(176 days)
The DTS G2 System is indicated for use for coagulation of soft tissue.
The DTS G2 System is designed to interact-using a surface contact applicator. The system consists of an applicator; external microwave generator with integrated 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, integrated vacuum pump, 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 distal end has a sterile, disposable applicator head that contacts the patient.
The provided 510(k) summary for the DTS G2 System is for a Class II medical device, specifically an electrosurgical cutting and coagulation device. The information provided in the document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than detailed studies demonstrating performance against specific acceptance criteria for a diagnostic AI/ML device.
Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to AI/ML performance, ground truth, expert consensus, and reader studies) are not applicable to this submission.
Here's a breakdown of the available information and why other fields are N/A:
Acceptance Criteria and Reported Device Performance
| Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Product Specification | Not explicitly detailed in the provided document | "The results showed the system met specification." |
| Equivalence to Predicate | "Indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent." | "The DTS G2 System is equivalent to the predicate product." |
| Safety and Materials | Materials suitable for use | "All materials used in the manufacture of the DTS G2 System are suitable for this use and have been used in numerous previously cleared products." |
Study Details for this Device
Given the nature of this 510(k) submission (a medical device for tissue coagulation, not an AI/ML diagnostic) and the provided text:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified for performance testing.
- Data Provenance: "Product and animal testing was conducted." No country of origin is specified. This was likely prospective bench and animal testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. This is a non-AI device; ground truth for performance was likely based on physical measurements and observations during product and animal testing, not expert interpretation.
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Adjudication method for the test set: N/A. Not relevant for this type of device testing.
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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: N/A. This is not an AI/ML diagnostic device requiring a reader study.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is a physical device, not an algorithm. Performance involves the device's physical interaction, not an algorithm's standalone output.
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The type of ground truth used: For the product and animal testing, the ground truth would have been established through direct observation, physiological measurements, and possibly histological examination in animal models to confirm "coagulation of soft tissue" and device function according to specifications. Pathology data would be relevant for animal testing outcomes.
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The sample size for the training set: N/A. This device does not use an AI/ML model that requires a training set.
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How the ground truth for the training set was established: N/A. No training set is applicable.
§ 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.