(136 days)
Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required.
Self-powered devices for the cauterization of tissues and capillary vessels during surgery, without the use of a high frequency generator. The system is started by pressing the button on the body of the cautery. The resistance of the wire of the tip, when the current passes, causes its heating guaranteeing its capacity of cauterization. The plastic and metal materials used in the devices comply with biocompatibility requisites. The energy produced by the continuous current is distributed as heat through a tip at a high temperature; the distribution is at short intervals of few seconds. The cautery has the weight, size and handle suitable to allow for easy use.
The provided text describes a 510(k) submission for FIAB's high-temperature battery-powered cauteries. It details the device's intended use and performance testing based on general electromedical standards, but it does not include a conventional clinical study comparing the device's performance against specific acceptance criteria in a human or animal model with clearly defined endpoints and statistical analysis.
Here's an analysis based on the information provided:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Temperature Reached by Incandescent Filament: 1200°C | Met: "Check the temperature reached by the incandescent filament is 1200°C." Internal measurements (using a simple encapsulated "S" thermocouple for indicative value and a self-built equipment for more accuracy) and external laboratory testing were conducted. While the text states "12009 C" which is likely a typo for 1200°C, it implies conformity. |
| Length of Operation of the Battery: Sufficient heating for at least 48 activations with predefined duration. | Met: "A visual operation test was made in order to verify a sufficient heating of the tip for all expected number of activations with predefined duration, being such number at least equal to 48." Theoretical calculations also supported the number of activations for a fixed duration. |
| Biocompatibility: Materials comply with biocompatibility requisites. | Met: "The plastic and metal materials used in the devices comply with biocompatibility requisites." (No specific testing details provided in this section, but implied compliance). |
| Safety and Effectiveness: Conformity to relevant electromedical standards. | Met: Compliance with CEI EN 60601-1 and CEI EN 60601-1-2 is certified by test report TRP 015 04. The document states, "the cauteries are tested and produced according to all requisites laid down by the regulations in force so as to guarantee safety and effectiveness." |
| Residual Risk: Acceptable | Met: According to the risk-benefit analysis, "the global residual risk has been deemed acceptable since it falls within the area between negligible risks and acceptable risks." (No specific details of the risk-benefit analysis provided in this section). |
Study Details for Device Performance
The provided document describes laboratory performance testing rather than a traditional clinical or comparative effectiveness study.
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 explicitly stated for each test. For the battery life test, it mentions "at least equal to 48" activations, implying a unit was tested to achieve this. For temperature, multiple measurements were taken both internally and by a third party.
- Data Provenance: The tests were conducted internally by FIAB (Vicchio Florence - Italy) and by an unspecified "third party" or "externally laboratory" presumably to corroborate internal findings. The data is prospective, as these are tests specifically carried out for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The "ground truth" for the performance criteria (temperature, battery life, biocompatibility, and safety standards) was established through objective physical measurements and adherence to engineering/biocompatibility standards, not through expert consensus on medical outcomes or images. Specialized technicians and engineers would have been involved in conducting these tests and interpreting the results against established physical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None (Not Applicable). Adjudication methods like 2+1 are typically used for subjective assessments (e.g., image interpretation). These tests involve objective physical measurements and comparisons to predefined numerical targets (e.g., 1200°C temperature, 48 activations).
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
- No. This type of study is entirely irrelevant for a simple electrosurgical cautery device. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical images, often with an AI assist. This device is a surgical tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This concept is not applicable. The device itself is a physical tool, not an algorithm. Its performance is inherent in its physical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Objective Technical Specifications/Standards. The ground truth for these tests was based on engineering design specifications (e.g., "target temperature of 1200°C") and compliance with recognized international safety and biocompatibility standards (CEI EN 60601-1, CEI EN 60601-1-2). For biocompatibility, it's implied that material certificates or standard testing results served as ground truth.
8. The sample size for the training set
- Not Applicable. This device uses a simple electrical resistance heating mechanism, not a machine learning algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an algorithm, this question is irrelevant.
§ 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.