(65 days)
The Aaron Electrosurgical Handcontrol Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided sterile and is intended for limited reuse.
The Aaron Electrosurgical Handcontrol Pencil is a sterile, limited reuse electrosurgical handcontrol pencil. It utilizes an insert-molded body that encapsulates a printed circuit board used to sense either CUT or COAG button activation thus activating an electrosurgical generator. It is an accessory to an electrosurgical generator.
The provided text is a 510(k) summary for the Aaron Electrosurgical Handcontrol Pencil. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through a detailed clinical or performance study with defined metrics. Therefore, many of the requested elements (like detailed acceptance criteria and a structured study proving device performance against those criteria, or information on AI/ML studies) are not present in this document.
However, I can extract information related to the demonstration of substantial equivalence and what could be inferred as "performance" in this context.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a basic electrosurgical pencil, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is that it functions identically or equivalently to these predicates.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Design: Identical or equivalent to predicate devices. | Identical to Medtrex Encore Electrosurgical Handcontrol Pencil (K970039). Substantially equivalent to Valleylab Model E2502B (K914400) and Aaron Medical Industries, Inc Model A801 (K955681) in design. |
| Operation: Identical or equivalent to predicate devices. | Substantially equivalent to predicates in operation. It utilizes an insert-molded body encapsulating a PCB to sense CUT/COAG button activation for generator activation. |
| Intended Use: Identical or equivalent to predicate devices. | Intended for general electrosurgical applications (cutting and coagulating during surgical procedures), identical to predicate devices. |
| Materials: Identical or equivalent to predicate devices. | Substantially equivalent to predicates in materials. |
| Components: Identical or equivalent to predicate devices. | Substantially equivalent to predicates in components. |
| Performance Claims: Identical or equivalent to predicate devices. | Testing indicates substantial equivalence in performance claims. |
| Safety: No new hazards presented compared to predicate devices. | Hazard analysis evaluations indicated no new hazards compared to predicate devices. |
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 provide details on specific sample sizes for a test set in the traditional sense of a clinical or performance study. The "testing" mentioned likely refers to engineering verification and validation testing to ensure the device performs as expected and meets safety standards, rather than a statistical sample involving human subjects or a large dataset.
- Sample Size: Not specified.
- Data Provenance: Not specified, but generally, such testing would be conducted internally by the manufacturer (Aaron Medical Industries, Inc.) in the USA.
- Retrospective/Prospective: Not applicable in the context of comparative equivalence for this type of device.
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 applicable to a 510(k) submission for an electrosurgical handcontrol pencil, as the "ground truth" is established by the functional performance and safety compliance of the device itself and its comparison to legally marketed predicate devices, not through expert consensus on medical images or outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The evaluation of this device is based on technical specifications, functional testing, and comparison to predicate devices, not on expert adjudication of a test set.
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 device is an electrosurgical handcontrol pencil, not an AI/ML-driven diagnostic or image analysis device that would involve human readers or cases in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The device's performance is measured against its ability to function safely and effectively in a manner substantially equivalent to these predicates. This relies on:
- Engineering specifications and testing (functional, electrical safety, biocompatibility, sterilization validation).
- Demonstration that its design, materials, and operation are comparable to legally marketed devices.
- Hazard analysis to ensure no new hazards are introduced.
8. The sample size for the training set
Not applicable. This device does not involve AI or machine learning, 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 this device.
§ 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.