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The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok® ligating clips to soft tissue during laparoscopic surgery.

Teleflex Medical's Percuvance™ Percutaneous Surgical System is a micro-laparoscopic platform that comprises fourteen (14) unique components, which are combined in various configurations to create a multifunctional set of instruments for laparoscopic procedures. In accordance with IEC 60601-1:2005 (A1:2012), the Percuvance™ system is classified as a BF active accessory with a rated accessory voltage of 1000VPeak. System components include two reusable Handles (Ratcheted and Non-Ratcheted), which are manipulated by the surgeon and connect to a Shaft, which is available in two lengths (29 cm and 36 cm), affords various Tool Tips (or End Effectors) to be attached in order to perform basic surgical manipulations. The Percuvance™ Handles, Shafts, and Tool Tips are not compatible or interchangeable with components from other percutaneous systems. Initial access to the surqical site is achieved with the Introducer Tool Tip attached to the Shaft. Once inside the patient, the Introducer Tool Tip is extracorporealized through a pre-inserted, central trocar and is then exchanged for one of the other Tool Tips, which include Scissors, Gripper Grasper, Johans Grasper, Maryland Dissector, Hook Cautery, Spatula Cautery and Clip Applier. No ligating clips are provided with the Percuyance™ Percutaneous Surgical System: however, the Clip Applier Tool Tip is compatible with Teleflex M/L Hem-o-lok® ligating clip (SKU 544230). Finally, the Seal Bridge, which is available in two sizes (5 mm and 12 mm), is used to protect the trocar seal and to aid in maintaining insufflation when it used in conjunction with a trocar to facilitate the extracorporeal exchange of Tool Tips.

This FDA 510(k) summary describes a medical device, the Percuvance™ Percutaneous Surgical System, and its substantial equivalence to a previously cleared predicate device. It does not contain information about the acceptance criteria or results from a study that typically involves human readers or AI.

Here's a breakdown of the information provided and what is missing in relation to your request:

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

• Not provided. The document states "Comprehensive bench testing was completed on the modifications identified below to ensure the system performed equivalently (or better) to the predicate system." However, specific quantitative acceptance criteria or detailed performance results in a table format are not present. The "Comparative Characteristics" table (pages 7-8) compares the proposed device to the predicate in terms of features and intended use, but not measured performance against pre-defined criteria.

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

• Not provided. The document mentions "bench testing" and "stability testing" but does not specify sample sizes for these tests or details about data provenance.

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)

• Not applicable. This information is relevant for studies involving human interpretation or image analysis where ground truth is established by experts. This document describes a surgical instrument and its functional testing, not a diagnostic or interpretive device.

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

• Not applicable. See point 3.

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 is not an AI-based diagnostic or interpretive device. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

• No. This is not an AI-based device.

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

• Not explicitly described in terms of "ground truth" for clinical outcomes. The document refers to "bench testing" and "stability testing" to ensure the device performs "equivalently (or better) to the predicate system." The "ground truth" for these types of tests would be established engineering standards, material properties, and functional performance measurements against design specifications and predicate device performance. For biocompatibility, the ground truth is adherence to ISO standards.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI-driven device.

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

• Not applicable. This is not a machine learning or AI-driven device.

Summary of the Study and Device Performance (based on the provided text):

The document describes the Percuvance™ Percutaneous Surgical System, a micro-laparoscopic platform for grasping, manipulating, cutting, cauterizing, and delivering ligating clips during laparoscopic surgery.

The study to support its 510(k) clearance (K181852) was a substantial equivalence review against a predicate device (K153063 for the system, and K133202 for the clip applier technology and ligating clips).

Device Performance Information (extracted from the text):

The document states:

• "Comprehensive bench testing was completed on the modifications identified below to ensure the system performed equivalently (or better) to the predicate system."
• "Existing design, usability validations and packaging (ship) testing, performed on the predicate device still adequately covers the proposed device."
• "Stability testing was repeated on the sterile components and their packaging to support the legacy extended 3 year shelf life according to aging methods and test methods previously submitted in the predicate 510(k) in support of the initial 1 year shelf life."
• "Though the majority of the electrosurgical safety testing submitted for the system is still valid, certain electrosurgical safety tests were repeated at a third party test house to support the Shaft metal lock tube change."
• "Biocompatibility data submitted for the Percuvance system still adequately represents the proposed system, as no new patient contacting materials were introduced. However, as a result of Shaft's green ink band modification, which is pad printed on the Shaft's proximal knob, a full biocompatibility panel was completed. Additionally, cytotoxicity testing was performed on the Shaft metal lock tube change."

Conclusion from the document:
"Based upon the testing presented throughout the submission and in this 510(k) Summary, Teleflex Medical's Percuvance™ Percutaneous Surgical System is substantially equivalent in to the predicate device cleared to market via 510(k) K153063. The modifications to the proposed Percuvance™ Percutaneous Surgical System do not introduce any new issues of safety and effectiveness."

This submission relies on demonstrating that the modified device performs as well as the predicate device through various engineering and material tests, rather than a clinical study with specific acceptance criteria on diagnostic accuracy or reader performance typically seen with AI/imaging devices.

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The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.

Teleflex Medical's next generation Percuvance™ Percutaneous Surgical System is a micro-laparoscopic platform that comprises fourteen (14) unique components, which are combined in various configurations to create a multifunctional set of instruments for laparoscopic procedures to be performed in a hospital setting. In accordance with IEC 60601-1:2005 (A1:2012), this next generation Percuvance™ system is classified as an active accessory with a rated accessory voltage of 1000V peak-. System components include two reusable Handles (Ratcheted and Non-Ratcheted), which are manipulated by the surgeon and connect to a Shaft. The Shaft, which is available in two lengths (29 cm and 36 cm), affords various Tool Tips (or End Effectors) to be attached in order to perform basic surgical manipulation. Initial access to the surgical site is achieved with the Introducer Tool Tip attached to the Shaft. Once inside the patient, the Introducer Tool Tip is extracorporealized through a pre-inserted, central trocar and is then exchanged for one of the other Tool Tips, which include Scissors. Gripper Grasper, Johans Grasper, Maryland Dissector, Hook Cautery, Spatula Cautery and Clip Applier. Finally, the Seal Bridge, which is available in two sizes (5 mm and 12 mm), is used to protect the trocar seal and to aid in maintaining insufflation when it used in conjunction with a trocar to facilitate the extracorporeal exchange of Tool Tips.

This document is a 510(k) summary for the Teleflex Medical Percuvance™ Percutaneous Surgical System. It describes a medical device, but does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/algorithm performance evaluation.

The provided document details the substantial equivalence of a surgical system (not an AI/algorithm) to predicate devices through various bench tests, biocompatibility evaluations, and usability studies. It focuses on the physical and functional performance of the surgical tools themselves, not on the performance of a diagnostic or predictive algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert qualifications, etc.) for an AI/algorithm from this document.

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