Search Results

The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

The Senhance® 3 mm Monopolar L-Hook Electrode instrument and adapter are intended as additions to the suite of monopolar hook instruments and adapters initially cleared for use with the TransEnterix Senhance Surgical System through K171120 (October 13, 2017) and then expanded through K191482 (July 11, 2019). The subject instrument and adapter are modifications of the predicate TransEnterix Senhance 5 mm Monopolar L-Hook Electrode instrument and adapter FDA cleared through K191482. Like the predicate devices, the subject devices are multi-use surgical devices that are cleaned and steam sterilized by the end user before the first use and after each use. The subject and predicate instruments consist of a polymer coated stainless steel shaft with an electrode at the distal end and a ceramic collar between the two to provide monopolar insulation. In order to be used with the Senhance Surgical System, the typical manual laparoscopic handle at the proximal end of the instrument is removed and replaced by a connector that mates with an adapter. The adapter provides the mechanism which allows the instrument to interface with the robotic manipulator arm of the Senhance Surgical System. Each instrument is laser marked with a unique identification number that matches its corresponding adapter.

The provided text is a 510(k) Summary for the TransEnterix Senhance Surgical System, specifically for a new 3 mm Monopolar L-Hook Electrode instrument and adapter.

Based on the information provided, this submission is not for an AI/ML medical device that requires clinical performance criteria based on diagnostic accuracy and human reader studies. Instead, it is a submission for a surgical instrument and adapter to be used with an existing surgical system. The performance data presented focuses on mechanical, electrical, and biocompatibility testing, aiming to demonstrate substantial equivalence to previously cleared predicate devices.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML device performance (like diagnostic accuracy, human reader improvement with AI, standalone algorithm performance, and ground truth establishment from expert consensus or pathology) is not applicable to this document.

The document discusses the following types of "performance data" which are relevant to this type of medical device:

• Biocompatibility testing: Conducted in accordance with ISO 10993-1, demonstrating the instrument is non-toxic, non-irritating, and does not result in adverse biological responses.
• Reprocessing, Cleaning, and Sterilization: Cleaning effectiveness was tested to confirm the overall effectiveness of prescribed cleaning procedures.
• Performance Testing (Mechanical Verification): Mechanical integrity under simulated use conditions was confirmed. ESU compatibility testing was also performed.
• Electrical Safety and Compatibility: Compliance with IEC 60601-2-2 and IEC 60601-2-18 was demonstrated.

The "acceptance criteria" for this device are implicitly tied to meeting the standards outlined in these tests to support a finding of substantial equivalence to the predicate device, K191482.

There is no information provided in this 510(k) summary regarding:

1. A table of acceptance criteria and reported device performance related to AI/ML.
2. Sample sizes for test sets or data provenance for AI/ML validation.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
6. Standalone (algorithm only) performance.
7. Types of ground truth (expert consensus, pathology, outcomes data).
8. Sample size for a training set (as this is not an AI/ML device in this context).
9. How ground truth for a training set was established.

This document is a regulatory submission for a surgical instrument, not an AI/ML diagnostic tool.

Ask a specific question about this device

The Senhance™ Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

The Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapter are intended as additions to the suite of monopolar hook instruments and adapters previously cleared for use with the TransEnterix Senhance™ Surgical System. Three monopolar electrodes and one monopolar electrode adapter are being added. The instruments and adapter are modifications of the predicate TransEnterix® Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapters FDA cleared through K181517 (October 9, 2018). Like the predicate devices, the subject devices are multi-use surgical devices that are cleaned and steam sterilized by the end user before the first use and after each use.

This document describes the 510(k) summary for the Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapter, which are additions to the TransEnterix Senhance™ Surgical System. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices (K181517).

Based on the provided information, the device is an accessory to a surgical system and thus the acceptance criteria relate to its physical and functional performance, rather than diagnostic accuracy.

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

Ask a specific question about this device