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The PadPro 2502 Sterile radiotransparent external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. Intended for use on adult patients.

When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).

The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand or model of defibrillation/pacing unit is being used. All PadPro products are Latex free.

The provided text describes a 510(k) premarket notification for the "PadPro" 2502 Sterile Multifunction Electrodes. This submission claims substantial equivalence to an existing device, the "PadPro" 2001 Electrode (K014209). The primary difference for the 2502 model is that it is sterilized and labeled as such.

The information primarily focuses on comparing the new device to its predicate device to establish substantial equivalence rather than detailing an independent study to prove specific performance against acceptance criteria in the traditional sense of a clinical trial. The "study" here is essentially the comparison to the predicate device and adherence to recognized standards.

Here's an attempt to extract and infer the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text does not explicitly describe a separate "test set" or a formal clinical study with a specified sample size for the PadPro 2502. The core of the submission is a claim of substantial equivalence to the predicate device, PadPro 2001. The "study" largely consists of demonstrating that the modification (sterilization) does not alter the fundamental safety and effectiveness when compared against established standards.

There is no mention of data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically associated with clinical trials, which are not detailed here.

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

This information is not provided. As there's no described independent test set or clinical study with patient data requiring expert review for ground truth, this aspect is not applicable to the summary provided. The "ground truth" for this submission relies on the established performance and safety of the predicate device and the adherence to recognized industry standards.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the nature of the submission (substantial equivalence claim based on predicate device and standards, not a new clinical study with expert adjudication).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on device characteristics and regulatory standards, not on human reader performance with or without AI assistance. The device in question is a medical electrode, not an AI-powered diagnostic tool.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. The device is an electrode, not an algorithm.

7. The Type of Ground Truth Used

For the PadPro 2502, the "ground truth" is established through:

• Performance of the predicate device (PadPro 2001): Its history of safe and effective use.
• Adherence to recognized industry standards: IEC 601-1 and ANSI/AAMI DF-39. These standards define the expected performance and safety characteristics of such electrodes.
• Sterilization validation (implied): While not explicitly detailed, the process of sterilization itself would have to be validated to ensure it achieves sterility without compromising the device's function or material integrity, thereby implicitly establishing a ground truth for its "sterile" claim.

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of this device submission. This concept typically applies to machine learning or AI models, which is not relevant for this medical electrode.

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

As there is no training set, this question is not applicable.

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The PadPro Radiotranslucent (minor shadowing) external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).

The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand or model of defibrillation/pacing unit is being used. All PadPro products are Latex free.

The provided text describes a 510(k) premarket notification for the "PadPro" 2516 Multifunction Electrodes. This submission aims to demonstrate substantial equivalence to an already legally marketed device, the Katecho KDP-60 K-Defib/Pace Adult Electrode (K981737), rather than proving the device meets acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert involvement, and ground truth establishment are not applicable in this context. The focus of a 510(k) is to show that the new device is as safe and effective as a predicate device, often through bench testing, design comparison, and adherence to recognized standards.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" for a 510(k) submission are primarily centered on demonstrating substantial equivalence to a predicate device and adherence to relevant industry standards, rather than specific performance metrics from a de novo clinical trial. The "reported device performance" is framed in terms of meeting these standards and being functionally similar to the predicate.

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

Not applicable in the context of this 510(k) submission. The document focuses on demonstrating substantial equivalence through design and feature comparison, and adherence to performance standards, rather than a clinical "test set" from a prospective study. The data provenance is primarily the product specifications and testing results from the manufacturer to demonstrate compliance with standards and equivalence.

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

Not applicable. The ground truth in this context is established by the recognized industry standards (IEC, ANSI/AAMI) and the performance characteristics of the predicate device. Expert consensus for a "test set" as in a diagnostic study is not mentioned or required for this type of submission.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a "test set" requiring adjudication in the sense of a clinical trial or diagnostic accuracy study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC comparative effectiveness study is not mentioned or implied. The submission is for a medical device (defibrillator electrodes) and not a diagnostic AI system where reader performance with and without AI assistance would be evaluated.

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

Not applicable. This device is a passive component (electrodes), not an algorithm or AI system. Its function is to provide an interface for human-operated defibrillators/pacemakers.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Established Industry Standards: IEC 601-1 and ANSI/AAMI DF-39. The device's compliance with these standards serves as a benchmark for its safety and basic performance.
• Predicate Device Characteristics: The features, indications for use, and performance claims of the legally marketed Katecho KDP-60 K-Defib/Pace Adult Electrode (K981737). Substantial equivalence to this device is the primary "ground truth" for regulatory clearance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable. As there is no training set mentioned or implied, the establishment of its ground truth is irrelevant to this submission.

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The PadPro pediatric electrodes are indicated for use in external pacing, defibiliation and monitoring applications as a non-sterne, disposable device for single pediatric use only. The PadPro 2603 electrodes provide ine conductive meetiatic patient's skin. The electrode is intended for use on

The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand of defibrillation/pacing unit is being used. All PadPro products are Latex free.

The provided documentation is a 510(k) premarket notification for a medical device (PadPro 2603 Pediatric Multifunction Electrodes). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data for a new, innovative device with a complex algorithm.

Therefore, much of the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies involving AI algorithms or novel diagnostics, is not applicable to this document. The document's purpose is to establish that the new device is as safe and effective as a previously approved device.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The primary "acceptance criteria" here is substantial equivalence to the predicate device (PadPro 2602 Pediatric Electrode K002280). This isn't a quantitative performance metric in the typical sense but rather a comparison of indications for use, technological characteristics, and safety/effectiveness. The document states that the device "meets the standards referenced above." The referenced standards are International Electrotechnical Commission (IEC) 601-1: Medical Electrical Equipment 601-1 (1988) Part 1: General requirements for safety Amendment No. 1 (1991) Amendment No. 2 (1995 and Sec.898.12 Performance standard; ANSI/AAMI DF-39 (3.3.19) standard, self adhesive electrodes for monitoring and defibrillation.
• Reported Device Performance: The document doesn't provide specific numerical performance metrics for the PadPro 2603. Instead, it asserts its performance is "SAME" or improved (e.g., "Slightly larger than 2602" for size, and features like "polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing").

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The PadPro radiotransparent external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).

The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand or model of defibrillation/pacing unit is being used. All PadPro products are Latex free.

The provided document is a 510(k) summary for the "PadPro" Multifunction Electrodes, seeking substantial equivalence to a predicate device. It does not describe a study to prove acceptance criteria in the manner typically seen for novel medical device performance claims. Instead, it argues for equivalence based on similar design, intended use, and adherence to recognized standards.

Here's an analysis based on the document, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the standards the device meets and the comparison to the predicate device. The performance is "reported" by stating it meets these standards and is equivalent to the predicate.

The document concludes: "In all respects, the PadPro System Defibrillator Electrodes are substantially equivalent to other electrodes that are legally marketed for this purpose. The device meets the standards referenced above."

This implies that demonstrating conformity to these existing standards and showing functional equivalence to the legally marketed predicate device (Katecho KDP-60A) constitutes the "acceptance criteria" and "device performance" for this 510(k) submission. No specific quantitative performance metrics from a dedicated study are presented.

Regarding specific study details (points 2-9):

The provided 510(k) summary does not describe a clinical performance study with a test set, ground truth, experts, or adjudication methods. Instead, it relies on:

• Comparison to a Predicate Device: The primary argument for safety and effectiveness is that the "PadPro" device is "identical in function" to the Katecho KDP-60A (K002806) and "nearly identical in design."
• Adherence to Recognized Standards: The device states it meets IEC 601-1 and ANSI/AAMI DF-39. Compliance with these standards is often assessed through bench testing and verification, not necessarily large-scale clinical trials in the context of a 510(k) for a well-established device type.

Therefore, many of your questions related to a performance study cannot be answered from this document:

2. Sample size used for the test set and the data provenance: Not applicable; no specific test set or clinical study described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no specific test set or ground truth established by experts described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable; no test set 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: Not applicable. This device is a passive medical electrode, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; no ground truth as typically understood for diagnostic performance studies is described. The "ground truth" here is compliance with established device standards for defibrillator electrodes and functional equivalence to a legally marketed predicate.

8. The sample size for the training set: Not applicable; this is not a machine learning device, so there is no "training set."

9. How the ground truth for the training set was established: Not applicable; no training set.

In summary: This 510(k) submission demonstrates substantial equivalence by comparing the device to an existing predicate and stating compliance with relevant industry standards. It does not present data from a clinical performance study with a test set, experts, or ground truth as typically requested for novel diagnostic or AI-driven devices.

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