(438 days)
This disposable electrosurgical return electrode with conductive adhesive gel is used in monopolar electrosurgical procedures for adult patients.
The Abbott Medical Grounding Pad is a dispersive electrode that is designed for use in monopolar electrosurgical procedures in adult patients. It is a single-use, non-sterile and disposable device. The Abbott Medical Grounding Pad is compatible with the lonicRF™ Generator and provides a path for radiofrequency (RF) energy produced at an RF electrode to return to the generator. The Abbott Medical Grounding Pad consists of a grounding pad component (also called a neutral electrode, dispersive electrode or return electrode) and an attached cable. The grounding pad component includes a conductive aluminum foil layer which acts as the neutral electrode that connects back to the generator. The aluminum foil layer is covered with a conductive hydrogel adhesive which is covered with a protective liner while it is packaged.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Abbott Medical Grounding Pad:
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against specific acceptance criteria in a clinical study. Therefore, some of the requested information (like effect size in MRMC studies, standalone algorithm performance, training set details) is not applicable or present in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical or percentage format typically associated with AI/software performance. Instead, it describes various non-clinical tests designed to show the device meets its performance requirements and specifications, thereby demonstrating substantial equivalence to the predicate.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | hydrogel material with PET liner meets ISO 10993-1 requirements for cytotoxicity, sensitization, and irritation | PASS: The hydrogel material with PET liner passed all testing for cytotoxicity, sensitization, and irritation. Differences in adhesive liner material do not raise new questions of safety and effectiveness. |
| EMC and Electrical Product Safety Testing | Device meets relevant requirements of IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 | PASS: The devices met all relevant requirements, confirming compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. |
| Grounding Pad Cable Tensile Strength | Tensile strength of cable attachment to grounding pad $\ge$ 20N | PASS: The devices met the tensile strength requirements of $\ge$ 20N. |
| Shelf Life and Operating Environment Testing | Device meets performance specifications within the range of operating environment and at end of 2-year shelf life | PASS: The devices met all requirements while within the range of the operating environment and at the end of the 2-year shelf life. |
| Usability | Device is usable when operated as intended | PASS: The devices met all relevant requirements and confirm that the device is usable when operated as intended. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for each specific test as per standards like ISO 10993-1 or IEC 60601 series. The testing involved physical devices (Abbott Medical Grounding Pad and some leveraging the predicate device).
- Data Provenance: The tests were non-clinical, involving laboratory testing of the physical device components and assembled device. There is no mention of country of origin for data as it's not a clinical data study. The nature of the studies is prospective in the sense that controlled tests were performed on the device to assess its compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as this is a non-clinical device submission. The "ground truth" for the non-clinical tests is established by industry standards (e.g., ISO 10993-1, IEC 60601 series) or the device's own internal specifications. Expert consensus or clinical diagnosis is not relevant here.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human interpretation or decision-making being assessed, only objective physical, electrical, and biological performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the cognitive performance of human readers, sometimes with AI assistance, which is outside the scope of this medical device (a grounding pad).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This device is a passive electrosurgical component (grounding pad), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these non-clinical tests refers to the established requirements and standards:
- Industry Standards: ISO 10993-1 for biocompatibility, IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 for electrical safety and electromagnetic compatibility.
- Device Specifications: Specific values like the $\ge$ 20N for cable tensile strength, and parameters for shelf life and operating environment.
- Predicate Device Equivalence: The primary "ground truth" for the overall submission is demonstrating that the subject device is substantially equivalent to the predicate device and that its differences do not raise new questions of safety and effectiveness.
8. The Sample Size for the Training Set
This information is not applicable as there is no AI algorithm being developed or "trained."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no AI algorithm or training set.
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).