(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.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.