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ClearHemograsper has been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

ClearHemograsper is a monopolar endoscopic instrument intended to coagulate or to perform hemostasis using high-frequency current within the digestive tract. It can assist in endoscopic surgical procedures such as ESD (Endoscopic Submucosal Dissection). ClearHemograsper consists a Slider for opening or closing the Jaw, a Catheter Tube which is a part passing through the working channel of endoscope, a pair of Jaw for catching the bleeding site and for delivering high-frequency current, a plug for connecting with high frequency transmission equipment, and an irrigation port for removing foreign substances by injecting distilled water or saline solution. It is available in various working lengths.

The provided FDA 510(k) clearance letter for ClearHemograsper is for an endoscopic electrosurgical unit and accessories, which is a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the provided text does not contain information on acceptance criteria, test sets, ground truth establishment, or clinical studies typically associated with the evaluation of AI models.

The information requested in the prompt (acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is specific to the validation of AI/SaMD, particularly for diagnostic or prognostic purposes where ground truth and human reader performance are critical.

Since the ClearHemograsper is a physical device used for cauterizing and coagulation, its performance is evaluated through bench testing (e.g., dimension, rotatable performance, pushability, actuation, tensile strength, output value, hemostatic performance, short circuit, catheter tube temperature tests), biocompatibility studies, sterilization validation, shelf-life studies, and electrical safety/EMC testing. Clinical studies were not considered for this submission (as stated on Page 10, Section 13).

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI/SaMD metrics.
• Sample sizes, data provenance, expert numbers, adjudication, MRMC studies, standalone performance, or ground truth establishment methods for an AI test set.

The document describes the device's technical specifications and comparisons to a predicate device, focusing on physical and electrical performance, and safety standards for a mechanical/electrical medical device.

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The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are intended for use in endoscopic procedures where fusion of vessels or tissue bundles is performed. The device can be used on vessels up to 3 mm and bundles as large as will fit in the jaws of the instrument. The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. It is not recommended for use with other manufacturer's generators.

The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps Device Description is a sterile, single-use device intended for use in endoscopic procedures where fusion of The device can be used on vessels up to 3 mm vessels or tissue bundles is performed. and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the instrument. The Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps sources RF energy from an electrosurgical generator. Specifically, the Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. This device passes through endoscopes having a 3.7 mm or larger working channels.

This document describes a 510(k) premarket notification for the "Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps". This is a medical device, not an AI/ML algorithm. Therefore, many of the requested categories in the prompt, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to traditional medical device submissions.

However, I can extract information related to performance testing that demonstrates the device meets its intended use.

Here's an analysis based on the provided document:

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

The document lacks a specific table detailing acceptance criteria alongside reported performance for each criterion. It broadly states that "Bench, animal, biocompatibility, and electrical testing was performed to demonstrate that the EES device performs as intended."

Device Performance Claimed:

• Vessel/Tissue Fusion: The device can perform fusion of vessels or tissue bundles.
• Vessel Size: Effective on vessels up to 3 mm.
• Bundle Size: Effective on bundles as large as will fit in the jaws of the instrument.
• Compatibility: Designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System.
• Endoscope Channel: Requires a 3.7 mm or larger working channel.
• Tissue Manipulation: Jaws contain atraumatic "grooves" to grasp and manipulate tissue.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the bench, animal, biocompatibility, or electrical testing. It also does not explicitly mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept of "ground truth established by experts" is not typically applicable to the performance testing of a physical medical device like electrosurgical forceps. The "ground truth" would be objective measurements of device function (e.g., burst pressure of fused vessels, thermal spread, electrical impedance).

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

Not applicable, as this refers to expert consensus for ground truth, which isn't detailed for this type of device.

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. This is a physical electrosurgical device, not an AI system.

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

Not applicable. This is a physical electrosurgical device, not an AI algorithm.

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

The "ground truth" for this device's performance would be derived from objective measurements and observations during typical medical device performance testing, including:

• Bench Testing: Mechanical properties, electrical safety, fusion strength (e.g., burst pressure), thermal effects.
• Animal Testing: In-vivo performance, tissue effect, hemostasis effectiveness, safety.
• Biocompatibility Testing: Assessment of biological response to materials (e.g., cytotoxicity, irritation, sensitization).

8. The sample size for the training set

Not applicable. This is a physical electrosurgical device, not an AI system that requires a "training set."

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

Not applicable. This is a physical electrosurgical device, not an AI system.

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