(101 days)
The High Frequency (HF) device is intended exclusively for the generation of electrical power for monopolar and bipolar cutting and coagulation of tissue structures in surgical operations.
The ARC 400 (REF: 900-400) is an electrosurgical device. It generates high frequency (HF) electrical current for the purpose of cutting (e.g. removing tissue) or coagulating (e.g. control bleeding) human tissue. It is used with compatible bipolar instruments (e.g. K953509) or with monopolar instruments (e.g. K982743) in combination with a neutral electrode (e.g. K173877). The ARC 400 offers 34 modes that represent four main categories: monopolar cutting (12 modes), monopolar coagulation (9 modes), bipolar cutting (4 modes) and bipolar coagulation (9 modes).
Here's a breakdown of the acceptance criteria and the study information for the ARC 400 Electrosurgical Unit, based on the provided document.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against specific clinical acceptance criteria in the way an AI/ML device might. Therefore, the "acceptance criteria" here are generally performance specifications that align with the predicate device and established standards.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of specific numerical "acceptance criteria" for clinical performance, this device demonstrates substantial equivalence by matching or exceeding the technological characteristics and performance of its predicate device, the AUTOCON III 400. The "reported device performance" are the specifications of the ARC 400.
| Attribute | Acceptance Criteria (Predicate Device: AUTOCON III 400) | Reported Device Performance (Subject Device: ARC 400) |
|---|---|---|
| Mechanism of Action | Generates high-frequency current (350 kHz / 1 MHz) | Generates high-frequency current (350 kHz / 1 MHz) |
| System Voltage | 100 - 127 V | 100 - 127 V |
| Monopolar Cutting Modes | ||
| Max. Power | 400 W (at 200 Ω) | 400 W (at 200 Ω) |
| Output Frequency | 350 kHz | 350 kHz |
| Max. Voltage Output | 1600 Vp | 1600 Vp |
| Crest Factor | 1.5, 3.5 | 1.5, 3.5 |
| Wave Forms | Sinusoidal Constant, Sinusoidal Modulated, Sinusoidal Alternating, Cut/Coag/Pause Phases | Sinusoidal Constant, Sinusoidal Modulated, Sinusoidal Alternating, Cut/Coag/Pause Phases |
| Monopolar Coagulation Modes | ||
| Max. Power | 250W (at 500 Ω) | 250W (at 500 Ω) |
| Output Frequency | 350 kHz | 350 kHz |
| Max. Voltage Output | 5000 Vp | 5000 Vp |
| Crest Factor | 1.6 - 7.4 | 1.6 - 7.4 |
| Wave Forms | Sinusoidal Constant, Sinusoidal Modulated, Pulse Modulated | Sinusoidal Constant, Sinusoidal Modulated, Pulse Modulated |
| Bipolar Cutting Modes | ||
| Max. Power | 400 W (at 75 Ω) | 400 W (at 75 Ω) |
| Output Frequency | 350 kHz | 350 kHz |
| Max. Voltage Output | 500 Vp | 500 Vp |
| Crest Factor | 1.5 – 1.6 | 1.5 – 1.6 |
| Wave Forms | Sinusoidal Constant | Sinusoidal Constant |
| Bipolar Coagulation Modes | ||
| Max. Power | 350 W (at 25 Ω) | 350 W (at 25 Ω) |
| Output Frequency | 350 kHz | 350 kHz |
| Max. Voltage Output | 550 Vp | 550 Vp |
| Crest Factor | 1.5 – 3.8 | 1.5 – 3.8 |
| Wave Forms | Sinusoidal Constant, Pulse Modulated | Sinusoidal Constant, Pulse Modulated |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical performance testing for an electrosurgical unit, not an AI/ML device. Therefore, the concept of a "test set" for clinical data or image data isn't directly applicable in the same way. The testing involves engineering and performance validations, such as:
- Electrical safety testing: ES 60601-1 / 19-4
- Electromagnetic Compatibility testing: IEC 60601-1-2 / 19-8
- Particular requirements for the basic safety and essential performance of high frequency surgical equipment: IEC 60601-2-2 / 6-389
- Performance testing: Applicable parts of FDA Guidance Document "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" May 2016
- Usability testing: IEC 62366 / 5-114
The "sample size" would refer to the number of devices tested or the number of test runs conducted within these engineering and performance evaluations. The document does not specify these exact numbers.
Data provenance (country of origin, retrospective/prospective) is not applicable here as the tests are non-clinical engineering and performance tests, not clinical data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided and is not typically relevant for the type of non-clinical testing described for an electrosurgical unit. The "ground truth" for these tests is defined by established engineering standards and specifications.
4. Adjudication Method for the Test Set
This information is not provided and is not typically relevant for the type of non-clinical testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating human reader performance, particularly with AI assistance, which is not applicable to this electrosurgical unit.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not Applicable. This is an electrosurgical unit, not an AI algorithm. Its performance is intrinsically "standalone" in the sense that it generates electrical current based on user settings, but it is not an algorithm that performs diagnostic or assistive tasks.
7. The Type of Ground Truth Used
The "ground truth" for the ARC 400 is based on established engineering standards, international and national recognized standards (e.g., IEC 60601 series), and the performance specifications of the legally marketed predicate device (AUTOCON III 400). The device is tested to ensure it meets these defined technical parameters.
8. The Sample Size for the Training Set
Not Applicable. This is an electrosurgical unit, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As explained above, this device does not utilize a training set in the context of AI/ML.
§ 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.