(286 days)
Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required. Specially suitable for ophthalmology.
Self-powered device for the cauterization of tissues and small vessels during surgery, without the use of a high frequency generator. The device is intended for use in ophthalmology. 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 is a 510(k) summary for a medical device (F7255 Fiab Disposable Cautery battery powered). This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or a detailed engineering performance study would.
Therefore, many of the requested details, such as specific acceptance criteria, reported device performance metrics against those criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set information are not present in the provided text.
The document states: "Although there are no performance standards as reported in Section 514, the cauteries are tested and produced according to all requisites laid down by the regulations in force so as to guarantee safety and effectiveness." This indicates that the regulatory pathway for this device at the time did not require detailed performance studies against specific acceptance criteria to demonstrate efficacy beyond what was required for substantial equivalence.
Here's a breakdown of what information can be extracted from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not present. The document does not specify quantitative acceptance criteria for performance (e.g., specific temperatures, duration of heat, precision of cauterization, etc.) nor does it report specific device performance metrics against such criteria. The submission is focused on demonstrating substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. No specific test set or data provenance for performance evaluation is mentioned. The submission relies on a comparison to a predicate device and adherence to general regulations.
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/Not present. No ground truth establishment for a test set is discussed in the context of device performance, as there's no performance study described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not present. No adjudication method is mentioned as there's no performance study with a test set.
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/Not present. This device is a simple battery-powered cautery, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not present. As mentioned above, this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not present. Given the nature of the device and the submission type, a "ground truth" for performance comparison as in diagnostic imaging or AI is not part of this document. The "ground truth" for regulatory approval here is substantial equivalence to a legally marketed predicate and compliance with general safety and effectiveness regulations.
8. The sample size for the training set
- Not applicable/Not present. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not present. No training set exists.
Summary of available information:
The provided document is a 510(k) summary for a "F7255 Fiab Disposable Cautery battery powered". The core of its regulatory submission is demonstrating substantial equivalence to an existing predicate device, the "AARON AA04 battery powered cautery".
- Intended Use (from the document): "The device is intended for use in ophthalmology." and "Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required. Specially suitable for ophthalmology."
- Comparison to Predicate: "The F7255 cautery has the same intended use as the predicate and do not imply new technological characteristics." This is the primary "proof" of meeting regulatory requirements for this type of submission.
- General Compliance: The document states, "Although there are no performance standards as reported in Section 514, the cauteries are tested and produced according to all requisites laid down by the regulations in force so as to guarantee safety and effectiveness." This indicates general compliance with manufacturing and safety regulations, rather than specific performance metrics.
- Risk Assessment: "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."
In essence, the "acceptance criteria" here are met by demonstrating the device is substantially equivalent to a legally marketed predicate and adheres to general safety and effectiveness requirements, rather than through specific performance metrics outlined in a detailed study within this document.
§ 886.4115 Thermal cautery unit.
(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.