Search Results

The OmniGuide® TRIO™ handpiece is indicated for the electrosurgical coagulation of soft body tissues and suction of fluids in general and ENT surgical procedures for the specialties of General Surgery, Head and Neck Surgery, Otolaryngology, and Oral surgery (including intra-oral tissues). When used with the OmniGuide® Laser waveguide, it is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues for the added specialties of Dermatology, Neurosurgery, Orthopedic Surgery, Plastic & Reconstructive Surgery, Podiatry and Urology.

The TRIO™ handpiece is a handheld single use device designed to act as a laser waveguide guide/holder for previously cleared waveguides. The TRIO™ handpiece combines three fundamental surgical instrument functions into one lightweight and compact handheld disposable surgical instrument. If enables a surgeon to provide fluid suction, bipolar cautery, and CO2 laser energy without the necessity of changing instruments, saving surgical time for both physician and patient and a corresponding reduction in cost. Laser energy is delivered via a flexible OmniGuide® fiber for minimally invasive surgery.

The instrument is provided sterile and is intended for single use only. The package has an accelerated shelf life of two years.

The sterile package includes a cable to connect the handpiece to an electrosurgical generator. The cables are generic in nature and several varieties available at a hospital/ office will function. The package also includes a small brush for cleaning coagulation tips with adhered material. The TRIO™ handpiece is intended to be used only with the family of OmniGuide® CO2 Laser fibers including Velocity™, Elite™ and Select™ fibers previously cleared in 510(k) K070157.

The OmniGuide® handpiece is intended for use by licensed surgeons only for open surgical procedures listed in the indications for use. The objective of the handpiece is to enable precision control and to stabilize surgeon hand motion. The waveguide fiber is inserted through the proximal end of the handpiece and fixated so that it is observed at the handpiece's distal tip. The surgeon wields the handpiece as a pencil and advances the handpiece so that its distal tip is near the target tissue to exert the desired effect of the waveguide fiber: suction and coagulation. The surgeon may use the handpiece distal tip in either non-contact mode or contact mode and may use the distal tip to enable tissue manipulation, electrosurgical portion is used for coagulation due to bleeding during laser surgery or tissue manipulation.

The TRIO™ handpiece can be used with any Electro-Surgical Unit (ESU) with output power of up to 750 peak to peak voltage (Vp-p) and footswitch actuation. The instrument is provided with a 12-foot bipolar cable with fixed leads. The TRIO™ handpiece instrument can be used with any hospital or office suction apparatus. Fluid aspiration is controlled via a suction control port on the handle of the instrument.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance for the OmniGuide TRIO Handpiece:

The document does not describe a study involving human readers or AI assistance. It focuses on the substantial equivalence of a medical device (a surgical handpiece) to predicate devices through engineering and biocompatibility testing. Therefore, sections related to MRMC studies, human reader improvement, and standalone algorithm performance are not applicable based on the provided text.

Acceptance Criteria and Reported Device Performance

The document describes the performance testing conducted to demonstrate safety and effectiveness. The acceptance criteria are implicitly defined by the successful completion of these tests in compliance with relevant standards.

Study Details (Based on available information)

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

   • The document describes bench-top testing and user validation. It does not specify sample sizes (e.g., number of handpieces tested for each bench-top test or number of users for validation).
   • Data Provenance: The testing was conducted by an "independent testing laboratory (Intertek)" for electrical safety, EMC, usability, and risk management. Bench-top tests (beam clipping, suction, fiber retention, reliability, mechanical robustness, thermal profile), sterilization validation, and biocompatibility tests were also performed. The origin of the sample devices for testing (e.g., specific manufacturing lot, country) is not specified, but it would presumably be from OmniGuide, Inc.

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

   • The document implies that the "ground truth" for the device's performance is compliance with established international standards (IEC, ISO). "User validation" was performed, which would typically involve qualified users (surgeons or surgical staff), but the number and qualifications of these users are not specified.

3. Adjudication method for the test set:

   • Not applicable in the context of this engineering and biocompatibility testing. Compliance was assessed against pre-defined standards and test protocols.

4. 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, an MRMC comparative effectiveness study was not done. This device is a surgical handpiece, not an imaging or diagnostic device involving human readers or AI.

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

   • No, this is not an algorithm or software device. The testing focuses on the physical and electrical performance of the surgical handpiece.

6. The type of ground truth used:

   • The ground truth is based on established international standards and regulatory requirements (e.g., IEC 60601-1, ISO 11135, ISO 10993 series) for electrical safety, electromagnetic compatibility, usability, risk management, sterilization, and biocompatibility. Additionally, engineering specifications and functional requirements for aspects like beam clipping, suction, fiber retention, reliability, mechanical robustness, and thermal profile serve as the ground truth.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this device.

Ask a specific question about this device