(31 days)
The SafeAir Smoke Pencil is designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
The SafeAir Smoke Pencil is a sterile, single-use, integrated electrosurgical pencil and smoke evacuation handpiece. The device is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The integration of the electrosurgical pencil and smoke evacuation enables the operator to activate an electrosurgical current as well as capture smoke plume simultaneously. The SafeAir Smoke Pencil is available in two activation switch configurations, a rocker style and push-button style, which activate monopolar cut or coagulate functions. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to surgical smoke plume. Electrodes are available in either 70 mm blade or 70 mm coated blade configurations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SafeAir Smoke Pencil:
The document provided is a 510(k) summary for a medical device, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This type of submission typically focuses on demonstrating "substantial equivalence" rather than presenting a full clinical trial with acceptance criteria for new device performance. Therefore, the information provided isn't structured to detail specific acceptance criteria for diagnostic performance or a study proving those criteria in the way one might expect for a diagnostic AI device.
Instead, the document focuses on non-clinical performance testing to demonstrate the safety and effectiveness of the modified device in comparison to a predicate device. The "acceptance criteria" can be inferred from the types of tests performed and the statement that "results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the SafeAir Smoke Pencil and electrodes are sufficient for their intended use and support a determination of substantial equivalence."
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the document (a 510(k) summary for a modified electrosurgical pencil), explicit numerical acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity) are not provided, as this is not a diagnostic device. The "acceptance criteria" here relate to engineering performance, biocompatibility, and sterility.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Device validated as biocompatible in accordance with ANSI/AAMI/ISO 10993-1:2009. |
| Sterility | Sterility validated to a Sterility Assurance Level (SAL) of 10⁻⁶ in accordance with ANSI/AAMI/ISO 11135-1:2007. |
| Electrical Safety | Device meets ISO 60601-1 and ISO 60601-2-2 standards (implied by "Same" in predicate comparison). |
| Integrity and Functionality after Aging | Testing performed and results supported substantial equivalence (specific outcomes not detailed). |
| Thermal Spread | Testing performed and results supported substantial equivalence (specific outcomes not detailed). |
| Functionality (Electrosurgical - cutting/coagulation) | Device enables remote conduction of electrosurgical current for desired surgical effect (implied to be consistent with predicate). |
| Smoke Evacuation Functionality | Device removes smoke when used with an effective smoke evacuation system (implied to be consistent with predicate). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of diagnostic AI (i.e., a dataset of cases used to evaluate an algorithm's classification performance). The testing described is non-clinical performance testing of the device itself.
- Sample Size: Not specified for individual non-clinical tests (e.g., how many pencils were tested for electrical safety, or how many materials for biocompatibility). The focus is on demonstrating compliance with standards and equivalence.
- Data Provenance: Not applicable in the context of clinical data provenance. The testing was performed on samples of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This device is not an AI diagnostic device that requires expert-established ground truth for a test set. The validation pertains to physical and electrical properties, and biological safety.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" of clinical cases requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed for evaluating diagnostic devices, typically AI, and their impact on human reader performance. This device is an electrosurgical tool, not a diagnostic one.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is not an AI algorithm. The device itself is a standalone medical instrument.
7. The Type of Ground Truth Used
The concept of "ground truth" as used in diagnostic AI is not applicable here. The "truth" for the non-clinical tests refers to compliance with established engineering standards (e.g., ISO 60601-1 for electrical safety, ISO 11135-1 for sterilization) and biocompatibility standards (ISO 10993-1).
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for an AI algorithm.
Summary of the Document's Focus:
This 510(k) submission is for a modification and line extension of an existing electrosurgical device (the SafeAir Smoke Pencil). The goal is to demonstrate "substantial equivalence" to a predicate device (K142538) by showing that the changes (electrode connector material, added accessories, pre-mounted components, and a new coated blade electrode) do not alter the intended use, indications for use, or fundamental scientific technology, and do not raise new questions of safety or effectiveness.
The "study that proves the device meets the acceptance criteria" refers to a battery of non-clinical performance tests covering:
- Biocompatibility (meeting ISO 10993-1)
- Sterilization validation (meeting ISO 11135-1 with a SAL of 10⁻⁶)
- Electrical safety (meeting ISO 60601-1 and 60601-2-2)
- Integrity and functionality after aging
- Thermal spread testing
The acceptance criteria for these tests are implicitly the successful demonstration of compliance with the relevant standards and the assurance that the device's performance is equivalent to, or better than, the predicate device. Specific numerical results for each test are not detailed in this summary document, but the conclusion states that the "results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness... are sufficient for their intended use and support a determination of substantial equivalence."
§ 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.