(29 days)
The Aaron 1200 High Frequency Electrosurgical Generator is intended for the removal and destruction of human tissue and the coagulation of bleeders. Modes of operation for this device include: cut, blend, coagulation, bipolar and fulguration. The Handcontrol pencil is an integral component which is used in conjunction with the Aaron 1200.
The Aaron 1200 is intended to be used for all low powered electrosury: cut, blend, coagulation, fulguration and bipolar procedures.
The Aaron 1200 High Frequency Electrosurgical Generator is a non-serile, reusable electrosurgical generator which is designed to generate high frequencies (RF) of high voltage and low amperage current.
This document is a 510(k) submission for an electrosurgical generator, which falls under the category of traditional medical device clearance, not an AI/ML-driven device. Therefore, many of the requested criteria, such as acceptance criteria based on AI performance metrics (sensitivity, specificity), sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative criteria in the way an AI/ML study would.
Here's an attempt to address the relevant points, indicating where the information is not applicable (N/A) for this type of submission:
Acceptance Criteria and Device Performance Study for Aaron 1200 High Frequency Electrosurgical Generator
The Aaron 1200 High Frequency Electrosurgical Generator's acceptance criteria and "study" are based on demonstrating substantial equivalence to legally marketed predicate devices, as per the 510(k) regulatory pathway. This involves comparing design, operation, intended use, materials, energy source, components, method of preparation, and performance claims to predicate devices, and demonstrating that no new safety or effectiveness concerns are raised.
The "acceptance criteria" can be inferred as the successful demonstration of this substantial equivalence, which includes safety testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance/Conclusion |
|---|---|
| Substantial Equivalence: Device is equivalent in design, operation, intended use, materials, energy source, components, and method of preparation to identified predicate devices. | The Aaron 1200 High Frequency Electrosurgical Generator is "substantially equivalent to the Aaron 800 High Frequency Desiccator (K955681) and ValleyLab SSE4 Electrosurgical Generator (K823924) in design, operation, intended use, materials, energy source, components, method of preparation and performance claims." |
| Performance Equivalence: Device performance claims are equivalent to predicate devices. | "Testing which has been performed on the Aaron 1200 High Frequency Electrosurgical Generator indicates that the devices are substantially equivalent in their performance and method of operation." |
| Safety: No new hazards are presented compared to predicate devices. | "Hazard analysis evaluations were performed on the Aaron 1200 High Frequency Electrosurgical Generator. Test results indicated that there are no new hazards presented with the use of the Aaron 1200 High Frequency Electrosurgical Generator as compared with the predicate devices." |
| Compliance with General Controls: (Implicit requirement for all medical devices). | The FDA letter states that the marketing approval is "subject to the general controls provisions of the Act," including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of an AI/ML study. The "testing" referred to in the summary would typically involve engineering verification and validation tests (bench testing) on a limited number of units of the device itself (e.g., electrical safety tests, power output measurements, functional tests) to confirm it meets its specifications and performs comparably to predicates. The document does not specify a "sample size" for such testing.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "data" here refers to the engineering test results and comparisons to predicate device specifications, not patient data or clinical study data in the AI/ML sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. "Ground truth" in the AI/ML sense (e.g., expert consensus on medical images) is not relevant for this type of electrosurgical generator submission. The "truth" is established by engineering specifications, performance standards, and comparison to the known characteristics of predicate devices.
4. Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human experts in AI/ML performance evaluation. This device relies on objective engineering tests and comparisons where "adjudication" would involve standard engineering practice or regulatory review criteria.
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 is a hardware medical device (an electrosurgical generator), not an AI/ML diagnostic or assistive tool. There are no "human readers" or "AI assistance" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device integrates into a human-controlled surgical procedure. There is no "algorithm only" performance to be evaluated independently in the AI/ML sense. The device performs its functions when operated by a human.
7. The type of ground truth used
- Engineering specifications and regulatory standards for electrosurgical generators, and the known performance characteristics of the predicate devices. The "ground truth" for showing substantial equivalence would be that the device meets its own specifications, consistently delivers expected outputs (e.g., power, current characteristics), and operates safely in a manner consistent with the predicate devices, as verified by technical testing.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/ML model is involved.
§ 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.