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The maxmorespine Bipolar Electrodes are indicated for the coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunctible radio frequency generator. The maxmorespine Bipolar Electrodes have not been shown to be effective for tubal coagulation for sterilization for sterilization procedures and should not be used for these procedures.

maxmorespine Bipolar Electrodes are designed with a rounded distal end, an ergonomic handle in various designs and a flat plug connection. The electrodes are sold as one-piece electrodes (1001-BE 003) or consist of a three-piece construction (shaft, electrode and handle). The one-piece electrode and electrodes (1001-BE 002 and 1001-BE 004) are sold as sterile, single-use devices. The handles and shafts (1001-BE 001/H, 1001-BE 001/s and 1001-BE 004/S) are intended for reuse. The maxmorespine Bipolar Electrodes can be connected to HF electrosurgical generators that have the permissible Vp voltage via a flat plug using the standard bipolar connection cables.

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them.

The document is a 510(k) premarket notification for the "maxmorespine Bipolar Electrodes." It focuses on demonstrating substantial equivalence to a predicate device (joimax Electrosurgical Instruments, K161378) by comparing indications for use, design characteristics, and general performance aspects.

Here's why I cannot fulfill your request based on this text:

• No explicit "acceptance criteria" are listed for device performance in the context of a specific study. The document states that the device's performance has been "evaluated with tissues of various density" and "shown to be substantially equivalent to the predicate device," but it doesn't quantify or define specific metrics for acceptability (e.g., a specific percentage of coagulation efficiency, a maximum tissue damage depth, etc.).
• The "study" described is a performance testing comparing the subject device to a predicate device, not necessarily a study against pre-defined acceptance criteria. While this is a form of testing, it's framed in terms of substantial equivalence rather than meeting independent performance targets.
• Missing details for your specific points:
  • Table of acceptance criteria and reported device performance: This is not present in the document.
  • Sample size and data provenance: The document mentions "tissues of various density (muscle, kidney, and liver)" but doesn't specify the number of samples, origin, or whether the study was retrospective or prospective.
  • Number of experts and qualifications: Not mentioned.
  • Adjudication method: Not applicable/mentioned for this type of comparison.
  • MRMC comparative effectiveness study: Not mentioned. This type of study usually involves human readers assessing images, which is not relevant for a bipolar electrode device.
  • Standalone algorithm performance: Not applicable, as this is a physical medical device, not an AI algorithm.
  • Type of ground truth used: Not explicitly stated for the "tissue performance testing," other than comparing its performance against the predicate device.
  • Sample size and ground truth for the training set: Not applicable, as this is a physical device, not an AI/ML model that requires training data.

The document primarily addresses the safety and effectiveness through general non-clinical data (biocompatibility, electrical safety, sterilization, packaging) and a performance comparison to the predicate device to establish substantial equivalence for regulatory clearance. It does not provide the detailed study design, acceptance criteria, and quantitative results often seen in studies evaluating specific performance metrics against pre-defined thresholds for a novel device or AI algorithm.

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