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The Physiotrace™Smart is a telemetry device intended for physiological monitoring of men and women above 18 years of age at home, workplace, exercise facilities and alternate care settings. The Physiotrace™ Smart records single lead ECG data for up to 60 minutes during resting and exercise activities; and transmits it to a server for review by healthcare team. The Physiotrace™ Smart is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional.

The Physiotrace™ Smart is not indicated for use on critical care patients. The Physiotrace™ Smart is not indicated for diagnosis of cardiac conditions.

The Physiotrace™ Smart has a wearable design that can be wrapped and fastened around the torso. The device uses dry ECG electrodes and embeds an ECG acquisition unit with a Bluetooth Low Energy transmitter. A mobile application controls the data acquisition, displays the status of the device, heart rate and optionally the ECG waveform during a recording session. The mobile App also stores the ECG and the exercise session information and relays it to a cloud server for permanent storage and review by healthcare staff. The Physiotrace™ Smart is designed to be used without electrolytic gels and without adhesives that necessitate skin preparation.

The Physiotrace™ Smart device is a wearable ECG monitor. The provided text outlines its acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device and meeting recognized standards, rather than providing specific quantitative acceptance criteria for ECG performance parameters in a table format. However, based on the text, we can infer some key performance aspects and how "acceptance" was determined:

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

• Sample Size: The document does not explicitly state the sample size (number of participants) used for the clinical study. It mentions "a clinical study was performed," implying a test set was used.
• Data Provenance: The document does not specify the country of origin. The study was described as a "clinical study performed during the exercise scenario." It is presented as a prospective study given it was an evaluation of the device in use.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study. It mentions the data is transmitted to "a server for review by healthcare team," implying professional review, but specifics are lacking.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication methods like 2+1, 3+1, etc., for the test set interpretation in the clinical study.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The device is an ECG monitor, not an AI-powered diagnostic tool, and the focus is on the accuracy of physiological data acquisition and transmission.

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

The document implies a form of "standalone" assessment in that the device acquires and transmits data for "review by healthcare team." While the device itself doesn't perform diagnosis, its ability to accurately record ECG data for up to 60 minutes was evaluated. The performance comparisons against standards (e.g., 60601-2-47) are a form of standalone performance assessment for the device's signal acquisition capabilities.

7. Type of Ground Truth Used:

For the clinical study, the ground truth for device performance (safety and effectiveness) would likely be based on:

• Clinical observation and assessment: To determine safety and effectiveness during exercise.
• Comparison against reference standards/predicate device: The document states "device performance and safety and effectiveness was found to be equivalent or better than the predicate device," suggesting direct comparison.
• Compliance with recognized physiological monitoring standards: As mentioned for ECG performance (e.g., 60601-2-47).

8. Sample Size for the Training Set:

The document does not mention a training set, as this is typically relevant for machine learning or AI-based devices. The Physiotrace™ Smart appears to be a physiological data acquisition and transmission device, not one that relies on a trained algorithm for its primary function.

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

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

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The HMicro Wired C-Patch ECG Electrode is a single patient use, disposable, radiolucent wired ECG electrode with a silver/silver chloride sensing element designed for short-term, adult ECG monitoring at rest. It is designed to provide a single patch alternative to distributed electrodes. It has been tested using the GE Marquette Eagle 4000 ECG monitor and patient cable and should be used with monitors with equivalent or better sensitivity.

The HMicro, Inc. Wired C-Patch is indicated for ECG monitoring of adults at rest when the upper left chest or center chest is available to place the patch.

The HMicro Wired C-Patch Electrode is a single 3-inch patch electrode designed to be placed on the left upper chest or center chest and used for ECG monitoring. It is disposable and single use. It has five pre-wired electrodes affixed to a 3-inch silicone patch, where wires from the electrodes are pulled through the silicone patch for connecting into the patient monitoring cable.

Here's the information about the acceptance criteria and the study for the HMicro Wired C-Patch Electrode, extracted from the provided text:

Acceptance Criteria and Device Performance Study for HMicro Wired C-Patch Electrode

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

2. Sample size used for the test set and the data provenance

• Sample Size: 15 volunteers (netting usable ECG tracings data from 13 volunteers).
• Data Provenance: The document does not explicitly state the country of origin. It was an engineering study involving volunteers, implying a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish a ground truth or their qualifications. The study focused on the usability of data by comparing ECG tracings from the subject device to a predicate device.

4. Adjudication method for the test set

The document does not describe an adjudication method involving experts for the test set. The comparison appears to have been based on similarity of ECG tracings.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an electrode, not an AI-powered diagnostic system, so the concept of human readers improving with AI assistance is not applicable here.

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

This is not applicable as the device is an ECG electrode, not an algorithm. The study evaluated the ability of the electrode to produce usable ECG data.

7. The type of ground truth used

The "ground truth" in this context was established by:

• Comparison to a predicate device: The 3M Red Dot electrodes, a commercially available and legally marketed device, served as the comparative standard.
• Usable ECG tracings: The primary outcome measured was the similarity of the ECG tracings produced by the HMicro C-Patch to those from the predicate device.

8. The sample size for the training set

This is not applicable. The device is hardware (an ECG electrode), not a machine learning algorithm that requires 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 device.

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The BioModule 3-M1 is a physiological monitoring telemetry device intended for monitoring ambulatory patients in alternate care settings. The device consists of adhesive electrodes and an electronics module. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioModule 3-M1 provides a facility to detect and transmit single lead ECG signals to be received by qualified instruments.

The BioModule 3-M1 collects and transmits measurements captured in alternate care settings as prescribed by the health care professional. Breathing rate values are accurately transmitted only during sedentary periods.

The BioModule 3-M1 is indicated for use as a general patient monitor to provide physiological information as part of general ward monitoring system.

The BioModule 3-M1, a physiological sensor / transmitter is composed of:

• proprietary hardware and firmware, enclosed in
• a user case (puck) with a re-chargeable battery. .
• . a adhesive electrode set and
• A cradle (to recharge battery and transfer internally stored date to an ancillary computer).

The BioModule 3-M1 is a physiological transmitter manufactured by Zephyr Technology Corporation with disposable, off the shelf electrodes that transmits data to a qualified receiving station. The BioModule 3-M1 is positioned against the patient's skin with light pressure then pressed to adhere.

The document provided is a 510(k) summary for the BioModule 3-M1, a physiological monitoring telemetry device. It focuses on establishing substantial equivalence to a predicate device (BioHarness 3.0, K113045) rather than on presenting a detailed study proving performance against specific acceptance criteria for the algorithm's accuracy.

Therefore, many of the requested details about acceptance criteria, specific study design elements (like sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies), and "reported device performance" in terms of algorithm accuracy, are not present in this type of regulatory submission.

The document primarily states general safety and effectiveness and claims that the device has been tested to confirm these. It emphasizes the similarity in technological characteristics and principles with its predicate device.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and what is explicitly not available:

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

• The document does not provide a specific table of acceptance criteria (e.g., minimum sensitivity, specificity, accuracy for ECG detection or heart rate measurement) or quantitative reported device performance metrics against such criteria.
• Instead, it states: "A series of factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life." This is a general statement about manufacturing quality control rather than a clinical performance study.
• The primary "performance" discussed is the capability to "detect and transmit single lead ECG signals" and that "Breathing rate values are accurately transmitted only during sedentary periods." These are functional descriptions, not quantitative performance metrics.

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

• Not provided. The document does not describe a test set or clinical study with patient data. It refers to "factory tests."

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)

• Not applicable / Not provided. Since there's no described test set with clinical data requiring expert ground truth, this information is not present.

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

• Not applicable / Not provided. No clinical test set or adjudication process is mentioned.

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 (or at least not described in this document). The device is a physiological sensor/transmitter, not an AI-assisted diagnostic tool that would involve human readers interpreting output.

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

• The document implies that "factory tests" were done to verify signal accuracy. However, no specific standalone algorithm performance study (e.g., sensitivity/specificity for arrhythmia detection) is described. The focus is on the device's ability to capture and transmit physiological signals reliably, rather than the performance of a sophisticated AI algorithm.

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

• Not provided. Given the nature of "factory tests," the "ground truth" would likely be derived from calibrated signal generators or known physiological inputs, rather than clinical data requiring expert consensus or pathology.

8. The sample size for the training set

• Not provided. The document does not describe a machine learning training set.

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

• Not applicable / Not provided. No training set is mentioned.

Summary of what is present:

• Device Description: BioModule 3-M1, a physiological sensor/transmitter composed of hardware, firmware, user case, adhesive electrode set, and a cradle. It captures electrical pulses from the skin via electrodes, converts them to digital signals, processes them, and transmits them.
• Intended Use/Indications for Use: Monitoring ambulatory patients in alternate care settings, providing physiological information (ECG, heart rate, respiration rate, body orientation, activity) as part of a general ward monitoring system. Breathing rate is accurate only during sedentary periods.
• Predicate Device: Zephyr Technology, BioHarness 3.0, K113045.
• Substantial Equivalence Claim: The BioModule 3-M1 is "substantially equivalent" to BioHarness 3.0, with "incidental and not significant" differences. Both use electrodes, convert analog to digital signals, use microprocessors/firmware/signal processing, and transmit signals for ECG waveforms.
• Safety and Effectiveness Justification: "Factory tests are conducted to verify the intended signals are accurate and can maintain a calibrated energy pattern over its useful life."

In essence, this 510(k) summary focuses on demonstrating that the new device is fundamentally similar to an already cleared predicate device, and that its basic function and manufacturing processes ensure safety and effectiveness, rather than detailing a clinical study with stringent acceptance criteria for an AI algorithm's specific performance metrics.

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The subject devices are ECG surface electrodes and will be manufactured in two configurations: one for diagnostic ECG use (CenterRidge Diagnostic ECG Electrode) and one for monitoring ECG use (CenterRidge Monitoring ECG Electrode).

The CenterRidge Diagnostic ECG Electrode is a diagnostic, single use (single patient), disposable ECG electrode. This electrode is intended to acquire ECG signals from the surface of the body. The intended population is adults and pediatrics. The intended duration of body contact is less than 24 hours.

The CenterRidge Monitoring ECG Electrode is a monitoring, single use (single patient), disposable ECG electrode. This electrode is intended to acquire ECG signals from the surface of the body. The intended population is adults and pediatrics. The intended duration of body contact is greater than 24 hours but less than 30 days.

The CenterRidge ECG Electrodes are non-traditional tab electrodes, capable of diagnostic or monitoring use, depending on materials used in construction, and are intended to acquire ECG signals from the surface of the body. Both the CenterRidge Diagnostic ECG Electrode and CenterRidge Monitoring ECG Electrode are of multilayer construction, using medical grade foam or cloth backing material, a silver/silver chloride coated sensing element and solid hydrogel. The raw materials used in the CenterRidge Electrodes are equivalent to the materials used in the predicate legally marketed ECG electrodes specified above. The intended patient population is adult and pediatric. The skin surface contact area and proportional electrode size will be adjusted to fit the specific procedure and patient population.

The primary difference between the CenterRidge Electrodes and the predicate devices are geometry and shape. The 3M Health Care model 2330 and the Bio-Detek model DE1070 are traditional tab electrodes with a tab sensing element located on the perimeter of the electrode, whereas the Team Innovation CenterRidge electrode has the sensing element located within the body of the electrode. The internal location of the CenterRidge sensing element emulates the snap on the Bio-Detek models LT301SG(PSG), LT401SG(PSG) and LT401SG(PSG).

The document describes the acceptance criteria and the study conducted for the CenterRidge Diagnostic ECG Electrode and CenterRidge Monitoring ECG Electrode.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document states that the electrodes "were not clinically tested." Testing was non-clinical, bench testing. Therefore, there is no test set in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set was used. The device underwent non-clinical bench testing for electromagnetic compatibility.

4. Adjudication method for the test set:

Not applicable, as no clinical test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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 for human readers.

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

The device's performance was evaluated in a standalone manner without human-in-the-loop performance in the context of its electrical characteristics. The testing focused on the electrode's ability to conform to electrical standards.

7. The type of ground truth used:

The ground truth for the non-clinical testing was defined by the specifications and requirements of the industry standard ANSI/AAMI EC12:2000/(R)2005 for electromagnetic compatibility and electrical performance.

8. The sample size for the training set:

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

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

Not applicable.

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ECG pre-wired harnessed sets of electrodes for short and long term use; for adults, pediatrics and neonates.

By design and manufacturing process, the IP-SET® ECG electrodes are of multidisciplinary use, and the unit choice is performed by the Physician, in function of the desired application.

Set of disposable, single-use, pre-gelled ECG electrodes are regrouped on a flat cable sole or by pair (dual electrodes) and located to ease their positioning on the patient. Electrode number and positioning design vary according to the monitoring/diagnostics application.

Pre-gelled (hydro-gel) electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 90 mm in diameter or oblong / rectangular shape.

Lead wires are regrouped in a flat cable and are made of copper (radio-opaque) or carbon fiber (radio-translucent).

Sets are supplied non-sterile. Each set / harness is packaged in one OPP/PE laminated pouch (sealed foil); 10 to 50 pouches are supplied per box; Shipping cartons contain 12 boxes.

The provided document, K101685, is a 510(k) summary for Integral-Process's ECG Electrode "IP-SET®". This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study on specific performance acceptance criteria. As such, it does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding specific acceptance criteria and detailed study results from a clinical trial or performance study.

The document primarily relies on comparisons to legally marketed predicate devices and compliance with relevant standards. Here's what can be inferred from the provided text regarding device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" (e.g., in terms of sensitivity, specificity, accuracy, or electrical performance thresholds) and reported device performance (e.g., percentages, mean improvements) from a dedicated study are provided. The device performance is generally stated as being "at least as well as other disposable ECG electrodes" based on comparison to predicate devices and compliance with standards.

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

Not applicable. The document does not describe a performance study with a test set. Substantial equivalence is demonstrated through technological comparisons and compliance with relevant standards.

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

Not applicable. There is no mention of a test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method is described.

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

No MRMC study was conducted or reported. This device is an ECG electrode, not an AI or image-based diagnostic tool that would typically undergo an MRMC study to compare human reader performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This device is a physical medical device (ECG electrode), not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

Not applicable. There is no mention of a primary ground truth established through expert consensus, pathology, or outcomes data. The "ground truth" for demonstrating substantial equivalence for this type of device relies on established performance characteristics of the predicate devices and compliance with recognized standards.

8. Sample Size for the Training Set:

Not applicable. This document pertains to the 510(k) clearance of a physical medical device (ECG electrode), not an AI or machine learning model that would require 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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The Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X electrodes are made for ECG monitoring of neonatal and paediatric patients. The ECG electrodes are applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. The electrodes are for single patient use only.

Ambu® Blue Sensor NEO/NEO X is non-sterile, self-adhesive ECG electrodes. Ambu® Blue Sensor NEO/NEO X should only be used by or on the order of a physician. Ambu® Blue Sensor NEO/NEO X is single patient use disposable devices. Ambu® Blue Sensor NEO/NEO X is a multi-layer construction containing a pre-attached lead wire with an attached connector, a top disc, a top film, a sensor, a hydrogel, and a medical adhesive. The NEO/NEO X electrodes can be used for all pediatric populations (including neonates) The adhesive on the NEO/NEO X electrodes is suitable in the high humidity environment in the incubators and still gentle to the fragile neonatal skin.

The primary document provided is a 510(k) summary for the Ambu® Blue Sensor NEO/NEO X disposable ECG electrodes. The study described focuses on demonstrating the substantial equivalence of the new device to previously marketed predicate devices, rather than a clinical efficacy study with human subjects.

Here's an analysis based on the provided text, addressing your specific questions:

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 for Test Set: The document describes non-clinical laboratory tests. It does not specify the sample size of electrodes used for these tests.
• Data Provenance: The tests are stated as "laboratory tests," implying they were conducted in a controlled environment. The country of origin of the data is not specified, but the manufacturer (Ambu A/S) is based in Denmark. The tests are prospective in the sense that they were conducted specifically for this 510(k) submission.

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)

Not applicable. This was a non-clinical study evaluating physical and biological properties against established standards, not a study requiring expert interpretation of diagnostic output to establish ground truth.

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

Not applicable. There was no expert review or adjudication of diagnostic performance. The tests were objective measurements against predefined 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 MRMC comparative effectiveness study was done. This device is a disposable ECG electrode, which is a hardware component for acquiring physiological signals. It does not involve AI or human readers for interpretation in the context of this 510(k) submission.

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

No standalone algorithm performance study was done. This document pertains to electrodes, not an algorithm.

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

The "ground truth" for this device's performance was established by recognized industry standards:

• ANSI/AAMI EC12:2000 for electrical and mechanical functionality.
• ISO 10993-1, ISO 10993-5, and ISO 10993-10 for biocompatibility.

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 for this device.

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INTCO Tab Electrodes are designed for use with general electrocardiographic procedures when ECG monitoring is deemed necessary by a physician. Such procedures include ECG surveillance and diagnosis recording. INTCO Tab Electrodes are non-sterile and are to only be used on intact (uninjured) skin.

INTCO Tab electrodes are composed of PET tape, Ag/AgCl or carbon conductive layer, and a conductive gel. These are configured as ten electrodes applied to a siliconized card, with 10 cards per pouch

The provided 510(k) summary describes the Intco Tab Electrode, a disposable ECG electrode. This device does not involve AI or algorithms, so the majority of the requested information about AI model performance, training sets, and expert adjudication is not applicable.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

Study Details

The submission focuses on demonstrating substantial equivalence to a predicate device (Leonard Lang GmbH Skintact ECG Tab Electrode K030509) by showing compliance with recognized consensus standards and comparable physical/technical characteristics.

1. Sample size used for the test set and the data provenance: Not explicitly stated as a clinical study with a "test set" in the context of an AI model. The performance evaluation is based on conformance to industry standards and biocompatibility testing. For the standards testing, specific sample sizes for tests within ANSI/AAMI EC12:2000/(R)2005 are not detailed, but standard conformance implies appropriate sampling for those tests. The data provenance is generally from laboratory testing performed by the manufacturer.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study requiring expert-established ground truth for an AI model. Biocompatibility testing results are laboratory-derived, and standard conformance is assessed against defined technical parameters.

3. Adjudication method for the test set: Not applicable. There is no expert adjudication process described.

4. 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 diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have an algorithm.

6. The type of ground truth used:

   • Standard Conformance: The "ground truth" is defined by the technical specifications and test methods outlined in the ANSI/AAMI EC12:2000/(R)2005 standard for disposable ECG electrodes. The device performance is measured against these established parameters.
   • Biocompatibility: The "ground truth" is established by the accepted scientific methodologies for assessing irritation, cytotoxicity, and sensitization as defined in ISO 10993-1.

7. The sample size for the training set: Not applicable. This device does not utilize a training set as it is not an AI/machine learning device.

8. How the ground truth for the training set was established: Not applicable.

Summary of Device Evaluation:

The INTCO Tab Electrode's acceptance criteria and proven performance are primarily based on:

• Conformance to the ANSI/AAMI EC12:2000/(R)2005 consensus standard, which specifies requirements for characteristics such as impedance, DC offset, combined offset and offset instability, and input noise performance for disposable ECG electrodes. The submission states the device "have been tested and conform to recognized consensus standard."
• Biocompatibility testing according to ISO 10993-1, which demonstrated the conductive gel to be non-irritating, non-cytotoxic, and non-sensitizing.
• Accelerated aging tests to substantiate a 24-month shelf life.

The submission aims to demonstrate substantial equivalence to a legally marketed predicate device by showing that the INTCO Tab Electrode meets these established performance and safety benchmarks.

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The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 97 - 104 cm.

The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram.

I am sorry, but the provided text from the FDA 510(k) letter does not contain the specific information required to answer your questions regarding the acceptance criteria, study details, and performance of the "12 Lead Glove" device.

The document is a clearance letter indicating that the device has been found substantially equivalent to a predicate device, allowing it to be legally marketed. It specifies the trade/device name, regulatory number, regulation name, regulatory class, product code, and the date of the 510(k) submission and review. It also includes the "Indications for Use" for the device, which states:

"The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 97 - 104 cm."

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
5. Details on standalone algorithm performance.
6. The type of ground truth used in studies.
7. Sample size or ground truth establishment for the training set.

To obtain this information, you would typically need to refer to the full 510(k) submission document, which would contain the clinical or non-clinical testing data that the FDA reviewed to make its substantial equivalence determination. This letter is merely the outcome of that review.

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These electrodes are to be used in the neonatal or pediatric unit of hospitals for the resting ECG monitoring of newborn and premature birth infants. They are applied to the surface of the body, single use only, and disposable. These electrodes should be changed every 24 hours.

The Neonatal ECG Electrodes are three prewired ECG electrodes supplied on the same release card in a single package. The electrodes are a multi-layer construction containing a first layer surface (made of tricot/polyester fabric, polyethylene foam, or polypropylene substrate), a second layer ( metallic with Ag/AgCl coating ) prewired for connection to patient leadwires, and a third layer (made of biocompatible conductive hydrogel coupling media) The electrodes are placed on the neonate patient's chests.

Here's a breakdown of the acceptance criteria and study information for the Neonatal ECG Electrodes (KD912744), based on the provided document:

This 510(k) summary does not describe an AI/ML device or a comparative effectiveness study involving human readers with and without AI assistance. The device is a traditional medical device (ECG electrodes) and the testing focuses on its physical and electrical performance against recognized standards. Therefore, many of the requested categories (like MRMC study, standalone algorithm performance, training set details, and expert qualifications for ground truth) are not applicable to this submission.

1. Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria was primarily bench testing to assess electrical characteristics and biocompatibility testing. The submission explicitly states:

• "The Neonatal ECG Electrodes and the predicate devices all meet the specifications as established in ANSI/AAMI EC12:2000/(R) 2005 and ANSI/AAMI EC53:1995/(R) 2008."
• "Biocompatibility testing was performed, and the device passed the required skin sensitivity testing criteria."
• "Bench testing demonstrated that the characteristics of the Neonatal ECG Electrodes are substantially equivalent to those of the predicate devices."

The conclusion is that "Test results support the conclusion that the electrical output is substantially equivalent to the predicate devices, and there are no differences in construction and materials between the devices to pose new questions of safety or effectiveness."

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the electrical performance bench tests. For biocompatibility, it states "Biocompatibility testing was performed," but does not detail the number of samples or subjects.
• Data Provenance: The data is from bench testing (electrical and physical characteristics) and biocompatibility testing. The country of origin is not explicitly stated, but it would be expected to be from controlled laboratory environments. The nature of these tests is inherently prospective as they are conducted specifically for the device submission.

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

• Not Applicable. This is a hardware medical device (ECG electrodes). Ground truth in this context refers to established technical standards (ANSI/AAMI EC12 and EC53) and laboratory measurements, not expert review of images or clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. As noted above, this involves technical measurements against standards, not subjective assessments requiring adjudication.

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

• No. An MRMC study was not done. This type of study is relevant for AI/ML diagnostic aids where human interpretation is involved. This device is an electrode.

6. Standalone Performance Study (Algorithm Only)

• No. This is a hardware device; there is no "algorithm" in the sense of AI/ML software for standalone performance evaluation.

7. Type of Ground Truth Used

• Technical Standards and Lab Measurements: The ground truth for this device's performance is defined by the requirements outlined in ANSI/AAMI EC12:2000/(R) 2005 (for ECG electrodes) and ANSI/AAMI EC53:1995/(R) 2008 (for biocompatibility and skin contact). The device's performance was measured against these objective standards.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. There is no training set for this type of device.

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The Easyrode is intended for use in ECG Monitoring. The Easyrode can be used in all ECG applications where standard ECG monitoring electrodes are used. This electrode can be used for short term and long term (2 Days) monitoring.

Easyrode is a self-adhesive, non-sterile, single use disposable electorode which includes a silver/silver chloride sensing element and conductive gel. These electrodes include a pressure sentive adhesive non-woven tape which hold the conductive elements of the electrodes in place on the patient's skin for short or long term ECG procedures.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with statistical results proving the device meets said criteria for the "Easyrode Disposal ECG Electrodes, Model Easyrode." The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with performance metrics.

However, based on the information provided, here's what can be extracted and inferred regarding the "acceptance criteria" and "study":

The "acceptance criteria" in this context are primarily informal, focusing on demonstrating that the Easyrode performs "as well as" the predicate device in fundamental ECG monitoring functionalities and meets general safety and effectiveness standards for such devices.

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on Available Text):

The document does not describe a clinical trial or a specific standalone study with statistical results to prove performance against pre-defined acceptance criteria in the way one might expect for a novel device. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "study" mentioned abstractly ("The results of these measurements demonstrated...") refers to comparative testing and analysis against the predicate device to support this equivalence. No details of these "measurements" are provided.

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

• Sample Size: Not specified. The document states "The results of these measurements," implying some form of testing was done, but no specifics on the number of electrodes tested, number of subjects, or duration of testing are provided.
• Data Provenance: Not specified. The manufacturer is based in Japan (SUZUKEN CO, LTD.). The context implies tests were likely conducted by the manufacturer or on their behalf, but the location and whether it was retrospective or prospective data are not provided.

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

• This information is not provided. Given the nature of a 510(k) for an ECG electrode, ground truth likely pertains to technical performance measurements (e.g., impedance, adhesion, signal quality) rather than expert clinical interpretation of ECGs produced by the electrodes. If human evaluation was part of the "measurements," no details are included.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. There is no mention of a human adjudication process for establishing ground truth, as the 'measurements' likely pertain to technical specifications rather than diagnostic output requiring clinical consensus.

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

• No. An MRMC study is typically associated with diagnostic imaging or interpretation where multiple readers evaluate medical cases. This type of study is not relevant or described for a disposable ECG electrode, which is a physical component, not an AI diagnostic tool.

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

• Not applicable/No. This device is a passive, disposable ECG electrode. It does not involve an algorithm or AI. Performance is inherently "standalone" in the sense that it's the electrode's physical properties being measured, but not an algorithm's.

7. The Type of Ground Truth Used

• Inferred Technical Performance Data/Comparison to Predicate: The "ground truth" (or basis for comparison) was the performance characteristics of the legally marketed predicate device (3M Red Dot 2560 Monitoring Electrode). "Measurements" were conducted to demonstrate that the Easyrode performs "as safe, as effective, and performs as well as" the predicate. This would typically involve measuring electrical characteristics (e.g., impedance, DC offset, AC impedance, defibrillation recovery), adhesion properties, and biocompatibility, all compared against established standards or the predicate's known performance. No specific details on which data types were collected are in the summary.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device (an electrode), not an AI algorithm. Therefore, 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 physical device, this question is not relevant.

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