Search Results

This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. Also indicated for sphincterotome-aided, wire-quided selective cannulation of the biliary ducts.

Tesla BiCord Active Cord:

This device is used to connect the Teslatome Bipolar Sphincterotome to compatible electrosurgical generators.

ln a sphincterotomy, access to the biliary tract is gained by passing a sphincterotome through a duodenoscope and positioning the distal tip adjacent to the major papilla is cannulated using the tip of the sphincterotome. The papilla is then incised using an electrosurgical current applied to the cutting wire by an electrosurgical generator that is connected to the sphincterotome by an active cord.

The Teslatome consists of a three-ring handle, tri-lumen catheter, and cutting wire with a connection to an electrosurgical generator via the Tesla BiCord active cord. The connection delivers a current to the cutting wire that is exposed at the device. A multilumen catheter allows for the injection of contrast and/or the passage over a prepositioned wire guide using the proximal end of the device.

The provided text is a 510(k) summary for the Teslatome Bipolar Sphincterotome and Tesla BiCord Active Cord. It details the device, its intended use, and a comparison to a predicate device. However, it does not contain information about specific acceptance criteria, a detailed study proving the device meets these criteria, or any clinical study details.

The document explicitly states: "The non-clinical tests for seal strength, functional testing after simulated distribution, current carrying capacity, device burnout, neutral electrode thermal performance, and force of device pushability demonstrate adherence to the quality design and risk management systems of the manufacturer. The Teslatome and BiCord active cord are substantially equivalent to the currently cleared predicate devices."

This indicates that while non-clinical tests were performed, the 510(k) relies on the substantial equivalence to a predicate device (K192339) rather than a de novo clinical study with specific acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered, along with the reasons why other information cannot be provided based on the input:

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

• Cannot be provided. The document broadly mentions "non-clinical tests for seal strength, functional testing after simulated distribution, current carrying capacity, device burnout, neutral electrode thermal performance, and force of device pushability." However, it does not list specific quantitative acceptance criteria for these tests or the reported performance values against those criteria. It only states that the tests "demonstrate adherence to the quality design and risk management systems of the manufacturer" and that the devices are "substantially equivalent."

2. Sample size used for the test set and the data provenance

• Cannot be provided. The document does not detail sample sizes for the non-clinical tests. It also does not discuss any test set in the context of clinical data or data provenance (country of origin, retrospective/prospective), as it relies on non-clinical testing and substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Cannot be provided. This information is relevant for studies involving human interpretation or clinical data with ground truth establishment. The provided text only discusses non-clinical device testing for substantial equivalence, not studies requiring expert ground truth.

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

• Cannot be provided. This is relevant for clinical studies involving multiple readers and ground truth adjudication. Not applicable to the non-clinical testing mentioned.

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

• Cannot be provided. The device described (Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord) is an endoscopic electrosurgical unit and accessories, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study or AI-related effectiveness is not applicable and not mentioned.

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

• Cannot be provided. As noted above, this is not an AI algorithm. The device is a physical medical instrument.

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

• Cannot be provided. For the non-clinical tests mentioned, the "ground truth" would be established engineering specifications, performance standards, or comparison to the predicate device's known characteristics, not clinical ground truths like pathology or expert consensus. Specific details are not included.

8. The sample size for the training set

• Cannot be provided. This information is related to machine learning models. The device discussed is a physical medical instrument, not an AI model requiring a training set.

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

• Cannot be provided. This information is related to machine learning models. Not applicable for this device.

Ask a specific question about this device

The TeslaTome Bipolar Sphincterotome is intended for cannulation of the ductal system and sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP (endoscopic retrograde cholangiopancreatography). Also indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.

The Tesla Bipolar Active Cord is used to connect the TeslaTome to compatible electrosurgical generators.

The TeslaTome Bipolar Sphincterotome is an endoscopic electrosurgical accessory composed of a single stainless steel drive wire within a triple-lumen polymer catheter. The proximal end of the catheter/wire assembly terminates in a handle, held by the physician or assistant during ERCP procedures and fulfills three (3) functions: connection to an electrosurgical generator, injection of diluted contrast, introduction of an endoscopic wire guide and manipulation of the cutting wire. The distal end contains a stainless steel cutting wire and ink and band markings. Half of the cutting wire is insulated with a non-conductive polymer coating. The device allows for short-wire, distal wire guide exchange through the separation of a weakened wall in the wire guide lumen that separates with manual control. The device is also compatible with traditional long wire guides. The TeslaTome Bipolar Sphincterotome is available in eight model numbers reflecting cutting wire length of 20 or 25 mm, and a .035" Acrobat II wire guide in either 260 cm or 450 cm length, and an optional rotatable handle.

The Tesla Bipolar Active Cord (TESLA-ACU-B) is used to facilitate connection to an Electrosurgical generator (ESU). It uses a magnetic connection at the sphincterotome alignment but facilitates connection with ERBE generators on the distal end with conventional ESU-compatible plugs. The Active cord is non-sterile and reusable.

The provided text describes a 510(k) premarket notification for the TeslaTome Bipolar Sphincterotome and Tesla Bipolar Active Cord. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in a way that would require a table of acceptance criteria and reported device performance.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific numerical performance metrics against predefined acceptance criteria for the new device itself. The "Discussion of Performance Tests and Test Results" section outlines various tests conducted, but these are verification tests to ensure design inputs are met and the device performs as intended, not a comparative study with quantitative performance metrics and acceptance thresholds.

Given the information provided, it's not possible to populate a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9, as they pertain to clinical study design and ground truth establishment, which are not detailed in this 510(k) summary.

Therefore, I must state that the requested information (a table of acceptance criteria and reported device performance, sample size, data provenance, expert details, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth establishment for the training set) is not present in the provided text.

The document primarily focuses on:

• Device Description: What the device is and how it functions.
• Intended Use: The medical purpose of the device.
• Substantial Equivalence Argument: Comparing the new device to previously cleared predicate devices, highlighting similarities in design, materials, and intended use, and explaining any minor differences.
• Performance Tests: A list of conducted tests (e.g., mechanical, electrical, biocompatibility, simulated use, cleaning validation) to ensure the device meets its design specifications and is safe, but without presenting quantitative acceptance criteria or detailed results of these tests that would fit into the requested table format. These tests are internal verification activities rather than external clinical performance studies with defined acceptance metrics for a specific clinical task.

Ask a specific question about this device