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The Bissinger SUPRA Non-Stick Bipolar Forceps are used for grasping, dissection and coagulation of biological tissues. The fully assembled instrument (if assembly is needed) has to be connected - with the appropriate cable - to the bipolar output of an HF generator. Supra Non-Stick Bipolar Forceps may not be used for tubal sterilization or tubal coagulation.

SUPRA Non-Stick Bipolar Forceps are available in several working length and tip width. They are delivered with a 2pin plug to connect them to bipolar output of an HF generator. The devices are supplied in sterile state and are intended for single use only.

This document is a 510(k) premarket notification for a medical device, the Supra Non-Stick Bipolar Forceps. It does not contain information about an AI/ML enabled device or a study proving that such a device meets acceptance criteria. The document focuses on establishing substantial equivalence to a predicate device for a electrosurgical cutting and coagulation device.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as this document does not pertain to such a device.

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Cables for electrosurgery are designed to conduct electrical power from the output of a high-frequency electrosurgical generator to the electrosurgical instrument. Do not exceed a maximum output of 6250 Vp of your generator.

Bissinger monopolar cables are non-sterile, reusable Monopolar Cables fitting Bovie Electrosurgical units. They are designed to conduct electrical power from the output of a high frequency generator to the instrument.

This document is a 510(k) summary for Bissinger Monopolar Cables, seeking clearance from the FDA. It declares substantial equivalence to previously cleared predicate devices. The information provided heavily focuses on describing the device and comparing it to predicates, rather than presenting a detailed study with specific acceptance criteria and performance metrics typically expected for AI/software-as-a-medical-device (SaMD) clearances.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this document, as they are not typically required for a mechanical device like electrosurgical cables that are seeking substantial equivalence based on material, design, and performance conformity to existing standards, rather than a clinical effectiveness study.

However, I can extract the relevant information that is available:

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

The document frames compliance with recognized standards as the performance criteria. The "new device" (Bissinger Monopolar Cables) is compared to predicate devices across several technological characteristics, with the "RE-SULT" column consistently indicating "Substantial Equivlent".

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

The document does not detail specific sample sizes for tests. The testing performed is related to electrical safety, sterilization validation, reprocessing, and manual cleaning. These are typically bench tests or validation studies for manufacturing processes, not clinical studies with patient data. Therefore, concepts like data provenance (country of origin, retrospective/prospective) are not applicable in the usual sense for this type of device.

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 is not applicable. The "ground truth" for this device's clearance is conformity to engineering standards (e.g., IEC 60601) and validated manufacturing processes (e.g., sterilization). Expert consensus of clinical data is not a part of this submission type.

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

This is not applicable. Adjudication methods are typically for clinical outcome assessments where there might be disagreement in interpretation. For engineering and process validation, the conformity to standards is typically assessed by engineers and quality control personnel.

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 is not applicable. This is not an AI/SaMD device, and no MRMC study was conducted.

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

This is not applicable. This is a physical medical device (monopolar cables), not an algorithm or software.

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

The "ground truth" for this submission are the recognized consensus standards (e.g., IEC 60601-2-2:2009 for electrical safety, and other "recognized standards" for sterilization, reprocessing, and biocompatibility). The device performance is assessed against the specifications and requirements outlined in these standards.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI device.

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

This is not applicable. There is no training set for this device.

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The Bissinger CLARIS NON-STICK bipolar forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current.

The Bissinger CLARIS NON-STICK bipolar forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

During the coagulation of tissue the coagulated tissue might stick to the tip of the forceps. This undesirable effect can almost completely be avoided by using the new CLARIS NON-STICK bipolar forceps. By applying a material with excellent thermal properties for the forceps, difficult and time-consuming cleaning of the forceps during an operation is no longer necessary and enables non-stop working. The non-stick effect is permanently ensured and will not be reduced, even if subject to frequent sterilization. By using a suitable connecting cable, CLARIS NON-STICK bipolar forceps can be connected to all high-frequency electrosurgical generators generally used.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a medical device which primarily focuses on establishing substantial equivalence to a legally marketed predicate device rather than presenting performance study results against predefined acceptance criteria.

The document mentions compliance with general performance standards (DIN EN 60601-1, DIN EN 60601-2-2, ANSI/AAMI HF18-2001) for electrosurgical devices, but these are general safety and performance standards for the device type, not specific acceptance criteria for a particular study.

Therefore, I cannot fulfill your request for the table, sample sizes, expert details, adjudication methods, MRMC study information, standalone study information, or details about the training set.

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BiTech bipolar scissors are designed for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.

The BiTech Bipolar Scissors has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

BiTech bipolar scissors enable cutting and dissection with simulataneous bipolar coagulation. They can also be used for precise pinpoint or zone coagulation of blood-vessels and tissue. The various working lengths allow the scissors to be used for a large number of applications in open surgery.

A petented construction priciple, which was developed by Dr. J. Manushakian*, ensures that the scissors are both easy to use and to repair. The electrical contacts for both scissor blades are conducted via one section of the handle, i. e. the connection cable only needs to be attached to one ring, which significantly reduces reference duriong handling. The scissor blades are flexibly joined by means of a standard steel scissor screw which does not need to be insulated and, as a result, is not subject to wear.

The provided document describes a 510(k) notification for the BiTech Bipolar Scissors. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the way a novel device might.

Therefore, the document does not contain the detailed information required for the requested output regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. Specifically:

• No specific acceptance criteria are listed for device performance in terms of accuracy, sensitivity, specificity, etc.
• No study is described that details a test set, training set, ground truth establishment, or expert adjudication for performance evaluation.
• There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only study.

Instead, the submission relies on demonstrating compliance with recognized performance standards for safety and electrical equipment, and stating substantial equivalence to existing devices.

Here's what can be extracted from the document, tailored to the spirit of your request where possible, but acknowledging the limitations of this type of submission:

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

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

• Not applicable. This submission relies on substantial equivalence and compliance with engineering standards, not on a clinical performance study with a test set.

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)

• Not applicable. No ground truth establishment by experts for a test set is described.

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

• Not applicable. No test set described.

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 not an AI-assisted diagnostic device, nor is an MRMC study mentioned.

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

• Not applicable. This is a surgical instrument, not an algorithm.

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

• Not applicable. For this type of device and submission, the "ground truth" for safety and efficacy is generally considered to be the established performance and safety record of the predicate devices and compliance with recognized industry standards.

8. The sample size for the training set

• Not applicable. No training set is described.

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

• Not applicable. No training set is described.

Summary of the Study/Evidence:

The "study" in a 510(k) submission like this is primarily a bench-testing and documentation effort to demonstrate:

• Compliance with recognized electrical and safety standards: DIN EN 60601-1, DIN EN 60601-2-2, and ANSI/AAMI HF18-2001. This would involve testing the device against the specific requirements and clauses within those standards.
• Substantial equivalence to legally marketed predicate devices: Ethicon (K981361) and Enable (K972558). This involves comparing the technological characteristics, intended use, and performance claims of the BiTech Bipolar Scissors to these established predicates. The document implies that the "patented construction principle" and how electrical contacts are conducted are key differentiating features, but these are presented as improvements in usability and repair, not as fundamentally altering the safety or efficacy compared to predicates for the stated intended use.
• Provision of validated user instructions: For cleaning, maintenance, and sterilization, ensuring the device can be safely and effectively prepared for use.

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device...and have determined the device is substantially equivalent...to legally marketed predicate devices..." This confirms the FDA's acceptance of the manufacturer's demonstration of substantial equivalence based on the provided documentation and compliance with the mentioned standards.

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The Bissinger bipolar cable/cord is intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar output of an electrosurgical generator to a bipolar foot-activated instrument.

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Bissinger cables are a line of non-sterile, reusable bipolar foot activated cables fitting Erbe, Martin, Valleylab, Aesculap GK50, Codman CMC II, and other ES units.

This document is a 510(k) premarket notification for a medical device (Bissinger Cables), not a study report detailing acceptance criteria and performance. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided text.

However, based on the context of a 510(k) submission, the "acceptance criteria" can be inferred as substantial equivalence to predicate devices. The "study that proves the device meets the acceptance criteria" is the comparison to predicate devices presented in the document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not explicitly present a table of acceptance criteria in the format typically used for a performance study (e.g., sensitivity, specificity, accuracy thresholds). Instead, the "acceptance criteria" for a 510(k) are met by demonstrating "substantial equivalence" to legally marketed predicate devices. The "reported device performance" is a comparison of characteristics to those predicates.

Here's an adaptation of the requested table format, using the substantial equivalence comparison:

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

• Sample Size: Not applicable. This document describes a comparison of device specifications, not a clinical or performance study with a "test set" in the context of data analysis. No patient or sample data is involved.
• Data Provenance: Not applicable. The "data" here refers to the device's technical specifications and intended use, which are provided by the manufacturer (Günter Bissinger Medizintechnik GmbH) from Germany.

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)

• Not applicable. There is no "test set" and no "ground truth" in the clinical or diagnostic sense within this 510(k) submission. The FDA reviews the provided information to determine substantial equivalence based on accepted regulatory standards and the comparison to predicate devices.

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

• Not applicable. There is no "test set" requiring adjudication in this technical comparison.

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 510(k) submission for an electrosurgical cable, not an AI-powered diagnostic device. No MRMC study was conducted.

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

• Not applicable. This is not an algorithmic or AI device.

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

• Not applicable in the direct sense of diagnostic "ground truth." The "ground truth" for a 510(k) in this context is established by the accepted specifications and performance of the legally marketed predicate devices and compliance with relevant industry standards (IEC, ANSI, AAMI).

8. The sample size for the training set

• Not applicable. There is no machine learning or AI training set involved.

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

• Not applicable. There is no machine learning or AI training set involved.

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Bipolar tissue coagulation in: Gynecology and and Laparascopic surgical procedures

The bissinger® detachable bipolar coagulation-forceps is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. The device consists of a Forceps Body (grip), Exterior tube (available in three working lengths), Interior tube (sliding tube, available in three working lengths), 1mm Electrode (fluted bit, available in three working lengths), 3mm Electrode (tong-type bit, available in three working lengths), Hirsch-electrode (rippled bar, available in three working lengths), and various types of plugs (Erbe-type, Martin/Berchtold-type, Codman-type, Valleylab-type) to connect to different current generators, and a Cable.

The provided text describes a 510(k) premarket notification for the bissinger® detachable bipolar coagulation-forceps. It addresses the device description, classification, and a comparison to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document specifically states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This indicates that the approval was based on a demonstration of substantial equivalence to a legally marketed predicate device (WISAP bipolar coagulators), rather than a separate device performance study with acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes, ground truth details, or expert information as this data is not present in the provided text.

The text focuses on administrative details of the 510(k) submission, including:

• Device Name: bissinger® detachable bipolar coagulation-forceps
• Common Name: Coagulation forceps
• Classification Name: Bipolar, Coagulator-Cutter, Endoscopic, Bipolar and Accessories
• Device Class: Class III (but noted that "No effective date has been established of the requirement for premarket approval. See § 884.3.")
• Classification Panel: OB/GYN
• Product Code: 85HIN (later updated in the FDA response letter to 85HET and 78KNS)
• Predicate Device: WISAP bipolar coagulators from WISAP USA
• Intended Use: Bipolar tissue coagulation in Gynecology and Laparoscopic surgical procedures.

The "Feature Comparison Table" (section 7) primarily details physical and material similarities between the device and the predicate, which is typical for demonstrating substantial equivalence for 510(k) submissions. It lists features like intended use, materials, length, forcep style, insulation material, and compliance with UL and ISO standards. All features are marked as "Yes" for "SE?" (Substantial Equivalence). This table does not represent performance acceptance criteria.

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