Search Results

The INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set 1s ıntended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues

The Relievant INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Sets are used in comunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lessons 11 soft tissue The device is a modification to the Relievant MedSystems INTRACEPT B1-Polar RF Probe and Instrument Set to incorporate a curved instrument set and a more flexible tip of the radiofrequency probe The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lessons in soft tissue The Instrument Sets are used to provide access to the target tissue

Here's an analysis of the provided text regarding the acceptance criteria and study for the INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set:

Summary of Acceptance Criteria and Device Performance

Study Details

• 1. A table of acceptance criteria and the reported device performance: (Provided above)

• 2. Sample size used for the test set and the data provenance:

  • Sample Size: Not explicitly stated. The document mentions "In vivo data," implying animal or human subject testing, but does not provide specific numbers of subjects or cases.
  • Data Provenance: "In vivo data" is mentioned, suggesting prospective experimental data collected for the purpose of this submission. The country of origin is not specified.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • This information is not provided in the given text. Establishing ground truth typically involves expert assessment, but the summary focuses on direct comparison of lesion characteristics.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • This information is not provided in the given text.

• 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 MRMC study was done. This device is a medical instrument (RF probe), not an AI diagnostic or assistance tool, so such a study would not be applicable.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • Not applicable. This is a physical medical device, not a software algorithm. The "performance" refers to its ability to create lesions, not a diagnostic output.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

  • The "ground truth" implicitly refers to the characteristics of the lesions created. This would likely be determined through direct measurement and observation of the lesions, possibly via histological analysis (pathology) or imaging, to compare their size and other clinically relevant features to those created by the predicate device. The document states "In vivo data demonstrated that... creates clinically relevant lesions that are equivalent in size," suggesting direct measurement was the basis.

• 8. The sample size for the training set:

  • Not applicable. This device is hardware; there is no "training set" in the context of machine learning. The device itself is "trained" through its design and manufacturing process, and tested directly.

• 9. How the ground truth for the training set was established:

  • Not applicable. As above, there is no training set for a hardware device.

Ask a specific question about this device