(90 days)
The Model 26-2500, Aura 20, Bipolar Electrosurgical Coagulator is a general purpose solid state bipolar generator used to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
The Model 26-2500, Aura 20, Bipolar Electrosurgical Coagulator, is a general purpose solid state bipolar generator used to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered. Its footswitch activation and solid state circuitry delivers low voltage RF/bipolar energy, interfacing with electrosurgical accessories via its standard female banana jacks. The Aura 20 differs technologically from its predicates with only minor operational features designed to enhance user interface. The following are some of those features.
- While operating on both 115 and 230 VAC mains supply as its predicates, the Aura 20 does not require the placement of an external jumper in order to select between the two different voltage levels.
- Activation of the Aura 20 is via footswitch only, eliminating the optional hand switch activation of its predicates, which is viewed as a little-used option and expendable in order to simplify construction, and limit size.
- While similarly relying on solid-state electronics, the Aura 20 has been greatly simplified over its predicates by the use of microprocessor technology and modular medical-grade power supply.
- The Aura 20 uses membrane keypads instead of potentiometers (knobs) as adjustable controls for tonal volume and power level settings.
The provided text is a 510(k) summary for the Aura 20 Bipolar Electrosurgical Coagulator. It focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with safety standards.
Crucially, the document does NOT contain information about acceptance criteria, device performance, or specific studies that would typically be described in the context of clinical or performance validation studies for AI/ML devices.
The document states that "Technological safety and effectiveness is established by the fact that the Aura 20, like its predicates, offers well-proven, basic electrosurgical unit technology." and "Performance safety has been tested in accordance with, and found to comply with, the requirements of the applicable sections of the following standards". It then lists relevant electrical safety standards (e.g., IEC 60601-1-2, IEC 60601-2-2, ANSI/AAMI HF 18).
Therefore, based solely on the provided text, I cannot complete the requested table or answer most of the questions about acceptance criteria and studies as they relate to performance or clinical outcomes. The device is not an AI/ML device, and the information is from 2003, predating the widespread use of clinical validation studies for AI.
Here's what I can extract and infer:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI/IEC 60601-1-2 (2001) - Medical Electrical Equipment Part 1; General Requirements for the Safety. | "found to comply with, the requirements of the applicable sections of the following standards" |
| Compliance with IEC 60601-2-2 (1998) - Medical Electrical Equipment Part 2; particular Requirements for the safety of High Frequency Surgical Equipment. | "found to comply with, the requirements of the applicable sections of the following standards" |
| Compliance with ANSI/AAMI HF 18 (2001) - American National Standard for Electrosurgical Devices. | "found to comply with, the requirements of the applicable sections of the following standards" |
| Substantial equivalence to predicate devices (26-1500, Kirwan 20 Watt Bipolar Micro Coagulator, and 28-1000, Kirwan 50 Watt Bipolar Generator) in intended use, technological safety/effectiveness, and performance. | The FDA granted 510(k) clearance, indicating agreement with the substantial equivalence claim. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document describes compliance with electrical safety standards and substantial equivalence, not a clinical performance study with a test set of data.
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 provided. This information is for clinical ground truth, which is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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 is not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device would be defined by its electrical and functional performance conforming to established engineering standards, rather than clinical outcomes or expert consensus on diagnostic tasks.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is not an AI/ML 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.