(137 days)
The Force TriVerse Electrosurgical Device is a single-use device intended for use in open surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic), and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrodes.
The Force TriVerse Electrosurgical Devices are radiation-sterilized, single-use, hand-held monopolar electrosurgical instruments. There are two models-FT3000DB. These models are identical except for the cord length. FT3000 has a 10-ft cord and FT3000DB has a 15-ft cord.
The instruments work with compatible electrosurgical generators to cut and coagulate tissue during surgical procedures. The surgeon uses the controls on the handset to select the electrosurgical mode and to adjust the power output from within the surgical field. The surgeon selects the desired electrosurgical mode by pressing one of three buttons. The surgeon controls the power level using a slider control on the instrument body. The device is assembled with a blade electrode. The surgeon is able to replace this electrode with other standard monopolar electrodes as needed for a specific surgical procedure.
The device is provided with a safety holster to provide a safe location for storing the instrument when it is not in use.
This looks like a 510(k) premarket notification for an electrosurgical device. 510(k)s typically demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in the way a clinical trial for a new drug or novel medical device might. The document doesn't provide detailed acceptance criteria and a study proving the device meets them in the format requested. Instead, it states that the device's overall functionality and performance characteristics are unchanged relative to the initially cleared device and lists several types of testing performed to demonstrate that the device still performs as expected following design changes.
Therefore, many of the requested fields cannot be filled directly from the provided text.
However, I can extract the information that is present and indicate where information is not available.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantifiable manner for specific performance metrics that would be directly comparable to a "reported device performance" table for an AI/algorithm-driven device. Instead, it refers to compliance with safety standards and functional testing.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary from text) |
|---|---|
| Compliance with IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment) | Device tested in accordance with applicable clauses of IEC 60601-1. |
| Compliance with IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories) | Device tested in accordance with applicable clauses of IEC 60601-2-2. |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests) | Device tested in accordance with applicable clauses of IEC 60601-1-2. |
| Mechanical Performance: |
- Mechanical strength
- Integrity of connections
- Performance of button and slider controls
- Resistance to fluids
- Label adhesion | Mechanical testing performed, covering:
- Mechanical strength
- Integrity of connections
- Performance of button and slider controls
- Resistance to fluids
- Label adhesion |
| Packaging Effectiveness: - Adequate protection of the device during shipping | Shipping tests performed to verify that the packaging adequately protects the device. |
| Biocompatibility: - Cytotoxicity
- Intracutaneous reactivity
- Sensitization
- Hemolysis
- Acute systemic injection (for direct and indirect patient-contacting materials) | Biocompatibility testing performed for direct and indirect patient-contacting materials, covering:
- Cytotoxicity
- Intracutaneous reactivity
- Sensitization
- Hemolysis
- Acute systemic injection |
| Maximum peak voltage rating compatibility (specifically mentioned as 3625 volts) | Instruments are rated for a maximum peak voltage of 3625 volts and, when used with specified generators, meet IEC 60601-1 criteria for Type CF applied parts. |
| Overall functionality and performance characteristics unchanged relative to the initially cleared device. | The overall functionality and performance characteristics of the device are unchanged relative to the initially cleared device. |
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 in the document. The document describes engineering and biocompatibility testing, not a clinical study with a human-based test set or data.
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 in the document. This is not a study that involved human expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. This is not a study that involved human expert interpretation or adjudication.
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
An MRMC study was not done. This device is an electrosurgical instrument, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an electrosurgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied to AI performance studies is not applicable here. The "truth" for this device's performance is based on meeting engineering specifications, safety standards (IEC 60601 series), and established physical or biological criteria (e.g., mechanical strength, biocompatibility).
8. The sample size for the training set
This is not applicable. This is not an AI/machine learning device that involves a training set.
9. How the ground truth for the training set was established
This is not applicable. This is not an AI/machine learning device that involves a training set or ground truth in that context.
§ 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.