(226 days)
The disposable grounding pad is an accessory for high-frequency surgery in monopolar applications. It is self-adhesive, ready-to-use, disposable, and single-patient-use.
Mecun disposable grounding pad has a cable and a neutral electrode, the electrode consists of a conductive adhesive area surrounded by a non-conductive border.
The neutral electrode is intended to be equipped with a compatible generator which has a CQM, loss of safe contact between the neutral electrode and the patient will result in an alarm.
The disposable grounding pad is a non-sterile, non-active conductor intended to be fastened to a patient and connected to a high frequency surgical equipment, to create a circuit for the return of electrical current to the generator after its emission to perform electrosurgery on the patient. It is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may or may not include a return cable(s). This medical device is intended for disposable and single-patient use.
The provided text describes the 510(k) premarket notification for a "Disposable Grounding Pad" (K231985). This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of the device's clinical performance against detailed acceptance criteria in the way one might see for a diagnostic AI device.
Therefore, the requested information elements related to "acceptance criteria," "reported device performance," "sample size," "ground truth," "expert qualifications," "adjudication method," "MRMC study," and "standalone performance" are not applicable in the context of this regulatory submission for a medical accessory like a disposable grounding pad.
Instead, the submission demonstrates adherence to recognized standards and verifies physical and electrical properties.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
Since this is not a performance study in the diagnostic sense, there isn't a direct "acceptance criteria" table for diagnostic accuracy. Instead, the device is evaluated against recognized standards and design requirements. The "performance data" section details compliance with these standards.
| Acceptance Criteria (Standards & Requirements) | Reported Device Performance (Compliance) |
|---|---|
| Biocompatibility (ISO 10993-1, -5, -10) | - Cytotoxicity testing conducted. |
- Intracutaneous Reactivity testing conducted.
- Skin Sensitization testing conducted.
Result: Passed, in accordance with ISO 10993-1, -5, -10. |
| Electrical Safety (IEC 60601-1: 2005 + A1:2012 + A2:2020) | Result: Complies with the standard. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2: 2014 + A1:2020) | Result: Complies with the standard. |
| Particular Requirements for HF Surgical Equipment Accessories (IEC 60601-2-2:2017) | Result: Complies with the standard. |
| Appearance and Size (Design Requirements) | Inspections performed on 3 lots (5 pieces each).
Result: Met design requirements. |
| Shelf-life | Validated by accelerated aging test. The difference (2 years for subject device vs. 3 years for predicate) does not raise new safety/effectiveness issues. |
2. Sample size used for the test set and the data provenance:
- Sample Size:
- Appearance and Size Inspection: 3 lots, 5 pieces per lot (total 15 units).
- Biocompatibility, Electrical Safety, EMC: The text does not specify the sample size for these tests, which typically involve a representative number of units to demonstrate compliance with the respective standards. The tests are for the device itself, not on patient data.
- Data Provenance: The tests are performed on the manufactured device itself, not on patient data. Thus, "country of origin of the data" and "retrospective or prospective" are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. The "ground truth" for this type of device (a passive accessory) is based on engineering specifications and compliance with recognized safety and performance standards. No experts were used to establish a "ground truth" in the clinical diagnostic sense. Compliance with standards is typically verified by testing laboratories or internal quality control.
4. Adjudication method for the test set:
This is not applicable. There was no need for adjudication as the device is not making a diagnostic claim or involving subjective interpretation. Performance is measured against objective engineering and biological safety 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:
This is not applicable. The device is a "Disposable Grounding Pad," an accessory for electrosurgery. It is not an AI diagnostic device, and therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a passive medical accessory, not an algorithm or software-driven device.
7. The type of ground truth used:
The "ground truth" is established by the recognized international and national standards (e.g., ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC) and the device's design specifications for physical properties.
8. The sample size for the training set:
This is not applicable. There is no training set as this is not an AI/machine learning product.
9. How the ground truth for the training set was established:
This is not applicable. There is no training set for this type of 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.