(122 days)
Indications for Use - VIO 3
The Erbe electrosurgical unit (ESU/Generator) model VIO 3 with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue, including ablation.
Indications for use - ERBECRYO 2
The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion (destruction) of tissue by the application of extreme cold, and cooling of tissue during radiofrequency ablation.
Indications for use - HybridTherm ablation probes
The HybridTherm probes are intended for ablation and coagulation of soft tissue. The following probes can also be used for cutting tissue: HybridTherm monopolar, eTip and HybridTherm bipolar, eTip.
The HybridTherm system consists of the electrosurgical unit (ESU) Model VIO 3, the cryosurgical unit Model ERBECRYO 2, the HybridTherm ablation probes and accessories.
HybridTherm ablation probes
The HybridTherm probes are a product family consisting of 8 probes to offer the user a range of instruments based upon the physician's preference. There are 4 monopolar and 4 bipolar ablation probes, which differ in the function of the distal end: with and without a monopolar cutting tip (eTip), as well as in their shape (i.e. straight or angulated/curved).
The HybridTherm probes combine high-frequency (HF) technology with cryotechnology. The HF technology is used for cutting (only variants with eTip), coagulation, and ablation of tissue. To reduce tissue desiccation and to increase the ablation zone, the probes are cooled. Cooling also minimizes tissue adhesion to the electrode. The primary function of the cooling is to support the ablation process.
VIO 3
The ESU Model VIO 3 delivers high frequency (HF) electrical current for cutting, coagulation and ablation of tissue. The unit can be mounted/secured to a cart/system carrier or on a ceiling mount. Different Footswitches are available for activating the ESU and as applicable to change modes of the ESU (Remode feature). The ESU Model VIO 3 has several clearly defined cutting, coagulation and ablation modes with different electrical waveforms and electrical parameters that are programmed with defined effect levels. Each effect level corresponds to a defined maximum power output and a voltage limitation. The ESU has a touchscreen monitor that provides the user with an onscreen tutorial as well as settings and operational information. It also provides a small number of physical controls, such as the power switch, instrument sockets and a neutral electrode receptacle.
ERBECRYO 2
The cryosurgical unit Model ERBECRYO 2 is connected to an electrical power source and a carbon dioxide (CO2) source. Upon activation, the Unit delivers a regulated CO2flow to the end of the connected instrument for cooling. The CO2 returning from the probe to the ERBECRYO 2 exists via the exhaust gas hose. Appropriate gas cylinder adapters are available for the various international gas cylinder connections.
HybridTherm System
The HybridTherm probes are connected to the units (VIO 3 and ERBECRYO 2) via respective plugs. The units are connected to each other via an Erbe Communication Bus (ECB) cable, whereby the user only interacts with the ESU Model VIO 3 (master-slave technology: the cryosurgical unit is controlled via the VIO 3). The ERBECRYO 2 additionally requires a CO2 gas cylinder. A footswitch is connected to the ESU, with which the activation of the available modes is started. The ESU supplies the HF current which is needed for cutting (only HybridTherm probe variants with eTip), coagulation and ablation of tissue. The ERBECRYO 2 supplies CO2 gas which is needed for cooling via the Joule-Thomson-effect to support the ablation.
The provided text is a 510(k) summary for the HybridTherm System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of technical characteristics and non-clinical performance testing. It does not include information about AI/ML models, human reader studies, or the establishment of ground truth for such studies.
Therefore, many of the requested details about acceptance criteria, human performance, and ground truth are not present in this document. The information provided heavily emphasizes hardware and traditional medical device testing rather than algorithmic performance.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions "Side-by-side tissue testing against the respective predicate device(s) shows that the performance (i.e. cutting, coagulation and ablation) is as good as the performance of the predicate device(s)." This indicates a comparative performance acceptance criterion, but specific numerical thresholds or a formal table are not provided in this summary. The acceptance criterion is qualitative: performance is "as good as" the predicate.
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. This was "side-by-side tissue testing," likely in a lab setting, not a clinical study with patients or image-based data. No information on sample size (e.g., number of tissue samples), country of origin, or retrospective/prospective nature is given.
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. Ground truth for the "tissue testing" was likely established through objective measurements of ablation zone size or tissue characteristics, not expert consensus (as there are no images or clinical interpretations involved).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no indication of adjudication for "tissue testing."
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. The document explicitly states "Side-by-side tissue testing" and discusses engineering safety and performance standards (e.g., electrical safety, EMC, biocompatibility, sterilization). There is no mention of a human reader study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a physical electrosurgical system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "side-by-side tissue testing," the ground truth would be physical measurements of the effect on tissue (e.g., ablation zone size, tissue integrity) rather than expert consensus or pathology from human subjects. The document does not specify the exact methods but implies objective performance metrics.
8. The sample size for the training set
Not applicable. There is no AI/ML model for which a training set would be defined.
9. How the ground truth for the training set was established
Not applicable, as there is no AI/ML model or training set.
Summary of available and missing information based on the provided text:
Available Information:
- Acceptance Criteria (Qualitative): Device performance (cutting, coagulation, ablation) is "as good as" the predicate device(s) based on side-by-side tissue testing.
- Study Type: Non-clinical (bench) testing, including:
- Side-by-side tissue testing
- Functional testing and design controls (21 CFR 820.30)
- Electromagnetic compatibility (IEC 60601-1-2)
- Electrical safety (IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18)
- Software verification and cybersecurity (IEC 62304, FDA Guidance) - Note: This relates to the software controlling the electrosurgical unit, not an AI/ML component.
- Biocompatibility (ISO 10993-1)
- Sterilization validation (ISO 11135)
- Packaging and shelf-life validation (ISO 11607-1, ISO 11607-2, ASTM F 1980)
- Ground Truth Type: Physical/objective measurements of tissue effects for performance testing.
Missing Information (Not contained in the provided 510(k) summary, as it pertains to AI/ML or human reader studies):
- Specific numerical acceptance criteria for tissue testing.
- Sample size for tissue testing (e.g., number of tissue samples).
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth establishment.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
- Standalone (algorithm-only) performance.
- Sample size or ground truth establishment for a training set (as no AI/ML component is discussed).
This document is a standard 510(k) for a physical electrosurgical device, not a submission for an AI/ML-driven device. Therefore, the detailed questions about AI model validation and human performance studies are not addressed within this text.
§ 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.