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Bipolar Micro-Coagulation Forceps are intended to remove tissue and control bleeding.

Bipolar Micro-Coagulation Forceps are electrosurgical tools available with different handles and different tip designs. The Bipolar Micro-Coagulation Forceps can be connected through an appropriate bipolar cable to an electrosurgical generator. The Bipolar Micro-Coagulation Forceps can be disassembled for cleaning and sterilization. The Bipolar Micro-Coagulation Forceps are delivered in unsterile condition and have to be sterilized prior to each use.

This document is a 510(k) premarket notification for the "Bipolar Micro-Coagulation Forceps" by Gunter Bissinger Medizintechnik GmbH. It describes the device and demonstrates its substantial equivalence to a predicate device, K150959, Sutter Bipolar Forceps - Calvian.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative metrics in the provided document, which is typical for a 510(k) for a Class II electrosurgical device where substantial equivalence to a predicate is the primary goal. Instead, equivalence in various characteristics is demonstrated. The "Result" column typically indicates "Substantially Equivalent," implying that the device's performance aligned with the predicate or relevant standards to demonstrate safety and effectiveness.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size (Test Set): The document mentions that "Three different tissue types were used" for evaluating thermal effects. However, it does not specify the number of samples or repetitions for each tissue type, neither does it mention specific patient data. For the other tests (Biocompatibility, Electrical Safety, Sterilization), the sample size typically refers to the number of devices tested to meet the respective standard, which is not explicitly quantified here beyond stating the tests were performed.
• Data Provenance: Not explicitly stated. Given the applicant is in Germany, it's highly likely the testing was conducted in Germany or a location deemed acceptable for gaining regulatory approval. The study type is not specified as retrospective or prospective, but as it involves testing of the physical device it would inherently be "prospective" for the specific tests performed (e.g., electrical safety, thermal effects).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device submission. The submission is for an electrosurgical tool, not an AI/diagnostic device that requires expert review for ground truth establishment. The ground truth for this device is based on physical performance measurements, compliance with international standards (IEC, ISO), and direct comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason mentioned above. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., reading medical images) to establish a consensus ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic tools or AI systems where human readers interpret cases. This submission is for a physical surgical instrument.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable. This device is a physical surgical instrument, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Compliance with Recognized Standards: Meeting the requirements of IEC 60601-1, IEC 60601-2-2 for electrical safety, and ISO 10993-1 for biocompatibility. These standards define the acceptable performance and safety limits.
• Direct Comparison to a Legally Marketed Predicate Device: The key "ground truth" or benchmark here is the performance and characteristics of the Sutter Bipolar Forceps - Calvian (K150959). The study aimed to demonstrate that the proposed device performs "as intended" and is "substantially equivalent" to the predicate.
• Laboratory Testing: Directly measuring physical properties, electrical characteristics, and thermal effects in a controlled environment.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" for this type of medical device as it does not involve machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set.

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Bipolar tissue coagulation in gynecologic and laparoscopic surgical procedures.

The POWERGRIP coagulation forceps are designed for grasping, cutting and bipolar coagulation in minimally invasive surgery. The POWERGRIP handle actuates the jaws of the electrode inserts by means of a double-hinge and serves as the point of attachment for accessories (shafts, inserts, cables).

The provided text is a 510(k) summary for the Guenter Bissinger Medizintechnik GmbH POWERGRIP Bipolar Coagulation Forceps. It's a regulatory document for a medical device and describes modifications to an existing device, rather than a study proving performance against acceptance criteria in the typical sense of a clinical trial or performance study.

Based on the document, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria or reported device performance in the way a clinical study report would. Instead, it makes claims of substantial equivalence to a predicate device and states that modifications improve handling and do not affect safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a test set or a study involving a particular sample size of cases/patients. The submission is for a modification to an existing device and relies on showing substantial equivalence to a predicate device and that the change does not adversely affect safety or effectiveness. There's no mention of country of origin or whether hypothetical data would be retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This document does not describe a study involving experts to establish ground truth. The claims made are based on design rationale and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable, as no test set or study with expert ground truth establishment is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done or described in this document. The submission is a regulatory filing for a device modification, focusing on substantial equivalence and design changes, not a comparative clinical effectiveness study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device (coagulation forceps), not an algorithm or AI.

7. Type of Ground Truth Used

Not applicable. No ground truth in the context of a performance study is mentioned. The "ground truth" for this regulatory submission is the substantial equivalence to the predicate device and the engineering/design justification that the modifications do not compromise safety or effectiveness.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set mentioned or relevant.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is mentioned.

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