(62 days)
The ProCam Medical Pediatric Dispersive Electrode is indicated for use in monopolar electrosurgical applications as a non-sterile, disposable device, for single patient use, only. It is intended to disperse the current as it is removed from the patient during the electrosurgical process. By connecting to the electrosurgical generator, via the pre-attached cable or re-useable cable, the circuit is completed causing successful cutting or coagulation in the patient. This electrode is intended for use in electrosurgery on pediatric patients weighing 25 lbs. or less and with the generator power settings less than 150 watts. The Pediatric Dispersive Electrode is not indicated for use for high-powered procedures such as transurethral resection (TUR). The device will work with any standard generator.
The function of the Ludlow Technical Products pediatric ESD electrodes is to complete the electrosurgical circuit between the patient, the active electrode, and the generator. The products are the same in their construction using conductive adhesive hydrogel along with a foil/polyester conductor plate and a foam insulation backing.
This document is a 510(k) premarket notification for a medical device submitted to the FDA, not a study report for an AI/ML device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop studies for an AI/ML device.
This submission is for an Electrosurgical Dispersive Electrode, a physical medical device. The "acceptance criteria" and "device performance" in this context refer to engineering and safety standards for this hardware, not algorithmic performance.
Here's what can be extracted from the document based on the device type:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ANSI/AAMI HF 18-1993 Section 4.2.3 and 4.2.5) | Reported Device Performance (Ludlow Technical Products Pediatric ESD Electrodes) |
|---|---|
| Section 4.2.3: Dispersive Electrodes | |
| - Maximum Safe Temperature Rise | Met the requirements of the standard |
| - Electrode Contact Impedance | Met the requirements of the standard |
| - Electrode Adherence | Met the requirements of the standard |
| - Packaging/Shelf life | Met the requirements of the standard |
| Section 4.2.5: Operating Conditions | Met the requirements of the standard |
| Biological Evaluation (ISO 10993 Part 1) | Tested successfully |
2. Sample size used for the test set and the data provenance: Not applicable. This is for a physical device, not an AI/ML model. Testing involved compliance with engineering standards on a physical product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model doesn't apply here. Compliance was assessed against established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a diagnostic or prognostic AI/ML device requiring human adjudication of results. Compliance was determined by meeting predefined technical specifications in standards.
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 physical electrosurgical dispersive electrode, not an AI/ML diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This section pertains to AI/ML algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/ML model. For this device, the "ground truth" or standard for safety and effectiveness was adherence to published industry standards such as ANSI/AAMI HF 18-1993 and ISO 10993.
8. The sample size for the training set: Not applicable. This section pertains to AI/ML models.
9. How the ground truth for the training set was established: Not applicable. This section pertains to AI/ML models.
§ 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.