(51 days)
Dr. OPPEL ST-501 is intended for the removal and destruction of skin legions and the coagulation of tissue. Non-sterile and reusable electrodes are used in conjunction with an electrosurgical handpiece and generator.
Dr. OPPEL ST-501 is a electrosurgical unit using high frequency current to cut and/or coagulate tissue. It consists of Electrosurgical Unit generator, Handpiece, Electrodes, a cable for disposable patient plate and foot switch. It is a compact source of high power RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of power level and time. All selection is effected through push buttons and lamps that give the operator feedback of status. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are provided. Monopolar electrodes have needle, ball, loop and blade types. Electrodes are supplied non-sterile and reusable.
The provided text is a 510(k) summary for the Dr. OPPEL ST-501 electrosurgical unit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information about acceptance criteria, study design, and ground truth establishment is not typically present in a 510(k) summary for this type of device.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
No explicit acceptance criteria or reported device performance metrics are provided in the 510(k) summary in the way you've described for an AI/diagnostic device. The submission demonstrates substantial equivalence primarily by comparing the technological characteristics and indications for use of the Dr. OPPEL ST-501 with its predicate devices.
| Feature | Dr. OPPEL ST-501 Reported Performance / Characteristic |
|---|---|
| Indications for use | Intended for the removal and destruction of skin legions and the coagulation of tissue. Non-sterile and reusable electrodes are used in conjunction with an electrosurgical handpiece and generator. (Substantially equivalent to predicate devices' indications for use.) |
| Design specification | IEC601-2-2, ANSI/AAMI HF-18 |
| Output energy | 100 Watt at 200Ω |
| Output waveform | 4.0 MHz Partially rectified |
| Delivery system | Monopolar and Bipolar |
| Tip configuration | Needle, Blade, Ball, Loop, Bipolar Forceps |
| Sterilization method | Non-sterile |
| Standard | IEC601-1, IEC601-1-2, IEC601-2-2, ANSI/AAMI HF18 |
2. Sample size used for the test set and the data provenance:
This information is not provided in the 510(k) summary. For electrosurgical units, performance is typically demonstrated through engineering testing, compliance with recognized standards, and potentially bench testing, rather than human subject clinical studies with "test sets" in the context of diagnostic algorithms.
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):
This information is not applicable/not provided. The concept of "ground truth established by experts" is relevant for diagnostic or AI-driven devices where human assessment is the gold standard for comparison. For an electrosurgical unit, the "ground truth" relates to its physical performance characteristics (e.g., power output, frequency), safety (e.g., electrical safety), and effectiveness in performing cutting and coagulation as designed, which is evaluated through engineering and bench testing, not expert consensus on a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. Adjudication methods are used in studies involving human interpretation or uncertain outcomes, which is not the primary focus of an electrosurgical unit's 510(k) submission.
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:
This information is not applicable/not provided. MRMC studies are relevant for diagnostic devices that involve human readers interacting with AI. This device is an electrosurgical unit that does not involve "human readers" or "AI assistance" in the sense of image interpretation or diagnostic aid.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided. This device is a physical electrosurgical unit, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for an electrosurgical unit's submission to demonstrate substantial equivalence typically involves:
- Engineering specifications and measurements: Verifying that the device meets its stated technical specifications (e.g., output power, frequency, waveform).
- Compliance with recognized standards: Adherence to standards like IEC601-2-2, ANSI/AAMI HF-18 for safety and performance.
- Bench testing: Demonstrating the ability to cut and coagulate tissue effectively and safely in a controlled environment.
- Comparison to predicate devices: Showing that its technological characteristics and intended use are similar to legally marketed devices.
The submission implies that these types of data were used to support the substantial equivalence claim.
8. The sample size for the training set:
This information is not applicable/not provided. "Training set" is a concept used for machine learning models. This device does not use a training set.
9. How the ground truth for the training set was established:
This information is not applicable/not provided. As above, there is no training set for this type of device.
In summary: The provided 510(k) summary for the Dr. OPPEL ST-501 is for an electrosurgical unit, a physical medical device. The information requested (acceptance criteria, test sets, experts, MRMC, training sets, etc.) is primarily relevant for software-as-a-medical-device (SaMD) or AI/diagnostic products. For this electrosurgical unit, the demonstration of safety and effectiveness relies on adherence to design specifications, recognized standards, and comparison of technological characteristics to predicate devices.
§ 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.