Search Results

The Electrosurgical Probes are disposable electrosurgical devices intended to be used in general surgical procedures where electro-coagulation and cutting of soft tissues is desired. They are intended to be used with ORATEC Interventions ElectroThermal™ Generators.

The ORATEC Interventions Electrosurgical Probes are single-use electrosurgical devices designed for use in minimally invasive procedures where electro-coagulation and cutting of soft tissues is desired. They are designed to provide minimally invasive access to the targeted tissue, and to deliver radio-frequency energy in a controlled fashion. The modified probes consist of the following features:

• a shaft with a radiofrequency-energized tip for minimally invasive access to . perform tissue coagulation and/or cutting;
• different electrode tip configurations to provide optimal access to tissue; .
• . handle and cable connection receptacle at the proximal end.

The modifications made from the predicate device are:

• Adding alternate electrode tip materials; .
• Adding alternate insulating materials on the probe shaft; .
• Adding different tip configurations; .
• Decreasing handle, probe shaft, and electrode dimensions for the smaller versions. ●

The provided text is a 510(k) Summary for a device modification, specifically for ORATEC TAC-S Monopolar Cautery Probe. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving safety and efficacy through new performance studies akin to those for a novel device or software.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of, for example, an AI/ML algorithm or a new medical device's clinical performance.

Here's why and what information is provided:

• Focus of a 510(k) for device modification: The primary goal of this Special 510(k) is to show that the modified device (ORATEC Electrosurgical Probes with altered materials, tip configurations, and dimensions) is as safe and effective as the existing, legally marketed predicate device (Electrosurgical Probes, K965007). It achieves this by highlighting similarities and explaining how differences do not raise new questions of safety or effectiveness.
• Nature of the device: This is an electrosurgical device, not an AI/ML system. Performance is typically assessed through engineering design verification and validation, biocompatibility, electrical safety, electromagnetic compatibility, and potentially bench testing to confirm physical properties and functionality.
• Lack of AI-specific or clinical study details: The document does not describe:
  • Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC).
  • Any study explicitly designed to "prove" the device meets such criteria using patient data, ground truth established by experts, or MRMC studies.

Based on the provided text, I cannot complete the table or answer most of the questions as they pertain to clinical performance studies, AI/ML models, or specific ground truth methodologies.

However, I can extract information relevant to the device modification and its comparison to the predicate:

Device Modifications and Comparison to Predicate:

Answers to Applicable Questions (based only on the provided text):

1. A table of acceptance criteria and the reported device performance: Not applicable in the traditional sense for a 510(k) device modification. The acceptance criteria essentially boil down to demonstrating "substantial equivalence" to the predicate device, meaning the modifications do not raise new questions of safety or effectiveness. The "performance" is implicitly deemed equivalent if substantial equivalence is established. No specific quantitative performance metrics (like accuracy, sensitivity) are presented for this type of device modification.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical or comparative test set data from patients is described. The "test" for a device modification in a 510(k) is typically a review of engineering changes, material specifications, and comparison to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set of patient data is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a device modification of an electrosurgical probe, demonstrating substantial equivalence to a predicate. It does not contain the detailed performance study information typically requested for AI/ML devices or novel medical devices requiring extensive clinical data.

Ask a specific question about this device