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Aslan Modular Instruments are intended to be used by a qualified surgeon for grasping, manipulating, cutting and/or coagulating tissue in endoscopic (videoscopic) procedures.

Aslan Modular Instruments comprise a modular line of re-usable instruments consisting of various size shafts, handles of various configurations, and a number of interchangeable tips which can be used in laparoscopic surgery for grasping, cutting, and cauterizing delicate tissues using monopolar electrocautery. The tips and shafts, sized to fit through 5mm, 10mm or 12mm cannulae, range in length from 12cm to 45cm. For ease of cleaning, the tip, together with its actuating rod, can be completely removed from the shaft, and the tip-and-shaft assembly may be completely removed from the handle.

The provided document describes the acceptance criteria and the study that proves the device meets those criteria for the ASLAN LAPAROSCOPIC SET (also referred to as Aslan Modular Instruments or Aslan Sensor™ Modular Instrument).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the "benchtop evaluations." It states "each of the instruments in the laparoscopic set" was tested, implying all instrument types/configurations were covered, but not how many units of each were tested.
• Data Provenance: The study was conducted as "benchtop evaluations." The country of origin of the data is not explicitly stated, but the manufacturer, Aslan Medical Technologies, Ltd., is based in Kalamazoo, Michigan, USA. The study type is prospective, as it involves testing the new device to demonstrate its performance.

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

This information is not applicable as the study involved benchtop evaluations of physical properties and electrical safety in a controlled environment, not clinical data requiring expert review for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the study involved objective physical and electrical tests, not subjective assessments requiring adjudication.

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

• Was it done? No.
• Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as this is a medical device (surgical tools) and not an AI-assisted diagnostic or imaging system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was it done? Yes, in a way. The "benchtop evaluations" represent a standalone performance assessment of the instrument's physical and electrical characteristics without direct human interaction (beyond operating the test equipment). However, it's not an "algorithm" in the conventional AI sense.

7. Type of Ground Truth Used

The ground truth was based on pre-defined engineering specifications and established industry standards (e.g., strength requirements, electrical conductivity benchmarks, cleaning protocols, and specifically, ANSI/AAMI HF18-1993 for high voltage resistance).

8. Sample Size for the Training Set

This information is not applicable. The device is a set of physical surgical instruments, not a machine learning model, so there is no concept of a "training set" in this context.

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

This information is not applicable for the reasons stated above (not an AI/ML model).

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