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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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The maxMorespine Endoscope when used with recommended third party accessories/components, is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy and foraminotomy.

The maxMorespine Endoscope is a rigid, multi-channel endoscope comprised of a working channel, rod lens optical system to transmit light and images with irrigation channel(s) and stopcocks. The body is designed of an outer and inner tube of surgical grade stainless steel. The proximal end of the endoscope; eyepiece and light post is adaptable to industry standard endoscopic camera and light systems. The endoscope will be introduced into the patient via a minimally invasive access through a working cannula with various instruments introduced through the Endoscope working channel (maxMorespine System submitted sepatately - K090132).

This document is a 510(k) premarket notification for the maxMorespine Endoscope. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about a study to prove acceptance criteria for device performance. It's a regulatory submission for a medical device cleared in 2009.

Therefore, I cannot provide the requested information, which typically applies to AI/ML software as a medical device (SaMD) or devices with performance claims that require clinical or analytical validation studies.

Here's why the requested information isn't present in the provided document:

1. Nature of the Device: The maxMorespine Endoscope is a physical, rigid multi-channel endoscope. Its performance is primarily assessed through design specifications, material compatibility, and intended use, rather than complex algorithms requiring validation against ground truth data.
2. 510(k) Paradigm for this Device Type: For devices like endoscopes, substantial equivalence is usually demonstrated by comparing design, materials, sterilization, and intended use to existing predicate devices already on the market. This often doesn't involve formal performance studies with acceptance criteria in the same way an AI/ML diagnostic tool would.
3. Absence of Software: The document explicitly states, "No Software is needed for the maxMorespine Endoscope" (page 2), eliminating the need for AI/ML specific validation criteria.
4. Date of Submission: This submission is from 2009, prior to the widespread adoption and regulatory focus on AI/ML in medical devices that necessitated the detailed performance study information you're requesting.

In summary, the provided document does not contain any of the requested information regarding acceptance criteria or a study proving device performance because it pertains to a traditional medical device (an endoscope) for which such studies are typically not required for 510(k) clearance, particularly in 2009, and it has no AI/ML component.

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The maxMorespine System is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures such as: arthroplasty, nucleotomy, discectomy and foraminotomy.

The maxMorespine System consists of basic cannulas, sheaths, dilators, drills, trephines, forceps, punches, mallet and quidewires which facilitate or compliment the maxMorespine Endoscope (submitted separately under K083552). The System is designed to provide the access and treatment of spinal anatomy and pathology.

This document is a 510(k) summary for the maxMorespine System, which is a spinal endoscopy system. It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating equivalence to existing devices rather than presenting performance data against specific acceptance criteria.

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