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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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The PRONEO Neonatal ECG Electrodes are designed for use whenever cardiac monitoring for neonatal or pediatric patients is deemed or desirable by trained medical or emergency This electrode is for use on neonatal and pediatric patients. The PRONEO Neonatal ECG Electrodes are non-sterile and are to be used on intact (uninjured) skin.

The PRONEO Neonatal ECG Electrodes (and also to be sold under various private label trade names; i.e. Multiple Labels) are 22mm in square and consist of a conductive adhesive hydrogel, a Ag/AgCl plated sensor element a non-woven substrate and vinyl label, and a 100cm flexible tinned copper or carbon lead wire terminating in a 1.5mm, 2.0mm standard DIN connector. Electrodes are packaged in pouches of 3, 100 pouches per carton and are supplied non-strerile.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for PRO-NEO NEONATAL ECG ELECTRODE (K053011)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated for electrical performance tests. For biocompatibility and shelf life, the sample sizes are not detailed in the provided summary.
• Data Provenance: The device was manufactured in the Republic of Korea. The testing was conducted by Bio Protech Inc.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The performance testing for this device (ECG electrodes) involved objective, standardized electrical and biological tests, not human interpretation or expert-established ground truth in the way it would for an AI-powered diagnostic device.

4. Adjudication Method

Not applicable, for the same reasons as #3.

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

Not applicable. This device is a medical accessory (ECG electrode) and does not involve AI or human interpretation in its primary function. Therefore, a comparative effectiveness study involving human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is an electrode, not an algorithm or AI system.

7. Type of Ground Truth Used

• Electrical Performance: Standardized measurements against the specifications outlined in ANSI/AAMI EC12:2000. These are objective engineering and electrical performance metrics.
• Biocompatibility: Results of laboratory tests (e.g., irritation, cytotoxicity, sensitization tests) against established biological evaluation criteria from ISO 10993.
• Shelf Life: Results from accelerated aging studies extrapolated to real-time shelf life.

8. Sample Size for Training Set

Not applicable. This is a medical device, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set for a machine learning model, this question is not relevant.

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The Brainz Instruments Ltd BRM2 Brain Monitor is an Electroencephalograph as per 21 CFR §882.1400 (a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head).

The BRM2 Brain Monitor is intended to monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in the intensive care unit, operating room, and for clinical research.

The BRM2 Brain Monitor is a two-channel EEG device, consisting of skin electrodes, Sensor Lead, Acquisition Unit, Isolation Unit, Serial and Power Cables, Monitor, and Roll-Pole. All components other than the skin electrodes and Sensor Lead are the same as described in 510(k) K030489 for the BRM2 Brain Monitor.

Changes to the BRM2 Brain Monitor consist of using the Neonatal Sensor Set for the EEG skin electrodes, which has two signal electrode pairs and a reference electrode all pre-wired to a single connector. The Sensor Lead has been modified to add a compatible connector for the Neonatal Sensor Set. Products used for skin preparation at the EEG electrode application sites have been made available in a convenience kit.

Here's a breakdown of the acceptance criteria and the study that indicates the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (BRM2 Brain Monitor) seeking substantial equivalence. As such, the level of detail regarding acceptance criteria, study methodologies, and exact performance metrics is often less comprehensive than what would be found in a full scientific publication or clinical trial report. The information is focused on demonstrating equivalence to predicate devices, rather than establishing de novo performance.

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: The document does not explicitly state the sample size used for the clinical testing of the Neonatal Sensor Set.
• Data Provenance: The document does not specify the country of origin for the clinical testing data. It mentions "Clinical testing was carried out," implying it was a prospective study, but doesn't explicitly state "retrospective" or "prospective."

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

• This information is not provided in the document. The clinical test was to demonstrate the effective duration of use for the Neonatal Sensor Set, implying observation of electrode function and patency rather than a diagnostic accuracy study requiring expert adjudication of ground truth for EEG interpretation.

4. Adjudication Method for the Test Set

• This information is not provided as the nature of the clinical test described (electrode duration of use) does not typically involve an adjudication method in the way a diagnostic accuracy study would.

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

• No, an MRMC comparative effectiveness study was not done. The document describes non-clinical and clinical testing focused on the device's technical performance and electrode efficacy, not a comparison of human reader performance with and without AI assistance. The device itself is an electroencephalograph, a signal acquisition device, not an AI-powered diagnostic interpretation tool.

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

• Not applicable / No. This device is an electroencephalograph, which is a hardware device for measuring and recording brain activity. It does not contain an AI algorithm for standalone performance evaluation that would be distinct from human interpretation. The "performance" being evaluated relates to the quality of the signal acquisition and the durability of the electrodes.

7. The Type of Ground Truth Used

• For the electrical safety, biocompatibility, and shelf-life testing, the "ground truth" is adherence to established international and national standards (e.g., IEC 60601-1, UL 2601-1, AAMI EC12).
• For the clinical testing of the Neonatal Sensor Set's effective duration of use, the "ground truth" would likely be direct observation of electrode integrity, signal quality over time, and possibly absence of adverse skin reactions (though not explicitly detailed beyond "acceptable performance"). It relies on objective measurements and clinical assessment, not expert consensus on diagnostic interpretation.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware system for signal acquisition. It does not use a "training set" in the context of machine learning or AI algorithms. The design and validation are based on engineering principles and regulatory standards.

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

• Not applicable for the reasons stated in point 8.

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