(79 days)
The DeRoyal® Electrosurgical Pencil is intended to be used to remove tissue and control bleeding by use of high frequency electrical current. The pencil can be used during electrosurgical procedures for both cutting and coagulation.
Electrosurgery can be used to accomplish any one of three functions in the surgical environment: incise, desiccate, or coagulate. The "pencil" is the portion of the system that delivers the current to the patient. It is a hand-held device operated by the surgeon or other trained professional. It has switches built into it for hand switching capability. This is a single use, disposable device. It plugs into the electrosurgical generator via an industry standard three-prong offset plug.
The provided text does not contain information about acceptance criteria for device performance or a study proving the device meets performance criteria in the way a diagnostic AI device would. Instead, it details the testing done to demonstrate the substantial equivalence of DeRoyal® Electrosurgical Pencil to a predicate device, focusing on safety, manufacturing, and general device characteristics.
However, I can extract the information related to the tests performed to demonstrate substantial equivalence, which can be thought of as "acceptance criteria" for regulatory approval in this context.
Here's the information based on the provided text:
- 1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Performed) | Reported Device Performance (Conclusion) |
|---|---|
| Pencil Feature (Technological Characteristics Comparison) | |
| Button Style | Two buttons for hand switching control (Same as predicate: DeRoyal Industries Inc. Electrocautery Pencil- K940909) |
| Rocker Style | One rocking button for hand switching control (Same as predicate: DeRoyal Industries Inc. Electrocautery Pencil- K940909) |
| Safety and Manufacturing-Related Tests | |
| Biocompatibility | Cytotoxicity, Irritation, Sensitization, System Toxicity, and Haemocompatibility tests were performed and passed according to ISO 10993-1. |
| Electrical | IEC 60601-2-2:2009 testing was performed and passed when used with over-molded electrodes only. |
| Sterilization | EO sterilization validation was performed and passed according to ISO 11135:2007. The SAL (Sterility Assurance Level) of the sterilized pencil reached 10⁻⁶. |
| Aging | Aging studies performed according to ASTM F 1980-02. The shelf life was determined to be 3 years. |
| Package Seal Integrity | Package seal integrity tests were performed and passed according to ISO 11607-1:2006, ASTM F 1929-98, and EN868-5:1999. |
-
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample sizes used for each of the tests (Biocompatibility, Electrical, Sterilization, Aging, Package Seal Integrity).
- The data provenance is not explicitly stated as country of origin, but the manufacturer is Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. in Jinhua City, Zhejiang Province, China, suggesting the testing data may originate from China or be conducted for a Chinese manufacturer seeking US market approval. The studies are technical validation studies rather than clinical studies with patient data.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable. The tests performed are technical and regulatory compliance tests (e.g., electrical safety, sterility validation, material biocompatibility) on the device itself, not diagnostic performance evaluations that require expert interpretation of results to establish ground truth.
-
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as the tests are objective compliance assessments, not subjective diagnostic interpretations requiring 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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an electrosurgical pencil and not an AI-powered diagnostic tool.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. The device is a physical electrosurgical pencil, not an algorithm or AI system.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the tests performed are established international standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601-2-2 for electrical safety, ISO 11135:2007 for EO sterilization, ASTM F 1980-02 for aging, ISO 11607-1 for package seal integrity). The device "passing" these tests means it meets the objective criteria defined by these standards.
-
8. The sample size for the training set
- This is not applicable. There is no concept of a "training set" for this type of medical device as it is not an AI/ML algorithm.
-
9. How the ground truth for the training set was established
- This is 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.