(48 days)
The NMX-1000™ is designed to surgically remove a strip of the Trabecular meshwork for surgical management of infantile and adult glaucoma.
The NMX-1000™ is a sterile single use device that consists of a bipolar probe and channels for irrigation and aspiration. These channels are connected to medical tubing designed to operate in the bipolar model. The handpiece is ABS plastic and incorporates a stainless steel probe of low energy output control. The special production of the device model is supplied when connected to a compatible electrosurgical generator of the handpiece to standard irrigation and aspiration devices.
The provided text is a 510(k) Premarket Notification for the NeoMedix Corporation's NMX-1000™ electrosurgical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials with detailed acceptance criteria and performance data like those typically seen for AI/ML devices. Therefore, much of the requested information about acceptance criteria, study design, and performance metrics for a novel device is not available or applicable in this context.
However, I can extract the relevant information that is present in the document.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for a non-AI/ML device demonstrating substantial equivalence to a predicate, explicit "acceptance criteria" in the sense of predefined thresholds for diagnostic performance (e.g., sensitivity, specificity) for a novel AI algorithm are not provided. Instead, the device's "performance" is demonstrated by its equivalency to a predicate device and compliance with relevant safety standards.
| Category | Acceptance Criteria (Demonstration) | Reported Device Performance |
|---|---|---|
| Technological Characteristics Comparison | Identical design and function to predicate device (NeoMedix MicroSurgical Bipolar Handpiece and Storz Maumenee Goniotomy Knife Cannula). | The NMX-1000™ probe is "identical in design" to the currently marketed NeoMedix MicroSurgical Bipolar Handpiece regarding the application of radio frequency current at the probe tip. Irrigation and aspiration capabilities are "the same as those of the Storz Maumenee Goniotomy Knife Cannula." |
| Material Safety | Use of materials with an established history of safe use in similar medical devices. | "materials used have an established history of safe use in similar medical devices." |
| Biocompatibility | Demonstration of biological safety of patient contact materials in accordance with standards. | "biological safety of the device has been demonstrated by biocompatibility studies of all patient contact materials in accordance with the Standards outlined in ISO 10993-1." |
| Electrical Safety | Compliance with IEC 60601-1 for leakage current and ANSI/AMI HF-18 for handpiece dielectric voltage. | "Electrical safety has been demonstrated by compliance to applicable requirements as outlined in IEC 60601-1 for leakage current and ANSI/AMI HF-18 for handpiece dielectric voltage." |
| Manufacturing/Sterility | Assurance of connector integrity, tip bend resistance, and sterility (SAL of 10⁻⁶). | "Hydroblister testing at critical tissues has been performed to assure connector integrity, tip bend resistance and nature is supplied sterile and sterility will confirm to a Sterility Assurance Level (SAL) of 10⁻⁶." |
| Indications for Use | Same indications for use as predicate device. | "Since the device indications are a subset of only glaucoma. Since the device is our modification of a that of a Goniotomy knife, there are no new safety or effectiveness issues related to this device." |
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 is not a study involving a "test set" of patient data for evaluating an algorithm's performance. The evaluations were engineering tests, biocompatibility studies, and comparisons to predicate devices.
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 as typically understood for an AI/ML diagnostic device (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's safety and performance is based on engineering standards, material science, and regulatory compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "adjudication method" for interpreting data is mentioned as it's not a diagnostic study.
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 a non-AI/ML electrosurgical device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is a non-AI/ML electrosurgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or basis for affirming the device's safety and effectiveness relies on:
- Compliance with recognized standards: IEC 60601-1, ANSI/AMI HF-18, ISO 10993-1.
- Engineering testing: Hydroblister testing for integrity, tip bend resistance.
- Material history: "established history of safe use in similar medical devices."
- Substantial equivalence: Direct comparison to legally marketed predicate devices (NeoMedix MicroSurgical Bipolar Handpiece (K024304) and Storz Maumenee Goniotomy Knife Cannula).
8. The sample size for the training set
Not applicable. This is a non-AI/ML electrosurgical device. There is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is a non-AI/ML electrosurgical 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.