(157 days)
The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA consists of the following components: Electrosurgical Unit - Main body, Two different handpieces ( motor and AC), Six different electrode tips for the motor handpiece and three needle tips for the AC handpiece; provided as single use, sterile products, Neutral electrode pad and neutral electrode pad cable, cleared under K092761, Handpiece stand, Foot switch, Power cord. The POTENZA generates radiofrequency (RF) energy by means of high RF at 1MHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The POTENZA has two operating modes: monopolar mode and bipolar mode.
This looks like a 510(k) summary for a medical device. Based on the provided text, the device in question is the "POTENZA," an RF electrosurgical device. However, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the way you've outlined for AI/CADe devices (i.e., sensitivity, specificity, reader studies, etc.).
This document describes the regulatory process for establishing substantial equivalence to a predicate device, which primarily relies on demonstrating that the new device has similar technological characteristics and performs comparably to devices already on the market. The performance data presented here are primarily engineering bench tests, electrical safety, biocompatibility, and software validation. These are standard tests for electrosurgical devices to ensure safety and functionality, not to evaluate diagnostic performance or AI algorithm effectiveness.
Therefore, many of the specific questions you've asked, particularly those related to AI/CADe system validation (sample sizes for test sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance), are not applicable to the information provided in this 510(k) summary for an electrosurgical device.
Here's a breakdown of what can be extracted, and why other parts are not present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a clinical performance metric (like sensitivity or specificity) with a target value. Instead, the acceptance criteria are implicitly met by passing various engineering and biocompatibility tests.
| Test Type | Standard / Objective | Reported Device Performance |
|---|---|---|
| Biocompatibility (for electrode tips) | FDA's "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process", June 6, 2016. Specific ISO-10993 and ASTM F756 standards for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemolysis, and Pyrogenicity. | All tests (Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Hemolysis, USP Rabbit Pyrogen) Pass. |
| Electrical Safety & Electromagnetic Compatibility (EMC) | IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2-12 (General requirements for basic safety and essential performance) | |
| IEC 60101-2-2:2017 (High-frequency surgical equipment) | ||
| IEC 60601-1-2:2014 (EMC) | ||
| IEC 60601-1-6:2010, AMDI:2013 (Usability) | System was tested according to these standards, implying "satisfactory" or "compliant" outcome for these safety and functional aspects (explicit "pass" not stated for each, but inferred). | |
| Software Verification and Validation | FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005, commensurate with a moderate level of concern. | Conducted, implying "satisfactory" or "compliant" outcome. |
| Bench Testing (Output Accuracy, Frequency, Power Fluctuation, etc.) | To assure the POTENZA operates safely and within predefined design specifications. Includes thermal testing per FDA guidance. | Conducted, implying "satisfactory" or "compliant" outcome for all listed parameters: Output accuracy (Monopolar/Bipolar, 1MHz/2MHz), Frequency, Power fluctuation, Negative output protection, Impedance measurement, HO count accuracy, Safety test of warnings/failsafe, Needle depth, Motor speed level, Thermal testing. |
Regarding the specific questions about AI/CADe validation:
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective).
- Not applicable. This device is an electrosurgical unit, not an AI/CADe system that analyzes data like images. The "test set" here refers to physical components and the device itself undergoing engineering and biological safety tests.
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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).
- Not applicable. Ground truth, in the context of AI/CADe, involves expert interpretation of data. For this electrosurgical device, "ground truth" relates to objective physical and biological properties measured by standardized tests (e.g., cytotoxicity assays, electrical measurements).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set.
- Not applicable. Adjudication is for resolving discrepancies in expert interpretations of data. This is not performed for physical device testing.
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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.
- Not applicable. This is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- Not applicable. This is not an AI algorithm. Its performance is evaluated as a standalone electrosurgical unit through bench and safety tests.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The "ground truth" for the tests performed are highly standardized scientific and engineering measurements. For example, for biocompatibility, the ground truth is whether specific biological responses (e.g., cell death, irritation) occur above a predefined threshold according to the specified ISO standards. For electrical safety, the ground truth is whether the device parameters (e.g., leakage current, output power) fall within the limits set by IEC standards.
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The sample size for the training set.
- Not applicable. There is no AI training set for this electrosurgical device.
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How the ground truth for the training set was established.
- Not applicable. There is no AI training set or associated ground truth.
In summary, the provided document is a 510(k) summary for an electrosurgical device, detailing its regulatory pathway to market based on substantial equivalence. It focuses on safety and fundamental performance characteristics through engineering and biocompatibility testing, not on the diagnostic accuracy or AI performance metrics you've requested.
§ 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.