(316 days)
The ACE Monopolar Attachment is intended to be used with the compatible ERBE Monopolar Disposable Electrosurgical Pencil (model: No.20190-109) for coagulation and cutting of soft tissue when used in conjunction with compatible ERBE Electrosurgical Generator (ESU) Systems.
The ACE Monopolar Attachment is used with compatible ERBE Electrosurgical Generator (ESU) Systems which deliver High Frequency (HF) energy through the electrode tip of the ACE Monopolar Attachment for coagulation and cutting of soft tissue. The ACE Monopolar Attachment is an electrode tip, made of stainless steel, and compatible with marketed plastic insulation handle. The compatible ERBE Electrosurgical Unit (ESU) to be used must have a Monopolar 3-pin bovie receptacle. The Monopolar Attachment is provided single-use.
The ACE Monopolar Attachment is a medical device designed for electrosurgical procedures involving soft tissue coagulation and cutting. The device underwent non-clinical testing to demonstrate its safety and effectiveness.
Here is a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ACE Monopolar Attachment are derived from established international and national standards for medical device safety, biocompatibility, and electromagnetic compatibility. Performance criteria are based on comparative testing against a predicate device.
| Acceptance Criteria Category | Specific Standard/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-1:2009 | Evaluation and testing within a risk management process for biological evaluation of medical devices. | Met the requirements. |
| ISO 10993-5:2003 | Tests for In Vitro cytotoxicity. | Met the requirements. | |
| ISO 10993-10:2002/Amd. 1:2006(E) | Tests for irritation and delayed-type hypersensitivity. | Met the requirements. | |
| Electrical Safety | IEC 60601-1 (1988, Amend. 1991, Amend. 1995) | General Requirements for Safety of Medical Electrical Equipment. | Met the requirements. |
| Electromagnetic Compatibility | IEC 60601-1-2:2007 | General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). | Met the requirements. |
| High Frequency Surgery Equipment | IEC 60601-2-2:2009 | Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories. | Met the requirements. |
| Sterilization | ISO 11137-2:2006 | Establishing the sterilization dose for radiation sterilization of health care products. | Met the requirements (Gamma irradiation for single-use). |
| Surface Wettability (Material) | ASTM D7334-08 | Standard Practice for Surface Wettability of Coatings, Substrates and Pigments by Advancing Contact Angle Measurement. (Likely for electrode tip or insulation material properties). | Met the requirements. |
| Ex Vivo Performance (Comparative) | Arcing Test | Performance similar to or better than the predicate device (GEIGER Disposable Electrosurgical Electrode). No excessive arcing that would compromise safety or effectiveness. | All test results demonstrated safety and performance met requirements. |
| Charring Test | Performance similar to or better than the predicate device. Minimized charring to prevent tissue damage and ensure effective cutting/coagulation. | All test results demonstrated safety and performance met requirements. | |
| Thermal Spread Test | Performance similar to or better than the predicate device. Controlled thermal spread to limit collateral tissue damage. | All test results demonstrated safety and performance met requirements. | |
| Mechanical Performance (Comparative) | Dropping Test | Device integrity and functionality maintained after dropping test, similar to the predicate device. | All test results demonstrated safety and performance met requirements. |
| Pulling Test | Device components (e.g., electrode tip attachment to insulation) maintain integrity under specified pulling forces, similar to the predicate device, ensuring safe use and preventing accidental detachment during a procedure. | All test results demonstrated safety and performance met requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of devices tested for arcing, charring, dropping, etc.). It generally states that "A series of preclinical physical, mechanical and biocompatibility tests were performed" and that "The Performance Tests were conducted on the subject device and the predicate device."
- Test Set Description: The test set for performance was a comparative study, meaning both the subject device (ACE Monopolar Attachment) and a predicate device (GEIGER Disposable Electrosurgical Electrode) were tested for
Ex vivoand Mechanical performance. - Data Provenance: The tests were "in vitro and in vivo" for biocompatibility, and "ex vivo" for performance. The location of testing is not explicitly mentioned, but the submitter "BioEconeer Inc." is based in Cupertino, CA, U.S.A., implying the testing was likely conducted in a controlled laboratory environment. The tests were retrospective in the sense that they were conducted to secure premarket clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the given document. The non-clinical tests described are primarily objective physical, mechanical, and biological evaluations based on established standards, rather than subjective expert interpretation of output. Therefore, "ground truth" as typically defined for clinical or diagnostic studies (e.g., expert interpretation of images) is not directly applicable here. The "ground truth" is defined by the passing criteria of the international and national standards or the comparative performance against the predicate device.
4. Adjudication Method for the Test Set
This information is not provided and is generally not applicable for the type of non-clinical bench and lab testing described. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving subjective human assessment (e.g., reading medical images) to resolve discrepancies in expert interpretation. For physical, mechanical, and biological tests, objective measurements and adherence to specified test protocols determine the outcome.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (often AI-assisted) that involve human readers interpreting data. The ACE Monopolar Attachment is an electrosurgical accessory, not a diagnostic device, and its evaluation focuses on its physical, mechanical, and biological performance, as well as its functional equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the ACE Monopolar Attachment is a physical medical accessory, not an algorithm or AI-driven system.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established through:
- Compliance with published International and National Standards: For biocompatibility (ISO 10993 series), electrical safety (IEC 60601 series), sterilization (ISO 11137-2), and material properties (ASTM D7334-08). The acceptance criteria are the requirements defined within these standards.
- Comparative Performance against a Predicate Device: For ex vivo tests (Arcing, Charring, Thermal Spread) and mechanical tests (Dropping, Pulling), the subject device's performance was evaluated relative to the legally marketed predicate device (GEIGER Disposable Electrosurgical Electrode). The "ground truth" here is that its performance must be "similar to or better than" the predicate device, demonstrating substantial equivalence and not raising new safety or effectiveness concerns.
8. The Sample Size for the Training Set
This question is not applicable. The ACE Monopolar Attachment is a physical device, not an AI or machine learning model that requires a "training set" for algorithm development.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8.
§ 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.