Search Results

The intended use of the AESOP System is a robotic computer driven system whose function is to hold and position a rigid laparoscope/endoscope . The AESOP System is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a rigid laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy. laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The AESOP System is a robotic computer-driven system whose basic function is to hold and position a laparoscope/endoscope under the direct control of a surgeon.

This document is a 510(k) summary for the AESOP System, a robotic computer-driven system for positioning laparoscopes/endoscopes. The information provided is insufficient to answer most of your questions, as it focuses on regulatory submission details and general device function rather than a clinical study demonstrating performance against specific acceptance criteria.

Here's what can be extracted and why other questions cannot be answered:

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

Based on the provided text, specific acceptance criteria and detailed performance metrics are not explicitly stated. The document lists compliance with several international and national standards (IEC, UL, AMMI, EMC, CSA) and mentions "AESOP System Functional Test Requirements." This implies that internal functional tests were performed to demonstrate the device meets its design specifications and adheres to relevant safety and performance standards. However, the results of these functional tests are not reported in a manner that allows for a "performance" column to be filled as you'd typically expect for clinical efficacy or accuracy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document does not describe any clinical study or test set involving patient data.

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)

This information is not provided. The document details regulatory compliance and intended use, but not the methodology for establishing ground truth for any performance evaluation.

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

This information is not provided.

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

This information is not provided. The AESOP system is described as a robotic positioning system, not an AI-assisted diagnostic or interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be applicable to the stated function of this device.

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

This information is not provided. The device's function is to assist a human surgeon in positioning a scope, not to operate autonomously in a diagnostic or therapeutic capacity.

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

This information is not provided.

8. The sample size for the training set

This information is not provided. The document does not mention any "training set," which would typically be associated with machine learning or AI algorithm development. The AESOP system is described as a robotic system with fixed functionalities.

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

This information is not provided. (See explanation for point 8).

Summary of Missing Information:

The provided text is a regulatory summary for a medical device that assists in scope positioning. It focuses on declaring substantial equivalence to previous devices and compliance with established safety and performance standards. It does not contain information about:

• Clinical trials or studies involving patient data.
• Specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) against defined clinical acceptance criteria.
• The use of AI/machine learning requiring training or test sets with ground truth.
• Human reader performance or MRMC studies.

To answer your questions comprehensively, a clinical study report or detailed technical documentation beyond this 510(k) summary would be required.

Ask a specific question about this device

The intended use of the AESOP System is a robotic computer driven system whose function is to hold and position a laparoscope. It is indicated for use in all forms of laparoscopic surgery. A few examples are cholecystecomy, laparoscopic hemia repair, and laparoscopic appendectomy.

The AESOP System is a robotic computer-driven system whose basic function is to hold and position a laparoscope under the direct control of a surgeon.

This 510(k) summary for the AESOP System primarily describes the device's intended use, its substantial equivalence to a predicate device, and the standards it meets. It does not contain specific acceptance criteria related to device performance in a clinical or image-based diagnostic setting, nor does it detail a study proving the device meets particular performance metrics.

The document focuses on:

• Safety and regulatory compliance: Referencing IEC, UL, AMMI, CSA, and EMC standards.
• Functional equivalence: Stating the new AESOP System uses the same control methods as the original, with the addition of voice control.

Therefore, many of the requested sections regarding performance acceptance criteria and a study proving their achievement cannot be answered from the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not provided: The document does not describe a "test set" in the context of clinical performance data, imaging data, or diagnostic accuracy. The testing mentioned refers to engineering and safety standards compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not provided: No ground truth establishment for a test set (in a clinical/diagnostic sense) is described.

4. Adjudication method for the test set

• Not applicable / Not provided: No test set (in a clinical/diagnostic sense) or adjudication method is described.

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

• No: This document describes a robotic surgical assistant, not an AI-powered diagnostic tool for human readers. No MRMC study is mentioned.

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

• Not directly applicable / Not provided: The device is a surgical assistant whose function is to hold and position a laparoscope under the direct control of a surgeon. The voice control is an interface for the surgeon, not an autonomous diagnostic algorithm. Its performance is intrinsically human-in-the-loop.

7. The type of ground truth used

• Not applicable / Not provided: No clinical or diagnostic "ground truth" is discussed. The "ground truth" for this device's performance would relate to its mechanical accuracy, response time, and safety as determined by engineering tests and adherence to standards.

8. The sample size for the training set

• Not provided: The document refers to a "speaker dependent speech recognition system" for voice control, which implies a training phase for individual users. However, no details on the sample size or nature of this training (e.g., number of voice commands, speakers) are given. It's likely a relatively small, user-specific training.

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

• Not provided: For the voice control system, the "ground truth" for training would typically be the correct command corresponding to a spoken word. The document states it's "speaker dependent," meaning it's trained to an individual's voice. The method of establishing this training ground truth (e.g., repeating commands, verifying recognition) is not detailed.

Ask a specific question about this device