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Tissue grasping and control of bleeding of small vessels by bipolar coagulation.

The Bipolar Forceps device is a single use hand held insulated medical device approximately 295mm in overall length featuring a 190mm distance from the user's grasp to the tip. The bayonet offset is 1.5cm. The tips are Titanium Nitride coated and have polished contact surfaces 1.5mm wide by 1cm long. The device is offered in straight and 20 degree angled tips. The Bipolar Forceps are sold as a single use sterile packaged device used in general surgical procedures. The Bipolar Forceps are limited to maximum 70 watts and shall be used only by personnel with training in electrosurgical procedures and with compatible generators compliant with IEC 60601 requirements. The Bipolar Forceps are rated at 1000V peak and can be used with a compatible reusable pin plug cable (1.8mm pin, 5.8mm spacing). The Bipolar Forceps are single use disposable devices packaged in double blisters with Tyvek lid.

The provided text describes the 510(k) submission for the Boston Endo Surgical Technologies (division of Lacey Manufacturing) Bipolar Forceps. However, it does not contain a study explicitly designed to prove device performance against specific acceptance criteria in the manner typically seen for complex diagnostic or AI-driven medical devices.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (K032327 Modern Medical Bipolar Forceps) through a comparison of technological characteristics and performance testing to ensure safety and basic functionality.

Here's an breakdown of the information that is present, and what is absent from the provided text, in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicitly stated numerical "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy) or device performance beyond general functional and safety standards. The performance section focuses on safety and biocompatibility.

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

• Test Set Sample Size: The text mentions "animal tissue of various diameters" for the electrosurgical function testing. No specific sample size (number of animals, number of tissue samples) or details about the tissue types or conditions (e.g., healthy vs. diseased) are provided.
• Data Provenance: Not specified. It's internal company testing, likely conducted in a lab setting rather than clinical data from a specific country.
• Retrospective/Prospective: Not applicable in the context of this device's performance testing. The biocompatibility and safety tests are laboratory-based, and the functional testing on animal tissue is a controlled experimental setup.

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

• Number of Experts: Not applicable. The "ground truth" for these types of tests (biocompatibility, electrical safety, functional cutting/coagulation) is typically determined objectively by laboratory measurements and observation against established standards, not by expert consensus on clinical findings.
• Qualifications of Experts: Not applicable beyond the implicit assumption that the testers were qualified laboratory personnel.

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

• Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1 for clinical image interpretation) is not relevant for the type of testing described for this 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

• MRMC Study: No. This is a basic surgical instrument, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant to this submission.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

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

• Ground Truth: For biocompatibility tests, the ground truth is defined by the results of the specific ISO 10993 tests (e.g., presence/absence of cytotoxic effects, irritation, sensitization). For electrical safety, it's compliance with electrical standards. For functional testing, "properly cut and coagulated" acts as the objective ground truth against the expected performance of an electrosurgical device on tissue.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no training set in the typical sense.

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

• Ground Truth for Training Set: Not applicable.

Summary of the Study Demonstrated in the K131058 Submission:

The submission for the Bipolar Forceps primarily relies on design and material equivalence to a predicate device (K032327 Modern Medical Bipolar Forceps), coupled with benchtop and laboratory testing to ensure safety, biocompatibility, and basic functional performance.

The "study" that proves the device meets (implied) acceptance criteria consists of:

• Biocompatibility Testing: Performed according to ISO 10993 guidelines, FDA General Program Memorandum No. G95-1, and ODE Bluebook Memorandum G95-1. These tests (Cytotoxicity, Irritation, Sensitization) concluded the device was non-cytotoxic, non-irritating, and non-sensitizing.
• Performance Testing: Conducted after sterilization, using "animal tissue of various diameters" to simulate vessels at different power settings. The conclusion was that "The device properly cut and coagulated the tissue."
• Safety and Efficacy Testing: This included Electrical safety, Biocompatibility (reiterated), Packaging validation, Shipping & transportation, Aging Shelf Life, and Hi-Pot tests. All testing "found no issues of safety or effectiveness."

The core argument for substantial equivalence is that the new device is almost identical to the predicate, with the only significant difference being that the subject device is sterile and single-use, while the predicate is reusable. This difference does not alter the fundamental mechanism of action or intended use.

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The Bipolar Forceps is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated. The submitted Bipolar Forceps are indicated for both GYN and general laparoscopic procedures.

The submitted Bipolar forceps are forceps that grasps, coagulate, and transects tissue, utilizing electrical current. The Bipolar forceps are compatible with all standard bipolar generators that have a bipolar outlet.

This document describes a 510(k) premarket notification for Bipolar Forceps by Richard Wolf Medical Instruments Corporation. The submission claims substantial equivalence to a previously cleared device (K012279).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The submission explicitly states "No clinical tests performed." The basis for substantial equivalence is direct comparison to an identical, previously cleared device.
• Data Provenance: Not applicable. No new test data generated for this specific submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. No clinical tests were performed, and thus no expert-established ground truth was required for a new test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No new test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical tests performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: Not applicable. This device is Bipolar Forceps, a surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of new performance testing. The "ground truth" for this 510(k) submission relies on the established safety and effectiveness of the predicate device (Patton Tripol Bipolar Forceps, K012279), to which the current device is claimed to be identical.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is not an AI/ML device where a training set would be used. The device is a surgical instrument.

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

• Ground Truth Establishment: Not applicable. As per point 8, there is no training set for this type of device.

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The coagulation of tubes, tissue coagulation and vascular coagulation, and to stop bleedings under endoscopic vision, including coagulation of the fallopian tube and the mesoalpinx for female sterilization.

The modular bipolar forcep set provides precise grasping and axial holding placement of the jaws, performs thorough hygiene, and site irrigation can be achieved without using additional instruments.

The provided document is a 510(k) summary for a medical device (Bipolar Forcep Set) seeking clearance for market. It does not describe AI device performance or a study proving an AI device meets acceptance criteria. Instead, it discusses the substantial equivalence of a new medical instrument to previously cleared predicate devices.

Therefore, I cannot extract the requested information about AI device acceptance criteria or performance from this document. The document primarily focuses on:

• Device Description: Bipolar forcep set (modular)
• Intended Use: Coagulation of tubes, tissue, and vasculature under endoscopic vision, including female sterilization.
• Technological Characteristics: Changes to insulation and addition of a cleaning port, but otherwise identical to a previously cleared device.
• Substantial Equivalence: Claimed to pre-enactment devices and K981321.
• Performance Data: No FDA performance standard, but tested against ANSV AAMI standard HF18 and IEC601-2-2, and biocompatibility tests. No clinical tests were performed.

All the requested fields regarding acceptance criteria and study details for an AI device are not applicable to the content provided.

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For the coagulation of tubes, tissue coagulation and vascular coagulation to stop bleedings under endoscopic vision.

For therapy in connection with endoscopic accessories used in medical specialies such as urology, gynecology, surgery.

Not to be used for female sterilization (coagulation of fallopian tubes).

The modular hipolar forcep set provides precise grasping and axial holding placement of the jaws. performs thorough hygiene, and site irrigation can be achieved without using additional instruments

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document describes a 510(k) submission for Modular Bipolar Forceps. It's crucial to understand that for this type of device (bipolar forceps), the regulatory pathway at the time primarily relied on demonstrating substantial equivalence to a predicate device, rather than detailed clinical performance studies with specific statistical acceptance criteria as might be seen for novel, higher-risk devices or software.

Therefore, the "acceptance criteria" here are framed around compliance with relevant standards and demonstrating equivalence, not necessarily quantitative performance metrics for a specific function like "accuracy" or "sensitivity" as one might expect from a machine learning algorithm.

Acceptance Criteria and Reported Device Performance

Study Details:

Given the nature of the device (medical instrument, not an AI/software device) and the regulatory context (510(k) for substantial equivalence in 1998), many of the questions related to AI/ML device studies are not applicable (N/A) to this documentation.

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

   • N/A. This document describes engineering performance tests and biocompatibility tests for a physical medical instrument, not a study involving patient data or a "test set" in the context of AI/ML evaluation.

2. 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):

   • N/A. No ground truth in the sense of expert annotation for a test set was established. The "ground truth" for this device's performance would be adherence to engineering standards and successful operation in simulated environments.

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

   • N/A. No such adjudication method was used as there was no expert review of a test set in this context.

4. 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:

   • N/A. This is a physical medical instrument, not an AI/ML system, so an MRMC study is irrelevant.

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

   • N/A. This is a physical medical instrument; there is no algorithm.

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

   • The "ground truth" or verification mechanism for this device's performance was primarily through:
     • Compliance with recognized industry standards: ANSI/AAMI 11518, IEC 601-1, IEC 601-2-2.
     • Biocompatibility testing: Assuring no irritation from new materials.
     • Demonstration of "Substantial Equivalence" to a legally marketed predicate device: This implies the predicate device's established safety and effectiveness forms the basis for the new device's acceptance.

7. The sample size for the training set:

   • N/A. There is no "training set" in the context of an AI/ML algorithm for this device.

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

   • N/A. There is no "training set" and therefore no ground truth establishment for it.

Summary of the Study:

The "study" described in this 510(k) summary is primarily a pre-market regulatory submission process focused on demonstrating substantial equivalence to previously marketed devices. It involves:

• Bench Testing: To meet electrical safety and performance standards (ANSI/AAMI, IEC).
• Material Biocompatibility Testing: For the new insulation material.
• Comparison to Predicate Devices: Analyzing technological characteristics to ensure no new questions of safety or effectiveness are raised and that safety/effectiveness are not diminished by changes.
• No clinical tests were performed, which is typical for 510(k) devices where substantial equivalence can be demonstrated through non-clinical means.

The document states: "These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." This constitutes the overall conclusion of their study.

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