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510(k) Data Aggregation
(170 days)
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."
| Acceptance Criteria (Inferred from testing standards and stated conclusions) | Reported Device Performance |
|---|---|
| Compliance with EC38, EN60601-1, EN60601-2-27 | Device found to meet these standards. |
| Functional features and safety comparable to predicate device | Successfully underwent bench and clinical testing to demonstrate this. |
| Clinical utility (ease of use, usefulness for monitoring/screening) | Found to be "easy to use and useful for ambulatory monitoring and as a screening tool to determine normal or pathologic ECG's." |
| Risk assessment (moderate level of concern met) | System risk assessment 8024-0002-00 Rev1 performed, device characterized as a moderate level of concern. |
| Biocompatibility | Evaluated and found to be satisfactory. |
| Accuracy for distinguishing normal/pathologic ECGs (compared to 12-lead ECG) | Found useful for screening to determine normal or pathologic ECG's in a comparative study against a 12-lead ECG. |
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.
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(105 days)
The AccuHeart™ Electrode Belt is a reusable electrode system intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician. The AccuHeart™ Electrode Belt is compatible for use with most ECG instruments on the market.
The AccuHeart™ Electrode Belt is a reusable electrode system consisting of an electrode assembly, an elastic chest belt, and a connectorized cable. The electrode assembly contains multiple dry electrodes. The electrodes are positioned against the skin with light pressure, using the elastic chest belt. The AccuHeart™ Electrode Belt is designed to be used without electrolytic gels and without adhesives on unprepared skin, i.e., without the requirements for shaving, abrading or other skin preparations.
The provided 510(k) summary for the AccuHeart™ Electrode Belt (K043361) does not contain information regarding detailed acceptance criteria or a specific study proving the device meets those criteria with performance metrics, sample sizes, or ground truth details.
The 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive de novo clinical trials with predefined performance metrics and acceptance criteria.
Based on the provided text, here's what can be inferred and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated. The core "acceptance criteria" for a 510(k) submission is typically demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This is not the same as a quantitative performance standard with defined thresholds.
- Reported Device Performance: Not explicitly stated in quantitative terms tied to specific performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, etc.). The summary describes the device's design (reusable electrode system, elastic chest belt, no gels/adhesives, no skin prep) and intended use, implying that its performance is comparable to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not mentioned. It's likely that performance data, if collected, was part of a non-clinical evaluation comparing the AccuHeart™ to the predicate devices, but the size of any such test set is not provided.
- Data Provenance (country of origin, retrospective/prospective): Not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Given that this is an electrode belt, "ground truth" might refer to expert assessment of ECG signal quality or clinical utility, but no details are provided.
4. Adjudication Method:
- Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not done/not mentioned. MRMC studies are typically for image-based diagnostic devices where reader interpretation is a key variable. This device is an ECG electrode belt, so such a study would not be applicable in the traditional sense. The emphasis is on the physical and electrical performance of the electrodes themselves.
6. Standalone Performance Study (Algorithm Only):
- Not applicable/not mentioned. This device does not involve an "algorithm" in the sense of AI/ML. It is a physical medical device (electrode belt). Its performance is inherently tied to its physical characteristics and ability to acquire ECG signals.
7. Type of Ground Truth Used:
- Not explicitly stated in the document. For an ECG electrode, "ground truth" would likely involve objective measures like impedance, noise levels, signal quality from a known ECG source, and potentially comparative clinical data demonstrating equivalent signal quality to predicate devices. The document implies equivalence to established ECG electrode performance.
8. Sample Size for the Training Set:
- Not applicable/not mentioned. There is no "training set" in the context of AI/ML for this device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/not mentioned.
Summary of what the document focuses on instead:
The 510(k) summary for the AccuHeart™ Electrode Belt focuses on demonstrating substantial equivalence to the following predicate devices:
This is achieved by stating that the AccuHeart™ Electrode Belt:
- Has the same intended use (general electrocardiograph procedures, ECG monitoring).
- Has similar technological characteristics (reusable electrode system, elastic chest belt, electrodes positioned against the skin with light pressure, compatible with most ECG instruments).
- Offers advantages like being used without electrolytic gels, adhesives, or skin preparation (shaving, abrading), which would be considered efficiency/usability improvements rather than a fundamental change in performance.
The FDA's decision letter (K043361) confirms that they found the device "substantially equivalent" for the stated indications for use. This means the FDA concluded that the device is as safe and effective as the predicate devices, based on the information provided in the 510(k) submission, without requiring a detailed performance study with explicit acceptance criteria as would be expected for novel or high-risk devices or AI/ML products.
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