(23 days)
The devices are intended to cut and or coagulate (soft) biological tissue with gas enhanced coagulation in ARCO models, e.g. during general surgical procedures.
ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 are an upgraded version of the ARCO MBC, ARCO MC, MBC 500 as described in K954171.
During the use of RF surgery devices, power is transmitted via an electrode in the contact zone to tissue. The active electrode then cuts or coagulates (depending upon its design and adjusted power form) the tissue. The inert gas coagulation uses an ionized beam of an inert gas (argon) to transmit the electrical energy to the tissue to achieve a coagulation effect.
The provided text is a 510(k) Summary of Safety & Effectiveness for electrosurgical devices (Soring GmbH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600). It describes an upgrade to existing devices and asserts substantial equivalence to a predicate device.
However, the document does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML-based medical devices or comparative effectiveness studies involving human readers.
The "Performance Data" section solely lists compliance with various electrical safety and electromagnetic compatibility standards, which are general safety and performance standards for medical electrical equipment, not specific clinical performance metrics related to diagnostic accuracy, a typical focus of the provided questions. It also mentions that the devices do not control life-sustaining functions.
Therefore, many of the requested details cannot be extracted from this document, as it pertains to traditional medical device approval based on substantial equivalence and adherence to general safety standards, rather than a clinical performance study with specific acceptance criteria and ground truth.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards | |
| IEC 950 - Safety of Information Technology Equipment | Complies |
| CISPR 22, class A - Electromagnetic Compatibility | Complies |
| IEC-801-2 - Electromagnetic Compatibility | Complies |
| IEC-801-3 - Electromagnetic Compatibility | Complies |
| IEEE 1003.1 - General Electrical Safety for medical devices | Complies |
| IEC 601-1 - Electrical Safety for medical devices using RF-power | Complies |
| IEC 601-2-2 - Special specifications for the safety of RF-surgery units | Complies |
| Functional Equivalence | |
| Intended use has not changed from predicate | Confirmed |
| Same conformance to performance standards as predicate | Confirmed |
| Function as RF surgery units | Confirmed |
| Does not control life sustaining functions | Confirmed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical test set or data provenance in the context of device performance. The approval is based on compliance with electrical safety standards and substantial equivalence to a predicate device.
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. No clinical ground truth was established for a test set in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication method is described.
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. This device is an electrosurgical unit, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a traditional medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is compliance with established electrical and safety standards, and the functional characteristics of an electrosurgical device as demonstrated through engineering testing and comparison to a predicate, not clinical outcomes or expert consensus on diagnosis.
8. The sample size for the training set
Not applicable. There is no training set for an algorithm mentioned.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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.