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The LapMan can be used during the laparoscopic procedures listed below and should not be used for any other surgical procedure or purpose.

1. General surgery: laparoscopic cholecystectomy, laparoscopic Nissen Fundoplication, laparoscopic inguinal hernia repair, laparoscopic gastric banding.
2. Gynaecology: laparoscopic adnexal surgery (ovarian cystectomy, oophorectomy, adnexectomy, salpingectomy, salpingoneostomy, tubal reanastomosis), laparoscopic management of ectopic pregnancy. laparoscopic treatment of endometriosis, laparoscopic myomectomy, laparoscopic hysterectomy, laparoscopic colposuspension
3. Urology: laparoscopic prostatectomy.

LapMan is a robotic computer-driven system used by surgeon to hold and position a rigid laparoscope/endoscope. Surgeon orders are transmitted to the robotic system by a radiofrequency Hand Controlled device.

The provided text describes the LapMan Laparoscope Manipulator System, a robotic computer-driven system used to hold and position a rigid laparoscope/endoscope. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (AESOP 3000 System) and compliance with various electrical and environmental standards.

However, the document does not contain information regarding acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy. The testing mentioned primarily relates to electrical safety, electromagnetic compatibility, and environmental standards, which are engineering and regulatory compliance tests, not performance studies evaluating the device's functional attributes against clinical acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and comparative effectiveness studies cannot be extracted from the provided text because such studies were not conducted or reported in this 510(k) summary.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided based on the text. The document describes various electrical and environmental standards the device complies with, but it does not specify "acceptance criteria" related to a clinical performance study or "reported device performance" in a functional or diagnostic sense. The text primarily states that the device "complies with the CE Declaration of Conformity European Directive 93/42/EC Annex VII" and "No differences were found to exist between the LapMan and the applicable standards."

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

• Cannot be provided based on the text. There is no mention of a human-based test set or any clinical data provenance. The testing described refers to laboratory-based electrical and environmental assessments (e.g., PHOENIX TEST-LAB GmbH in Germany, SNCH laboratory in Luxembourg).

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)

• Cannot be provided based on the text. No clinical test set or ground truth establishment by experts is described.

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

• Cannot be provided based on the text. No clinical test set and thus no 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

• Cannot be provided based on the text. This device is a surgical manipulator (a robotic arm), not an AI-powered diagnostic tool for "human readers." Therefore, an MRMC study is not applicable, and no such study was reported.

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

• Cannot be provided based on the text. As mentioned, this is a surgical manipulator, not an algorithm, and the performance described is compliance with technical standards, not standalone diagnostic performance.

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

• Cannot be provided based on the text. No clinical ground truth is discussed. The "ground truth" for the tests performed was compliance with specific engineering and safety standards.

8. The sample size for the training set

• Cannot be provided based on the text. There is no mention of a "training set" as this device does not appear to involve machine learning in a way that would require one in the context of diagnostic accuracy or clinical decision support.

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

• Cannot be provided based on the text. (See #8)

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The LapMan Laparoscope Manipulator System and Accessories is indicated for use in General Surgery, Gynecology, and Urology where a laparoscope/endoscope is incorporated into the surgical procedure. The LapMan is indicated for specific laparoscopic surgical procedures as defined in the Operations Manual and should not be used for any other surgical procedure or purpose.

LapMan is a robotic computer-driven system used by surgeon to hold and position a rigid laparoscope/endoscope. Surgeon orders are transmitted to the robotic system by a radiofrequency Hand Controlled device. It is indicated for use in General surgery (laparoscopic cholecystectomy, laparoscopic Nissen Fundoplication, laparoscopic inguinal hernia repair, laparoscopic gastric banding), Gynaecology (laparoscopic adnexal surgery i.e. ovarian cystectomy, oophorectomy, salpingectomy, salpingoneostomy, tubal reanastomosis, laparoscopic management of ectopic pregnancy, laparoscopic treatment of endometriosis, laparoscopic myomectomy, laparoscopic hysterectomy, laparoscopic colposuspension) and Urology (laparoscopic prostatectomy).

The provided text is a 510(k) summary for the LapMan Laparoscope Manipulator. It does not contain information about acceptance criteria for device performance related to a clinical study, nor does it describe a study proving the device meets specific performance criteria through clinical outcomes or comparative effectiveness.

Instead, the document focuses on:

• Predicate Device Comparison: Highlighting differences in communication systems (radiofrequency vs. voice/wired) and motion characteristics (lower magnitude/speed for LapMan) compared to the AESOP 3000 System.
• Compliance with Standards: Detailing extensive testing conducted by accredited laboratories (PHOENIX TEST-LAB GmbH, SNCH laboratory) to ensure compliance with a range of electrical, electromagnetic compatibility (EMC), and environmental standards (e.g., EN 60529, IEC 601, EN 300 220-3, EN 60601-1-2, EN 61000 series).
• Regulatory Clearance: The FDA's substantial equivalence determination based on these engineering and safety tests, allowing the device to be marketed.

Therefore, the specific information requested about acceptance criteria and a study proving device performance in a clinical context (e.g., accuracy, sensitivity, specificity, or human reader improvement) is not present in the provided 510(k) summary. The document describes engineering and safety tests against established standards, not a clinical performance study with human subjects or AI-assisted performance analysis.

Based on the provided text, I cannot complete the table or answer the subsequent questions as they relate to clinical performance criteria and studies that are not described in this regulatory submission.

The information provided only relates to technical and safety evaluations against international standards.

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