(108 days)
The Microwave Ablation System is indicated for the coagulation (ablation) of soft tissue. The Microwave Ablation System is not intended for cardiac use.
The Microwave Ablation System is a microwave power (energy) source that can meet the needs of clinical soft tissue microwave thermal ablation therapy. The microwave energy is transmitted to the disposable microwave ablation needle through coaxial transmission cable, and the disposable microwave ablation needle is directly inserted into the targeted soft tissue, and the electromagnetic wave (microwave) is radiated from the front end of the disposable microwave ablation needle to cause the soft tissue to produce heat and rise. When it reaches the temperature of tissue coagulation and necrosis, in-situ inactivation is formed, that is, the purpose of microwave ablation therapy is achieved.
The Disposable Thermometer Needle and Foot Switch are accessories for the proposed device. And the proposed device is used in conjunction with the Disposable Microwave Ablation Needle made by our company.
The provided text describes a 510(k) premarket notification for a Microwave Ablation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic device would.
Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable or available from this 510(k) summary. This document primarily focuses on engineering and regulatory compliance rather than clinical performance metrics as might be found in a diagnostic AI device submission.
Here's an attempt to answer the questions based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for a clinical outcome in the way an AI diagnostic device might. Instead, the "acceptance criteria" are implied by the conformance to various safety, performance, and software standards. The reported "performance" focuses on meeting these standards and demonstrating equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criteria (Implied from standards) | Reported Device Performance/Compliance |
|---|---|---|
| Electrical Safety | Conformance to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 | Designed and tested in accordance with the specified IEC 60601-1 standards. |
| EMC | Conformance to EN 60601-1-2: 2015+A1: 2021/ IEC 60601-1-2: 2014+AMD1:2020 | Designed and tested in accordance with the specified EN/IEC 60601-1-2 standards. |
| Device Performance | Conformance to IEC 60601-2-6: 2012, AMD1:2016 (Particular requirements for microwave therapy equipment) | Designed and tested in accordance with IEC 60601-2-6. The overall performance test of the proposed device was conducted "as same as the predicate device," addressing main functions (power module, control feedback, microwave transmitting, water circulation). |
| Software Life-cycle | Conformance to ANSI AAMI IEC 62304:2006/A1:2016 and FDA Guidance: Content of Premarket Submissions for Device Software Functions. | Software verification was conducted on the proposed device according to FDA software guidance, and the test result proves the functions in each operational mode can be achieved, and the differences in operational modes do not raise new risks. |
| Thermal Effects | Conformance to FDA Guidance: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (Thermal Effects test and Temperature monitoring test). | Thermal Effects test and Temperature monitoring test were conducted in accordance with the FDA Guidance. The device includes temperature monitoring features to ensure system safety and utilizes a pumped cooling system (distilled water or saline) for the ablation needle (consistent with predicate). |
| Intended Use | Indicated for coagulation (ablation) of soft tissue, not intended for cardiac use. | The stated indication for use is identical to the predicate device. |
| Safety and Effectiveness | No new questions of safety or effectiveness are raised compared to the predicate device. | Differences from the predicate device (e.g., operational modes, specific design of components) were analyzed and determined to not raise new risks or affect substantial equivalence. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical study is included in this submission." This means there isn't a "test set" of patient data in the context of evaluating a diagnostic or AI-driven device's clinical performance. The testing mentioned (electrical safety, EMC, thermal effects) would involve laboratory setups and devices, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study or test set using patient data for ground truth establishment was conducted or reported.
4. Adjudication method for the test set
Not applicable, as no clinical study or test set requiring expert adjudication was conducted or reported.
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 device is a Microwave Ablation System, which is a therapeutic device, not a diagnostic device that would typically involve human readers or AI assistance for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a therapeutic system, not an algorithm or AI product. Its performance is related to its physical functions and safety, not an AI's standalone interpretation capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering and safety tests, the "ground truth" would be the specifications and requirements defined by the relevant international standards (e.g., IEC 60601 series) and FDA guidance documents. For instance, an electrical safety test's ground truth is whether the device does or does not meet the leakage current limits. This is based on objective measurements against engineering standards, not clinical ground truth like pathology.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set.
§ 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.