Search Results

The intended use of the SEER Light Compact Digital Holter Recorder is to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for no longer than 24 hours. The device stores this data along with patient demographic information to on board flash memory. It does not perform any analysis on the ECG data.

The SEER Light Compact Digital Holter Recorder is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

The SEER Light Compact Digital Holter Recorder is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface for no longer than 24 hours. The device stores the acquired ECG data in its on-board 32 megabytes of flash memory. Additionally, the SEER Light controller downloads patient demographic information into the SEER Light recorder and checks the signal quality of the ECG data at hookup time via isolated, infra-red communications. At the end of the recording the SEER Light controller is connected to the SEER Light recorder by cable and the stored ECG data is transferred to it and onto a standard compact flash memory card.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SEER Light Compact Digital Holter Recorder:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly define specific numerical acceptance criteria for performance metrics. Instead, it states that the device "complies with the voluntary standards as detailed in Section 9 of this submission" (Section 9 is not provided here) and that the "results of these measurements demonstrated that the SEER Light Compact Digital Holter Recorder is as safe, as effective, and performs as well as the predicate device."

Therefore, the acceptance criteria are implicitly tied to meeting the performance of the predicate device (K001317 Aria Digital Holter Recorder®) and relevant voluntary standards. Specific quantitative performance data from comparative testing are not detailed in this summary.

Important Note: Without access to "Section 9 of this submission" and the specific test results comparing the SEER Light to the predicate device, it's impossible to provide granular numerical acceptance criteria or performance metrics specific to ECG signal quality, data storage integrity, or accuracy that would typically be expected for such a device. This summary focuses on demonstrating equivalence rather than establishing new performance benchmarks.

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

The provided text does not specify the sample size used for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). It only broadly mentions "software and hardware testing," "safety testing," and "environmental testing" as part of the quality assurance measures.

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

The provided text does not mention the use of experts or the establishment of ground truth for any test set in the context of clinical performance or diagnostic accuracy, as the device states it "does not perform any analysis on the ECG data." Its function is purely for acquisition and storage.

4. Adjudication Method

Given that no experts or clinical performance evaluations involving diagnostic interpretation are mentioned, there is no adjudication method described in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or is mentioned. The device, by its stated intended use, does not perform analysis on ECG data, so a study evaluating human readers' improvement with or without AI assistance would not be applicable.

6. Standalone Performance Study

The provided text does not describe a standalone (algorithm only without human-in-the-loop performance) study in the context often associated with diagnostic AI algorithms. The device itself is a standalone recorder, but its "performance" is based on its ability to acquire and store ECG signals reliably, not on its analytical capabilities. The testing mentioned (software, hardware, safety, environmental, final validation) would fall under performance testing, but not in the context of an "algorithm only" diagnostic performance study.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used for diagnostic algorithms (e.g., pathology, outcomes data, expert consensus) does not apply to this device's stated function. The device acquires ECG signals; it does not interpret them. Therefore, its "ground truth" would relate to the accuracy of the recorded signal itself (e.g., comparison to a reference ECG machine for signal fidelity, absence of artifact, proper data storage). However, the document does not elaborate on how this type of ground truth was established.

8. Sample Size for the Training Set

The provided text does not mention a training set sample size. This device is a hardware recorder, not an AI/machine learning model that typically requires a training set.

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

As this is a hardware device for ECG data acquisition and not an AI/machine learning model, the concept of a "training set" and establishing "ground truth for a training set" as typically understood in AI/ML development is not applicable. The device's "performance" is validated through engineering and functional testing against specifications and standards, not through training on data with established ground truth for diagnostic purposes.

Ask a specific question about this device