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Aesculap's AdTec® is indicated for use in adult and pediatric (3.5mm instruments only) diagnostic and therapeutic general endoscopy and laparoscopy surgery.

AdTec® is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery. The system consists of single-use and reusable forceps, clamps, and scissors made of Stainless Steel with monopolar or bipolar capabilities. They facilitate in the grasping, cutting, and manipulation of soft tissue and blood vessels during laparoscopic procedures. The single-use instruments come completely assembled in one single piece, and are available in various lengths ranging from 220mm - 420mm. The reusable instruments are modular and consist of a jaw insert and an insulated outer tube with interchangeable ratcheting and non-ratcheting handles. They are also available in lengths ranging from 220mm - 420mm. The system also includes a single use trocar sleeve and a reusable trocar pin. The trocar sleeve is made of Grilon, and the trocar pin is made of Stainless Steel and PEEK. The trocar sleeve and trocar pin are available in a 3.5mm diameter and a 70mm length. They are accessories for the 3.5mm trocars cleared under K123102.

This document does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria (commonly seen for AI/ML devices). This is an FDA 510(k) clearance letter for the AdTec® surgical instruments, which are physical medical devices, not an AI/ML diagnostic or therapeutic device. As such, the types of performance studies and criteria you've asked about (e.g., sample size for test/training set, expert ground truth, MRMC studies, standalone performance) are not applicable to this submission.

The document discusses substantial equivalence to predicate devices based on design, intended use, material composition, function, and range of sizes. It also briefly mentions a "failure mode and effects (FMEA) risk analysis" which identified no new risks, but this is not a study in the context of AI/ML device performance.

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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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