(63 days)
The NeoMedix MicroSurgical Bipolar Handpiece is to be used in electrosurgical applications where low power radio frequency current is applied through a bipolar probe for the purpose of cutting and coagulation of soft tissues. The Handpiece is intended to be used in general and ophthalmic surgery where low impedance or wet field conditions exist.
The Handpiece is a sterile single use device that consists of a bipolar probe and channels for irrigation and aspiration. These channels are connected to medical grade tubing with standard luer fittings. The Handpiece is ABS plastic and incorporates a stainless steel probe designed to operate in the bipolar mode when connected to any compatible bipolar electrosurgical generator capable of low energy output control. The irrigation and aspiration sets provide for connection of the handpiece to irrigation and aspiration devices.
The provided text describes a 510(k) premarket notification for a medical device, the NeoMedix MicroSurgical Bipolar Handpiece. However, it does not include a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/algorithm-based device would.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with established standards for safety.
Therefore, for aspects like "AI/algorithm performance," "sample size for test/training sets," "expert ground truth establishment," or "MRMC studies," the information is not present because this is a traditional medical device submission, not an AI/software device submission.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance/Compliance |
|---|---|---|
| Biocompatibility | ISO 10993-1 | Demonstrated through biocompatibility studies of all patient contact materials. |
| Electrical Safety | IEC 60601-1 (leakage current) | Compliance to applicable requirements. |
| Electrical Safety | ANSI/AAMI HF-18 (handpiece dielectric voltage) | Compliance to applicable requirements. |
| Physical Integrity | Connector integrity | Physical testing performed. |
| Physical Integrity | Tip bend resistance | Physical testing performed. |
| Physical Integrity | Fluidic flow capability | Physical testing performed. |
| Sterility | Sterility Assurance Level (SAL) | Conforms to SAL of 10⁻⁶. |
2. Sample sizes used for the test set and the data provenance
- Not applicable / Not provided. This type of information (sample size, data provenance) is typically for studies involving data analysis or algorithm performance, which is not the primary focus of this 510(k) submission. The "testing" here refers to engineering and safety tests rather than clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. Ground truth establishment by experts is relevant for diagnostic or AI-driven devices. This submission relies on engineering standards and physical testing.
4. Adjudication method for the test set
- Not applicable / Not provided. Adjudication methods are relevant for expert review processes, which are not detailed here.
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. An MRMC study was not done, as this is not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a surgical handpiece, not an algorithm.
7. The type of ground truth used
- Physical/Engineering Standards and Biocompatibility Testing. The "ground truth" for this device's performance is compliance with established international and national standards for material safety (biocompatibility), electrical safety, and mechanical integrity.
8. The sample size for the training set
- Not applicable / Not provided. This refers to training data for algorithms, which is not relevant to this device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This refers to ground truth for training data for algorithms, which is not relevant to this device.
§ 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.