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The Electrode Pad is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

Electrode Pad is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of Electrode Pad is first transmitted via the snap button or lead wire then transmitted to the conductive gel which is adhered to patient skin.

Electrode Pad is composed of a top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, and a carrier liner. The carrier liner is made of PET (polyethylene terephthalate).

Electrode Pad is non-sterile and intended for single adult patient multiple application use. The electrode pad has various shapes and sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Electrode Pad (K241512), focusing on the requested information.

It's important to note that the provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for an AI-powered medical device. Therefore, much of the requested information, particularly concerning AI device performance metrics, human reader studies, and detailed ground truth establishment for a test or training set, is not present in this type of document because the device is a simple "Electrode Pad" and not an AI-enabled diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document describes performance testing for a non-AI hardware device (an electrode pad). Therefore, the concept of a "test set" in the context of machine learning, with associated data provenance, is not applicable here. The tests conducted are non-clinical, laboratory-based tests on the physical device components and batches of manufactured electrodes. The document does not specify general "sample sizes" for all tests, but implies testing was sufficient to meet standard requirements. The provenance of the data is from the manufacturer's internal testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As this is a physical medical device, not an AI diagnostic tool, there is no "ground truth" derived from expert interpretation for a test set. Acceptance is based on meeting technical specifications and international standards.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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 device is an electrode pad, not an AI system. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical electrode pad, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by:

• International Standards: Adherence to standards like ISO 10993 series for biocompatibility, ASTM F1980-16 for accelerated aging, and AAMI/ANSI ES 60601-1 / IEC 60601-2-2 for electrical safety and impedance.
• Predicate Device Specifications: Demonstrating performance within ranges or equivalent to a legally marketed predicate device (K182111 DL Adhesive Electrode) for key parameters such as impedance and adhesion.
• Design Specifications: The device met its own design specifications.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device. The concept of a "training set" is irrelevant in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/machine learning device and therefore has no "training set" or corresponding ground truth establishment.

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This device is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators.

Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.

The device is intended to be used as a 24-month reusable patient return electrode for patients age 12 years and older. The Universal (model 0845) and Universal Plus (model 0847) have a single cord that connects to one generator. The Universal Dual (model 0846) and Universal Plus Dual (model 0848) have two cords that can connect to one or two generators.

The Mega Soft Universal Patient Return Electrodes (ie. Mega Soft) are constructed of a layer of conductive material strain-relieved between an insulative polymer gel, and sealed between two layers of a thermal polyurethane plastic film. The thermal polyurethane plastic film and the contained polymer gel enveloping the conductive material is compressable but does not laterally move under pressure. The polymer acts as a dielectric protection and is encapsulated by a layer of urethane film. The dielectric protection remains between the thermal polyurethane plastic film and the conductive layer irrespective of pressure.

A two-conductor cable connects the conductive layer of the device to a two-conductor DetachaCable™. The DetachaCable is connected to a standard monopolar ESU. The DetachaCable is available in a variety of configurations and lengths, designed to be compatible with the various compatible generators available on the market and was cleared under K080741 on 16 December 2008.

The provided document is a 510(k) summary for the Megadyne Patient Return Electrode Pads (models 0845, 0846, 0847, 0848). This document describes the device, its intended use, comparison to predicate devices, and performance testing. However, it does not contain information about acceptance criteria, detailed study designs, sample sizes for test or training sets, ground truth establishment, or expert involvement as typically required for AI/ML device evaluations.

The reason for this is that the Megadyne Patient Return Electrode Pad is a physical medical device (an electrosurgical accessory), not a software or AI/ML algorithm. The performance data provided is related to electrical and mechanical properties, not diagnostic accuracy or AI performance metrics.

Therefore, I cannot fulfill your request for detailed information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies for an AI device. This information is not relevant to the described device.

Instead, I can extract the acceptance criteria and study information that is applicable to this physical medical device:

Acceptance Criteria and Reported Device Performance (Physical Device)

Study Information (Physical Device Testing):

1. Sample size used for the test set and the data provenance: Not explicitly stated regarding specific numerical samples for each test parameter. The studies were bench performance testing and acute animal studies. Provenance typically refers to the origin of data; for bench testing, it's specific laboratory conditions, and for animal studies, it's a controlled animal model.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are engineering and animal model tests, not clinical evaluations requiring expert interpretation for ground truth. Compliance standards (IEC 60601 series) define the "ground truth" for success.
3. Adjudication method: Not applicable. This is not a clinical study involving human readers or AI output requiring adjudication.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable for this physical device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable for this physical device.
6. The type of ground truth used: For bench performance, the ground truth is defined by the technical specifications and safety standards (e.g., IEC 60601 series) that dictate acceptable electrical resistance, mechanical integrity, and cleaning effectiveness. For animal studies, the ground truth is the physiological response and absence of adverse events in the animal model, as per the standard (IEC 60601-2-2).
7. The sample size for the training set: Not applicable; there is no training set as this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

Summary from the document for this device:

The document primarily focuses on demonstrating substantial equivalence of the new Megadyne Patient Return Electrode Pads to a predicate device (Mega Soft Universal Patient Return Electrode, K133726 model 0845) based on identical technological characteristics (indications, materials, operational principles, packaging, shelf-life) and performance data from bench and acute animal studies. The differences identified (intended population, pad thickness, dual cord option, model number) were assessed through these tests to ensure they do not raise new questions of safety and effectiveness. The performance testing confirmed compliance with relevant IEC standards.

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OKLand Patient Return Electrode Pad is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU) or generators in monopolar surgery.

This device is restricted to use with isolated monopolar electrosurgical generators, not intended for radio frequency ablation.

The device consists of a layer of conductive Copper-Nickel fibbers-coated polyester mesh, encased in a viscoelastic and dielectric polyurethane (PU) gel. These two materials are wrapped and sealed with PU membrane. A (or two) BVR lead (s) is attached outside of the pad, one side of the lead is connected to the conductive mesh, and the other side of the lead is assembled with different kinds of connectors.

This device should be operated by qualified healthcare personnel and is intended to be used for patients with a body weight no less than 0.35 kg (0.81b). , with no upper body weight limit.

The provided text is a 510(k) summary for the OKLand Patient Return Electrode Pad. Within this document, the manufacturer demonstrates the device's substantial equivalence to predicate devices, focusing on technological characteristics and non-clinical performance data.

However, the provided text does not contain information about acceptance criteria or a study that uses a test set, expert readers, or ground truth for evaluating performance metrics like sensitivity, specificity, accuracy, or AUC. Instead, the performance data presented is related to biocompatibility, electrical safety and compatibility, and bench performance tests, which are typical for an electrosurgical accessory.

Specifically, the document states:

• "No clinical data is presented in this submission" (page 5, "Clinical Studies" section). This indicates that the type of study typically involving human-in-the-loop performance, multi-reader multi-case studies, or direct clinical outcomes to establish AI performance metrics is not applicable here.
• The "Bench Performance Test" section mentions that "Performance testing was conducted as recommended by the FDA guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery to support substantial equivalence to the predicate device." It concludes that "The results demonstrated the subject device can perform the intended use as safe and effective as the predicate device." This refers to engineering and lab-based testing, not clinical performance or AI algorithm validation with a test set and ground truth.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device meets those criteria using expert readers and ground truth data, as the nature of this device (an electrosurgical return electrode pad) and the provided 510(k) summary do not involve such a study design. The device approval relies on demonstrating equivalence through non-clinical testing for safety and performance (e.g., electrical safety, biocompatibility, and bench testing).

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The samaritan® Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation.

The samaritan® Pediatric-Pak is specially designed for use only with the samaritan® PAD (Model SAM 300P). This product allows the samaritan PAD to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.

The samaritan® Pediatric-Pak is intended as a direct replacement for the Adult Pad-Pak but Tor use with children between the ages of 1 year and 8 years or 55 pounds (25 kilograms) in weight. The clectrodes and lead wires are identical in materials and construction to those used in the adult samaritan® Pad-Pak, cleared under K042088 for use with patient above 8 years old or 55 pounds in weight. They are use in the same way as with the adult samaritan® PAD-Pak. The energy reduction required for children is accomplished by means of purely resistive attenuation in concert with a separate energy look-up table incorporated into the PAD embedded software. The Pediatric-Pak incorporates a magnet which is sensed, on insertion, by the host PAD which automatically prompts the user "child patient" and, while the Pediatric-Pak is in position, uses the Pediatric look-up table to define the voltage and duration of the therapeutic shock commensurate with the required energy deliverable (50 Joules), taking into account the attenuation by the resistors incorporated into the Pediatric-Pak. The electrodes are sealed inside poly/foil. peelable pouches of the same materials and construction as the current adult PAD-Pak electrodes. The purely resistive attenuator circuit board is enclosed inside the Pediatric-Pak requiring a slightly lengthened version of the current PAD-Pak molded housing. A different color scheme (pink) is used to help differentiate the samaritan Pediatric-Pak from their adult counterparts. The product labeling for the samaritan® Pediatric-Pak indicates a "anterior/posterior" placement to be preferred, while allowing for the typical adult "apex/sternum" placement under some circumstances.

Here's an analysis of the provided text regarding the acceptance criteria and study for the samaritan® Pediatric-Pak (Model SPP 351).

Disclaimer: The provided text is a 510(k) summary, which is a regulatory document. It summarizes the findings and conclusions of studies and does not typically contain exhaustive details about the methodologies of those studies. Therefore, some information requested may not be explicitly present.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria and a detailed performance table for the new device's efficacy. The core acceptance criteria appear to be implicit in the comparison to the predicate device's established safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for the "pediatric heart rhythm database" used for validation. The summary only mentions "validation against a pediatric heart rhythm database."
• Data Provenance: Not explicitly stated (e.g., country of origin). The data is described as a "pediatric heart rhythm database," implying it contains recorded heart rhythms from pediatric patients.
• Retrospective or Prospective: Not explicitly stated, however, the phrase "validation against a pediatric heart rhythm database" strongly suggests a retrospective analysis of existing recorded data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of a "heart rhythm database," it's likely that established medical criteria or a consensus of cardiologists previously annotated the rhythms within the database, but this is not detailed in the summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No, an MRMC comparative effectiveness study is not mentioned in the provided 510(k) summary. The comparison is between the new device's technology and performance (as evaluated via bench testing and database validation) against a predicate device, not typically involving human readers.
• Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable, as no MRMC study involving human readers and AI assistance was reported.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Standalone Study Done: Yes, a standalone evaluation of the device's performance was conducted. The summary states: "The results of bench testing and validation against a pediatric heart rhythm database indicates that the HeartSine Technologies samaritan Pediatric-Pak is substantially equivalent in safety and effectiveness to the predicate devices." This implies that the device's ability to appropriately identify and deliver a shock (or withhold if not required, though the focus is on reduced energy delivery) was evaluated without a human-in-the-loop, against pre-recorded rhythms.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the standalone performance was based on a "pediatric heart rhythm database." This implies that the rhythms in the database were classified according to their clinical significance (e.g., shockable vs. non-shockable rhythms for pediatric patients, or specific energy requirements for different rhythm types). This would typically be established by expert medical consensus or established diagnostic criteria.

8. Sample Size for the Training Set

• Sample Size: The provided 510(k) summary does not mention a training set or its sample size. This device appears to rely on a fixed resistive attenuation and a "pediatric look-up table" for energy delivery, rather than an adaptive algorithm that would typically require a training set. The "pediatric heart rhythm database" was used for validation, not training.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Established: Not applicable, as no training set is mentioned for an adaptive algorithm. The device's operation is described as a "purely resistive attenuation in concert with a separate energy look-up table incorporated into the PAD embedded software," indicating a deterministic rather than machine-learning-based approach requiring a training set. The "pediatric look-up table" itself would have been developed based on established medical guidelines for pediatric defibrillation.

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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

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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.

• Prevent patient/user burns
• Return electrode monitoring (

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