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510(k) Data Aggregation
(28 days)
Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
The intended use of the ST/AR cardiotach is to monitor a neonatal, pediatric, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients.
The intended use of the ST/AR arthythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient ECG's for heart rate and ventricular arrhythmias and produce events/alarms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients.
The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients.
The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.
The modification is a software-based change that adds QT/QTc interval monitoring features.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets those criteria. Instead, it is a 510(k) summary and an FDA clearance letter for the Philips ST/AR ST and Arrhythmia Software, Release H.0.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a detailed performance study with specific acceptance criteria and results.
However, based on the limited information available, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." It also says, "The results demonstrate that ST/AR Release H.0 meets all defined reliability requirements and performance claims."
Since the specific "specifications cleared for the predicate device" are not provided, a table of acceptance criteria and reported performance cannot be fully constructed. The performance is generally stated as "substantial equivalence" and meeting "all defined reliability requirements and performance claims," without quantifiable metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
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 does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The focus is on the device's standalone performance in relation to predicate devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, based on the description, the testing appears to be a standalone evaluation of the device's performance. The text mentions "system level tests, performance tests, and safety testing from hazard analysis." This type of testing typically focuses on the algorithm's direct output and adherence to specifications without explicitly involving human-in-the-loop scenarios for comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the given text. The reference to "specifications cleared for the predicate device" suggests that performance was measured against established standards, but the basis of those standards (e.g., expert annotations on specific datasets) is not detailed.
8. The sample size for the training set
This information is not provided in the given text.
9. How the ground truth for the training set was established
This information is not provided in the given text.
Summary of the Study (as described in the document):
The study referenced is a set of "Verification, validation, and testing activities" aiming to establish the performance, functionality, and reliability characteristics of the new Philips ST/AR ST and Arrhythmia Software, Release H.0, with respect to its predicate devices.
- Test Types: System level tests, performance tests, and safety testing from hazard analysis.
- Acceptance Criteria Basis: Pass/Fail criteria were based on specifications cleared for the predicate device.
- Outcome: Test results reportedly showed substantial equivalence to the predicate device and demonstrated that ST/AR Release H.0 meets all defined reliability requirements and performance claims.
The document serves as a regulatory filing for substantial equivalence, which typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate, rather than providing a detailed scientific study with specific acceptance metrics and comprehensive dataset information. Therefore, many of the requested details about sample sizes, expert qualifications, and ground truth establishment are not present in this type of regulatory submission.
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(88 days)
MARS Holter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The MARS Holter Analysis Workstation is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric (greater than 10Kg) human patients. The MARS Holter Analysis Workstation provides the user arrhythmia studies and holter analysis capabilities.
Data acquired may be use for the following indications:
- Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction disturbances
- Evaluation of symptoms that may be due to myocardial ischemia
- Detection of ECG events that alter prognosis in certain forms of heart disease
- Detection and analysis of pacemaker function and failure
- Determination of cardiac response to lifestyle
- Evaluation of therapeutic interventions
- Investigations in epidemiology and clinical trials
The MARS Holter Analysis Workstation system is a software-system that runs on PC based hardware. The MARS Holter Analysis Workstation supports a number of software applications including analysis, user editing and final report processing.
The MARS Holter Analysis Workstation analyzes ambulatory ECG data, to detect and label beats, and then presents it in a variety of screens to the user for review and data editing purposes. The MARS Holter Analysis Workstation system stores and prints final reports and allows reports to be sent to the MUSE Cardiology Information Management System for long- term archive. The MARS Holter Analysis Workstation supports acquisition from ambulatory ECG Recorders. A variety of different final report formats can be stored and printed. The final report is used by trained medical personal to diagnosis a patient's cardiac abnormalities.
Here's an analysis of the provided text regarding the MARS Holter Analysis Workstation's acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not explicitly state specific numerical acceptance criteria for the MARS Holter Analysis Workstation. Instead, it relies on a statement of substantial equivalence to predicate devices and adherence to voluntary standards and quality assurance measures.
Therefore, the table will reflect this qualitative approach.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Overall Safety and Effectiveness: Device should be as safe and effective as predicate devices. | "The results of these measurements demonstrated that the MARS Holter Analysis Workstation is as safe, as effective, and performs as well as the predicate devices." (Predicate devices: K991786 GEMS-IT MARS Unity Workstation, K010949 Agilent Technologies 2010 Plus Holter for Windows). |
| Compliance with Voluntary Standards: Device should comply with relevant voluntary standards. | "The MARS complies with the voluntary standards as detailed in Section 9 of this submission." (Specific standards not detailed in this extract). |
| Quality Assurance Measures: Development should adhere to established quality assurance processes. | "The following quality assurance measures were applied to the development of the device:Requirements specification reviewRisk analysisSoftware and hardware testingPerformance testingSafety testingEnvironmental testingClinical use evaluationFinal validation" |
| Functional Equivalence: Device should employ the same technology and functionality as predicate devices. | "The proposed MARS Holter Analysis Workstation employs the same functional scientific technology as the predicate devices MARS Unity (K991786) and 2010 Plus Holter for Windows (K010949)." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for a distinct "test set." The document mentions "clinical use evaluation" as a quality assurance measure, but no details of such a study are provided. The "results of these measurements" (referring to the quality assurance measures) form the basis for the conclusion that the device performs as well as predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The provided text does not specify the number or qualifications of experts used to establish ground truth for any test set. While the intended use states that "Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data" and "This information is not intended to serve as a substitute for the physician overread of the recorded ECG data," it doesn't detail how this physician overread was used in a testing context.
4. Adjudication Method for the Test Set:
The provided text does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed, nor does it mention any effect size related to human reader improvement with or without AI assistance. The focus is on the device's standalone performance compared to predicate devices, with the understanding that a trained operator and physician will be supervising and interpreting the results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance assessment was effectively done. The document states that the MARS Holter Analysis Workstation "analyzes ambulatory ECG data, to detect and label beats, and then presents it in a variety of screens to the user." The "results of these measurements demonstrated that the MARS Holter Analysis Workstation is as safe, as effective, and performs as well as the predicate devices." This implies that the algorithm's performance in analyzing ECG data was evaluated independently as part of the "performance testing" and "final validation" phases mentioned in the quality assurance measures. The focus is on the system's ability to perform the analysis, even though the output is for physician review.
7. The Type of Ground Truth Used:
The provided text does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the nature of Holter analysis and the reliance on predicate devices, it's highly probable that ground truth would involve:
- Established interpretations by qualified cardiologists/electrophysiologists from previously analyzed Holter recordings.
- Comparison against outputs of the predicate devices which themselves would have been validated against expert interpretation or established clinical standards.
8. The Sample Size for the Training Set:
The provided text does not specify the sample size for the training set.
9. How the Ground Truth for the Training Set was Established:
The provided text does not explicitly state how the ground truth for the training set was established.
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