial Equivalence "Study" (Rationale):

The "study" or justification for the device's acceptance is the comparison to predicate devices.

• Predicate Devices:

  • KSEA Rhino-Laryngo-Broncho-Fiberscope and Broncho-Fiberscope (K981458)
  • TNE-2000 marketed by Vision Sciences, Inc. (K031786)

• Reasoning for Substantial Equivalence: The document states:

  "The Karl Storz Trans-Nasal Esophagoscopes are substantially equivalent to the predicate devices since than haudi ESOphagoscopes are substantialiy are the same. The minor differences between the Karl Storz and interined does Esophagoscopes and the KSEA Rhino-Laryngo-Broncho-Fiberscope and Broncho-Fiberscope and Broncho-Fiberscope (K981458), and the TNE-2000 marketed by Vision Sciences, Inc. (K031786) raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices."

This statement implies that the device's design, materials (medical grade polyurethane for body contact portions), performance, function, and intended use are sufficiently similar to the predicate devices, and any minor differences do not raise new safety or effectiveness concerns. This is the "proof" or "study" in the context of this traditional 510(k).

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