(154 days)
The Soring MBC200/BCC140 devices are intended to cut and or coagulate (soft) biological tissue during surgical procedures. Typical users of this system are trained medical professionals.
Soring MBC200/BCC140 device has 2 configurations. Depending on the unit variant, the user can choose from the following functions:
- . MBC200: Monopolar cutting and Coaqulation and Bipolar Coagulation
- . BCC140: Bipolar Cutting and Coagulation
Electrosurgical devices are frequently used during surgical operations helping to prevent blood loss in hospital operating rooms or in outpatient procedures. Electrosurgery is performed using an Electrosurgical Generator (also referred to as Power Supply or Waveform Generator) and a handpiece including one or several electrodes, sometimes referred to as an RF Knife. Lower RF-voltages (below 150) lead to a slower heat-up of the tissue, resulting in coagulation with no separation. Short RF-impulses with high voltage lead in a build-up of sparks together with a strong surface coaqulation. During the use of the Soring MBC200/BCC140 device, power is transmitted via an electrode in the contact zone to tissue. When RF energy reaches a certain upper limit, an arc will occur at the contact zone of the active electrode to the tissue. This leads to a quick warm-up of the intercellular fluid. This vaporization of the intercellular fluid results into a burst of the cells and the tissue looses its cohesion, the electrode then cuts.
The provided 510(k) summary is for an electrosurgical cutting and coagulation device (Soring MBC200/BCC140), which is a hardware medical device. The information requested regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth is typically applicable to AI/ML-enabled devices or diagnostic devices that rely on complex algorithms and data analysis for performance claims.
For a device like the Soring MBC200/BCC140, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally focused on engineering specifications, electrical safety, electromagnetic compatibility, and biocompatibility, as demonstrated through compliance with recognized consensus standards and internal (non-clinical) verification and validation testing.
Therefore, I cannot populate the requested table and answer many of the questions (2 through 9) in the manner typically expected for AI/ML or diagnostic devices. The 510(k) summary provided does not contain the type of clinical study data with patient samples, expert ground truth, or statistical power calculations that would be found in the approval for a device making diagnostic or predictive claims based on data analysis.
However, I can extract the relevant information regarding safety and performance criteria and the testing performed, reinterpreting some of the prompts to fit the context of this type of device.
Acceptance Criteria and Device Performance (Reinterpreted for a Hardware Electrosurgical Device)
| Acceptance Criteria (Performance/Safety Objectives based on Standards Compliance) | Reported Device Performance (Summary of Non-Clinical Test Results) |
|---|---|
| Safety: Device meets general requirements for safety of medical electrical equipment. (IEC 60601-1) | Software verification and product validation tests were performed and meet the acceptance criterion. The device complies with IEC 60601-1, Amendment 1, Amendment 2. |
| Electromagnetic Compatibility (EMC): Device meets requirements for EMC. (EN 60601-1-2) | The device complies with EN 60601-1-2. |
| Specific Safety for High Frequency Surgical Equipment: Device meets particular safety requirements for high-frequency surgical equipment. (EN 60601-2-2) | The device complies with EN 60601-2-2. |
| Biological Compatibility: Materials in contact with patient are biologically compatible. (ISO 10993-1) | The device complies with ISO 10993-1:1998. |
| Risk Management: Risks associated with the device are identified, analyzed, evaluated, and controlled to acceptable levels. (EN ISO 14971) | The device complies with EN ISO 14971. |
| Functional Performance: Device effectively cuts and coagulates soft biological tissue as intended. | Software verification and product validation tests were performed and meet the acceptance criterion. The device performs monopolar cutting and coagulation and bipolar cutting and coagulation. |
| Substantial Equivalence: Device performs in a manner similar and is intended for the same use as the predicate device (K024059, MBC Series). | The 510(k) contains adequate information and data to enable FDA to determine substantial equivalence. The device functions in a manner similar and is intended for the same use as the predicate device. |
Inapplicable or Not Provided Information
The following questions are not applicable or the information is not provided in the context of this 510(k) summary for a hardware electrosurgical device:
- Sample sizes used for the test set and the data provenance: This device is not an AI/ML or diagnostic device that uses a "test set" of patient data in the conventional sense. Testing involved non-clinical engineering validation and verification.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML or diagnostic devices (e.g., expert consensus on image interpretation) is not relevant for proving the safe and effective operation of an electrosurgical unit.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 or interpretation device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrosurgical unit, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, "ground truth" relates to objective engineering measurements (e.g., power output, safety limits, thermal effects on tissue models in a lab setting) and compliance with recognized standards, rather than clinical outcomes or pathology from patient data.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Approval Context:
The 510(k) for the Soring MBC200/BCC140 relies on demonstrating "substantial equivalence" to a predicate device (K024059) and compliance with established performance and safety standards. The "study" that proves the device meets the criteria consists of non-clinical verification and validation tests conducted against the enumerated international and national standards (e.g., ISO 10993-1, EN 60601-1-2, IEC 60601-1, EN 60601-2-2, EN ISO 14971). These tests ensure the device meets electrical safety, electromagnetic compatibility, biological compatibility, and specific performance requirements for electrosurgical equipment without raising new issues of safety or effectiveness. The standard approach for such devices does not involve clinical studies with patient data or expert read-outs in the same way an AI diagnostic algorithm would.
§ 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.