(106 days)
PHi-Res is a software option for Marquette ECG analysis systems for high resolution P wave analysis. PHi-Res is intended to be used in a hospital or clinic environment by health care professionals for recording low amplitude/high frequency components of the surface electrocardiogram for P wave analysis.
PHi-Res analysis is only intended to provide the measurements of the signal averaged P wave and is not intended to provide any interpretation of those measurements or any kind of diagnosis. The P wave measurements provided by PHi-Res analysis are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment.
PHi-Res is intended for patient populations including adult and pediatric.
PHi-Res analysis is a software option for Marquette MAC-series electrocardiographs for high resolution P wave analysis.
The provided document, K972199, details a 510(k) submission for the Signal-Averaged High Resolution P Wave Analysis (PHi-Res) Option. However, it does not contain specific acceptance criteria or an explicit study proving the device meets said criteria in a quantifiable manner as per the requested information. Instead, it relies on general quality assurance measures and substantial equivalence to a predicate device.
Here's an analysis of the information that is available, and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion / Performance Metric | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety | Not explicitly stated with quantifiable metrics | "demonstrated that PHi-Res analysis is as safe... as the predicate device" |
| Effectiveness | Not explicitly stated with quantifiable metrics | "demonstrated that PHi-Res analysis is as... effective... as the predicate device" |
| Performance | Not explicitly stated with quantifiable metrics | "demonstrated that PHi-Res analysis... performs as well as the predicate device" |
| P-wave measurement accuracy | Not explicitly stated with quantifiable metrics | "intended to provide only the measurements of the signal averaged P wave." (Implies accuracy is expected to be comparable to predicate) |
| Agreement with predicate device | Not explicitly stated with quantifiable metrics | "employs the same technology as the predicate device," "as safe, as effective, and performs as well as the predicate device" |
Missing Information: The document states that PHi-Res is "as safe, as effective, and performs as well as the predicate device," but it does not provide quantifiable acceptance criteria (e.g., minimum sensitivity, specificity, or error rates) or specific data demonstrating this performance for PHi-Res itself. It relies on the assertion of substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
The document mentions "software testing and field tests," but no details on the size or nature of these tests are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
The document refers to the data being used by "qualified personnel" and "competent health professionals," but this relates to the intended use of the device, not the establishment of ground truth for testing.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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, this type of study was not reported.
The device provides P-wave measurements and is not intended to provide interpretation or diagnosis. Therefore, a study on human reader improvement with AI assistance would not be applicable to this device's stated function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Implied, but no specific study or metrics are provided. The device's primary function is to provide automated P-wave measurements. The "software testing" and "field tests" would likely assess this standalone performance against some internal standard or the predicate device, but no details are given.
7. The type of ground truth used
- Type of Ground Truth: Not specified.
Given the reliance on substantial equivalence to the predicate device and the "software testing and field tests," the ground truth likely involved comparing PHi-Res measurements to those from the predicate device or a gold standard ECG measurement technique, but this is not explicitly stated.
8. The sample size for the training set
- Training Set Sample Size: Not applicable/not specified.
The document states the PHi-Res analysis "employs the same technology as the predicate device." There is no indication that this device uses machine learning or AI that would require a separate "training set" in the modern sense. It appears to be a software option based on established signal processing algorithms.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable/not specified, as there is no indication of a training set for an AI/ML model.
Summary of Device and Evidence:
The PHi-Res device is a software option for Marquette MAC-series electrocardiographs designed for high-resolution P-wave analysis. Its purpose is to perform signal averaging of the atrial wave and provide its measurements; it explicitly states it is not intended to provide interpretation or diagnosis.
The "study" or evidence provided to support its safety and effectiveness is based on the following:
- Quality Assurance Measures: Requirements specification reviews, code inspections, software testing, and field tests. The results of these measures "demonstrated that PHi-Res analysis is as safe, as effective, and performs as well as the predicate device, Marquette High Resolution Option for MAC-Series Electrocardiographs."
- Substantial Equivalence: The submission heavily relies on demonstrating substantial equivalence to a predicate device (Marquette High Resolution ECG Option for MAC-Series Electrocardiographs) by stating it "employs the same technology" and performs "as well as" it.
In conclusion, the document provided is a 510(k) summary focused on demonstrating substantial equivalence through general quality assurance processes rather than a detailed performance study with specific acceptance criteria, sample sizes, and ground truth methodologies that are common in more recent medical device submissions, especially those involving AI/ML.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).