(60 days)
The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are intended for use in standard electrosurgical chucks and pencil type accessories wherever standard monopolar electrosurgical cutting and coagulation blade electrodes are used.
The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are similar in design to the predicate devices. They weigh about 2 grams, and have an industry standard 0.0937-inch (2.38 mm) diameter x 0.825inch (22.22 mm) connector pin, with various tip lengths and configurations. They are made from a stainless steel metal alloy. Some models are available with a stick resistant coating. The transition point between the shaft and the tip has a protective plastic insulator sheath. Electrodes are packaged individually in sealed pouches, sold sterile, and intended for single use.
This document describes the ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes, and not a device that would typically have acceptance criteria and a study proving those criteria in the same way an AI/ML powered device would. The core of this submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo performance metrics with a "study" in the modern sense.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set) are not applicable to this type of medical device submission.
However, I can extract the relevant information from the provided text regarding the device's performance and the methods used to demonstrate its safety and effectiveness.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance (Adapted for Electrosurgical Electrodes)
The "acceptance criteria" for this device are framed around demonstrating safety, effectiveness, and substantial equivalence to legally marketed predicate devices, rather than specific quantitative performance thresholds like accuracy or sensitivity for an AI algorithm.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness when used as intended. | "The performance evaluations indicate that the ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes met all of the performance requirements, consistently performed within their design parameters; and performed equivalently or superior to the predicate devices, thus demonstrating that they are safe and effective when used as intended." |
| Compliance with relevant industry standards: (e.g., ANSI/AAMI HF18-1993 for Electrosurgical devices, ANSI/AAMI 11137 for Radiation sterilization). | "The ITI Medical Technologies, Inc. Electrosurgical Electrodes have been designed to comply with, and are manufactured to pertinent parts of the following standards: ANSI/AAMI HF18-1993 Electrosurgical devices, and ANSI/AAMI 11137 Sterilization of health care products." Also complied with FDA 510(k) Guidelines. |
| Functional equivalence to predicate devices: (MegaDyne Medical Products, Inc. K903302 and Aaron Medical Industries. Inc. K913623) in terms of intended use, design, materials, and technological characteristics. | "The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are similar in design to the predicate devices." "The intended use is identical to that of the predicate devices." "incorporate no significant change in design, materials, energy source or other technological characteristics than those found in the predicate devices." "Comparison tests following written protocols were conducted using the ITI devices and the predicate devices. No findings of adverse effects or complications were reported in any of the tests." |
| No adverse effects or complications during comparison tests. | "No findings of adverse effects or complications were reported in any of the tests." |
Study Details (Adapted for a 510(k) Electrosurgical Electrode Submission)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of "cases" or "patients" in the same way an AI study would. The comparison tests involved using the ITI devices and the predicate devices. It is implied that a sufficient number of devices were tested to draw conclusions, but numerical details are absent.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests were "conducted" in support of the 510(k) submission, likely in a controlled laboratory setting or in a pre-clinical manner, and are specific to the performance of the devices themselves rather than clinical data from human subjects in a population.
- Retrospective/Prospective: Not applicable in the traditional sense for this type of device comparison test.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The "ground truth" here is the established performance characteristics and safety profile expected of electrosurgical electrodes, and compliance with standards. This is likely assessed by engineers and quality control personnel, potentially with clinical input on expected function, but not "experts" establishing a diagnosis in the way a medical image review would.
- Qualifications of Experts: Not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This type of device testing does not involve subjective human interpretation of outputs that would require adjudication in the typical sense of AI/ML performance evaluation. The "adjudication" is through objective performance measurements and compliance checks.
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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:
- MRMC Study: No, an MRMC study was not done. This device is an electrosurgical electrode, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device. Its "performance" is inherently standalone in the sense that it performs its function (cutting and coagulation) without a human "algorithm" in the loop determining its output. Human practitioners use it, but they are not part of its "performance algorithm."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" is based on established engineering specifications, performance standards (e.g., ANSI/AAMI HF18-1993), and the documented performance characteristics of legally marketed predicate devices. This involves objective measurements of electrical properties, material properties, sterility, and functional performance (e.g., ability to cut/coagulate effectively without issues) in controlled environments.
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The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device does not use machine learning, so there is no "training set."
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
§ 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.