Search Results

The Single Use Electrosurgical Knife has been designed to be used with flexible endoscopes to cut tissue using highfrequency current within the digestive tract.

The device is an endoscopic electrosurgical knife for Endoscopic Submucosal Dissection (ESD). The Single Use Electrosurgical Knife is used with flexible endoscopes to cut tissue using high-frequency current within the digestive tract.

It is recommended to use an ERBE VIO-200s electrosurgical unit to supply power to the device.

The provided text focuses on the 510(k) summary for the "Multi-Functional Electrosurgical Knife" and details why it is considered substantially equivalent to existing predicate devices. It does not describe a study that involves acceptance criteria for device performance based on AI/human reader comparison or ground truth established by experts in a diagnostic context. Instead, the performance data section outlines bench and electrical testing to ensure the device performs similarly to predicate devices and meets safety standards for an electrosurgical knife.

Therefore, many of the requested details, such as those related to AI effectiveness, human reader improvement, and expert-adjudicated ground truth, are not applicable to this submission as it doesn't describe such a study.

However, I can extract information related to the performance data and the general approach to demonstrating substantial equivalence for this medical device.

Here's a summary of the information available based on the provided text, addressing the points where information is present or clearly not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with reported numerical performance values in the format requested (e.g., sensitivity, specificity, AUC). Instead, it lists performance tests conducted to demonstrate equivalence to predicate devices and conformance to standards. The "acceptance criteria" are implicitly that the proposed device performs "without significant difference" compared to predicate devices and meets established safety standards.

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

• The document does not specify exact sample sizes for each bench test conducted.
• Data provenance is not explicitly mentioned in terms of country of origin, but the testing was conducted to support a submission to the U.S. FDA. The type of study is bench testing and conformance testing against standards, rather than a clinical trial or study on patient data.

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

• This question is not applicable. The device is an electrosurgical knife, and its performance evaluation involves physical and electrical bench testing against established engineering and safety standards, and comparison to predicate devices, not interpretation of diagnostic images or data by human experts for ground truth establishment.

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

• This question is not applicable. As in point 3, the evaluation of an electrosurgical knife's performance is based on measurable physical and electrical properties, not on subjective expert consensus or adjudication of diagnostic cases.

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:

• This question is not applicable. The device is an electrosurgical knife, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers or AI assistance was performed.

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

• This question is not applicable. The device is a surgical instrument, not an algorithm.

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

• The "ground truth" for this device's performance evaluation is based on established engineering and safety standards (e.g., IEC 60601 series) and the performance characteristics of legally marketed predicate devices. For biocompatibility, it's based on ISO 10993 standards. For tissue cutting and thermal damage, it's based on measurable physical effects demonstrated during bench testing.

8. The sample size for the training set:

• This question is not applicable. The device is a physical electrosurgical knife; it does not involve machine learning or a "training set" of data in the conventional sense.

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

• This question is not applicable for the same reason as point 8.

Ask a specific question about this device

These instruments have been designed to be used with endoscopes and electrosurgical for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.

The proposed device Single Use Electrosurgical Knife is a sterile, single-use endoscopic device, intended to be used with endoscopes and electrosurgical units for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.

The Single Use Electrosurgical Knife is used with the Electrosurgical Unit (ESU), the ESU supplies high frequency (HF) energy through a retractable electrode of the Single Use Electrosurgical Knife for the cutting and coagulation of tissue. The Single Use Electrosurgical Knife consists of Cutting Knife, outer tube assembly, Middle Tube assembly and handle assembly. Physicians would attach it to the ESU. For endoscopic procedures, the Single Use Electrosurgical Knife is placed down the channel of an endoscope that has a working channel equal to or greater than 2.8mm.

Upon the setup of the ESU, the Single Use Electrosurgical Knife is ready for use. To activate cautery, the Cutting Knife is extended out and the ESU's footswitch is depressed. The subject devices with injection models can supply fluid into the submucosa to supply liquid, use a syringe or pump to connect with luer tap on the hand components.

The Single Use Electrosurgical Knife is divided into I type, T type, O type and IT type according to the shape of the Cutting Knife. The main materials include ABS, Stainless Steel, PTFE, Zirconia, TPU and Gold. The physical and chemical performances of the device are stable. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The Single Use Electrosurgical Knife has twenty-two (22) specifications; the main differences of these specifications are Cutting Knife Shape, Cutting Knife Length, and Effective Working Length and with injection function or without injection function.

The provided text describes a 510(k) premarket notification for a medical device, the "Single Use Electrosurgical Knife". This document establishes substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a comparative study with a "reported device performance" in the way an AI/ML device would.

Therefore, the requested information elements such as "reported device performance," "sample sizes for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "effect size," "standalone performance," "type of ground truth," "training set sample size," and "how ground truth for training set was established" are not applicable to this submission, as they pertain to clinical or AI/ML performance evaluation, which is not the focus of this 510(k) summary.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics and performance data from bench testing.

Here's a breakdown of the information that is available in the document, formatted as requested where applicable, with explanations for missing sections:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the context of clinical metrics (e.g., sensitivity, specificity for diagnostic devices, or specific outcomes for therapeutic devices) that would typically be associated with an AI/ML or comparative effectiveness study. Instead, it lists performance data from bench testing used to establish substantial equivalence to a predicate device. The acceptance criteria for these tests are implied to be that the proposed device performs comparably to the predicate device and works as intended.

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

• Sample size: Not explicitly stated in terms of a specific numerical count for each bench test. The document refers to "bench testings" but does not give a specific n-value for the items tested.
• Data provenance: The performance data comes from "bench testings" performed by the manufacturer, Micro-Tech (Nanjing) Co., Ltd., based in China. This is not clinical data, so country of origin of patient data or retrospective/prospective is not applicable.

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

• Not applicable. This is a 510(k) for a physical electrosurgical knife, not an AI/ML diagnostic or prognostic device that would require expert-established ground truth for a test set. The "ground truth" for its performance is assessed via engineering and biocompatibility standards.

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

• Not applicable. As noted above, this is not a study requiring expert adjudication of results.

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

• Not applicable. No MRMC study was conducted. This device is a physical electrosurgical knife, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an AI/ML algorithm.

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

• Not applicable in the context of clinical ground truth. For the bench testing, "ground truth" is defined by established engineering standards (e.g., ISO, IEC, ASTM) and performance expectations for electrosurgical devices, and comparison to the predicate device's known performance.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling.

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

• Not applicable. This device does not involve a "training set."

Ask a specific question about this device