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The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.

The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

The physiological parameters monitored include ECG, non-invasive blood pressure, noninvasive temperature and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro Telemetry System is also intended to provide physiologic data over the Unity Network to clinical information systems for display.

The ApexPro Telemetry System provides clinicians with patient data while allowing for patient mobility. The system consists of the following main components:
• The patient worn data acquisition transmitters
• Receiver Infrastructures
• Computer platforms hosting the ApexPro Software
• Computer platforms hosting the central station application
• Accessories to the patient-worn data acquisition transmitters
Serviceability tools

The provided text describes a 510(k) submission for the ApexPro Telemetry System, which is a design modification. However, it does not contain a table of specific acceptance criteria or detailed results of a study demonstrating the device meets those criteria, as typically found in a comprehensive clinical or performance validation report.

Instead, it lists the quality assurance measures applied during development and states a general conclusion about its safety and effectiveness compared to a predicate device.

Here's an analysis based on the available information, addressing what is and is not present:

1. Table of Acceptance Criteria and Reported Device Performance

(Information Not Provided in Detail)

The document does not include a quantifiable table of acceptance criteria or specific performance metrics with reported values. It broadly states:

The "Test Summary" lists types of tests conducted:

• Risk Analysis
• Requirements Review
• Design Reviews
• Testing on Unit Level (Module verification)
• Integration testing (System Verification)
• Final Acceptance testing (Validation)
• Performance testing
• Safety and environmental testing

These are categories of testing, not specific acceptance criteria or performance results.

2. Sample Size Used for the Test Set and Data Provenance

(Information Not Provided)

The document does not specify the sample size for any test set or the provenance of data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

(Information Not Provided)

There is no mention of experts being used to establish ground truth for a test set, nor their number or qualifications. The submission focuses on internal testing and comparison to a predicate device.

4. Adjudication Method for the Test Set

(Information Not Provided)

No adjudication method is described, as the document does not detail a test set requiring expert adjudication.

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 Applicable / Information Not Provided)

This device (ApexPro Telemetry System) is a physiological patient monitor, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device and is not mentioned.

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

(Partially Applicable/Implied)

The submission implies that performance testing was done on the system itself (algorithm/device only) to ensure it performs "as well as the predicate device." This would be a form of standalone testing, as it doesn't describe human interaction being part of the primary performance evaluation shown here. The "Performance testing" mentioned in the Test Summary would have evaluated the device's inherent capabilities, including its ability to "detect various ECG arrhythmia events and select physiological parameter limit violations" according to its intended use.

7. The Type of Ground Truth Used

(Implied Standard Device Performance)

For a telemetry system, the "ground truth" for its performance would typically come from:

• Known, validated physiological signals: Using signal generators or previously recorded, carefully annotated cardiac or physiological waveforms to test the device's detection and measurement accuracy (e.g., against established medical standards for arrhythmia detection).
• Comparison to a predicate device: The document explicitly states the system "employs the same functional technology as the predicate devices" and that it was demonstrated to be "as safe, as effective, and performs as well as the predicate device." This indicates the predicate device's established performance serves as a benchmark for ground truth.

8. The Sample Size for the Training Set

(Not Applicable / Information Not Provided)

This submission describes a telemetry system, not an AI/machine learning algorithm that typically requires a "training set" in the conventional sense. The "development" process would involve engineering and software validation, not machine learning model training.

9. How the Ground Truth for the Training Set was Established

(Not Applicable / Information Not Provided)

As this is not an AI/ML device that uses a "training set," this question is not applicable.

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The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.

The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

The physiological parameters monitored include ECG, non-invasive blood pressure and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro is also intended to provide physiologic data over the Unity network to clinical information systems for display.

The ApexPro Telemetry System is composed of six major components:

• The patient worn data acquisition transmitters
• The receiver antenna system infrastructure
• The receivers
• The receiver subsystem
• A computer platform running the ApexPro Telemetry Application
• A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)

The provided regulatory submission (K032369) for the ApexPro Telemetry System does not contain the detailed information required to fill out the requested table and study specifics regarding acceptance criteria and performance against those criteria.

The document is a 510(k) summary and the FDA's clearance letter. It primarily states that the device is "as safe, as effective, and performs as well as the predicate devices" (K021325 ApexPro Telemetry System) and "complies with the voluntary standards as detailed in Section 9 of this submission." However, Section 9 (which would likely contain the standards and test data) is not included in the provided text.

Based on the provided text, here's what can be extracted and what is missing:

Information NOT available in the provided text:

• Specific Acceptance Criteria (quantitative thresholds for performance).
• Reported Device Performance (quantitative results against acceptance criteria).
• Details of the study that proves the device meets acceptance criteria. This includes:
  • Sample size for the test set and its provenance.
  • Number of experts for ground truth and their qualifications.
  • Adjudication method.
  • MRMC comparative effectiveness study results (effect size).
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

Information AVAILABLE from the provided text:

The "Test Summary" section mentions the types of quality assurance measures applied, but these are general development and testing practices, not specific performance study details:

• Requirements specification review
• Code inspections
• Software and hardware testing
• Safety testing
• Environmental testing
• Final validation

The "Conclusion" states: "The results of these measurements demonstrated that the ApexPro System is as safe, as effective, and performs as well as the predicate devices." This is a qualitative statement of equivalence, not a quantitative report of performance against specific criteria.

Therefore, I cannot populate the table or provide the detailed study information as requested, as that specific data is not present in the provided FDA submission excerpts. The submission relies on demonstrating substantial equivalence to a predicate device and adherence to voluntary standards, rather than providing a detailed performance study with specific acceptance criteria and results within this summary document.

To answer your request thoroughly, I would need access to "Section 9 of this submission" or specific test reports from GE Medical Systems Information Technologies for K032369.

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The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.

The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

The physiological parameters monitored include ECG, non-invasive blood pressure and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro is also intended to provide physiologic data over the Unity network to clinical information systems for display.

The ApexPro Telemetry System is composed of six major components:
• The patient worn data acquisition transmitters
• The receiver antenna system infrastructure
• The receivers
• The receiver subsystem
• A computer platform running the ApexPro Telemetry Application
• A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)

The provided text is a 510(k) summary for the ApexPro Telemetry System. While it states that the device complies with voluntary standards and mentions quality assurance measures, it does not include detailed acceptance criteria or a study proving that the device meets specific performance metrics.

Here's what can be extracted based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The document states that the ApexPro "complies with the voluntary standards as detailed in The following quality assurance Section 9 of this submission." However, Section 9 is not provided in this document, so the specific voluntary standards and their associated acceptance criteria are unknown. No quantitative performance metrics for the device (e.g., accuracy of arrhythmia detection, sensitivity, specificity) are given in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

Missing Information: The document does not specify any sample size used for a test set, nor does it mention the data provenance (country of origin, retrospective/prospective). The study described is a general "test summary" of quality assurance measures, not a clinical trial with a defined test set of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Missing Information: Since no specific clinical test set is described, there is no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set:

Missing Information: No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

Missing Information: No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technological similarity and quality assurance, rather than a comparative effectiveness study with human readers.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

The document describes the device as processing "physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations." This implies an algorithmic component. However, no standalone performance study details (e.g., sensitivity, specificity of the algorithm itself) are provided in this summary. The "Test Summary" section refers to "Software and hardware testing," which might include standalone performance, but no results are detailed.

7. The Type of Ground Truth Used:

Ground truth for "software and hardware testing" and "safety testing" would likely refer to internal verification and validation against known standards and simulated or real-world scenarios. However, the exact type of ground truth (e.g., expert consensus, pathology, outcomes data) for specific physiological data detection claims is not stated.

8. The Sample Size for the Training Set:

Missing Information: No training set or its sample size is mentioned, as this document is not describing a machine learning model training process in detail.

9. How the Ground Truth for the Training Set was Established:

Missing Information: Since no training set is described, there is no information on how its ground truth was established.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through system description, intended use, and a high-level overview of quality assurance measures, rather than a detailed performance study with specific acceptance criteria and outcome metrics.

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