(84 days)
The Olympus UES-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light sources and ancillary equipment. Do not use the instrument for any purpose other than its intended use.
Olympus UES-20 Electrosurgical System and its associated accessories.
This 510(k) summary (K970184) for the Olympus UES-20 Electrosurgical System describes the device and its intended use but does not provide specific acceptance criteria or details of a study proving the device meets acceptance criteria.
The document states it is "a summary of 510(k) safety and effectiveness information" and lists the predicate device as the Olympus UES-10 Electrosurgical Unit (K911904). This implies that the UES-20 is considered substantially equivalent to the predicate device, meaning it has the same intended use and the same technological characteristics, or, if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness.
For a medical device submitted in 1997, particularly an electrosurgical unit, the "acceptance criteria" would typically revolve around demonstration of substantial equivalence to a predicate device, adherence to recognized electrical safety standards (e.g., IEC 60601-1), and functional performance equivalent to the predicate. The "study" demonstrating this would often involve:
- Bench testing: Verifying output power, waveform, safety features (e.g., patient return electrode monitoring), and electromagnetic compatibility.
- Comparison to predicate: Direct comparison of technical specifications, intended use, and performance characteristics.
- Performance testing: In some cases, performance on animal tissue or in a simulated clinical setting might be conducted to show functionality across various modes (cutting, coagulation).
However, the provided text does not contain the specific data required to fill out all the fields in your request. Modern AI/ML device submissions have very different requirements regarding performance metrics and study designs compared to electrosurgical units from the late 1990s.
Here's a breakdown based on the information provided and what is typically understood for a 510(k) submission of this type and era:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred for Electrosurgical Units) | Reported Device Performance (Not explicitly stated in provided document) |
|---|---|
| Substantial Equivalence to Predicate (UES-10) | Implied by 510(k) clearance |
| Compliance with Electrical Safety Standards (e.g., IEC) | Implied, typically verified by bench testing and certification |
| Functional Performance (Cutting, Coagulation) | Assumed to be met, likely through bench testing and comparison |
| Compatibility with Accessories | Assumed |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable or not explicitly detailed in the provided summary. For an electrosurgical unit, "testing" would involve evaluating the device itself, not a dataset of patient cases.
- Data provenance: Not applicable.
3. 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 devices is not relevant for an electrosurgical unit clearance.
4. Adjudication method for the test set
- Not applicable.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device. The device itself (an electrosurgical unit) is the standalone performance.
7. The type of ground truth used
- Not applicable in the context of AI/ML ground truth. For an electrosurgical unit, the "ground truth" equivalent would be the device's adherence to engineering specifications, safety standards, and functional output (e.g., measured power output at a given setting is accurate).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
In summary: The provided 510(k) summary from 1997 for the Olympus UES-20 Electrosurgical System is a regulatory document focused on demonstrating substantial equivalence to a predicate device. It addresses device classification, intended use, and identification information. It does not contain the detailed performance metrics, study designs, or data characteristics that would be found in a submission for an AI/ML device today, and therefore, most of the requested fields are not applicable or cannot be answered from the provided 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.