(59 days)
The intended use for the DERM 942 is for removal and destruction of skin lesions and the coagulation of tissue.
The intended use for the Bantam/PRO is for removal and destruction of skin lesions and for electrosurgical cutting, blending, coagulation, fulguration, and bipolar procedures.
The intended use for the DERM 941 and DERM 942 is for removal and destruction of skin lesions and the coagulation of tissue.
The intended use for the Bantam/PRO is for removal and destruction of skin lesions and for electrosurgical cutting, blending, coagulation, fulguration, and bipolar procedures.
The Bantam/PRO performs the following functions:
Cut mode: Allows the user to utilize electrosurgical current to vaporize or cut tissue.
Blend mode: Combines cutting with hemostasis, which achieves a bloodless cut.
Coagulation mode: Is used for the destruction of tissue and hemostasis.
Fulguration mode: Allows the user to coagulate over a broad area with less tissue penetration.
Bipolar mode: Allows coagulation of tissue using forceps.
The DERM 942 has the following functions shared with the Bantam/PRO: Fulguration mode: Allows the user to coagulate over a broad area with less tissue penetration.
Bipolar mode: Allows coagulation of tissue using forceps.
The DERM 941 has only the basic Fulguration mode function.
The DERM 942 and 941 are termed High Frequency Dessicators since they perform treatment of skin lesions. The fulguration and bipolar are termed the dessication modes. The Bantam/PRO performs treatment of skin lesions but also has the basic cut and coagulation functions of a typical electrosurgical generator. All these units are considered low wattage (
This document is a 510(k) premarket notification for electrosurgical generators and does not describe a study involving an AI device or its acceptance criteria. Therefore, most of the requested information regarding AI device performance, sample sizes, ground truth establishment, or expert evaluation methods is not applicable.
The document focuses on demonstrating substantial equivalence of the new Bovie Bantam/PRO, Bovie Derm 941, and Bovie Derm 942 Electrosurgical Generators to legally marketed predicate devices.
Here's the information that is available from the provided text, adapted to the closest relevant categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Purpose | Verification Performed |
|---|---|---|
| Electrical Verification | To verify electrical product and performance specification requirements where the test method is other than inspection or proof by design evidence. | Perform testing required to verify the electrical functionality of the generator. |
| FPGA Validation for Main Board | To specify the FPGA validation procedure for the logic design used in the generator. | Validate the operation of the programmable systems on the main board of the generator to ensure FPGA design meets functional and timing requirements. |
| Mechanical Verification | To verify mechanical product and performance specification requirements. | Perform testing required to verify the mechanical functionality of the generator and to ensure generator has adequate mechanical strength and resistance to heat. |
| Usability Validation | Validate the user interface of the Electrosurgical Generator. | Validate that the device fulfills the user needs and intended uses. |
No specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, etc., for an AI device) are reported in this document beyond verification that the devices pass these tests and meet relevant standards. The conclusion states that "Performance testing demonstrates equivalence between the proposed and predicate devices," implying successful completion of these tests.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study assessing an AI device on a test set of data. The "test set" here refers to the physical devices being tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth in the context of an AI device is not relevant here. The "ground truth" for these electrosurgical generators would be their functional specifications and safety standards.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study with expert adjudication of data.
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 document does not describe an AI device or an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by adherence to recognized international standards and specifications for electrosurgical equipment. The document explicitly lists:
- IEC-60601-1, Edition 3.1: Medical Electrical Equipment - Part 1: General Requirements For Safety
- IEC 60601-1-2:2007: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC-60601-2-2 : 2009: Particular requirements for the safety of high frequency surgical equipment
8. The Sample Size for the Training Set
Not applicable. This is not an AI device trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.