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Skintact® Multifunction Electrodes are for use on adults and children weighing more than 25 kg for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.

Skintact® Multifunction Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin. Skintact® Multifunction Electrodes are accessories to defibrillators. Skintact® Multifunction Electrodes are passive devices and do not contain active electronics, software or firmware.

Skintact® Multifunction Electrodes consist of a backing material, conductive layer and conductive adhesive gel. The Multifunction Electrodes are applied on a release liner. This is the same composition like used for devices approved in existing K072233.

The shape of the electrodes has been slightly modified in comparison with K072233. The difference in shape of electrodes is an enhanced total area, but the active area is equivalent like approved in existing K072233.

Also this submission adds additional models of multifunction electrodes compatible with additional models of defibrillators.

An additional type of packaging is offered. This type of packaging is substantially equivalent to reference device approved in existing 510(k) K082090 9131 Defibrillation Electrodes, Cardiac Science Corporation, decision date: 12/12/2008.

This document is a 510(k) summary for the Skintact® Multifunction Electrodes. It describes the device and its intended use, and argues for its substantial equivalence to previously cleared devices. It is a submission to the FDA, not a study report, and therefore does not contain the detailed study information requested in the prompt.

Here's a breakdown of why the requested information cannot be fully provided from this document:

• This is a 510(k) submission, not a study report. A 510(k) demonstrates substantial equivalence to a predicate device, often through a combination of comparisons to existing devices, design verification, and some performance testing. It is not generally a study designed to "prove" a device meets acceptance criteria in the same way a clinical trial or a formal comparative effectiveness study would.
• The device is "passive" and an "accessory." The Skintact® Multifunction Electrodes are described as passive devices without active electronics, software, or firmware. This means the performance evaluation focuses on physical and electrical characteristics as an accessory, rather than complex algorithm performance.
• Focus on Substantial Equivalence: The primary objective of this document is to establish substantial equivalence to predicate devices (K072233 and K082090). Therefore, the "acceptance criteria" discussed are largely related to meeting the performance characteristics of those predicates and relevant safety standards.

Despite these limitations, I can extract and infer some information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. This document only states that "Performance testing was conducted" and "Biocompatibility testing has been performed." It does not provide details on the number of electrodes or test subjects used.
• Data Provenance: Not specified. The submission is from Leonhard Lang GmbH, based in Innsbruck, Austria. The testing would likely have been conducted in a laboratory setting, but specifics are not provided. It is not mentioned whether it was retrospective or prospective data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The testing described is for the physical and electrical performance and biocompatibility of a medical device accessory, not the interpretative accuracy of an AI or diagnostic tool. Ground truth in this context would be established by laboratory measurements against defined standards, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically used when human interpretation or judgment is involved in establishing a ground truth (e.g., in reading medical images), which is not the case for the type of device testing described here.

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

No, an MRMC comparative effectiveness study was not done. This device is a passive accessory (electrodes) for a defibrillator, not an AI-powered diagnostic or interpretive tool that would assist human readers.

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

No, this question is not applicable. The device is a physical electrode, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be:

• Physical measurements against established engineering standards: For electrical impedance, adhesion strength, and physical dimensions.
• Biocompatibility test results: Against ISO standards or other recognized guidelines for biological safety.
• Functional tests with compatible defibrillators: To ensure proper signal transmission and energy delivery.

This is fundamentally different from a clinical ground truth for a diagnostic device.

8. The sample size for the training set

Not applicable. This device is a passive medical accessory, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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Skintact Neutral Electrodes for Neonates are designed for use with electrosurgical generators for cutting and coagulation of human tissue of newborn or prematurely born patients of between approximately 1 and 11 lbs (0.45 kg and 4.99 kg).

Skintact® Neutral Electrodes for Neonates are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.

Skintact® Neutral Electrodes for Neonates consist of a backing material, conductive layer and conductive adhesive gel. The Neutral Electrodes for Neonates are applied on a release liner. The only change in construction materials is a slight modification of the conductive hydrogel. This modification was carried out to adapt the gel to the skin of neonates. Skintact® Neutral Electrodes for Neonates are accessories to surgery devices.

Skintact® Neutral Electrodes for Neonates are passive devices and do not contain active electronics, software or firmware Skintact® Neutral Electrodes for Neonates are packaged in water-vapour-proofed, heat-sealed, non-transparent, aluminized pouches.

Here's a breakdown of the acceptance criteria and study information for the Skintact® Neutral Electrodes for Neonates, 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 provided document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance testing was conducted according standard EN60601-2-2:2009" and "Biocompatibility testing has been performed."

3. Number of Experts Used and Qualifications

Not applicable. This device is a passive, non-diagnostic accessory (neutral electrodes) and its performance evaluation does not involve expert interpretation or ground truth establishment in the manner of an AI diagnostic device. The evaluation is based on objective physical, electrical, and biological safety standards.

4. Adjudication Method

Not applicable for the reasons stated above.

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

Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers or comparative effectiveness in that context.

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

Not applicable. This is a passive medical device, not an algorithm or software. Its performance is inherent to its physical properties and material composition.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by adhering to recognized international standards and specifications for medical electrodes:

• Engineering Standards: EN60601-2-2:2009 for thermal performance, contact impedance, and adhesion.
• Material Science Standards: Tests for material durability (release and shelf-life) and biocompatibility.

These standards define the acceptable range of physical, electrical, and biological properties for safe and effective use.

8. Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no training set in the conventional sense.

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

Not applicable.

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Skintact® Radioiransparent Multifunction Electrodes are for use on adults and children over eight years old or weighing more than 25 kg for external defibrillation, pacing, monitoring and cardioversion. The device is non - sterile and single use only.

All Skintact Multifunction Electrodes are self-adhesive, non-sterile, single use disposable electrodes. Multifunction electrodes can be used for defibrillation, pacing, cardioversion and monitoring. These multifunction electrodes have the additional feature "radiotransparent" which allows these electrodes to stay on the patient when moving through different departments.

This document is a 510(k) summary for a medical device called "Skintact Radiotransparent Multifunction Electrodes." It is not a study report or clinical trial. Therefore, it does not contain the detailed information necessary to answer all the questions about acceptance criteria, device performance, and study methodology as typically found in a clinical study report for AI/ML-based devices.

However, I can extract the information that is present and explain why certain details are missing.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly present a table of "acceptance criteria" for an AI/ML device or detailed "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity, accuracy).

Instead, it states that the device's performance met specifications established in existing standards:

These standards relate to the electrical safety and performance of defibrillation electrodes and biocompatibility, not to the diagnostic performance of an AI/ML algorithm.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes performance testing against established standards for medical devices, which typically involves laboratory testing or bench testing, not clinical studies with "test sets" in the context of AI/ML evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided as the device is a piece of hardware (multifunction electrodes) and not an AI/ML diagnostic tool requiring expert-established ground truth for performance evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided for the same reason as 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

This information is not applicable and therefore not provided. The device is an electrode, not an AI system designed to assist human readers.

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

This information is not applicable and therefore not provided. The device is a physical electrode, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The concept of "ground truth" as typically discussed for AI/ML devices is not applicable here. The "ground truth" for this device's performance would be objective measurements against the technical specifications outlined in the mentioned standards (ANSI/AAMI DF80:2003, IEC/EN 60601-2-4:2003, ISO 10993).

8. The sample size for the training set

This information is not applicable and therefore not provided. This device is not an AI/ML model, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable and therefore not provided. There is no training set for this device.

Summary of Device and Evaluation:

The document describes the submission of "Skintact Radiotransparent Multifunction Electrodes" for 510(k) clearance. The purpose of the submission is for an additional feature: "radiotransparent," allowing the electrodes to remain on a patient during imaging.

The basis for equivalence (and thus, acceptance) to predicate devices is primarily focused on:

• Biocompatibility testing: Passed ISO 10993 for intact skin.
• Performance data: Met specifications as established in ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003. These standards relate to the electrical and functional performance of defibrillation electrodes.

The crucial point is that this document is for a traditional medical device (electrodes), not an AI/ML-driven diagnostic or treatment device. Therefore, the questions related to AI/ML specific evaluation metrics, ground truth, expert adjudication, and training/test sets are not relevant to this submission. The "study" mentioned refers to performance testing against established safety and efficacy standards for the hardware itself.

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ECG Skintact Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintact ECG Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.

All Skintact® ECG Tab Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® ECG Tab Electrodes with KH06D Gel are composed of the same materials as the predicate devices by Leonhard Lang except the modified gel.

Here's an analysis of the provided 510(k) summary regarding the Skintact® ECG Tab Electrodes with KH06D Gel, focusing on acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for the test set.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of performance testing against established standards (biocompatibility, electrical performance, shelf life), it's highly likely this was prospective testing conducted by the manufacturer to verify compliance.

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

For this specific device (ECG electrodes), the "ground truth" is typically established by objective measurements and standardized tests rather than expert interpretation of images or patient data. The provided documentation does not mention using experts to establish ground truth for the performance testing. Instead, the ground truth is defined by the requirements of the standards (ISO 10993, ANSI/AAMI EC12).

4. Adjudication Method for the Test Set

As the "ground truth" is based on objective measurements against industry standards, an adjudication method like "2+1" or "3+1" (which typically applies to human interpretation tasks) is not applicable here and is not mentioned in the document.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. The device in question is a medical accessory (ECG electrode), and its performance is evaluated through technical standards.

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

Yes, the studies described are essentially standalone performance assessments of the device itself (the ECG electrode). The biocompatibility, electrical performance, and shelf-life tests involve the device operating on its own or in a controlled environment, without a human-in-the-loop for its basic function.

7. The Type of Ground Truth Used

The ground truth used for the performance testing is based on objective technical standards and material properties:

• Biocompatibility: Conformance to ISO 10993 standards.
• Electrical Performance: Conformance to ANSI/AAMI EC12:2000/(R)2005 specifications.
• Shelf Life: Results of accelerated aging tests, compared to the predicate device's established shelf life.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning or AI algorithms. As this device is an ECG electrode and not an AI/ML diagnostic tool, there is no training set in the conventional sense mentioned or implied for its development or testing.

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

Since there is no training set mentioned, the question of how its ground truth was established is not applicable.

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Skintact® Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only. These electrodes have been qualified for use with defibrillators delivering a maximum of 100 joules such as: Zoll M and E series and PD1200, 1400, 1600 & 1700 defibrillators; Medtronic LifePak 9, 10, 12 and 20 defibrillators; Philips Heartstart MRx and XL defibrillators; Welch Allyn PIC 30, PIC 40 and PIC 50 defibrillators; Philips Codemaster XE, XL, XL+ and 100 defibrillators.

All Skintact® Multifunction Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® Pediatric Multifunction Electrodes with DH03 Gel are composed of the same materials as the predicate device K073322 by Leonhard Lang except the modified DH03 Gel (made by Leonhard Lang).

The provided text describes a 510(k) submission for the "Skintact® Pediatric Multifunction Electrodes with DH03 Gel". The submission aims to demonstrate substantial equivalence to predicate devices, rather than proving that the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this type of regulatory document.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific numerical targets. Instead, it states that the device "met specifications as established in ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003". This implies that the acceptance criteria are defined by these international standards for defibrillation electrodes. The "reported device performance" is the statement that the device met these specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the performance testing or the provenance of the data (country of origin, retrospective/prospective). This level of detail is typically not included in a 510(k) summary but would be part of the full test reports.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the performance testing involved meeting engineering and biocompatibility standards, not clinical diagnosis or interpretation by medical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as the evaluation was against technical standards and not subjective interpretation 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 device is an electrode, not an AI-powered diagnostic tool, and no MRMC study was conducted or is relevant to its substantial equivalence claim.

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

A standalone performance evaluation was done in the sense that the electrodes themselves were tested against the specified standards (biocompatibility, electrical performance). This is an "algorithm only" equivalent for a physical device, where the "algorithm" is the device's design and materials performing its intended function. The testing did not involve human-in-the-loop performance studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this type of device is defined by the technical specifications and testing methodologies outlined in the referenced standards (ANSI/AAMI DF80:2003, IEC/EN 60601-2-4:2003, and ISO 10993). These standards define acceptable performance parameters for biocompatibility and electrical characteristics of defibrillation electrodes.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

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Skintact ECG Electrodes are designed for use in general electrocardioaraphic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintact ECG Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.

All Skintact® ECG Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® Pre-wired ECG Electrodes with Conductive Adhesive are composed of the same materials as the predicate devices by Leonhard Lang except the pre-attached lead wire. The lead wires are similar to those in predicate devices.

This 510(k) submission is for a modification to an existing device, the Skintact® Pre-wired ECG Electrodes with Conductive Adhesive. The primary change is the addition of a pre-attached lead wire to an already cleared ECG electrode. As such, the submission focuses on demonstrating that this modification does not introduce new issues of safety or effectiveness and that the modified device remains substantially equivalent to its predicate.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission (a modification to an existing device, primarily adding a pre-attached lead wire), the acceptance criteria generally revolve around demonstrating that the new feature (pre-attached lead wire) and the overall device performance meet established standards for ECG electrodes.

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

The provided document does not explicitly state specific sample sizes for the performance tests (biocompatibility, ANSI/AAMI EC12:2000, shelf life). It refers to the tests being conducted and meeting standards, implying that sufficient samples were used to generate statistically meaningful results in line with the standards' requirements.

The data provenance is not explicitly stated regarding country of origin or retrospective/prospective nature for these specific tests. However, given the submitting company (Leonhard Lang GmbH) is based in Austria, it's reasonable to infer that some testing might have been conducted in Europe. The reference to FDA-recognized standards (ANSI/AAMI EC12:2000 and ISO 10993) indicates adherence to internationally accepted methodologies.

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

This type of information is not applicable to this 510(k) submission. The device is a medical accessory (ECG electrode) and the performance testing described (biocompatibility, electrical/mechanical performance, shelf life) relies on objective measurements against established engineering and safety standards (ISO 10993, ANSI/AAMI EC12:2000). There is no "ground truth" in the clinical diagnostic sense that would require expert consensus for these particular tests.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable here. Adjudication methods are typically employed in clinical trials or studies where subjective assessments by multiple experts need to be resolved to establish a definitive "ground truth" (e.g., in image interpretation studies). The performance tests mentioned in this submission are objective laboratory tests against pre-defined specifications.

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 relevant for diagnostic devices where human readers interpret medical images or data, and the goal is to assess improvements in reader performance with or without AI assistance. The Skintact® Pre-wired ECG Electrodes are not a diagnostic imaging device, nor do they involve AI assistance or human interpretation in their intended use.

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

No, a standalone (algorithm only) performance study was not done. This concept is specifically applicable to AI/ML software as a medical device (SaMD) where the algorithm's performance is assessed independently of human intervention. The Skintact® Pre-wired ECG Electrodes are a physical medical device (an electrode), not a software algorithm.

7. The Type of Ground Truth Used

For the performance tests mentioned:

• Biocompatibility: The "ground truth" is adherence to the criteria outlined in ISO 10993. This involves laboratory tests to detect potential cytotoxic, irritation, or sensitization effects.
• ECG Electrode Performance: The "ground truth" is meeting the technical specifications and criteria defined in the ANSI/AAMI EC12:2000 standard. This involves objective measurements of electrical and mechanical properties in a laboratory setting.
• Shelf Life: The "ground truth" is stability over time, demonstrated by maintaining performance (e.g., adhesion, electrical properties) after accelerated aging that simulates real-time aging, according to established test protocols.

These are all objective, laboratory-based performance benchmarks against recognized standards, rather than clinical outcomes or pathology data.

8. The Sample Size for the Training Set

Not applicable. This submission is for an ECG electrode, which is a hardware medical device. It does not involve any artificial intelligence (AI) or machine learning (ML) models that would require a "training set."

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

Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment process for a training set.

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Skintact ECG Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintact ECG Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.

All Skintact® ECG Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® ECG Electrodes with Conductive Adhesive are composed of the same naterials as the predicate devices by Leonhard Lang except the gel, which is made by AmGel Technologies.

Here's a breakdown of the acceptance criteria and study information for the Skintact® ECG Electrodes with Conductive Adhesive, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary does not explicitly state the sample size for the test set used in the performance testing. It refers to "performance data" and "biocompatibility testing."

Regarding data provenance:

• Country of Origin: Not explicitly stated, but the submitter (Leonhard Lang GmbH) is based in Austria. The testing itself could have been conducted anywhere.
• Retrospective or Prospective: Not explicitly stated. For performance standards like ANSI/AAMI EC12:2000, testing typically involves prospective laboratory measurements of electrode characteristics. Biocompatibility testing is also generally prospective lab testing.

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

This type of information is not applicable to this 510(k) submission. ECG electrodes are physical medical devices, and their "ground truth" for performance is established by objective measurements against recognized engineering and safety standards (like ISO 10993 for biocompatibility and ANSI/AAMI EC12:2000 for electrical performance). There are no experts establishing "ground truth" in the way one would for diagnostic image interpretation.

4. Adjudication Method for the Test Set

This is not applicable. As discussed above, the "truth" is determined by objective measurements against established standards, not by expert consensus or adjudication.

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 primarily relevant for diagnostic imaging systems or AI algorithms where human interpretation is a key component and the AI's effect on human performance is being evaluated. This 510(k) is for a disposable ECG electrode, a hardware component.

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

No, a "standalone" study in the context of an algorithm's performance was not done. This 510(k) is for a hardware device, not an algorithm. The performance evaluation focuses on the physical and electrical characteristics of the electrode itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements against recognized industry standards:

• Biocompatibility: Conformance to ISO 10993 standards.
• Electrical Performance: Conformance to ANSI/AAMI EC12:2000 for ECG electrodes.

8. The Sample Size for the Training Set

This is not applicable. This submission is for a physical medical device (ECG electrode), not an AI algorithm or a diagnostic system that uses a "training set."

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

This is not applicable as there is no training set for this type of device.

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Skintact® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators are for use on adults and children over eight years old for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.

Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators (and as also to be offered for sale under various private label tradenames) consist of a foam backing, a laminated metallic substrate and conductive adhesive gel DH02 [all materials cleared in existing 510(k) K041883]. Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators are packaged in pairs in water-vapor-proof, heatsealed, non-transparent, aluminized pouches, non-sterile and single-use.

This 510(k) summary describes a device that is essentially identical to a previously cleared predicate device, with no significant differences in materials or design. Therefore, the "acceptance criteria" and "device performance" in this context refer to the device meeting the same standards and specifications as the predicate device, demonstrated through bench testing.

Here's a breakdown of 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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Performance and safety tests were conducted," but not the specific number of units tested.
• Data Provenance: The tests were conducted by SGS, an independent third-party testing organization, presumably in Austria where Leonhard Lang GmbH is located. This is a prospective test for this specific device, demonstrating its performance against established standards, rather than analyzing existing datasets.

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

• This information is not applicable in this context. The "ground truth" for this device's performance is defined by adherence to recognized international standards (ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003) for defibrillation electrodes, not by expert consensus on clinical findings. The "experts" are likely the engineers and technicians at SGS who performed the tests according to these standards. Their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., image interpretation). For bench testing against objective standards, the "adjudication" is whether the test results fall within the specified acceptance criteria of the 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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. This submission is for a medical electrode.

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

• No, this is not applicable. This device is a physical electrode, not a software algorithm. Its performance is evaluated through physical and electrical testing.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by objective engineering and safety standards (ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003).

8. The Sample Size for the Training Set

• This document describes a medical device, not a machine learning model. Therefore, there is no training set in the context of artificial intelligence/machine learning.

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

• Not applicable, as there is no training set.

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Skintact® Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue.

Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel (and as also to be offered for sale under various private label tradenames) are self-adhesive, nonsterile, single use disposable electrodes, available in a comprehensive range of shapes and sizes (adult and pediatric), standard and split, with or without lead wires.

The provided text is a 510(k) summary for a medical device. It describes the device, its intended use, and a summary of testing performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain a detailed study with acceptance criteria and reported device performance in the way a clinical or diagnostic AI study would.

Instead, the "study" referred to here is a series of engineering and biocompatibility tests conducted to demonstrate that the device, which is an electrosurgical grounding plate with a new gel formulation, meets the safety and performance requirements of a recognized standard (ANSI/AAMI HF 18:2001) and is substantially equivalent to a previously cleared predicate device.

Therefore, I will extract information based on this context.

Here's an interpretation based on the provided text, recognizing its nature as a 510(k) summary rather than a standalone AI or clinical study:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document states that "All performance and safety tests are according to ANSI/AAMI HF 18:2001." This implies that the acceptance criteria for each test are those set forth in that recognized standard. The summary does not provide specific numerical thresholds from the standard, but affirms that the device met them.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for each test. The testing involved "Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel" across a "range of electrodes with different geometry and area." The specific number of units tested per parameter is not provided.
• Data Provenance: The tests were conducted by Leonhard Lang GmbH, Austria, and Univ. Klinik für Radiodiagnostik, Innsbruck, Austria. This indicates the data is prospective, generated specifically for this submission. The country of origin is Austria.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Two experts are mentioned: Dr. Michael Verius and Dr. Ralf Huttary.
• Qualifications: Both are from the Univ. Klinik für Radiodiagnostik, Anichstraße 35, 6020 Innsbruck, Austria. Their specific specialties or years of experience are not listed, but their affiliation with a university radiology clinic suggests medical and perhaps technical expertise relevant to device performance evaluation. They acted as a testing facility rather than establishing a ground truth in a diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. This was not a study involving human interpretation of diagnostic data requiring adjudication of ground truth. The "adjudication" was effectively the testing against a standard and the determination of "no adverse results" or "according to standard."

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

No, this was not an MRMC study. It was a technical performance and biocompatibility study comparing the new device characteristics to those required by a recognized standard and demonstrating equivalence to a predicate device.

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

Yes, in a sense, the performance tests outlined (Maximum safe temperature rise, Electrode contact impedance, etc.) represent a "standalone" evaluation of the device's physical and electrical properties without human intervention during the measurement process. However, this is not an "algorithm-only" performance in the context of AI.

7. Type of Ground Truth Used

The ground truth was based on:

• Recognized Standard: ANSI/AAMI HF 18:2001, which defines the safety and performance requirements for electrosurgical devices.
• Biocompatibility Standards: Implicitly, the biocompatibility tests (Cytotoxicity, Skin Irritation, Sensitization) follow established standards for evaluating material safety for medical devices.
• Predicate Device: The performance and materials were assessed for equivalence to the predicate device (K030362).

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning study.

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

Not applicable. As there is no training set mentioned.

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