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Skintact radiolucent and MRI-compatible 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 radiolucent and MRI-compatible ECG electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.

Skintact® ECG Electrodes (and as also to be offered for sale under various private label tradenames) will now also be offered radiolucent and MRI-compatible. Just like the predicate electrodes, radiolucent and MRI-compatible ECG electrodes are self-adhesive, nonsterile, single-use disposable snap electrodes. The radiolucent and MRI-compatible ECG electrodes are identical in size, shape and configuration to the Skintact ECG electrodes currently marketed by Leonhard Lang, GmbH.

The Skintact radiolucent and MRI-compatible ECG Electrodes are composed of the same materials as the predicate devices except the snap, which is made of carbon snap guarantees an unimpaired performance during the shelf-life of the product. All electrodes include an carbon ABS sensor element coated with silver. The silver layer is either completely or partially (in the areas in contact with the conductive gel) covered with a silver chloride layer.

The provided documents detail the 510(k) submission for the Skintact® radiolucent and MRI-compatible ECG Electrodes. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than an AI-powered diagnostic device. Therefore, many of the typical AI-specific criteria (like AI vs. human reader improvement, multi-reader multi-case studies, expert consensus for ground truth on training/test sets, or specific AI model performance metrics like AUC, sensitivity, specificity, F1-score) are not applicable to this submission.

The acceptance criteria and performance are primarily based on established industry standards for ECG electrodes, material biocompatibility, and specific testing for radiolucency and MRI compatibility.

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 for the Test Set and the Data Provenance

• Sample Size for Test Set: Not explicitly stated for each specific test. The testing involved, for example, "real-time aging" and a comparison of "ECG traces between carbon electrodes... and predicate device ECG electrodes." For biocompatibility, it's inferred that sufficient samples were tested to demonstrate no adverse results based on cleared materials. For electrical performance, tests were conducted according to ANSI/AAMI EC 12:2000, which would specify sample sizes for those tests. The radiolucency and MRI compatibility studies (referenced by authors) would have used defined sample sizes per those specific ASTM standards.
• Data Provenance: The company is Leonhard Lang GmbH, located in Innsbruck, Austria. The studies are referenced as being conducted by personnel from this company ("Radiopacity of ECG-Electrodes by Leonhard Lang GmbH - A study by Dr.Recheis Wolfgang, Dr.Verius Michael, Dr.Huttary Ralf, Mag.Torbica Pavle"). All testing described appears to be prospective laboratory and engineering testing, rather than retrospective clinical data.

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

• Not applicable for this type of device. This submission did not involve diagnostic interpretation or AI model training requiring expert-established ground truth on a test set in the traditional sense of medical imaging or diagnostic algorithms. The "truth" for this device is based on objective measurements against established engineering and material standards (e.g., electrical performance, material safety, radiolucency, MRI compatibility). The referenced studies for radiolucency and MRI compatibility were authored by: Dr.Recheis Wolfgang, Dr.Verius Michael, Dr.Huttary Ralf, Mag.Torbica Pavle. Their specific qualifications (e.g., radiologist, engineer) are not given, but they are implied to be experts in their respective fields based on the nature of the studies.

4. Adjudication Method for the Test Set

• Not applicable. There was no "test set" requiring adjudication by multiple experts in the context of diagnostic performance. Adjudication is typically used to resolve discrepancies in human interpretations or AI outputs against a ground truth. Here, the testing involves quantifiable physical and electrical properties benchmarked against 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. This was not an AI-powered diagnostic device, and therefore, no MRMC comparative effectiveness study was conducted or is relevant.

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

• No. This is a medical device (ECG electrode), not a standalone algorithm.

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

• The "ground truth" for this device is established by objective measurements against recognized industry standards and regulatory requirements. For example:
  • Biocompatibility: Established by testing against known safety profiles for cleared materials.
  • Electrical Performance: Defined by the specified limits within the ANSI/AAMI EC 12:2000 standard.
  • Radiolucency: Defined by the parameters and methods of ASTM F640-79.
  • MRI Compatibility: Defined by the parameters and methods of ASTM F 2052-00, ASTM F 2182-02a, and ASTM F 2119-01.
  • Equivalence: Demonstrated by showing that the new device performs within the acceptable levels of variance compared to legally marketed predicate devices, as per the 510(k) pathway.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm that requires a "training set." The development process relies on engineering design, material selection, and testing against established performance standards.

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

• Not applicable. As there is no AI algorithm "training set" for this device, a ground truth for a training set was not established.

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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 non-sterile and are to be used on intact (uninjured) skin.

Skintact® ECG Electrodes (and as also to be offered for sale under various private label tradenames) will be offered with KL 02 liguid gel. Just like the QR liquid gel electrodes, KL 02 liquid gel electrodes are self-adhesive, non-sterile, single use disposable snap electrodes. The KL 02 liquid gel electrodes are identical in size, shape and configuration to the QR liquid gel Skintact ECG electrodes currently marketed by Leonhard Lang, GmbH. All electrode configurations include a stainless steel stud to guarantee an unimpaired performance during the shelf-life of the product. All electrodes include an ABS sensor element coated with silver. The silver layer is either completely or partially (in the areas in contact with the conductive gel) covered with a silver chloride layer. This is the same construction as the current Skintact® ECG electrode using QR liquid gel conducting media.

Here's an analysis of the provided 510(k) summary regarding the Skintact® ECG Electrodes with KL 02 liquid gel, focusing on acceptance criteria and supporting studies:

Overview:

This 510(k) submission seeks to demonstrate substantial equivalence of the Skintact® ECG Electrodes with KL 02 liquid gel to a predicate device (Skintact® ECG Electrodes with QR liquid gel) that was previously cleared (K982521). The primary change is the type of liquid gel used. The testing focuses on proving that this change does not negatively impact the device's performance regarding biocompatibility, electrical properties, and clinical utility.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the ANSI/AAMI EC 12:2000 standard for "Disposable ECG electrodes" and equivalence comparisons to the predicate device.

Study Details:

Based on the provided text, the studies are primarily intended to demonstrate equivalence to a predicate device and adherence to industry standards, rather than proving novel clinical effectiveness.

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

• Biocompatibility Testing: The specific sample sizes for cytotoxicity, skin irritation, and sensitization tests are not provided in the summary.
• Electrical Performance Testing: The specific sample sizes for AC impedance, DC offset voltage, etc., are not provided. The testing "was used to define the requirements for Skintact ECG Electrodes with KL 02 liquid gel" and involved a "certification to conformance EC12:2000."
• Shelf-Life Testing: "Real-time aging" was performed, and "retain samples" were tested. Specific sample sizes are not provided.
• Clinical Data (Trace Testing & Wear Tests):
  • Trace Testing: No specific sample size is mentioned for the "clinical trace testing per the FDA guidance." It states the gel was evaluated, implying direct comparison.
  • Wear Tests: "Three wear test reports for Holter monitoring electrodes used for 48 hours were provided." This implies a small sample size, likely involving a few participants per report, but the exact number of individuals is not specified.
  • Data Provenance: The manufacturer is Leonhard Lang GmbH, located in Austria. It is highly probable the data originated from Austria or a European location, given the company's geographical information. The studies appear to be prospective as they were specifically conducted for this submission (e.g., repeating clinical trace testing, real-time aging, wear tests).

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

• Biocompatibility/Electrical Performance/Shelf-Life: These tests typically use validated laboratory methods and standards (ANSI/AAMI EC 12:2000) for determining "ground truth." Expert review would be part of the lab's quality assurance, but no specific external experts are mentioned for establishing the objective pass/fail criteria.
• Clinical Data (Wear Tests): "A physician reviewed the performance of the wear tests and examined for skin irritation."
  • Number of Experts: One physician is explicitly mentioned.
  • Qualifications: "Physician." No further specific qualifications (e.g., years of experience, specialty) are provided in the summary.

4. Adjudication Method for the Test Set:

• Biocompatibility/Electrical Performance/Shelf-Life: Not applicable in the context of standard human-read adjudication. These are objective measurements against defined technical standards.
• Clinical Data (Wear Tests): A single "physician reviewed the performance." There is no explicit multi-reader adjudication method (like 2+1, 3+1) described for the clinical wear tests or the trace comparisons. The "clinical trace testing" simply states the KL 02 gel "performs the same" as the QR gel, implying a direct comparison without detailing an adjudication process.

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

• No, an MRMC comparative effectiveness study was NOT done. The studies focused on demonstrating equivalence of the device (specifically the new gel) to a predicate device and adherence to technical standards. There is no mention of human readers and their improvement with or without AI assistance. This device is an electrode, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone algorithm performance study was NOT done. This device is an ECG electrode, which is a hardware component for collecting physiological signals, not a software algorithm.

7. Type of Ground Truth Used:

• Biocompatibility: Ground truth is established by standardized, validated laboratory protocols for cytotoxicity, irritation, and sensitization (e.g., ISO 10993 series, though not explicitly cited here, implied by "biocompatibility testing").
• Electrical Performance: Ground truth is defined by the objective limits and testing methodologies specified in the ANSI/AAMI EC 12:2000 "Disposable ECG electrodes" standard.
• Shelf-Life: Ground truth is the adherence to the electrical performance limits defined by ANSI/AAMI EC 12:2000 over time, as measured through real-time aging.
• Clinical Data (Trace Testing & Wear Tests):
  • Trace Equivalence: The "ground truth" for trace equivalence is likely a visual or quantitative comparison by experts of the generated ECG waveforms from the new gel electrodes versus the predicate gel electrodes, judged to be "the same" or "equivalent."
  • Skin Irritation/Performance: The "ground truth" for skin irritation and overall electrode performance (adhesion, gel drying, electrical performance during wear) is the physician's review and observation for the wear tests.

8. Sample Size for the Training Set:

• Not applicable. This submission describes a medical device (ECG electrode), not a machine learning or AI model. Therefore, there is no "training set" in the context of AI development.

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

• Not applicable. As stated above, there is no training set for an AI model.

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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 non-sterile and are to be used on intact (uninjured) skin.

Skintact® ECG Electrodes (and as also to be offered for sale under various private label tradenames) will now also be offered with solid adhesive gel. Just like the liquid gel electrodes, solid adhesive gel electrodes are self-adhesive, non-sterile, single use disposable snap electrodes. The solid adhesive electrodes are identical in size, shape and configuration to the liquid gel Skintact ECG electrodes currently marketed by Leonhard Lang, GmbH. All electrode configurations include a stainless steel stud to guarantee an unimpaired performance during the shelf-life of the product. All electrodes include an ABS sensor element coated with silver. The silver layer is either completely or partially (in the areas in contact with the conductive gel) covered with a silver chloride layer. This is the same construction as the current Skintact® ECG electrode using liguid gel conducting media.

Here's a breakdown of the acceptance criteria and study information for the Skintact® ECG Electrode, based on the provided text:

Acceptance Criteria and Device Performance

• DC Offset Voltage: Met requirements of ANSI/AAMI EC 12:2000.
• Defibrillation Overload Recovery: Met requirements of ANSI/AAMI EC 12:2000.
• Combined Offset Instability and Internal Noise: Met requirements of ANSI/AAMI EC 12:2000.
• Bias Current Tolerance: Met requirements of ANSI/AAMI EC 12:2000. |
  | Shelf Life (24 months) | The electrical performance of electrodes with solid adhesive gel stays within ANSI/AAMI EC12-2000 limits for 24 months, as confirmed by real-time and accelerated aging (3 months at 40°C). |
  | Equivalence to Liquid Gel Electrodes (Electrical) | Electrical performance of solid adhesive gel electrodes is equivalent to liquid gel electrodes, with negligible differences compared to ANSI/AAMI EC12-2000 limits. |
  | Clinical Performance (Signal Quality) | Clinical trace testing confirmed that the solid adhesive gel performs the same as liquid gel, demonstrating equivalence in ECG traces. |
  | Clinical Performance (Wear Test - 48 hours) | - No deterioration of electrical performance.
• Gel did not dry out.
• Electrodes were not replaced and showed no displacement, even with normal activities and sports.
• No skin problems/irritation for volunteers. |

Study Information

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

• Test Set Sample Size:
  • For biocompatibility: Not specified in detail, but implied to be sufficient for cytotoxicity, skin irritation, and sensitization tests.
  • For electrical testing: Not specified, but a "certification to conformance EC12:2000 with this standard has been provided." This implies sufficient devices were tested to meet the standard.
  • For shelf-life: Electrodes were used for real-time and accelerated aging, but the specific number is not provided.
  • For clinical trace testing: Not specified, but implied to be sufficient to evaluate the potential effect of material change.
  • For wear tests: "Three wear test reports" were provided. The number of volunteers per report is not explicitly stated.
• Data Provenance: The document implies the testing was conducted by Leonhard Lang GmbH (based in Austria). The data is retrospective in the sense that it's reported after the testing.

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

• Wear Tests: "A physician reviewed the performance of the wear tests and examined for skin irritation." The number of physicians is not specified (it states "a physician," implying one, but doesn't explicitly rule out more if separate reports were reviewed). Qualifications are stated as "physician."

4. Adjudication Method for the Test Set:

• Not applicable/Not specified as human "reader" adjudication in the typical sense for image-based diagnostics. The assessments were based on meeting objective electrical standards and physician review for wear tests.

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 ECG electrode, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is an ECG electrode; its performance is standalone in the sense that it collects the ECG signal itself, without an AI algorithm.

7. The Type of Ground Truth Used:

• Electrical Performance: Ground truth was defined by the requirements of the ANSI/AAMI EC 12:2000 "Disposable ECG electrodes" standard.
• Biocompatibility: Ground truth was based on established biocompatibility testing standards (cytotoxicity, skin irritation, sensitization).
• Clinical Performance (Wear Test): Ground truth was based on direct observation and clinical assessment by a physician regarding electrode performance (electrical stability, gel integrity, adhesion) and patient outcomes (skin irritation).
• Equivalence: Comparisons were made against performance data from the predicate liquid gel electrodes and against the ANSI/AAMI EC 12:2000 limits.

8. The Sample Size for the Training Set:

• Not applicable. This is a medical device (electrode), not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set was established:

• Not applicable (as above).

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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 recordings. Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.

Skintact ECG electrodes are self-adhesive, non-sterile, single use disposable ECG electrodes. All include a silver/silver chloride sensing element, a stainless steel stud and a conductive gel. These conductive elements are held in place on the patient's skin by a carrier tape coated with a pressure sensitive medical qrade adhesive.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Skintact ECG Electrodes:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective or prospective) for the electrical performance, biocompatibility, or shelf-life studies. It only mentions that the studies were performed and that the device met the requirements.

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

This information is not provided in the document. The studies referenced are technical performance tests against a voluntary standard, not studies requiring expert interpretation of diagnostic output to establish ground truth in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of performance testing against a voluntary standard for electrical characteristics and biocompatibility, an adjudication method in the context of expert consensus on ground truth is not applicable here.

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 device is an ECG electrode, a consumable medical device, not an AI-powered diagnostic tool that would typically involve human readers interpreting output with and without AI assistance.

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

This question is not applicable to the Skintact ECG Electrodes. This is a hardware medical device (an electrode), not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance was established by voluntary standards (ANSI/AAMI EC12/1991 for electrical performance, labeling, shelf life, packaging, and safety) and international standards (ISO 10993-1 for biocompatibility). For shelf life, it was based on real-time shelf-life studies. In essence, the ground truth was defined by the specified technical and biological requirements of these standards.

8. Sample Size for the Training Set

This information is not applicable. The Skintact ECG Electrodes are a hardware device, not a machine learning model, and therefore do not have a "training set."

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

This information is not applicable for the same reason as point 8.

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