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Intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on neonatal and pediatric patients.

A neonatal ECG monitoring electrode consisting of a conductive adhesive gel, a silver/silver chloride plated eyelet, a foam substrate and vinyl label and a 24 inch lead wire terminating in a 0.059" DIN standard safety socket.

Here's a breakdown of the acceptance criteria and the study details for the Graphic Controls Corporation Medi-Trace® 4103 Neonatal ECG Electrode with Preattached Lead Wire, based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The document states that the modified device was found "comparable" to the predicate for ECG trace quality. Specific quantitative metrics for ECG trace quality or a detailed comparison are not provided.

Study Details

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

   • The document does not specify the exact sample size for the test set used in the performance summary. It broadly states that "the device and the predicate were subjected to AAMI electrical tests" and implies a comparison.
   • The data provenance is not explicitly mentioned (e.g., country of origin). The testing seems to have been conducted by the manufacturer, Graphic Controls Corporation.
   • The nature of the data (retrospective or prospective) is not indicated, but given the context of device testing for a premarket notification, it would typically be prospective testing conducted by the manufacturer.

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

   • This information is not provided in the document. The performance tests appear to be objective electrical and biocompatibility assessments against standards rather than expert-derived ground truth. For "ECG trace quality," it's mentioned as comparable to the predicate, but the methodology for this comparison (e.g., expert review vs. automated measurement) is not detailed.

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

   • There is no mention of an adjudication method. The reported performance is based on meeting voluntary standards for electrical characteristics and biocompatibility testing.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is an ECG electrode, not an AI-powered diagnostic tool, so such a study would not be applicable.

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

   • Not applicable. This device is a physical medical device (an electrode) and does not involve an algorithm or AI.

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

   • The "ground truth" for the electrical tests and biocompatibility was defined by the specifications of the ANSI/AAMI DF-12, 1991 voluntary standard and the recommendations in the ISO-10993 Biological Evaluation of Medical Devices Part 1. For "ECG trace quality," the ground truth was the performance of the legally marketed predicate device.

7. The sample size for the training set:

   • Not applicable. This device is a physical electrode and does not utilize a training set in the context of machine learning or algorithms.

8. 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 Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode is intended for use in defibrillation procedures, cardioversion, pacing and ECG monitoring on adults.

A pre-gelled conductive electrode consisting of a pre-attached leadwire, and insulating layer of a vinyl substrate, a secondary vinyl piece covering the crimped wire connector, a layer of metal foil, a conductive adhesive hydrogel, a pressure sensitive adhesive (PSA) ring and a release liner. Device is packaged in pairs in a heat sealed pouch; 10 pouches are packaged into one shelf box shipper.

This document describes the performance summary for the Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided summary does not explicitly state the numerical sample size for the test set used in the performance studies. It mentions "the device and the predicate device" were subjected to AAMI electrical tests and energy throughput testing, and "the device" was subjected to simulated use testing. This implies a comparative study against a predicate device and then simulated usage for the new device.

The data provenance (country of origin, retrospective/prospective) is not specified. However, given that this is a 510(k) submission to the FDA, the testing would have been conducted to meet US regulatory requirements, likely by the manufacturer, Graphic Controls Corporation, based in Buffalo, NY, USA. The studies would be considered prospective for the purpose of demonstrating substantial equivalence.

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

This type of device (defibrillation, monitoring, and pacing electrode) typically does not involve human expert interpretation for "ground truth" in the same way an imaging or diagnostic AI device does. The "ground truth" here is defined by the technical specifications and performance standards outlined in AAMI DF-39. The validation involves objective measurements against these predefined engineering and safety standards. Therefore, no "experts" with specific clinical qualifications like radiologists would be used to establish a ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable for this type of device and study. The testing involves direct measurement against specified performance criteria as outlined by AAMI DF-39. There is no human interpretation or subjective assessment that would require adjudication.

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

No. This document does not describe an MRMC comparative effectiveness study. The device is a medical electrode, and its performance is evaluated based on technical specifications and functional testing, not on human reader performance with or without AI assistance. There is no AI component mentioned in the context of improving human reader performance.

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

Yes, in essence. The performance studies described (electrical tests, energy throughput, simulated use, biocompatibility, shelf life) are all evaluating the device itself, functioning independently, against pre-defined technical and safety standards. There is no "human-in-the-loop" component in assessing the intrinsic performance of the electrode. These are tests of the physical device's characteristics and functionality.

7. Type of Ground Truth Used

The ground truth for this device's performance evaluation is based on:

• Established Technical Specifications and Standards: Primarily the requirements outlined in AAMI DF-39 for self-adhesive electrodes for monitoring and defibrillation and pacing.
• Biocompatibility Standards: ISO-10993, Part I.
• Functional Performance Benchmarks: The ability to perform its intended functions (defibrillation, pacing, ECG monitoring) within acceptable parameters during simulated use.

8. Sample Size for the Training Set

Not applicable. This device is a physical electrode, not a software algorithm or AI 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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The Softrans® Temp UPC & System may be used during the intrapartum period to monitor intrauterine pressure, to monitor intrauterine temperature, to amnioinfuse or to perform amniotic fluid sampling.

An intrauterine catheter with a pressure transducer at the tip, a thermistor located near the tip, a port for amnioinfusion and amniotic fluid sampling, signal wires, and an introducer which is removed after placement. System includes a reusable cable that contains a rezero mechanism, cable check and temperature display unit. An attachment strap is provided.

This 510(k) summary describes a medical device, the Softrans® Plus Intrauterine Pressure Catheter System (IUP 5000 Softrans® Plus IUPC), which is intended to monitor intrauterine pressure and temperature during labor, and to facilitate amnioinfusion or amniotic fluid sampling.

Here's an analysis of the provided information, structured according to your request:

Acceptance Criteria and Reported Device Performance

The provided document states: "FDA has not established special controls or performance standards for this device. Graphic Controls has established its own specifications and the product meets or exceeds those specifications."

This indicates that external, regulatory acceptance criteria were not predefined by the FDA for this specific device at the time of submission. Instead, the manufacturer, Graphic Controls, developed its own internal specifications. The document does not explicitly list these internal specifications. Therefore, a table of acceptance criteria and reported performance cannot be fully constructed from the provided text.

However, based on the description of the device's functionality and the comparison to predicate devices, the implied performance criteria would be:

Study Details

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed performance statistics.

Here's how the other requested study information applies:

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

   • The 510(k) summary does not mention any specific clinical study sample sizes or patient data related to the performance of the device's pressure or temperature measurement functions. The primary "test set" for this submission appears to be comparisons of the device's design, technology, and functionality to predicate devices and established standards, rather than direct patient outcome data from a large cohort.
   • For biocompatibility, it states: "Biocompatibility This device was subjected to biocompatibility testing and the data was submitted with the predicate device notification." This implies a previous study with the predicate, but details are not provided here.

2. 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 in the context of this 510(k) summary, as it does not describe a clinical study requiring expert ground truth establishment for a test set. Substantial equivalence relies on comparing the new device's technical characteristics and intended use to a predicate.

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

   • Not applicable as no clinical study with expert adjudication is described in the provided document.

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 a medical monitoring instrument (catheter system), not an AI-assisted diagnostic tool involving human readers/interpreters.

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

   • Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent in its measurement capabilities, which would be validated through engineering tests and comparison to predicate devices, not algorithm-only performance.

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

   • For the biocompatibility aspect, the ground truth was derived from specific biocompatibility tests (e.g., irritation, cytotoxicity, sensitization) following established standards.
   • For the functional performance of pressure and temperature measurement, the ground truth would typically be established by calibrated reference instruments or established measurement standards, against which the device's readings are compared. The document implies these internal tests were conducted as it states "the product meets or exceeds those specifications," but it doesn't detail them.
   • For substantial equivalence, the "ground truth" is the performance and safety profile of the legally marketed predicate device (Softrans® IUPC System and Welch Allyn (DIATEK) SureTemp Thermometer).

7. The sample size for the training set:

   • Not applicable within this 510(k) summary, as it describes a hardware medical device and not a machine learning model that would require a training set.

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

   • Not applicable, as there is no training set mentioned or implied for this device's submission.

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Intended for use in defibrillation procedures, cardioversion and pacing. This device is intended for use on adults and pediatric patients weighing over 10kg.

A pre-gelled conductive electrode consisting of a pre-attached leadwire, an insulating layer of a vinyl substrate, a layer of metal foil, a conductive adhesive hydrogel, a pressure sensitive adhesive ring and a release liner. Device is packaged in pairs in a heat sealed pouch; 10 pouches are packaged into one shelf box shipper.

The provided text describes the 510(k) summary for the Medi-Trace® 1310P Combination Defibrillation, Monitoring and Pacing Electrode. Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "the device and the predicate were subject to AAMI electrical tests" and "the device was subjected to simulated use testing." However, it does not specify the sample size for the test set used in any of these tests.

The data provenance is not explicitly stated, but the tests appear to be conducted by the manufacturer, Graphic Controls Corporation, in their facility (189 Van Rensselaer Street, Buffalo, NY). These are likely prospective tests conducted during the development and validation of the device. There is no information provided about countries of origin if external data were used.

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

This information is not provided in the document. The performance evaluation relies on meeting specifications established in AAMI DF-39 and ISO-10993, which are standards-based, rather than relying on expert ground truth in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided in the document. The testing described is against established technical standards (DF-39) and biocompatibility standards (ISO-10993), not against adjudicated clinical observations or diagnostic interpretations.

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 typically associated with diagnostic imaging or interpretative AI systems where human readers evaluate cases. The Medi-Trace® 1310P is an electrode, and its performance is evaluated against physical and electrical standards, not human diagnostic accuracy.

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

This concept is not applicable to this device. The Medi-Trace® 1310P is a medical device (electrode), not an algorithm or AI system. Its performance is inherent to its physical and electrical properties.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on pre-established engineering and biological standards:

• AAMI DF-39: This standard defines performance requirements for self-adhesive defibrillation and pacing electrodes.
• ISO-10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing: This standard provides guidelines for biocompatibility testing.
• Manufacturer-established specifications: Implicitly, the manufacturer sets internal specifications based on these standards.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided in the document. As this is not an AI/ML device, 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 in the document, as there is no training set for this device.

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Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing Electrode is intended for use on adults. Not for use on children or infants.

A pre-gelled conductive elecrode consisting of a means of attaching the electrode to the cable, an insulating layer of vinyl, a layer of metal foil, a conductive adhesive hydrogel. a pressure sensitive adhesive ring and a release liner. Device is packaged in pairs in a heat sealed pouch, 10 pouches are packaged into one shelf-box/shipper

This 510(k) summary describes a medical device, the Medi-Trace® 1510M Combination Defibrillation, Monitoring and Pacing Electrode, and its performance against established standards. However, it does not describe an AI device. The document predates widespread AI in medical devices and focuses on physical and electrical device performance rather than algorithmic performance.

Therefore, many of the requested criteria related to AI/algorithm performance (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to this submission.

Here's an analysis based on the provided text, focusing on what is available:

Acceptance Criteria and Reported Device Performance

Study Details (where applicable to a non-AI device):

1. Sample size used for the test set and the data provenance: Not explicitly stated as this is a physical device. The testing was done on the device and its predicate. The provenance would be the manufacturing facility, Graphic Controls Corporation, in Buffalo, New York, USA. The testing would be prospective, as new devices were manufactured and tested.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance is typically established by established engineering standards and validated test methods, not expert clinical consensus in the way an AI algorithm might be.
3. Adjudication method for the test set: Not applicable. The "ground truth" for electrical and physical performance is defined by the AAMI DF-39 standard specifications. A pass/fail determination against these specifications would be direct, not requiring expert adjudication in the classic sense.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable. This is not an AI device.
6. The type of ground truth used: Engineering standards (AAMI DF-39) and established biocompatibility testing protocols (ISO-10993).
7. The sample size for the training set: Not applicable. This is not an AI device, so there is no "training set."
8. How the ground truth for the training set was established: Not applicable.

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The Point of Use II Sharps-A-Gator® will be used as a sharps container/disposal system. It can be used in any area requiring sharps collection prior to their final disposal. e.g. operating room, emergency room, patient room, pediatrics, doctor's office etc. The Point Of Use II Sharps-A-Gator® is for single use only and must be disposed of after its maximum capacity level is reached.

Devon's Point of Use II Sharps-A-Gator" wil: be used as a single use only container . for sharps collection/disposal. The Point of Use II Sharps-A-Gator® comes in 2 3 -7- 5 gallon and 2.8 +/- 5 gallon . containers. Both container buckets are available in clear. translucent and opaque color versions. The top housing assembly and base are made of polypropylene plastic material and processed through injection molding. The top cover includes the top cover housing, moving tortuous path with an actuator, a flapper and a lid. These components are assembled during the manufacturing process. The base is joined with the top cover assembly by the end user. The assembled container can be secured to a locking bracket or into a cabinet, or used as a free standing unit. The Point of Use II Sharps-A-Gator" has a horizontal top load opening and a moving tortuous path with an actuator that enable the user to "flush" sharps that lodge in the tortuous path without reaching into the container. The Point of Use II Sharps-A-Gator® moving tortuous path restricts hand entry. The Point of Use II Sharps-A-Gator" is made with heavy metal free materials that . are safe to incinerate and autoclave.

The provided text describes the Point of Use II Sharps-A-Gator™ device, a sharps collection and disposal system. The information is from a 510(K) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results for acceptance criteria.

Therefore, the requested information regarding acceptance criteria and performance study details (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, ground truth establishment, training set size) is largely absent from the provided text.

However, I can extract the stated acceptance criteria and the general claim of compliance.

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not available in the provided text):

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests mentioned (ASTM, ECRI, OSHA) are standards, but the specific testing data provenance is not detailed.

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

• Not applicable/Not specified. The performance tests appear to be physical/mechanical tests against established standards, not requiring expert ground truth establishment in the diagnostic sense.

4. Adjudication method for the test set:

• Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in subjective assessments (e.g., image interpretation), which is not the nature of these engineering and safety tests.

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 a physical sharps container, 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 is a physical device, not an algorithm.

7. The type of ground truth used:

• For the physical performance tests, the "ground truth" would be the successful completion of the test criteria outlined by the respective standards (ASTM Draft #17 for puncture resistance, ECRI for functional drop, OSHA for leak resistance).

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI model that requires a training set.

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

• Not applicable.

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Intended for use in measuring the intensity, duration, and frequency of uterine contractions during labor. Also, the catheter may be used for amnioinfusion of fluid into the uterus or to sample amniotic fluid.

An intrauterine catheter with a pressure transducer at the tip, a port for amnioinfusion and amniotic fluid sampling signal wires, and an introducer which is removed after placement. System includes a reusable cable with a zero mechanism and an attachment strap. Catheters are packaged within a PETG tray with a heat sealed tyvek lid. Unit of sale is a case of 10 IUPC's.

The provided text describes a 510(k) Summary for a medical device called the Softrans™ Intrauterine Pressure Catheter System (IUP 4000 Softrans™ IUPC). This is a premarket notification for a Class II medical device, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specified acceptance criteria for novel performance metrics.

Based on the provided information, I can answer some of your questions and explain why others cannot be answered:

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

The document explicitly states: "FDA has not established special controls or performance standards for this device. Graphic Controls has established its own specifications and the product meets or exceeds those specifications."

Therefore, specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy, etc.) and their corresponding reported performance values are not provided in this document. The "performance summary" refers to the device meeting its internal specifications, which are not detailed here.

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. The document describes a "Performance Summary" and "Biocompatibility Testing," but these are general statements and do not detail the methodology, sample sizes, or provenance of any testing data beyond the biocompatibility section which refers to data submitted with the predicate device notification.

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. The device is an intrauterine pressure catheter, which measures physical parameters (uterine contraction intensity, duration, frequency). Its "ground truth" would be direct physical measurements by the device itself or comparison to other established measurement methods, not typically expert consensus on image interpretation.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reviewing images), which is not the primary focus for validating this type of medical device.

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 provided and is not applicable to this device. This document is for a physical medical device (an intrauterine pressure catheter), not an AI-powered diagnostic or interpretive tool that would involve "human readers" or "AI assistance."

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

This information is not applicable as this is not an algorithm-only device. It's a physical medical device for measuring physiological parameters.

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

Since the device measures physical parameters (uterine contractions), the "ground truth" would inherently be the physical measurement itself or comparison against a known, validated standard for pressure measurement. The document does not specify the exact type of ground truth used for any performance testing, other than stating internal specifications were met.

8. The sample size for the training set

This information is not provided. As this is a physical medical device and not an AI/machine learning system, the concept of a "training set" in the context of data for model development does not apply. If "training set" refers to samples used during the device's design verification, that detail is not included.

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

This information is not provided and is not applicable for the reasons stated in point 8.

Summary of Device and Performance Information Provided:

The Softrans™ Intrauterine Pressure Catheter System is intended for measuring uterine contractions during labor and for amnioinfusion/fluid sampling. Its performance summary states that "Graphic Controls has established its own specifications and the product meets or exceeds those specifications."

The document primarily focuses on demonstrating substantial equivalence to a predicate device (also named Softrans™ Intrauterine Pressure Catheter System) based on:

• Physical and technical characteristics: Stated as "comparable," including materials and size.
• Intended Use: Identical to the predicate.
• Biocompatibility: Testing was done, and data from the predicate device notification was submitted. The device was found to be non-irritating, non-cytotoxic, and non-sensitizing.
• Sterility: Sold as a sterile unit (except for the reusable cable).

This 510(k) summary is designed to show the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed clinical trials with acceptance criteria for novel performance claims.

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Intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician.

A conductive wet gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated ABS cyelet, nickel plated brass stud, an adhesive foam substrate, vinyl label and polystyrene release liner. Electrodes are packaged either as 100 per pouch (Medi-Trace® 200) or 30 per pouch (Medi-Trace® 200-30); pouches are heat sealed. Unit of sale for each packaging is a case of either 600 or 1000 electrodes.

This document describes a 510(k) summary for ECG electrodes, which are hardware devices and do not involve AI or algorithms. Therefore, much of the requested information (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) is not applicable.

However, I can extract the acceptance criteria and performance summary related to the physical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• This information is not explicitly provided in the document. The tests performed are for device performance as per AAMI standards.
• Data provenance is not specified, but the testing would have been conducted by or for Graphic Controls Corporation.

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

• Not applicable as this is a hardware device. Device performance is measured against established industry standards (AAMI EC12-1991) and internal specifications, not expert-established ground truth in a diagnostic sense.

4. Adjudication method for the test set:

• Not applicable. Performance is measured against objective standards, not through expert 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, as this is a hardware device (ECG electrode), not an AI algorithm.

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

• Not applicable, as this is a hardware device (ECG electrode), not an AI algorithm.

7. The type of ground truth used:

• The "ground truth" here is the set of specifications and performance requirements outlined in the AAMI EC12-1991 standard for Disposable ECG Electrodes, as well as Graphic Controls' internal specifications and the biocompatibility standards of ISO 10993.

8. The sample size for the training set:

• Not applicable, as this is a hardware device (ECG electrode), not an AI algorithm.

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

• Not applicable, as this is a hardware device (ECG electrode), not an AI algorithm.

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