(74 days)
The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue. The device consists of an Insulated Handle and a Shaft and Electrode Tip. The Insulated Handle encases the controlling mechanism for the flow of saline, and activation of the RF current. The activation of RF current is accomplished by a single push button on the top of the handle. The Handle has a flow control mechanism so the flow of saline can be regulated by the user within the sterile field. The tubing length is approximately ten (10) feet in length and incorporates an I.V. spike on the end to attach directly to a hanging IV (saline) bag. The Handle power cord is approximately ten (10) feet in length and incorporates a 3-prong electrical plug. The electrode tip delivers RF energy for cutting and coagulation and delivers saline which is gravity-fed from an Intravenous bag to the tip. These devices use technology substantially equivalent to the TissueLink Solid Cylinder Monopolar Device (K014260). Both consist of an electrode tip that is used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy. Resection Devices are provided sterile, sterilized using ethylene oxide gas, and are for single use only.
The provided text describes a 510(k) summary for the Saline Enhanced Electrosurgical Resection (SEER) Device, now called "Resection Device." However, it does not include a detailed study or specific acceptance criteria with reported device performance metrics in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device.
Based on the provided information, here's what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary states that "There are no significant differences in technology, performance, or intended use between the Resection Device and the given predicate device," and that the device "conforms to the requirements of safety standard IEC 60601-2-2." This implies that the device meets some performance standards, but the specific acceptance criteria and detailed reported performance metrics are not explicitly listed.
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. The 510(k) summary does not describe any specific test set or clinical study conducted with human or animal subjects that would require sample sizes or data provenance details. The demonstration of safety and effectiveness appears to be primarily based on substantial equivalence to the predicate device and conformance to an international safety standard.
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. Since no specific test set or clinical study for performance evaluation is described, there's no mention of experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not provided. The device is an electrosurgical tool, not an AI or imaging diagnostic device, so an MRMC study with human readers is not relevant to its intended use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The "Resection Device" is a physical electrosurgical tool, not an algorithm, so the concept of standalone algorithmic performance doesn't apply. It's intended for human-in-the-loop use by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not provided.
9. How the ground truth for the training set was established
This information is not provided.
Summary of what is available regarding acceptance and performance:
The document emphasizes substantial equivalence to the TissueLink Solid Cylinder Monopolar Device (K014260) as the primary method of demonstrating safety and effectiveness.
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Acceptance Criteria (Implied):
- Substantial equivalence to the predicate device (TissueLink Solid Cylinder Monopolar Device K014260) in technology, performance, and intended use.
- Conformity to safety standard IEC 60601-2-2.
- Sterility (sterilized using ethylene oxide gas).
- Single-use only.
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Reported Device Performance (Implied):
- Functions for cutting and coagulating soft tissue using radiofrequency (RF) current and sterile saline, similar to the predicate.
- Meets dielectric withstand requirements for accessories.
- No significant differences in technology, performance, or intended use compared to the predicate.
- Meets the requirements of safety standard IEC 60601-2-2.
In essence, the "study" that proves the device meets acceptance criteria, as presented in this 510(k) summary, is the assertion of substantial equivalence to a legally marketed predicate device, along with adherence to a recognized international safety standard. No specific clinical performance study or testing data with sample sizes, expert evaluations, or ground truth establishment is detailed in this regulatory submission summary.
§ 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.