(97 days)
The Microwave Tissue Coagulation System (MTCS) is intended for coagulation of soft tissue.
The Microwave Tissue Coagulation System (MTCS) is designed to coagulate soft tissue using a surface contact applicator. The system consists of an applicator, external microwave generator, vacuum pump, and a cooling fluid pump and tubing. The desired power and delivery time are set manually by the operator. The generator contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, microwave module and the front panel/control board assembly. The applicator is a specifically designed to deliver microwave energy at the frequency and power levels that the generator outputs. The proximal end of the applicator has a microwave connector that fits onto the generator and allows the energy to be delivered to the applicator.
The provided text does not contain detailed acceptance criteria for the Microwave Tissue Coagulation System (MTCS) or a dedicated study report proving its compliance to specific performance metrics. It primarily focuses on the device's description, intended use, and substantial equivalence to predicate devices for 510(k) clearance.
However, based on the limited information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Conformance to product specification | "The results showed the system met specification." |
- Inference: The "product specification" would likely include parameters related to the microwave generator's output power, frequency, safety controls, the applicator's ability to deliver energy, and the overall system's functional integrity. Without the actual specifications, the specific criteria are unknown.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Product testing was conducted to evaluate conformance to product specification." It does not provide details on:
- Sample size for the test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
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. The testing described is "product testing" to evaluate conformance to specifications, not a clinical study involving experts establishing ground truth for diagnostic or therapeutic outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is typically used in clinical studies with human readers or experts reviewing cases, which is not described 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. The document describes a medical device for tissue coagulation, not an AI-powered diagnostic or assistive tool. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (Microwave Tissue Coagulation System), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "product testing" mentioned, the "ground truth" would be the engineering and performance specifications defined by the manufacturer. The device was tested to ensure it met these predetermined physical and functional requirements.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an artificial intelligence or machine learning device. The "training" for such a device would likely refer to manufacturing processes and quality control, not data-driven model training.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 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.