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Where the clinician decides to monitor cardiac arthythmia 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, pediatic, 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 arrhythmia analysis algorithm is to monitor a neonatal, pediation of adult patient ECG's for heart rate and ventricular arthythmias, 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.

Note: The ST algorithm does not analyze ventricularly paced or ventricular ectopic beats.

The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatic and adult patients with and without symptoms of arrhythmia. OT 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.

EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates. EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

RLS ECG is intended for monitoring multiple leads of ECG of adults.

RLS ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult patients including arrhythmia, ST segment changes, and QT/QTc, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The modification is a software-based change that adds the following features:
· Support derived 12-lead ECG (RLS ECG) from a 6-electrode lead set.
· Provide enhanced AF and Irregular HR alarms detection
· Provide enhanced QT and ST analysis and alarms.

The provided text is a 510(k) summary for the Philips ST/AR ST and Arrhythmia Software, Release K.0. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a study proving the device meets said criteria in the format requested.

Here's an analysis of what is and is not provided, based on your request:

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

• Not provided. The document states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test.results showed substantial equivalence. The results demonstrate that ST/AR Release K.O meets all defined reliability requirements and performance claims."
• This statement indicates that acceptance criteria (pass/fail criteria) were established and met, but it does not specify what those criteria were (e.g., sensitivity, specificity, accuracy targets) nor does it report the device's performance against those criteria with specific metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document mentions "system level tests, performance tests, and safety testing from hazard analysis" but does not detail the sample sizes for these tests or the nature of the data (e.g., patient population, retrospective/prospective).

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)

• Not provided. The document does not describe the establishment of a "ground truth" using experts for performance evaluation. The testing described focuses on functional equivalence to predicate devices and adherence to existing specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not provided. There is no mention of an adjudication process for the test set.

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

• Not provided. This document describes a software update for a physiological monitor with expanded features (e.g., derived 12-lead ECG, enhanced AF/Irregular HR alarms, enhanced QT/ST analysis). It is not focused on an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study to assess human reader improvement. The focus appears to be on the algorithm's performance itself, rather than its impact on human interpretation.

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

• Implied, but not explicitly detailed. The statement "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate" suggests that the algorithm itself was tested for performance against established specifications. However, specific metrics (like sensitivity, specificity, accuracy) are not provided in this summary. The testing appears to be focused on whether the new features function as intended and meet the specifications set for the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated how ground truth was established, if at all, for performance claims. The document uses the term "specifications cleared for the predicate device" as the basis for pass/fail criteria. This suggests that the ground truth for evaluation would be derived from comparisons to the expected outputs or performance of the cleared predicate devices, rather than an independent clinical ground truth like pathology or expert consensus on new data.

8. The sample size for the training set

• Not provided. Training sets are typically associated with machine learning or AI development. While the device includes "algorithms" (e.g., ST/AR arrhythmia analysis algorithm, ST/AR ST analysis algorithm), this document does not provide details of their development processes that would include training sets. Given the submission date (2010), these algorithms likely rely on more traditional signal processing and rule-based methods rather than large-scale machine learning requiring explicit "training sets" in the modern sense.

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

• Not applicable / Not provided. As no training set information is given, the method for establishing its ground truth is also not mentioned.

In summary, this 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices. It confirms that testing was conducted and specifications were met, but it does not provide the detailed performance metrics, study designs, or ground truth establishment methods typically requested for a deeper understanding of a device's clinical performance and validation against specific acceptance criteria. The "study" mentioned is a general "Verification, validation, and testing" activity, not a specific clinical trial with reported outcomes.

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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 arrhythmia 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 modification is a software-based change that provides Cardiotach functionality without arrhythmia analysis and ST Segment Analysis without arrhythmia analysis.

The provided text describes a 510(k) summary for the Philips ST/AR ST and Arrhythmia Software, Release E.1. However, it does not contain detailed information regarding acceptance criteria, specific device performance metrics, sample sizes for test or training sets, ground truth establishment methods, or whether MRMC or standalone studies were conducted.

The document mainly focuses on establishing substantial equivalence to previously cleared predicate devices through software-based changes. It states that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." and "The results demonstrate that ST/AR Release E.1 meets all reliability requirements and performance claims." but does not elaborate on what these specifications or claims are.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer the questions based only on the provided information, noting where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: Specific numerical criteria for performance (e.g., sensitivity, specificity, accuracy for arrhythmia or ST detection) are not provided in the text.)

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

• Sample Size for Test Set: Not specified. The document mentions "test results" and "system level tests, performance tests, and safety testing from hazard analysis" but does not provide details on the number of cases or patients used.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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.

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: Not specified. The document describes the device as "ST/AR ST and Arrhythmia Software" which is a standalone software, not explicitly an AI-assisted interpretation tool for human readers in the context of comparative effectiveness.
• Effect Size: Not applicable/not provided.

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

• Standalone Performance Evaluation: Yes, implied. The testing activities mentioned ("system level tests, performance tests") evaluated the device's inherent capabilities against predicate device specifications, suggesting a standalone evaluation of the algorithm. The device itself is described as "Software" that provides "Cardiotach functionality" and "ST Segment Analysis," indicating it operates independently to perform these functions. However, specific standalone metrics (e.g., sensitivity, specificity) are not provided.

7. The type of ground truth used

• Type of Ground Truth: Not specified. Given the context of arrhythmia and ST segment analysis, it would typically involve expert consensus on ECGs, potentially correlated with clinical outcomes or other diagnostic tests, but this is not explicitly stated in the document.

8. The sample size for the training set

• Sample Size for Training Set: Not specified.

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

• Ground Truth for Training Set: Not specified.

In summary, the provided submission primarily focuses on the regulatory aspect of substantial equivalence based on a software modification, rather than a detailed technical performance study with quantitative results and specific methodologies for clinical validation. This type of information is often found in more detailed technical reports or other sections of a 510(k) submission not included in this summary.

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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 STAR cardiotach is to monitor a neonatal, pediatric, or adult patient's heart rate and produce events/alarms for one of one of on paced and non-paced patients.

The intended use of the STAR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient's heart rate and ventricular and other arrhythmia events/alarms for one of two following both paced and non-paced patients.

The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient of all possible ECG leads. The ST analysis produce events/alarms for ST segment elevation or depression and repatients.

The modification is a software-based change that provides ST analysis for conventional 12-lead, MCL/V ST derivation, and single-lead QRS detection with adjustable QRS detection threshold capabilities.

The provided text is a 510(k) summary for the Philips ST/AR ST and Arrhythmia Software, Release E.0. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data in the format requested.

Therefore, much of the specific information requested, such as a table of acceptance criteria with reported performance, sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, details of comparative effectiveness studies (MRMC), detailed standalone performance data, and detailed information about training set ground truth and size, is not explicitly available in the provided text.

However, I can extract and infer some information:

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

   • Acceptance Criteria: "Pass/Fail criteria were based on the specifications cleared for the predicate device."
   • Reported Device Performance: "Test results showed substantial equivalence. The results demonstrate that ST/AR Release E meets all reliability requirements and performance claims."
   • Inference: The document does not provide a specific table of quantitative acceptance criteria or detailed performance metrics (e.g., sensitivity, specificity, accuracy for ST segment detection or arrhythmia). It only states that the device met the "specifications cleared for the predicate device" and passed testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified.
   • Data Provenance: Not specified.

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)

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified.
   • Inference: The document does not mention the use of human experts to establish ground truth for testing. Testing involved "system level tests, performance tests, and safety testing from hazard analysis."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not specified. (Likely "none" as no human adjudication is mentioned for establishing ground truth.)

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: Not mentioned.
   • Effect Size: Not applicable as no such study is described.
   • Inference: This device is software for monitoring, not described as an AI assistance tool for human readers in a diagnostic setting.

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

   • Standalone Performance: Implied. The document states "performance tests" were conducted and that the "ST/AR Release E meets all reliability requirements and performance claims." This refers to the software's inherent performance. However, specific performance metrics are not given.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • Type of Ground Truth: Not explicitly stated. Given the nature of cardiac arrhythmia and ST segment monitoring, ground truth would typically come from well-characterized ECG databases or expert-annotated ECG recordings, but the document does not specify this. "Pass/Fail criteria were based on the specifications cleared for the predicate device," suggesting the predicate's established performance served as a benchmark for what constituted acceptable behavior.

8. The sample size for the training set

   • Not applicable/Not specified. This document pertains to a software release that is a modification of an existing device, and the focus is on verification and validation against predicate specifications, not on a new algorithm developed through machine learning training.

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

   • Not applicable/Not specified. This information is not relevant to the type of submission described (a software modification to an existing cleared device, primarily demonstrating substantial equivalence).

Summary of what is available from the text:

The provided 510(k) summary focuses on demonstrating that a new software release (Philips ST/AR ST and Arrhythmia Software, Release E.0) is substantially equivalent to a previously cleared predicate device. It states that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate." The "Pass/Fail criteria were based on the specifications cleared for the predicate device," and the test results showed "substantial equivalence," indicating the device "meets all reliability requirements and performance claims." However, it does not provide detailed quantitative acceptance criteria, specific performance metrics (e.g., sensitivity, specificity), sample sizes for test data, details about data provenance, expert involvement, or adjudication methods. The study appears to be a validation against an existing cleared standard/predicate, rather than a de novo clinical study with new ground truth established by experts.

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Ask a specific question about this device

Ask a specific question about this device