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Aesculap's Needlescopic Instrument System (N.I.S.) is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery.

The system consists of three primary components: a 2.5mm trocar, a 2.0mm endoscope, and 2.5mm modular instruments. The N.I.S. trocar is intended to establish ports through which endoscopes and endoscopic instruments pass into the abdominal cavity. The N.I.S. endoscope is used to examine body cavities, hollow organs and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures. The N.I.S. instruments are used to cut, manipulate, grasp and/or cauterize selected tissue.

This submission is for a 510(k) Premarket Notification for the Aesculap Needlescopic Instrument System (N.I.S.). The document does not describe a study with acceptance criteria to demonstrate device performance in the manner typically associated with clinical trials or AI/software validation. Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This submission does not define specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a study. The "performance data" section states that "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." The primary performance criterion mentioned is compliance with an electrical safety standard for electrosurgical instruments.

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

Not applicable. This document describes a submission for substantial equivalence based on technological characteristics and predicate device comparison, not a study involving a "test set" of data or patient samples to measure performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth establishment with experts is not relevant to this type of 510(k) submission, which focuses on comparing a new device to existing ones rather than evaluating diagnostic accuracy against a true condition.

4. Adjudication Method

Not applicable for the same reasons as points 2 and 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic imaging devices or algorithms where human readers' performance is being assessed with and without AI assistance. This submission is for surgical instruments, where such a study design is not relevant.

6. Standalone Performance Study

No, a standalone (algorithm only without human-in-the-loop performance) study was not done. This concept is applicable to AI algorithms, not to physical surgical instruments.

7. Type of Ground Truth Used

Not applicable. The concept of "ground truth" as a reference standard for diagnostic accuracy is not relevant here. The "truth" for this submission is whether the device is functionally and technologically similar to predicate devices and meets safety standards (like IEC 601-2-18).

8. Sample Size for the Training Set

Not applicable. This submission does not involve an AI algorithm or machine learning that would require a training set.

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

Not applicable, as there is no training set mentioned in the document.

In summary:

The Aesculap Needlescopic Instrument System 510(k) submission demonstrates "substantial equivalence" to predicate devices, focusing on the absence of new technological characteristics (other than reduced diameter) and compliance with relevant safety standards (IEC 601-2-18 for electrosurgical components). It is a regulatory submission for physical medical devices, not an AI/software performance study, and therefore the criteria for evaluating AI algorithm performance (like test sets, ground truth, expert adjudication, MRMC studies) do not apply.

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The device is intended for use for direct visualization, diagnosis and therapeutic application during intracranial procedures, such as

• cyst fenestration
• shunt placement
• intraventricular coagulation
• ventriculostomy of the 3rd ventricle when the aqueduct is obstructed
• coagulation of small intraventricular lesions
• biopsy of lesions which lead to the stricture of a ventricle

The instrument simultaneously permits visual control and utilization of a working, an irrigation, and an aspiration channel.

The Neuro-Endoscope can be used with or without a stereotactic frame. A special adapter is available to affix the endoscope.

The set consists of a sheath, obturators, telescope, forceps, scissors, electrodes, suction needle, and adapters.

Here is a summary of the acceptance criteria and study information for the Neurological Endoscope, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K970162) is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria for a new device type. Therefore, explicit, quantifiable acceptance criteria in the typical sense (e.g., minimum sensitivity/specificity thresholds, precision limits) are not stated for clinical performance. Instead, the "acceptance criteria" are implied to be that the device performs safely and effectively for its intended use, comparable to its predicate devices.

The reported device performance is described through various safety and functional tests:

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

• Sample Size: This information is not provided in the 510(k) summary. The document mentions "Clinical tests were performed," but does not explicitly state the number of patients, endoscopic procedures, or specific data points included in these clinical tests.
• Data Provenance: The clinical tests were performed in the USA at the University of South Alabama. The document does not explicitly state whether the study was retrospective or prospective, but clinical trials typically imply a prospective approach.

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

• Number of Experts: The document states that clinical tests were performed by "Eric Weber, MD, PhD." This identifies a single individual as the primary investigator. It does not mention a panel of experts or a specific number of individuals involved in establishing ground truth for the test set.
• Qualifications of Experts: Eric Weber, MD, PhD. His specific specialization (e.g., neurosurgeon, neurologist) is not explicitly stated, but his role in performing "clinical tests" for a neurological endoscope strongly implies relevant medical expertise in neurosurgery or a related field.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical tests or for establishing ground truth. With only one named clinical investigator, it's unlikely a formal multi-reader adjudication process was employed as part of this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. The device is a medical instrument (endoscope), not an AI-powered diagnostic or assistive tool.
• Effect Size of AI: This question is not applicable as the device is not an Artificial Intelligence product.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, a standalone (algorithm only) performance study was not done. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The type of ground truth used for the clinical tests is not explicitly detailed. However, for a surgical instrument like an endoscope, ground truth would likely be based on clinical observation, surgical findings, and potentially pathology of biopsied lesions, as assessed by the operating physician(s).

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument and does not employ a "training set" in the context of machine learning or AI.

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

This information is not applicable, as there is no "training set" for this type of device.

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