(94 days)
Microwave Ablation Generator is indicated for the coagulation (ablation) of soft tissue. The device is not intended for cardiac use.
Microwave ablation is a kind of thermal ablation technology used in the treatment of soft tissue, utilizing electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) to produce tissue-heating effects. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis.
Microwave Ablation Generator consists of microwave source, pump, foot pedal etc. It is a software-controlled microwave generator that delivers the microwave energy at a working frequency of 2450 MHz and can meet various clinical needs of soft tissue ablation therapy. Microwave Ablation Generator delivers microwave energy to Microwave Ablation Antennas into the target tissue through Microwave Ablation Cable(sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged, leading to irreversible necrosis. The Microwave Ablation Temperature Probe is applied to monitor the temperature of the target location and to protect important organs and tissues in the periphery of the lesion from unexpected damage by microwave energy. Coagulated zones are monitored during treatment using appropriate imaging techniques.
The provided document is a 510(k) Premarket Notification from the FDA for a Microwave Ablation Generator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new device's performance. Therefore, detailed information required by the request, such as sample sizes, data provenance, number and qualifications of experts, and ground truth establishment, is not present because this type of submission typically relies on non-clinical performance and equivalence to a previously cleared device.
However, I can extract the acceptance criteria for non-clinical performance tests and the reported performance, as well as general information about the submission.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Electrical Safety as per IEC 60601-1 | Meets requirements of IEC 60601-1 |
| Electromagnetic Compatibility as per IEC 60601-1-2 | Meets requirements of IEC 60601-1-2 |
| Specific Performance as per IEC 60601-2-6 | Meets requirements of IEC 60601-2-6 |
| Software validation as per IEC 62304 and FDA Guidance | Embedded software meets requirements of IEC 62304 |
| Thermal Effects Test and Temperature Monitoring Test | Not explicitly stated as "meets criteria" but "Non-clinical performance data is provided in support of the substantial equivalence determination" implies satisfactory results. The table also states "Temperature monitoring features used to ensure safety" for both subject and predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document, as the submission is a 510(k) based on non-clinical performance and substantial equivalence, not a clinical study with patient samples. The document focuses on technical specifications and international standards compliance.
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 provided. The submission relies on engineering and regulatory experts to ensure compliance with standards and equivalence to a predicate device. There is no mention of "ground truth" establishment in the context of expert consensus on medical images or diagnostic outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or outcome assessment, which is not the focus of this 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
There is no mention of an MRMC comparative effectiveness study, nor is the device an AI-assisted diagnostic tool. This device is a Microwave Ablation Generator.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to the device. The "Microwave Ablation Generator" is a medical device for coagulation of soft tissue, not a standalone algorithm. Performance is assessed through compliance with technical standards and physical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the context of medical imaging or diagnostic accuracy is not applicable to this device's submission. The "truth" for this device's performance is established by its compliance with recognized electrical safety, electromagnetic compatibility, specific performance standards, and software validation according to established engineering and regulatory guidelines. The "Thermal Effects Test" results would be compared against expected thermal ablation patterns or temperatures.
8. The sample size for the training set
This information is not provided and is not relevant for this type of device submission. The device is not an AI/ML algorithm that requires training data in the traditional sense.
9. How the ground truth for the training set was established
This information is not provided and is not relevant for this type of device submission.
§ 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.