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510(k) Data Aggregation
(26 days)
The Mega 2000 Soft Dual Cord Patient Return Electrode Pad is to be used as a general purpose return electrode for one or two electrosurgical generators 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 Dual Cord is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two asymmetric layers of a viscoelastic polymer. (The top layer of polymer is thinner than the bottom layer.) The polymer is encapsulated by a layer of urethane film. Two cables connect the conductive layer of the device to two DetachaCables". The DetachaCable(s) are connected to a standard monopolar electrosurgical unit (ESU). The device cables are insulated and 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 patient torso. Pad size is 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".
The provided text describes a 510(k) premarket notification for the "Mega 2000 Soft Dual Cord Patient Return Electrode Pad." This document focuses on demonstrating substantial equivalence to a predicate device and safety and performance testing for a medical device that assists in electrosurgery. It is not an AI/ML device, so many of the requested categories (e.g., training set, MRMC study, ground truth for training set) are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum Safe Temperature Rise (ANSI/AAMI HF-18, paragraph 4.2.3.1) | "The device is well within the requirements of the standard." (Tested with human volunteers and two electrosurgical generators, with and without a single linen layer between the pad and the patient). Infrared camera used to record temperature changes. |
| Electrode Contact Impedance (Minimum Capacitance Requirement) | "Conformance with the minimum capacitance requirement was demonstrated through bench testing. Device capacitance was evaluated under several different test setups intended to simulate clinical use." |
| Current Limiting (<100 mA/cm²) | "This device is designed to be current limiting (<100 mA/cm²) so as to prevent the patient from getting return electrode site burns. This current limiting attribute is achieved by selecting materials with high impedance per area." (This is a design characteristic, not explicitly a test result for the Dual Cord device, though implied by materials selection and overall safety claims). |
| Similar Technological Characteristics to Predicate Device | "The technological characteristics of the proposed device are similar to the predicate device. The only difference is the addition of a second cord... Other technological characteristics (capacitive coupling and pressure reduction) are identical to the predicate device." |
2. Sample Size for Test Set and Data Provenance
- Maximum Safe Temperature Rise: "human volunteers" were used. The exact number is not specified in the abstract, but the protocol document (X1150075-10 revision 3) would likely contain this detail.
- Electrode Contact Impedance: Bench testing was performed; no human subjects or patient data.
- Data Provenance: The testing was conducted by Megadyne Medical Products, Inc. in Draper, UT, USA. This suggests the data is from the USA. It is prospective testing designed to evaluate the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a medical accessory, and the "ground truth" is based on objective measurements against engineering and safety standards, not expert interpretation of clinical data in the same way an AI diagnostic tool would be. The "ground truth" is defined by the ANSI/AAMI HF-18 standard.
4. Adjudication Method for the Test Set
Not applicable. Testing involves direct measurement and comparison to an established engineering standard, not subjective interpretations requiring adjudication.
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 not an AI/ML device, nor is it a diagnostic device that involves human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical electrosurgical accessory. Its performance is evaluated through physical and electrical testing.
7. The Type of Ground Truth Used
The "ground truth" is defined by the ANSI/AAMI HF 18-2001, Electrosurgical Devices standard. This standard sets objective performance criteria for maximum safe temperature rise and minimum capacitance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth for the training set" in the context of machine learning. The device's performance is tested directly against engineering standards.
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(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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(87 days)
The MegaDyne Mega 2000™ reusable patient return electrode is to be used as a general purpose return electrode in any electrosurgical application in which a standard monopolar electrosurgical generator is used.
The MegaDyne Mega 2000™ reusable patient return electrode is constructed of a layer of conductive material, laminated between two sheets of dielectric plastic material. A two conductor cable to connect the device to a standard monopolar electrosurgical unit (ESU) is connected to the conductive layer of the electrode. This cable is insulated and strain-relieved well inside the device to prevent possible patient or user burns. The electrode is approximately 20'' x 36". This size is large enough to extend at least half the length and full width of the typical patient torso. The device is not intended to be attached to the patient. A clear plastic sheath is placed over the device. This sheath, which is replaced at a minimum each day, provides a second layer of dielectric protection.
This document is a 510(k) summary for the MegaDyne Mega 2000™ reusable patient return electrode. It outlines the device's description, intended use, and substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Safety: Prevention of Patient Burns (low current density) | The current density of capacitively-coupled current flow is designed to be less than 100 mA per square inch at an ESU output of 700 mA rms. This low current density prevents the patient from getting return electrode site burns. |
| Functionality: Sufficient Current Flow for Electrosurgery | The large capacitive contact area between the electrode and the patient allows for enough current flow for electrosurgery to be performed at the surgical site. |
| Conformance to Standards (ANSI/AAMI HF 18-1993): Minimum Capacitance Requirement | Conformance to the minimum capacitance requirement of the ANSI / AAMI HF 18 standard is no longer claimed for the Mega 2000™. (This is a change from the predicate device). |
| Conformance to Standards (ANSI/AAMI HF 18-1993): Other applicable sections | With the exception of the requirement for minimum capacitance, the device conforms with all applicable sections of ANSI / AAMI HF 18-1993. |
| Sheath Replacement Frequency | The electrode sheath is to be replaced on at least a daily basis (as a maximum interval between changes). |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a test set in the conventional sense for a medical imaging or diagnostic device. The evaluation presented here is for an electrosurgical patient return electrode, focusing on electrical safety and functional characteristics, primarily through design specifications and conformance to standards. Therefore, information about a "test set" sample size or data provenance (country, retrospective/prospective) for a clinical performance study is not applicable to this submission. The "testing" appears to be engineering design and validation focused on achieving specific electrical and safety parameters.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As noted above, this submission does not describe a clinical study involving experts establishing ground truth for a test set. The safety and functional claims are based on engineering design, specified current densities, and expected adherence to industry standards.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as no clinical test set requiring expert adjudication is described.
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 typically performed for diagnostic devices where human readers interpret results, and the document describes an electrosurgical patient return electrode.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Not applicable. This device is an electrosurgical patient return electrode, not an algorithm or AI system. Its function is physical and electrical contact for current return during electrosurgery, not the standalone processing of data or images.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on:
- Engineering Design Specifications: Such as designing for a current density of less than 100 mA per square inch.
- Conformance to Industry Standards: Specifically, ANSI / AAMI HF 18-1993 for electrosurgical devices, with the exception of the minimum capacitance requirement.
- Predicate Device Equivalence: The primary assertion for clearance is that the device is substantially equivalent to a legally marketed predicate device (K972273), implying that the predicate device's established safety and effectiveness serve as the "ground truth" for the new device's performance.
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. This is not an AI/ML device that requires a training set.
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