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The CONMED ABC D-Flex Probes are intended for use with a CONMED ABC Generator for delivery of argon gas and electrosurgical current for non-contact ablation and hemostasis at the operative site. The ABC D-Flex Probes are indicated for use during general, urological, and gynecological laparoscopic surgical procedures when manipulated by CONMED manual laparoscopic graspers or similar manual instruments.

CONMED ABC® D-Flex Probes™ are monopolar, electrosurgical devices indicated for non-contact ablation and hemostasis of the operative site in laparoscopic surgery. The CONMED ABC® D-Flex Probes™ are composed of a catheter tube, ceramic tip, the D-Flex attachment, insufflation seal, and a shrink tube. The CONMED ABC® D-Flex Probes™ are provided sterile for single use only and are controlled by the appropriate ABC® footswitch used in conjunction with compatible CONMED ABC generators.

The ABC® D-Flex Probes™ are intended for use with a CONMED ABC® Generator for delivery of argon gas and electrosurgical current for non-contact ablation and hemostasis at the operative site. The probes should be used with a maximum output of 6.5kV at a power setting of 80W.

The provided document is a 510(k) summary for the CONMED ABC D-Flex Probes, an electrosurgical device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information related to specific acceptance criteria for diagnostic performance (such as sensitivity, specificity, accuracy), nor does it describe a study involving human readers, ground truth establishment by experts, or sample sizes related to AI performance evaluation.

The "Performance Data" section (Section I) refers to:

• Compliance with standards: AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-2-2:2009, ANSI/AAMI ST67:2011, and ANSI/AAMI/ISO 10993-1:2009 (Biological Evaluation). These are general safety, essential performance, and biocompatibility standards, not diagnostic performance metrics.
• Benchtop verification testing: Grasping, release, manipulation, axial pull force, and argon flow.
• Functionality testing: Beam initiation, non-contact ablation, and reliability.
• Ex-vivo comparison testing: Assessment of thermal spread depth at comparable power settings.

These tests are designed to demonstrate the physical and functional aspects of the electrosurgical device itself, not an AI or diagnostic algorithm. Therefore, I cannot extract the requested information in the format provided, as it is not present in the document.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy (e.g., sensitivity, specificity).
2. Sample sizes for test sets or data provenance for an AI study.
3. Number or qualifications of experts used for establishing ground truth.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
6. Results from a standalone (algorithm only) performance study.
7. Type of ground truth used for AI-related evaluation.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document pertains to the regulatory clearance of a physical medical device (electrosurgical probes) based on established electrical safety, biocompatibility, and functional performance, rather than the evaluation of a diagnostic AI system.

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