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PocketView ECG software is a version of Cardioview™ 3000 software, a Windows-based program intended to interpret electrocardiograms. PocketView ECG software receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, and interpret the ECG signal. PocketView ECG Software allows the ECG information to be displayed on a commercially available personal digital assistant (PDA) running the Windows CE operating software.

The proposed device is modification to the Cardioview™ 3000 software that allows the 12 Lead Simultaneous Cable to be linked to commercially available personal digital assistants (PDA) running the Windows CE operating system.

The provided text describes a 510(k) submission for the "PocketView ECG software," which is a modification of the "Cardioview™ 3000 software." The key modification is the ability to display ECG information on commercially available personal digital assistants (PDAs) running Windows CE.

Based on the provided text, the following information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed in the provided text. The document states, "Nonclinical testing was performed to evaluate the modification to the predicate device. Testing verified that the modified device displayed acceptable performance." However, specific criteria (e.g., accuracy percentages, error rates) or how "acceptable performance" was quantified are not provided.

2. Sample Size Used for the Test Set and Data Provenance: This information is not provided in the text. The document only mentions "Nonclinical testing was performed."

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 text.

4. Adjudication Method for the Test Set: This information is not provided in the text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: An MRMC study is not mentioned. The focus of this 510(k) is the display capability on a PDA, not an AI interpretation improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: The document indicates that the device "contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal." This implies a standalone algorithm for interpretation. However, specific standalone performance metrics or a dedicated standalone study are not detailed in this submission. The "nonclinical testing" was performed to evaluate the modification (PDA display), not necessarily to re-evaluate the core interpretation algorithm's standalone performance, which is presumably a characteristic inherited from the predicate device.

7. Type of Ground Truth Used: This information is not explicitly provided. Since it's an ECG interpretation device, the ground truth would typically be established by expert cardiologists.

8. Sample Size for the Training Set: This information is not provided in the text.

9. How the Ground Truth for the Training Set Was Established: This information is not provided in the text.

In summary, the provided 510(k) submission focuses on the substantial equivalence of adding PDA display functionality to an existing ECG interpretation software. It does not detail specific performance studies, acceptance criteria, or ground truth methodologies for the interpretation algorithms themselves, as these would have been established for the predicate device. The "nonclinical testing" mentioned primarily verified the acceptable performance of the modification (PDA connectivity and display).

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The Biolog™ 3000i Electrocardiograph with BLY-501 Adaptor detects an ECG using a single lead patient cable or alternatively can receive ECG data detected by the Micromedical 12 Lead Simultaneous Cable. The Biolog™ 3000i Electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running CardioView 3000 software or to the Micromedical Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices. The device includes a Biolog™ 3000i Electrocardiograph, a User's Manual, a BLY-501 Adaptor, and accessories. It is intended for use with the Medtronic Physio Control LIFEPAK 500 defibrillator to visually display the patient's ECG to the user of the LIFEPAK 500 defibrillator.

The proposed device is an ABS plastic docking station for the Biolog™ 3000i electrocardiograph that allows the Biolog™ 3000i electrocardiograph to be connected to a LIFEPAK 500 defibrillator. The defibrillator does not have a visual display, and the connection to the Biolog™ 3000 electrocardiograph allows the patient's EKG to be visually displayed on the Biolog™ 3000i electrocardiograph to enhance the usability of the defribrillator.

This 510(k) summary (K012540) for the BLY-501 Adaptor for Biolog™ 3000i electrocardiograph provides very limited information regarding detailed acceptance criteria or a comprehensive study demonstrating direct performance metrics.

Here's an analysis of the provided text, structured to address your questions, while acknowledging the inherent limitations of the available information:

Analysis of Acceptance Criteria and Study Details:

This submission is for an adaptor (BLY-501) that enables connectivity between an existing electrocardiograph (Biolog™ 3000i) and a defibrillator (LIFEPAK 500). The primary function of the adaptor is to allow the ECG signal, already detected and processed by the Biolog™ 3000i, to be visually displayed on the Biolog™ 3000i's screen when connected to the defibrillator. The adaptor itself does not perform any signal analysis or algorithm-based detection. Therefore, the "acceptance criteria" and "study" described are focused on the functionality and safety of this connectivity, rather than on algorithmic performance as typically seen in submissions for AI-powered diagnostic devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly mentioned. The document states "Nonclinical testing was performed," but does not specify the number of devices or test scenarios involved. Given the nature of an adaptor, the "test set" would likely involve a limited number of physical units subjected to functional tests.
• Data Provenance: Not explicitly mentioned. Since it's nonclinical testing for device functionality, it would have been conducted in a lab or testing facility rather than with patient data.

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

• Number of Experts: Not applicable or not mentioned. For a simple connectivity adaptor, "ground truth" as it pertains to clinical interpretation would not be relevant. The "ground truth" for the nonclinical tests would be defined by engineering specifications and functional requirements (e.g., "does the ECG display correctly?").
• Qualifications of Experts: Not applicable or not mentioned. Testing personnel would likely be engineers or technicians ensuring functional specifications are met.

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

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical judgment in complex diagnostic tasks. For functional testing of an adaptor, the assessment is typically binary (pass/fail) against engineering specifications.

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

• MRMC Study: No, an MRMC study was not done.
• Effect Size: Not applicable. This device is purely for displaying an already detected ECG; it does not involve AI or assist human readers with diagnostic interpretation in the way an AI algorithm would. Its purpose is to make pre-existing information accessible.

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

• Standalone Study: The device itself (the BLY-501 Adaptor) does not contain a diagnostic algorithm. The Biolog™ 3000i electrocardiograph contains "proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory," but the performance of those algorithms is not the subject of this particular 510(k) submission, which is only for the adaptor. The adaptor simply facilitates the display of the Biolog™ 3000i's output. Therefore, a standalone algorithm performance study for the adaptor was not applicable and not performed.

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

• Type of Ground Truth: For the nonclinical testing of the BLY-501 Adaptor, the "ground truth" would be defined by the functional and electrical specifications of the Biolog™ 3000i and LIFEPAK 500 equipment and the adaptor itself. This would involve ensuring correct electrical connections, signal integrity, and proper display. It does not involve medical ground truth like expert consensus or pathology, as the adaptor is not an interpretive device.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. The BLY-501 Adaptor is a hardware component (an ABS plastic docking station) that enables connectivity. It does not use machine learning or AI, and therefore, no "training set" is required.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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The 12 Lead Simultaneous Cable is used to acquire a patient's ECG via 10 leads connected to a patient's chest. It converts the ECG signal into a digital format and transfers this information to a Micromedical monitor or software system using a proprietary digital data transfer protocol.

The proposed device is a 12 Lead Simultaneous Cable to connect electrodes to an electrocardiograph or to a Micromedical monitor or to a software system to display the ECG signal on a personal computer.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a "Modified 12 Lead Simultaneous Cable" and a letter from the FDA. It outlines the device description, its intended use, and states that "Nonclinical testing was performed to assure that the device works with the Cardio View 3000 software." However, it does not provide any specific details about the acceptance criteria for this testing, the methods used, or the results.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, ground truth, experts, adjudication, MRMC studies, or standalone performance.

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