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The OptoMedic Laparoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The OptoMedic Laparoscopes are intended to be used by trained healthcare professional in diagnostic and therapeutic procedures.

The OptoMedic laparoscopes are rigid endoscopes that are used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source. The Laparoscope has 8 models which are available in two insertion widths (5.6 mm and 10.1mm), two working lengths (320mm and 310mm) and two different directions of view (0° and 30°).

This document is a 510(k) Premarket Notification for the OptoMedic Laparoscope, signifying its clearance by the FDA based on substantial equivalence to predicate devices. The information provided is primarily focused on the device's technical specifications and comparisons, rather than a clinical study demonstrating performance against specific acceptance criteria in the context of AI/ML.

Therefore, for the request regarding acceptance criteria and a study proving the device meets them, it's important to understand that this submission is for a medical device (a laparoscope), not an AI/ML diagnostic tool. As such, the typical metrics and study designs for AI/ML performance (like those related to sensitivity, specificity, reader studies, etc.) are not directly applicable or provided in this document.

However, I can extract the information related to the device's performance testing as described for regulatory clearance, which serves a similar purpose to demonstrating that the device meets its design specifications and is safe and effective for its intended use.

Here's a breakdown based on the provided document, addressing the closest analogues to your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" are generally derived from recognized industry standards and regulatory requirements for safety, performance, and functionality. The "reported device performance" is the demonstration that the device complies with these standards.

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

The document does not detail specific "sample sizes" in the context of clinical or AI/ML test sets. The performance evaluation primarily involved non-clinical tests conducted to verify compliance with national and international standards. These tests typically involve physical and functional evaluations of the device itself rather than patient data.

• Sample Size: Not applicable in the context of AI/ML test sets. For device testing, it would involve a representative number of device units.
• Data Provenance: Not applicable in the context of clinical data. The testing involves the physical device and its components, complying with engineering and safety standards.

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

This information is not applicable to this type of device clearance. Ground truth, in the context of image analysis or diagnostic performance, is not established for a rigid laparoscope in this document. The "ground truth" for this device's performance is its adherence to the technical specifications defined by the relevant standards (e.g., whether its field of view is indeed 68°, its resolution meets the specified criteria, or its materials are biocompatible). These are verified through engineering and laboratory testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews of data (often medical images) to establish a consensus ground truth. This document describes non-clinical engineering and bench testing, not clinical data review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This document does not mention any MRMC comparative effectiveness study. These studies are typically conducted for AI/ML diagnostic tools to evaluate how AI assistance impacts human reader performance. The OptoMedic Laparoscope is a physical medical instrument, not an AI system.

6. If a Standalone (Algorithm Only) Performance Study was Done

No. This is not an AI/ML algorithm. Therefore, a standalone algorithm performance study was not conducted or reported.

7. Type of Ground Truth Used

The "ground truth" used for this device's regulatory clearance is compliance with established engineering, safety, and performance standards (e.g., ISO, IEC, AAMI standards) as verified through non-clinical laboratory testing. This is distinct from clinical ground truth based on pathology, expert consensus, or outcomes data, which would be relevant for diagnostic devices or AI algorithms.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable, as there is no AI/ML training set for this device.

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