(88 days)
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
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance / Compliance |
|---|---|---|
| Material Biocompatibility | Assure biocompatibility of new material (for insulation) | Device materials tests were performed to assure biocompatibility of the new material. The tests indicated that no irritation would occur. |
| Electrical Safety & Performance | Meet appropriate sections of ANSI/AAMI standard on high frequency devices 11518 | The bipolar forceps were tested to meet the appropriate sections of ANSI/AAMI standard on high frequency devices 11518. |
| Electrical Safety & Performance | Meet appropriate sections of IEC 601-1 and IEC 601-2-2 | The bipolar forceps were tested to meet the appropriate sections of IEC 601-1 and IEC 601-2-2. |
| Safety and Effectiveness (General) | Designed and tested to guarantee safety and effectiveness | "These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." (Conclusion) |
| Substantial Equivalence | Device poses same type of questions about safety/effectiveness as predicate | "The submitted devices pose the same type of questions about safety or effectiveness as the compared devices." |
| Substantial Equivalence | New technological characteristics do not diminish safety/effectiveness | "The new technological characteristics have not diminished safety or effectiveness." (Changes noted: more durable coated insulation, added irrigation port). |
| Intended Use | Suitable for "coagulation of tubes, tissue coagulation, and vascular coagulation to stop bleedings under endoscopic vision." | The device is marketed for this intended use, implying it meets this criterion through its design and testing against standards. |
| Non-Interference (Irrigation Port) | No irrigation would occur (implying unintended irrigation) | Device materials tests indicated that no irrigation would occur (likely meaning no unintended fluid leakage or issues related to the new irrigation port when not being used for irrigation). This is ambiguous but suggests performance related to the new feature. |
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.
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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.
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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.
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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.
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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.
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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.
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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.
- The "ground truth" or verification mechanism for this device's performance was primarily through:
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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.
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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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.