(24 days)
The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgical ablation of soft tissue and striated, cardiac, and smooth muscles. The system is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.
The FLEX 10® MIS Ablation Probe is designed for use in conjunction with the Guidant 1000 Series Microwave Generator. The Ablation Probe is an intraoperative, sterile, single-use, hand-held device that applies microwave energy to tissue. The Ablation Probe is comprised of a 24-cm-long, rigid handle with position indicators, a metallic shaft, a proximal control tube, a flexible sheath featuring black numbered markings together with right and left hand side markings, a detachable distal control tube, and a guide lead with sutures. The Ablation Probe further includes a 2-m-long insulated coaxial cable, which attaches to the generator output cable connector. The Microwave Generator's output (2450 MHz) is conducted through the output cable connector, into the cabling of the Ablation Probe, and out the antenna at the distal section of the Ablation Probe. The emitted microwave energy is directed toward the target tissue from the active surface opposite the corresponding numbered marking (segment), and creates a continuous lesion approximately 26 mm long. The black side-markings indicate the sides of the sheath. The numbered markings designate each numbered segment of the sheath and correspond to the position indicators on the handle. The ablations are created by independently activating the microwave ablation element at one or more of the corresponding numbered segments, which are selected by moving the sliding ring on the handle.
The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgical ablation of soft tissue and striated, cardiac, and smooth muscles. The system is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.
Here's an analysis of the provided text regarding the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list specific numerical acceptance criteria for the device's performance. Instead, it states a general conclusion about meeting established criteria.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| General Performance: Device meets established acceptance criteria and performs in a manner substantially equivalent to the predicate device. | "The results of the verification testing demonstrate that the Guidant FLEX 10® MIS Ablation Probe meets the established acceptance criteria and performs in a manner substantially equivalent to the predicate device." |
| Technological Characteristics: Incorporates the same fundamental scientific technology as the predicate device. | "The Guidant FLEX 10® MIS Ablation Probe incorporates the same fundamental scientific technology as the predicate device." |
2. Sample Size and Data Provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "verification testing."
3. Number and Qualifications of Experts for Ground Truth
The document does not mention the use of experts to establish ground truth for a test set. This type of information would typically be relevant for studies involving subjective assessment (e.g., image interpretation), which is not explicitly described here.
4. Adjudication Method
The document does not describe any adjudication method. This is generally relevant when multiple experts are involved in assessing data for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There is no mention of human readers or "AI vs. without AI assistance." The device is a medical probe, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
The document does not refer to a standalone performance study in the context of an algorithm. The device described is a physical medical device (ablation probe), not a software algorithm or AI. The "verification testing" would likely refer to engineering and functional tests of the physical device.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used. Given the nature of the device (an ablation probe), the "verification testing" would likely involve objective measurements of the ablation lesion's characteristics (size, temperature, tissue necrosis) rather than subjective assessments requiring expert consensus, pathology, or outcomes data in the usual sense of a diagnostic device. The ground truth would likely be established through physical measurements and observations in a laboratory or preclinical setting.
8. Sample Size for the Training Set
The document does not mention a training set sample size. Training sets are typically associated with algorithmic development (e.g., machine learning), and this device is a physical medical instrument.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set, the document does not provide information on how its ground truth was established.
§ 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.