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510(k) Data Aggregation
(14 days)
The Mega 2000 Soft Patient Return Electrode Pad is to be used as a general purpose return electrode and/or a pressure reduction pad in any surgical application. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators.
The Mega 2000 Soft Patient Return Electrode Pad is constructed of a layer of viscoelastic polymer called Akton®, sealed between two asymmetric layers of urethane material, and a conductive material strain-relieved inside the device. (The top layer of polymer is thinner than the bottom layer, approximately 1.0000m layer.) The Akton polymer is encapsulated by a layer of urethane. A two conductor DetachaCable™ connects the conductive layer of the device to a standard electrosurgical generator. The DetachaCable is connected to a strain-relieved well inside the device to prevent patient or user burns. The device is large enough to extend at least the length and width of a typical operating room table, approximately 20" x 46" x ½". In use, this device will lay on an operating room table with the patient lying on top, on the side labeled "patient side".
Here's an analysis of the provided text regarding the acceptance criteria and study for the Mega 2000 Soft Patient Return Electrode Pad (K021077).
Important Note: The provided 510(k) summary (K021077) for the Mega 2000 Soft Patient Return Electrode Pad heavily relies on demonstrating equivalence to predicate devices rather than independent performance testing against strict acceptance criteria. This is typical for Class II devices seeking 510(k) clearance where substantial equivalence is the primary pathway. Therefore, the information you're looking for regarding explicit acceptance criteria and a detailed study proving performance against them is largely absent in this specific document. The "study" mentioned is primarily a series of safety and performance tests to ensure the device performs as intended and is equivalent to the predicate, rather than a clinical trial with statistical endpoints.
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned above, explicit numerical acceptance criteria, as might be found in a clinical trial to prove a specific efficacy, are not detailed in this 510(k) summary. The "acceptance criteria" here are largely implied by compliance with standards and demonstration of equivalent functional performance and safety to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrosurgical Safety: - Prevent patient/user burns - Return electrode monitoring (<100 nW/cm²) - High impedance per area | - Conductive layer connected to a "strain-relieved well" inside the device to prevent patient or user burns. - Designed for current monitoring (<100 nW/cm²) to prevent patient burns. - Achieved by selecting materials with high impedance per area. |
| Contact Area/Current Dispersion: - Large enough contact area to lower total current density | - Large contact area between electrode and patient lowers total current density. - Device dimensions: approximately 20" x 46" x ½". - Large enough to extend at least the length and width of a typical patient. |
| Pressure Reduction & Skin Protection: - Provides load distribution - Reduces pressure - Decreases shear and friction - Maintains dielectric protection | - Use of Akton® as a dielectric layer and cushioning agent provides load distribution and reduces pressure. - Softness of material decreases shear and friction, which are chief causes of pressure sores. - Akton® polymer compresses but does not laterally move under pressure, thus maintaining dielectric protection. |
| Compliance with Standards: - AAMI HF-18/2001 (Electrosurgical Devices - Safety Guidelines) | - "This device conforms to the applicable sections of AAMI HF-18/2001." |
| Technological Equivalence to Predicate: - Identity of technological characteristics to predicate devices (Mega2000® Reusable Patient Return Electrode (K982826) and Action® Operating Table Pad (K801694)) | - "The technological characteristics of the proposed device are identical to the predicate devices." (This is a key claim for 510(k) clearance and implies that if the predicate devices meet safety and performance, so does the new device). The predicate Mega2000 used a viscoelastic polymer (Akton), as does the new device. The predicate Action® Operating Table Pad is also made of Akton® and offers similar pressure reduction properties. The key distinction acknowledged is the added electrosurgical function to the pressure reduction pad concept. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the sense of a clinical trial patient cohort. The "testing" appears to be largely bench testing and verification against engineering specifications and standards.
- Sample Size: Not applicable in the context of a patient-based test set described. Any material or device-level functional tests would have their own sample sizes (e.g., number of pads tested for impedance), but these are not specified in the summary.
- Data Provenance: Not applicable for a clinical test set. The data presented is from the manufacturer's internal testing and analysis for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Relevant to clinical trials or performance studies involving human assessment, this information is not applicable here as no such "test set" or human assessment of results to establish ground truth is described.
4. Adjudication Method for the Test Set
Not applicable, as no external adjudication of a clinical test set is described.
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 an electrosurgical patient return electrode pad, not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, "ground truth" relates to fundamental physical principles, material science, and engineering standards.
- Electrosurgical Safety: Ground truth is established by electrical engineering principles, heat transfer physics, and compliance with recognized safety standards (like AAMI HF-18/2001) that define safe current densities and impedance pathways to prevent burns.
- Pressure Reduction: Ground truth is established by biomechanical principles, material properties of the Akton® polymer, and clinical understanding of pressure sore prevention.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable. This device does not involve machine learning or a "training set."
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