Search Results

The Nuubo System is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, presyncope, syncope, fatigue, or anxiety.

The Nuubo system continuously records and stores ECG and activity data for up to 30 days at a time. The Nuubo System detects arrhythmias at the end of the monitoring period upon download of the ECG data. The Nuubo System is Rx use device.

The Nuubo System, developed by Smart Solutions Technologies (SST), is a wearable device designed for ambulatory recording electrocardiogram (ECG) up to 30 days. The system is composed of 3 main components:

• Nuubo30 – The Nuubo30 wearable is a single patient textile like a chest-belt that contains 4 textile electrodes in the inner side that are used for sensing patient 's ECG.
• NuuboREC - The Nuubo recorder is a small, lightweight device that records ECG continuously. The device records 2 Leads of ECG data up to 30 days. The device also records data from a 3-axis accelerometer located inside the device.
• Nuubo Leonardo - The Leonardo Software is installed on a computer where the patient´s ECG data stored in the recorder will be downloaded for subsequent analysis and report.

This document is a 510(k) summary for the Nuubo System, submitted to the FDA. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "The results obtained validate the Nuubo Arrhythmia Algorithms and prove equivalence to Monebo Automated ECG Analysis And Interpretation Software Library, version 3.0 [manufacturer Monebo Technologies, 510(k) number K062282]." It further mentions that "All results are comparable to the results claimed by Monebo."

While specific numerical acceptance criteria (e.g., minimum sensitivity/specificity for each arrhythmia) and the Nuubo System's reported performance for each criterion are not directly listed in the provided text, the document indicates that the device's arrhythmia detection performance was validated and found comparable to the Monebo device, which was referenced by the predicate ZioPatch. The table below lists the arrhythmia functionalities and their detection criteria, implying these are the targets for the algorithm:

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

The arrhythmia detection algorithms were tested using:

• Public Databases: MIT-BIH, AHA, and MITAF. These are well-known, established retrospective ECG databases. The country of origin for these databases is primarily the United States.
• Private Database: Comprised of 90 ECG registries from 58 patients. The provenance (country of origin) is not explicitly stated, but the context of the submission to the FDA suggests it aligns with U.S. medical practice. This data is described as "anonymized," potentially retrospective, selected to contain all arrhythmias detected by the algorithm.

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

For the private database (90 ECG registries from 58 patients), the ground truth was established by "experienced medical professionals." The specific number of experts is not provided, nor are their detailed qualifications (e.g., specific sub-specialty or years of experience). For the public databases (MIT-BIH, AHA, MITAF), ground truth is typically established by consensus of multiple cardiologists or electrophysiologists based on established annotation guidelines, though the document doesn't detail this for these specific databases.

4. Adjudication Method for the Test Set

The document states that the private database "was annotated using experienced medical professionals, using prospectively defined guidelines, consistent with US medical practice." This suggests an expert review process. However, the exact adjudication method (e.g., 2+1, 3+1, or simple consensus from a single annotator if a single expert annotated) is not specified. For the public databases, adjudication methods are usually defined by the database creators, often involving multiple experts to establish consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No MRMC comparative effectiveness study involving human readers' improvement with AI vs. without AI assistance is reported in this document. The study focuses on the standalone performance of the algorithm.

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

Yes, a standalone performance study of the algorithm was done. The document states: "The Nuubo Arrhythmia detection algorithm was tested per requirements of AAMI/IEC60601-2-47. To validate the arrhythmia detection algorithms were used three public databases and one private database." The results of this testing were compared to the performance claimed by the Monebo Automated ECG Analysis And Interpretation Software Library (K062282), indicating a standalone comparison. The caveat is that "The Nuubo Arrhythmia Detection Algorithm is not intended to replace the Clinician review of signals. The software menu prompts the Clinician or trained technician to review events prior to generating a report," which implies that the intended use is with a human-in-the-loop for final review, even if standalone performance was tested.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth used for the private database was expert annotation/consensus based on "experienced medical professionals, using prospectively defined guidelines." For the public databases (MIT-BIH, AHA, MITAF), the ground truth is also based on expert annotation (often expert consensus).

8. The Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set for the Nuubo arrhythmia detection algorithm. It only mentions the databases used for validation/testing.

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

Since the training set size and specific databases are not mentioned, how the ground truth for any training set was established is also not described in this document. The description of ground truth establishment is specifically for the test/validation data.

Ask a specific question about this device

The Textronics™ ECG Electrode is intended for use in general electrocardiograph monitoring and recording procedures.

The Textronics™ ECG Electrode is indicated for use with most ECG instruments on the market. It is indicated for applications including resting ECGs, exercise ECGs, and/or ambulatory monitoring. The device is indicated for both prescription and over-the-counter use.

The Textronics ™ ECG Electrode consists of electrodes, an exterior housing for the electrodes that makes contact with the patient, and a means of connecting the device to an ECG instrument. The Textronics™ ECG Electrode has textilebased electrodes made of electrically conductive yarns knitted together with electrically non-conductive yarns. The conductive yarns are silver coated polyamide (nylon). The non-conductive yarns can include cotton, spandex, polyester, and/or nylon. The Textronics™ ECG Electrode's textile-based electrodes have an exterior housing made of fabric, which can be made out of common textile materials, including polypropylene, nylon, Lycra® Spandex, polyester, and/or cotton. This fabric exterior housing can take the shape of a variety of garments, such as chest straps, wrist bands, shirts, bras, or vests. The Textronics™ ECG Electrode connects to ECG instruments via a conductive snap.

Here's an analysis of the provided information regarding the Textronics™ ECG Electrode's acceptance criteria and substantiating study:

This 510(k) summary does not provide explicit acceptance criteria in the typical sense of quantitative thresholds (e.g., minimum sensitivity, PPV). Instead, the "acceptance criteria" are implied to be "functional as intended" and "clarity and resolution of the tracings were observed to be substantially equivalent to the commercially available electrodes."

The study is a comparative performance study against commercially available ECG electrodes.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "ECGs were recorded," implying multiple recordings, but no specific number of patients or recordings is provided.
• Data Provenance: Not explicitly stated, but the study was conducted "in the lab." This suggests a controlled environment, likely in the US where Textronics, Inc. is located. It is a prospective study as the device was tested against existing commercial electrodes.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not stated.
• Qualifications of Experts: Not stated.

The evaluation of "clarity and resolution" would typically involve expert interpretation, but the document does not specify who performed this assessment or their qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not stated. Given the qualitative nature of the performance assessment ("observed to be substantially equivalent"), it's possible a formal adjudication process was not used, or at least not described.

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

• MRMC Study: No. This type of study is not described. The assessment focuses on the device's technical performance in generating ECG tracings, not on human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study: Yes, in the sense that the performance data presented is for the device itself.
  • The Textronics™ ECG Electrode was "tested in the lab using ECG recording devices with the commercially available ECG electrodes and the Textronics ™ ECG Electrode used simultaneously."
  • "ECGs were recorded, and the tracings were compared."
  • The device's output (ECG tracings) was directly assessed for functionality, clarity, and resolution.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance is effectively concurrent comparison to commercially available, predicate ECG electrodes. The "ground truth" for what constitutes a "functional" and "clear, resolute" ECG tracing is established by the accepted performance of these predicate devices. It is based on expert observation/interpretation of these comparative tracings, rather than pathology or long-term clinical outcomes.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The Textronics™ ECG Electrode is a hardware device (electrode), not an AI algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

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

Ask a specific question about this device

The CardioBelt™ is a single patient reusable electrode system intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. The CardioBelt™ is compatible for use with Bluetooth equipped ECG instruments capable of receiving Bluetooth™ Serial Port Protocol.

The Monebo CardioBelt™ is a reusable electrode system consisting of an electrode assembly, an elastic chest belt, and an electronics package containing a Bluetooth transceiver. The CardioBelt™ electrodes are positioned against the patient's skin with light pressure, using the elastic chest belt. The CardioBelt™ is designed to be used without electrolytic gels and without adhesives on unprepared skin; that is without the requirements for shaving, abrading, or other skin preparation. The CardioBelt transmits ECG information to a compatible Bluetooth enabled device. The CardioBelt contains a class II Bluetooth radio with a range of approximately 30 feet (spherical range). The CardioBelt™ is powered by a rechargeable lithium ion battery. The electronics package must be physically separated from the electrode belt to charge the battery.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics for the Monebo CardioBelt™ Electrode Belt. Instead, it offers a summary of verification and validation testing, and mentions a comparative study, but lacks the granular data requested in the prompt.

However, based on the information provided, here's what can be extracted and inferred:

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

The document mentions that the device "meets the generally accepted safety testing requirements for an EC38 1.2 c type 3 ECG device" and "meets the clinical requirements." It also states the device was found to be "easy to use and useful for ambulatory monitoring and as a screening tool to determine normal or pathologic ECG's."

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

The text mentions "a study at Bad Oeynhausen Herzzentrum hospital in Germany" that "compared the performance of the single lead Cardiobelt to a 12 lead ECG (Gold Standard)."

• Sample Size: Not specified.
• Data Provenance: Prospective (implied by "a study"), from Bad Oeynhausen Herzzentrum hospital in Germany.

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

The document does not specify the number or qualifications of experts involved in establishing ground truth for the clinical study. It only mentions the comparison to "a 12 lead ECG (Gold Standard)," implying that the interpretation of the 12-lead ECG by clinicians would serve as the ground truth.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in the ground truth or the device's output.

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

The document describes a comparative study between the CardioBelt and a 12-lead ECG. However, this was a comparison of the device's performance against a gold standard, not a multi-reader multi-case study evaluating the improvement of human readers with AI assistance versus without. The CardioBelt is described as a "single lead acquisition system that transmits ECG data via Bluetooth™ communication to a generic Bluetooth™ recording and/or analysis system. The device does not perform ECG analysis." Therefore, it's not an AI-assisted device in the context of interpretation.

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

This is not directly applicable as the CardioBelt is an electrode system for acquiring ECG data, not an algorithm for analyzing it. The device itself is "algorithm-only" in the sense that it doesn't involve human interpretation for its primary function (data acquisition). However, the results of the acquired ECG data would then be interpreted by a physician. The statement "The device does not perform ECG analysis" reinforces that it's a data acquisition tool, not an analytical one.

7. The type of ground truth used

For the clinical study, the ground truth was established by comparison to a 12-lead ECG (Gold Standard). This implies expert interpretation of the 12-lead ECG to determine "normal or pathologic ECG's."

8. The sample size for the training set

The document does not mention any "training set." This device is an electrode belt that acquires physiological signals, not an AI/machine learning algorithm requiring a separate training phase. The described testing (bench and clinical) is for verification and validation of the hardware and its ability to acquire data reliably.

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

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

Ask a specific question about this device