(59 days)
The SEER Light Extend Compact Digital Holter Recorder and Controller System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric and adult patients. acquire annoulatory 2 of 5 chamic 20 C stient demographic information to on board flash memory.
The SEER Light Extend Compact Digital Holter System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility.
The SEER Light Extend Compact Digital Holter System does not perform any analysis of the ECG data.
The SEER Light Extend Compact Digital Holter System ismot intended for use on patients weighing less than 10Kg.
The SEER Light Extend Compact Digital Holter Recorder is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for up to 48 hours. The device stores the acquired ECG data in its on-board flash memory. The SEER Light Extend Controller downloads patient demographic information into the SEER Light Extend Compact Digital Holter Recorder and allows the user to check the signal quality of the ECG data at hookup time. At the end of the recording, the SEER Light Extend Controller is connected to the SEER Light Extend Compact Digital Holter Recorder by a cable and the stored ECG data is transferred from the recorder to the controller onto a standard compact flash memory card. Alternately, the SEER Light Connect, a USB interface, can download patient demographic information from a PC into the SEER Light Extend Compact Digital Holter Recorder and, via a PC, allows the user to check the signal quality of the ECG data at hookup time. At the end of recording, the SEER Light Extend Compact Digital Holter Recorder can be connected to the SEER Light Connect and the stored ECG data is transferred from the recorder directly to a PC.
Here's a breakdown of the acceptance criteria and study information for the SEER Light Extend Compact Digital Holter System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio). Instead, it relies on demonstrating equivalence to a predicate device and compliance with general quality measures.
Therefore, the "acceptance criteria" can be inferred from the overall claim of safety, effectiveness, and performance being "as well as the predicate device" and compliance with voluntary standards.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device (SEER Light Compact Digital Holter Recorder and Controller System K021470) in terms of Safety, Effectiveness, and Performance | "The results of these measurements demonstrated that the SEER Light Extend Compact Digital Holter System is as safe, as effective, and performs as well as the predicate device." |
| Compliance with Voluntary Standards | "The SEER Light Extend Compact Digital Holter Recorder and Controller Test Summary: System complies with the voluntary standards as detailed in Section 9 of this submission." (Specific standards are not detailed in the provided text.) |
| Functional Scientific Technology Equivalence | "The proposed SEER Light Extend Compact Digital Holter System employs the same functional scientific technology as the predicate device SEER Light Compact Digital Holter Recorder and Controller System (K021470)." |
| Quality Assurance Measures | Application of: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration Testing (System verification), Final acceptance testing (Validation), Performance testing, Safety testing, Environmental Testing. |
| Intended Use Fulfillment | "The SEER Light Extend Compact Digital Holter System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric and adult patients. The device stores this data along with patient demographic information to on board flash memory." (The device description confirms it meets these capabilities). |
| No ECG Data Analysis Performed (for the device itself) | "The SEER Light Extend Compact Digital Holter System does not perform any analysis of the ECG data." (Explicitly stated). |
| Not for use on patients weighing less than 10Kg | "The SEER Light Extend Compact Digital Holter System is not intended for use on patients weighing less than 10Kg." (Explicitly stated). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective). The "Test Summary" lists various testing stages (unit level, integration, final acceptance, performance, safety, environmental) but does not provide details about the data used for these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not mention the use of experts to establish ground truth or their qualifications. Given that the device is a data acquisition system that does not perform any analysis of ECG data, it is unlikely that clinical ground truth (e.g., disease diagnosis) would be directly established for the device's testing. The focus of the "ground truth" would likely be on the accuracy and integrity of ECG signal acquisition and storage.
4. Adjudication Method for the Test Set
The provided text does not mention any adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve With AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not applicable and therefore not done. The device is a "Digital Ambulatory Holter Recorder" for ECG signal acquisition. It "does not perform any analysis of the ECG data." Therefore, there is no AI component or analysis capability for human readers to interact with or be assisted by.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study for an algorithm was not applicable and therefore not done. As stated, the device "does not perform any analysis of the ECG data," implying no embedded algorithms for data interpretation or diagnosis. Its function is solely to acquire and store raw ECG data.
7. The Type of Ground Truth Used
The provided text does not explicitly state the type of ground truth used. Given the nature of the device (ECG data acquisition and storage), the "ground truth" for its testing would primarily revolve around:
- Accuracy of ECG signal acquisition: Comparing the acquired digital signal to known input signals or reference recordings.
- Integrity of data storage: Verifying that the stored data is identical to the acquired data.
- Functionality of controls and data transfer: Ensuring all features operate as designed.
It would not involve clinical ground truth like "expert consensus," "pathology," or "outcomes data" directly related to disease diagnosis, as the device does not perform analysis.
8. The Sample Size for the Training Set
The provided text does not mention a training set sample size. This type of device, which acquires and stores raw data without performing analysis, typically does not utilize a "training set" in the machine learning sense. Its development and verification would involve engineering testing and validation against specifications, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or applicable for this type of device, the method for establishing its ground truth is not discussed.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).