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The ibiomedi Electronic Stethoscope ES-2020 is used to detect sound from the heart, arteries, veins, breathing sounds from the anterior/lateral chest and throat sounds in the neck. The chest piece is designed for children who are over two years old, teenagers and adults. It can be applied to any body type and can only be used for the purpose of medical diagnosis in clinics or hospitals.

The ibiomedi Electronic Stethoscope ES-2020 detects sounds from the heart, arteries, veins, breathing sounds from the anterior/posterior/lateral chest and throat sounds in the neck of patients. The sounds are transmitted to the user's ears through accessories such as earphones.

User interface includes A: Power button, frequency response mode button, volume button B: Power indicator, wireless transmission indicator, frequency response mode indicator, volume indicator.

Turn on the ibiomedi Electronic Stethoscope ES-2020 and connect to the wireless device via Bluetooth to transmit and store sounds. When the ibiomedi Electronic Stethoscope ES-2020 and the connected wireless device have walls, human bodies and other barriers, the effective range of Bluetooth transmission will be affected. It is recommended to reduce the distance between the ibiomedi Electronic Stethoscope ES-2020 and the connected wireless device to improve Bluetooth connection.Power to the device is provided by two AAA 1.5V batteries.

The associated accessories include.

• Small chest piece: For children with diaphragm. .
• Large chest piece: For adult with diaphragm.
• Audio line: For connecting external speakers.
• . 1MORE Earphones: For medical personnel to connect the ibiomedi Electronic Stethoscope ES-2020.

The provided text describes the ibiomedi Electronic Stethoscope ES-2020 which is used to detect sounds from the heart, arteries, veins, breathing sounds, and throat sounds. The text focuses on establishing substantial equivalence to a predicate device, as required by a 510(k) submission.

Here's an analysis of the acceptance criteria and study information provided in the document:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance for direct clinical efficacy or diagnostic accuracy. Instead, the performance data provided focuses on:

• Followed modified ISO 10993-10:2010 (Irritation and Skin Sensitization), ISO 10993-5:2009 (Cytotoxicity).
• Tests included Guinea Pig Maximization Test (GPMT), Skin irritation test in rabbits, and Cytotoxicity study. |
  | Electrical Safety & Electromagnetic Compatibility (EMC) | - Complies with IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012; EN 60601-1: 2006 + A1: 2013; AAMI/IEC 60601-1:2005 + AMD 1:2012; CAN/CSA-C22.2 No. 60601-1:14 (for safety).
• Complies with IEC 60601-1-2: 2014 / EN 60601-1-2: 2015 (for EMC). |
  | Software Verification & Validation | - Level of concern identified as "Minor" (unlikely to cause injury).
• Software passed tests and met requirements of relevant standards. |
  | Performance Testing (Sound Amplification) | - Tests determined that sound amplification was not affected by the use of earphones.
• Performance data presented by traditional stethoscope and the subject device are "similar." |
  | Usability Study | - Acceptance Criteria: At least 85% of participants with no experience in this type of product will be able to use it properly after reading Instruction Manual for around 30 minutes.
• Summary: The summative evaluation objective of usability was met. |

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

• Usability Study: The sample size was 15 doctors and 15 nurses.
• Data Provenance: Not explicitly stated, but given that the applicant is Sound Land Corp. in Taiwan, it is likely that the usability study participants were from Taiwan. The document does not specify if the study was retrospective or prospective.

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

The document does not describe an expert-based ground truth establishment for the "Performance Testing" or "Usability Study" beyond the participants in the usability study being "doctors and nurses."

For the "Performance Testing" which compared the device to a traditional stethoscope, it's mentioned that their performance data are "similar," implying an unquantified comparison, not a ground truth derived from expert adjudication of sound quality or diagnostic outcomes.

4. Adjudication method for the test set

There is no mention of an adjudication method for establishing a ground truth.

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

There is no information about an MRMC comparative effectiveness study in the provided text. The device is an electronic stethoscope, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images with or without AI assistance. The "doctors and nurses" in the usability study were likely evaluating ease of use, not diagnostic improvement with AI.

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

This section is not applicable as the ibiomedi Electronic Stethoscope ES-2020 is a sound detection and amplification device, not an algorithm that performs standalone analysis or diagnosis without human interaction.

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

The document does not report the use of a formal ground truth (like expert consensus, pathology, or outcomes data) for evaluating the diagnostic accuracy or clinical effectiveness of the stethoscope. The tests focused on safety, EMC, software functionality, and usability, as well as a general comparison to traditional stethoscopes regarding sound amplification.

8. The sample size for the training set

No information about a training set is provided. This is consistent with the nature of the device, which is an electronic stethoscope rather than a machine learning or AI-based diagnostic system that would require a distinct training set.

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

Not applicable, as there is no mention of a training set or ground truth for such a set.

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The Ibis® Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – Sacrum/Ilium) for the following indications:

1. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Degenerative Spondylolisthesis with objective evidence of neurologic impairment
3. Trauma (fracture or dislocation)
4. Spinal tumor
5. Failed previous fusion (pseudarthrosis)
6. Spinal stenosis
7. Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

The Ibis® Pedicle Screw System consists of bulleted rods; cannulated polyaxial, monoaxial, extended length (Ibis® XL) and extended tab screws; and set screws; which can be variously assembled to provide immobilization of the thoracolumbar and lumbosacral spine. The Ibis® Pedicle Screw System maintains compatibility with the Pagoda Pedicle Screw System. All components are made from Titanium Alloy (Ti6Al4V).

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, the study that proves the device meets those criteria, or any details about an AI algorithm or its performance.

The document is an FDA 510(k) premarket notification for the "Ibis® Pedicle Screw System," specifically focusing on a line extension (Ibis® XL Cannulated Polyaxial Screws). It discusses:

• Device Name and Classification: Ibis® Pedicle Screw System, Class II, Regulation Number 21 CFR 888.3070 (Thoracolumbosacral pedicle screw system).
• Indications for Use: Provides immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, tumor, failed fusion, spinal stenosis, spinal deformities).
• Substantial Equivalence: The primary purpose of the document is to demonstrate substantial equivalence to previously cleared predicate devices (Ibis® Pedicle Screw System K142146, Pagoda® Pedicle Screw System K131785, and additions to EXPEDIUM® and VIPER® Systems K101993).
• Device Description: Components, materials (Titanium Alloy), and compatibility with other systems.
• Nonclinical Test Summary: Mentions mechanical tests performed (Static Compression Bending, Dynamic Compression Bending, Axial Torque Gripping Capacity) in accordance with ASTM standards, to support the device's mechanical integrity and performance, aligning with equivalence to predicate devices. These are engineering performance tests, not clinical performance or AI performance.

Therefore, I cannot answer your specific questions regarding acceptance criteria, AI study details, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.

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The Ibis™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, noncervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (TI - S1/Illium) for the following indications:

1. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Degenerative Spondylolisthesis with objective evidence of neurologic impairment
3. Trauma (fracture or dislocation)
4. Spinal tumor
5. Failed previous fusion (pseudarthrosis)
6. Spinal stenosis
7. Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

The Ibis™ Pedicle Screw System consists of bulleted rods; cannulated polyaxial, and extended tab screws; and set screws; which can be variously assembled to provide immobilization of the thoracolumbar and lumbosacral spine. The Ibis™ Pedicle Screw System maintains compatibility with the Pagoda™ Pedicle Screw System. All components are made from Titanium Alloy (Ti6Al4V).

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria, specifically concerning AI/ML performance metrics, a test set, expert involvement, or training data.

The document is a 510(k) premarket notification from the FDA to Ortho Development Corporation for their Ibis™ Pedicle Screw System. It primarily focuses on the substantial equivalence of this pedicle screw system to previously marketed predicate devices. The information provided is standard for a medical device clearance and includes:

• Device Description: What the Ibis™ Pedicle Screw System is made of and how it works.
• Indications for Use: The medical conditions it is intended to treat.
• Technological Characteristics: How it compares to predicate devices in terms of materials, screw types, and mechanisms.
• Non-Clinical Testing: References to static and dynamic compression and torsion testing performed according to ASTM F1717.
• Conclusion of Substantial Equivalence: Based on similarities in intended use, design, materials, manufacturing, packaging, and mechanical test results.

This document does not involve any AI/ML components, and therefore, the specific questions regarding acceptance criteria for AI/ML performance, test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to the content provided.

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IBIS Explorer and Markup Software is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

Besides general image interpretation and processing tools, IBIS provides specific tool sets for several clinical applications, including:

• . Oncology, including lesion marking and analysis
• . Anatomic structure marking, volume measurement and analysis

Only DICOM for presentation images can be used on an FDA approved monitor for mammography for image diagnosis.

Only uncompressed or non-lossy compressed images must be used for image diagnosis in mammography.

The IBIS Explorer and Markup Software is a picture archival and communications system (PACS) providing researchers, radiologists or health care professionals with the tools to accept, display, store, archive and manipulate digital medical images. The IBIS Explorer stores, archives and displays digital medical images, while the Markup Software allows for measurements of specified regions and report generation. Digital images supported by the software include but are not limited to bone scans, chest radiograph (x-ray), ultrasound, computed tomography (CT), and magnetic resonance imaqing (MRI).

The System is to be used by trained professionals who are responsible for the correct and accurate use of medical images and the subsequent diagnosis. In a typical clinical environment, the system would be used by a trained technician and radiologist.

The software is installed on an off-the-shelf PC computer system. It is intended to be used with uncompressed digital images that are saved in DICOM format.

Here's an analysis of the provided text regarding the IBIS Explorer and Markup Software, focusing on acceptance criteria and the study that proves device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are not explicitly numerical thresholds but rather functional and validation requirements. The device performance is generally stated as meeting these requirements.

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

• Sample Size for Test Set: The document does not explicitly state a sample size for the test set of images used for verification and validation. It mentions "various DICOM image modalities."
• Data Provenance: The document states that testing was "conducted using various DICOM image modalities from different scanners (GE, Toshiba, Philips and Siemens)." This suggests a diverse set of images, likely retrospective data collected from these different scanner types. The country of origin of this data is not specified, but the testing itself was "conducted at MedQIA."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The testing primarily focuses on software functionality, compliance with requirements, and comparison of measurement accuracy against a predicate device.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. Given the nature of the testing described (functional verification and comparison against a predicate device for measurement accuracy), it seems unlikely an adjudication method for case interpretation or diagnosis was employed in the usual sense.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document describes design verification and validation, including functional testing and measurement accuracy comparison to a predicate device. It does not mention any study involving human readers or comparing performance with and without AI assistance.

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

Yes, the testing described appears to be a form of standalone testing for the functionality and measurement accuracy of the software itself. The phrase "verifying the accuracy of the measurements of the Markup Software against the Visage PACS/CS predicate device" implies testing the algorithm's output directly. However, the device is intended for use by trained professionals, implying a human-in-the-loop for interpretation and diagnosis, not the algorithm making diagnoses independently. The clinical usability was also assessed, which would be in the context of human use. So, while foundational testing was standalone, the overall clinical use is human-interfaced.

7. The Type of Ground Truth Used

For the "accuracy of the measurements of the Markup Software," the ground truth was essentially the measurements provided by the predicate device (Visage PACS/CS). This means the predicate device served as the reference standard for measurement accuracy. For other functional aspects, the ground truth was the expected output based on software and user requirements. There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for this particular submission.

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning components. The device is described as a PACS system with image manipulation and measurement tools, not an AI-driven diagnostic algorithm that would typically require a training set. The "Performance Data" section describes Verification & Validation activities, not algorithm training.

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

As no training set is mentioned or implied for this device, this question is not applicable based on the provided text.

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The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac anatomy and physiology as well as visualization of other devices in the heart.

The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is comprised of a single-use, disposable ultrasonic phased-array imaging transducer. A Inquiry ClearICE catheter is steerable: catheter, 9 Fr (2.97 mm) in diameter, 90 cm to 110 cm insertable length and available in various curve configuration. The distal portion of the catheter can be deflected in four directions in two orthogonal planes: left-right (in a plane perpendicular to imaging plane) and anterior-posterior (in a plane coincident with the image plane). Bi-directional steering controlled by push/pull handle mechanism and quad-directional steering controlled by a push/pull mechanism and rotating knob. The non-sterile, reusable GE Connector Cable is use to connect IBI InquiryTM ClearICE™ Intracardiac Echocardiography Catheter to the GE Vivid i Ultrasound system. The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is used with commercially available GE Connector Cable and Vivid- i Diagnostic Ultrasound System. The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is comprised of three major components: (1) the catheter itself; (2) the steering mechanism; and (3) the reusable GE Connector Cable & GE Vivi i Ultrasound System.

This looks like a 510(k) premarket notification for a medical device called the IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter. This document asserts substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study to establish new acceptance criteria or device performance.

Therefore, the document does not contain the information required to answer your prompt. Specifically, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for test sets.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance studies.
• The type of ground truth used in any performance studies.
• Sample size for training sets or how ground truth was established for training sets.

Instead, the submission focuses on demonstrating that the IBI Inquiry™ ClearICE™ catheter is "substantially equivalent" in its technologies and functionality to existing, legally marketed ACUSON AcuNav ultrasound catheters. Substantial equivalence means that the device is as safe and effective as a legally marketed predicate device. This typically involves comparing design, materials, performance specifications, and indications for use against the predicate, rather than conducting new clinical trials to establish de novo performance criteria.

The document lists the following predicate devices:

• #K042593 (January 5, 2005) cleared as ACUSON AcuNav 8Fr Ultrasound Catheter.
• #K033650 (February 24, 2004) cleared as ACUSON AcuNav 90/10 Diagnostic Ultrasound Catheter.
• #K992632 (November 8, 2001) cleared as ACUSON AcuNav Diagnostic Ultrasound Catheter.

The submission confirms that "The IBI Inquiry™ ClearICE Intracardiac Echocardiography Catheter designed and validated in compliance with the following standards," and then lists several ISO, IEC, BS EN, and AAMI standards, along with FDA regulations and guidance documents. Compliance with these standards and regulations is part of the process of demonstrating substantial equivalence for safety and performance, but it does not involve the kind of specific performance study details you requested for AI/algorithm-driven devices.

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The Island Biosurgical, Inc. Bladder Neck Suspension Bolster is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation. This bolster is recommended where the possibility of reduced suture and mosh reaction is desired.

A surgically implantable polypropylene mesh bolster with monofilament sutures.

The provided text is a 510(k) summary for the Island Biosurgical Bladder Neck Suspension Bolster. It explicitly states:

"Performance testing: Performance testing was not included in this 510 (k)."

Therefore, based on the provided document, there is no information available regarding acceptance criteria, device performance against such criteria, or any study that proves the device meets acceptance criteria.

As a result, I cannot provide the requested information. This device received substantial equivalence without requiring performance testing to demonstrate its safety and effectiveness.

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Electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.

The Irvine Biomedical, Inc. 181-1100" Bi-directional Steerable Electrophysiology Catheter System is a multiple electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.

The provided text is a 510(k) Pre-Market Notification for the IBI-1100™ Bi-directional Steerable Electrophysiology Catheter System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than a clinical study proving device performance against specific acceptance criteria.

Therefore, the document does not contain details about acceptance criteria, a study proving the device meets those criteria, or information related to AI/algorithm performance. The submission relies on the device being "substantially equivalent" to predicate devices, meaning it has the same intended use, technological characteristics, and safety/effectiveness profile.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria & Reported Device Performance: Not mentioned. The focus is on substantial equivalence, not a direct performance comparison against predefined metrics in a clinical study.
• Sample size for test set & data provenance: Not applicable. This isn't a clinical trial with a test set of patient data.
• Number of experts for ground truth & qualifications: Not applicable for a 510(k) that isn't a clinical study.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable. This device is not an AI-assisted diagnostic tool.
• Standalone algorithm performance: Not applicable. This is a physical medical device, not an algorithm.
• Type of ground truth: Not applicable.
• Sample size for training set & how ground truth was established for training set: Not applicable, as this is not an AI/ML device.

Instead, the document states:

• "The components of the IBI-1100™ Bi-directional Steerable Electrophysiology Catheter System are all biocompatible and have all been tested for use in the body. Specifically, the patient contact materials are the same as the predicate devices and have been a Electrophysiology Catheter has passed the biocompatibility and performance test."
• "Its manufacturing process will follow the Good Manufacturing Practice with quality assurance and validated sterilization process."
• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the "proof" for this submission is biocompatibility testing, performance testing (likely bench testing or non-clinical trials demonstrating functionality), adherence to manufacturing standards, and comparison to existing, legally marketed predicate devices. It is not a clinical study with detailed acceptance criteria as one would expect for a novel diagnostic algorithm.

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This device is to be used for taking histological and cytological biopsies of soft tissue.

IBI® Needle

The provided document is a 510(k) clearance letter from the FDA for a device named "IBI® Needle". This letter confirms substantial equivalence to a predicate device and outlines regulatory information. However, the document does not contain information about specific acceptance criteria for device performance, a study proving the device meets these criteria, or any details related to AI performance, sample sizes for testing or training, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based on the given text.

The document only states the "Indications for Use: This device is to be used for taking histological and cytological biopsies of soft tissue." It does not delve into the performance metrics of the device itself.

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The IBI-1100" Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies.

The Irvine Biomedical, Inc. IB1-1100" Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.

The provided text describes a medical device, the Irvine Biomedical, Inc. IBI-1100 Steerable Electrophysiology Catheter System, and asserts its safety and effectiveness. However, it does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/device performance evaluation.

The text focuses on:

• Device Description: What the IBI-1100 is (electrophysiology recording catheter) and its components (multiple electrodes, connecting cable, dimensions).
• Intended Use: For electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies, typically placed in the high right atrium, right ventricular apex, and HIS bundle.
• Safety and Effectiveness Claims: Based on biocompatibility, performance tests, and material similarity to predicate devices already approved by the FDA. It also mentions compliance with manufacturing practices and sterilization processes.

Therefore, I cannot populate the requested table or answer the specific questions below based on the provided input. The document is a summary of safety and effectiveness, not a detailed study report on device performance against specific acceptance criteria.

If this were an AI device, the information you're asking for would be crucial for its evaluation. However, the IBI-1100 is a physical medical catheter, and its "performance" is assessed through traditional biocompatibility, sterility, and functional tests, not through AI-specific metrics like AUC, sensitivity, or specificity against a ground truth dataset.

To illustrate what the answers would look like if the document did contain the necessary information (for an AI device), here's a hypothetical structure:

Hypothetical Description if the input was an AI device performance study:

This document describes the Irvine Biomedical, Inc. IBI-1100 Steerable Electrophysiology Catheter System, which in this hypothetical scenario, incorporates an AI component for [e.g., automated arrhythmia detection, signal quality assessment]. The following sections outline the acceptance criteria and the study that proves the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 500 patient ECG recordings, totaling 10,000 ECG segments.
• Data Provenance: Retrospective data collected from five major cardiology centers across the United States (Massachusetts, California, Texas, Florida, and New York) and three centers in Europe (Germany, France, UK).

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 5
• Qualifications: All experts were board-certified electrophysiologists with an average of 15 years of experience in cardiac arrhythmia diagnosis and management, specializing in electrophysiology study interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: 2+1. Each case was independently reviewed by two electrophysiologists. If their interpretations differed, a third senior electrophysiologist (the "tie-breaker") reviewed the case and made the final determination.

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

• Was an MRMC study done? Yes.
• Effect Size: The AI assistance improved human reader diagnostic accuracy by an average of 12% (absolute increase in AUC from 0.82 to 0.94) compared to human readers without AI assistance, particularly in complex or noisy ECG segments. The average time to diagnosis was reduced by 25% with AI assistance.

6. Standalone Performance Study

• Was a standalone study done? Yes.
  • The algorithm-only performance (without human-in-the-loop) achieved a sensitivity of 90.1% and specificity of 86.5% for atrial fibrillation detection on the test set.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert Consensus, validated against patient outcomes data (e.g., successful ablation procedures, confirmed diagnoses from follow-up).

8. Sample Size for the Training Set

• Training Set Sample Size: 5,000 patient ECG recordings, totaling 50,000 ECG segments.

9. How Ground Truth for the Training Set was Established

• Ground Truth Establishment: Ground truth for the training set was established through a combination of automated annotations derived from established clinical reporting systems (e.g., confirmed diagnoses in electronic health records) and further independent review by 3 experienced cardiology fellows. A smaller subset (10%) was also adjudicated by the same panel of 5 expert electrophysiologists used for the test set, to ensure consistency and quality.

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