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The red dot™ software platform is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. red dot™ analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. red dot™ is not intended to direct attention to specific portions of an image or to anomalies other than Pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.

Behold.ai red dot™ is a radiological computer-assisted triage and notification software system. The software automatically analyzes PA/AP chest x-rays and alerts the PACS/RIS workstation once images with features suggestive of pneumothorax are identified.

Through the use of the red dot™ device, a radiologist is able to review studies with features suggestive of pneumothorax earlier than in standard of care workflow.

In summary, the red dot™ device provides a passive notification through the PACS/workstation to the radiologists indicating the existence of a case that may potentially benefit from prioritization. It doesn't output an image and therefore it does not mark, highlight, or direct users' attention to a specific location on the original chest X ray.

The device aim is to aid in prioritization and triage of radiological medical images only.

The main components of the red dot™ device are described below.

1. Image input, validation and anonymization
   After a chest x-ray has been performed, a copy of the study is received and processed by the red dot™ device. Following receipt of a study, the validation feature ensures the image is valid (i.e. has readable pixels) and the anonymization feature removes or anonymizes Personally Identifiable Information (PII) such as Patient Name, Patient Birthdate, and Patient Address.

2. red dot™ Image Analysis Algorithm
   This component of the device is primarily comprised of the visual recognition algorithm that is responsible for detecting images with potential abnormalities. Once a study has been validated, the algorithm analyzes the frontal chest x-ray for detection of suspected findings suggestive of pneumothorax.

3. PACS Integration Feature
   The results of a successful study analysis is provided to an integration engine in a standard JSON message containing sufficient information to allow the integration engine to notify the PACS/workstation for prioritization through the worklist interface.

Here's a breakdown of the acceptance criteria and the study proving the red dot™ device meets them, based on the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document explicitly states that the AUROC was above 0.95 and "all lower bounds of the 95% confidence intervals exceeded 80% and achieved the prespecified performance goals in the study" for the classification metrics (AUROC, Sensitivity, Specificity). For the timing, the acceptance criterion is defined as being "substantially equivalent" to the predicate.

Study Details Proving Device Meets Acceptance Criteria

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

• Test Set Sample Size: 888 CXR images.
• Data Provenance: Retrospective, anonymous study.
  • Country of Origin: United States (n=738 cases from 2 clinical sites) and United Kingdom (n=150 cases from 2 clinical sites).

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

• Number of Experts: At least two ABR certified radiologists reviewed each CXR image. A third reader was involved in the event of disagreement/discrepancy.
• Qualifications of Experts: All readers were "ABR certified radiologists" and "received training related to imaging findings defining each condition per protocol prior to the review."

4. Adjudication Method for the Test Set

• Adjudication Method: "The ground truth was determined by two readers with a third reader in the event of disagreement/discrepancy." Ground truth for a condition was defined as agreement between two readers. This is a 2+1 adjudication method.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported as having been done to directly compare human readers with and without AI assistance. The study described is a standalone performance validation of the AI algorithm against a consensus ground truth.

6. If a Standalone Performance Study Was Done

• Standalone Study: Yes, a standalone (algorithm only without human-in-the-loop performance) study was explicitly done. The reported metrics (AUROC, Accuracy, Sensitivity, Specificity) are for the red dot™ algorithm's performance in detecting pneumothorax.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus. Specifically, "agreement between two readers" from ABR certified radiologists, with a third radiologist for discrepancy resolution.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not specify the sample size for the training set. It only describes the test set.

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

• Training Set Ground Truth Establishment: The document does not provide details on how the ground truth for the training set was established. It only focuses on the data used for the performance evaluation (test set).

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The 3M Red Dot™ Resting EKG Electrode can be used on a patient undergoing an EKG diagnostic procedure while resting. These electrodes are applied to the patient's skin for short term use. These electrodes are disposable and are for single use. They are not indicated for use in long term monitoring.

3M Red Dot™ Resting EKG Electrode, Catalog Number 2360 has a conductive adhesive which is laminated to a conductive Ag/AgCl backing. The conductive backing has a tab end for connection to the electrocardiograph leadwire.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3M Red Dot™ Resting EKG Electrode, 2360 (K974445):

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the performance testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the test data.

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

This information is not provided in the document. The testing primarily focuses on the device's adherence to a recognized electrical performance standard (ANSI/AAMI EC12/1991) and biocompatibility standards, rather than a clinical ground truth established by medical experts for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. The performance testing described is likely based on objective measurements against a standard, not on subjective expert review requiring an adjudication method.

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

No. The document focuses on the device's technical specifications and adherence to standards, not on a clinical effectiveness study involving human readers or comparative analysis with and without AI assistance.

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

Yes, in a sense. The described "Performance Testing" evaluates the electrical performance of the electrode itself, independent of a human operator's interpretation or involvement beyond setup. This is a standalone evaluation of the device's physical and electrical properties, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for performance assessment is based on voluntary standard requirements (ANSI/AAMI EC12/1991 for electrical performance) and biocompatibility standards (ISO 10993-1). These are established, objective measures against which the device's properties are compared.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (electrode) and not an AI/algorithmic device that would require a "training set" in the machine learning sense. The testing described is for physical and electrical performance.

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

Not applicable, as there is no training set for this type of device.

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The 3M™ Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are intended for use in ECG Monitoring Procedures. The 2234 & 2266 Radiolucent Monitoring Electrodes can be used in all ECG applications where standard ECG monitoring electrodes are used. These electrodes can be used for short term and long term (up to 3 days) monitoring.

The 3MTM Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are a selfadhesive, non-sterile, single use, disposable electrode which includes a silver/silver chloride sensing element and conductive gel. These electrodes include a self-adhesive tape backing which holds the conductive elements of the electrode in place on the patient's skin for short or long term (up to 3 days) for ECG monitoring. The 3MTM Red Dot™ 2234 & Radiolucent Monitoring Electrode with Clear Tape is composed of the same materials as the predicate device 3MTM Red Dot™ 2234 Radiolucent Monitoring Electrode (K939312) with the exception of the snap which has been modified to include a higher percentage of carbon. The 3M™ Red Dot™ 2266 Radiolucent Monitoring Electrode with Breathable Comfort Backing is composed of the same materials as the predicate device 3M™ Red Dot™ 2234 Radiolucent Monitoring Electrode (K939312) with the exception of the sensing snap which has been modified to include a higher percentage of carbon and the tape backing and adhesive.

The provided text describes the 510(k) summary for the 3M™ Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes. Below is the requested information based on the provided document:

Acceptance Criteria and Device Performance

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not specify a distinct "test set" sample size or data provenance for a clinical study. The performance is assessed against recognized standards (ISO 10993-1 and ANSI/AAMI EC12/1991). These standards typically involve a series of tests performed on device samples. The number of samples tested to demonstrate compliance with these standards is not detailed in this summary.

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 device is an electrode for ECG monitoring, and its performance is evaluated against established technical and biological standards, not through expert-reviewed diagnostic image/data interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods typically apply to studies where expert interpretation of data (e.g., images, clinical records) is required to establish ground truth for a diagnostic device. For this device, compliance is determined by meeting technical specifications and biocompatibility requirements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an ECG monitoring electrode, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI-based device. Its performance is inherent to its physical and chemical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is defined by compliance with established voluntary consensus standards:

• Biocompatibility: ISO 10993-1, "Biological Evaluation of Medical Devices".
• Electrical Performance: ANSI/AAMI EC12/1991, "Disposable ECG Electrodes".
• Substantial Equivalence: Comparison to legally marketed predicate devices for stated indications for use.

8. The sample size for the training set
Not applicable. This device is not an AI/machine learning device that requires a "training set."

9. How the ground truth for the training set was established
Not applicable. As noted above, there is no training set for this type of device.

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The 3M Red Dot™ 2560 & 2570 Monitoring Electrodes are intended for use in ECG Monitoring. The 2560 and 2570 electrodes can be used in all ECG applications where standard ECG monitoring electrodes are used. These electrodes can be used for short term and long term (up to 5 Days) monitoring.

The 3M Red Dot™ 2560 & 2570 ECG Monitoring Electrodes are a selfadhesive, non-sterile, single use disposable electrode which includes a silver/silver chloride sensing element and conductive sticky gel. These electrodes include a pressure sensitive adhesive foam tape which hold the conductive elements of the electrode in place on the patient's skin for short or long term ECG procedures.

This document describes the safety and efficacy of the 3M Red Dot™ 2560 and 2570 Monitoring Electrodes. However, it does not provide the information requested in the prompt regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, or ground truth for a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Biocompatibility Testing: Stating that materials were selected based on ISO 10993-1.
• Performance Testing: Stating that electrical performance meets ANSI/AAMI EC12/1991 for Disposable ECG Electrodes.

Therefore, I cannot populate the requested tables and information based on the provided text. The prompt asks for details related to a study proving the device meets acceptance criteria, which is not present in this 510(k) summary excerpt beyond a general statement of compliance with a standard.

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The ECG lead wire is intended only for the purpose of connecting an ECG monitoring electrode to either an ECG monitor trunk cable or directly into a monitor or transmitter and conducting the patients ECG signal.

This device is a patient lead wire. These patient lead wires are manufactured from a variety of electronic conductors, electronic insulating materials, patient end termination and patient lead wire connectors. This variety of materials and assembly configurations is needed to allow for designs that would be disposable, reusable, x-ray translucent or non x-ray translucent. These materials are all typically and commonly used by other companies participating in the market.

The provided text describes a 510(k) submission for 3M Red Dot™ ECG Lead Wires and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document focuses on the device description, regulatory classification, and predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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