(212 days)
The RhythmStat XL System is indicated for use in the diagnostic evaluation and recording of ECG waveforms from a cardiac event recorder. It is intended to provide remote access to ECG data by transtelephonic transmission from an ambulatory cardiac event monitor to the portable PSION palmtop computer with RhythmStat XL software, where the ECG waveforms are demodulated, recorded, displayed and stored.
The RhythmStat XL System is a telephone electrocardiograph (ECG) receiving system used for recording and reporting of ECG data from a cardiac event recorder. The System has three main components:
- . A commercially available cardiac event recorder such as the Micromedical Industries BIOLOG or the Instromedix® Heart Card™, that conditions and transmits ECG data in the form of a frequency-modulated acoustic waveform to the PSION Series 3 palmtop computer:
- Two proprietary software programs, contained in the commercially available PSION Series 3 . palmtop computer, that 1) recondition the received signal format and display the signal to the physician on the computer screen, then 2) transmit the ECG data, along with the physician's comments, from the PSION palmtop computer to the Reporting Server via modem; and
- . The Data Critical Reporting Server that accepts the ECG data and commentary and generates a printed report that is automatically transmitted to the physician's office via fax.
The provided K971650 document describes a 510(k) premarket notification for the RhythmStat XL System. This system is a telephone electrocardiograph (ECG) receiving system. The performance data section focuses on demonstrating equivalency to predicate devices, rather than establishing specific, quantified acceptance criteria and proving the device meets them in a traditional sense with statistical endpoints.
Here's an attempt to extract the requested information based on the provided text, with significant limitations due to the nature of the submission (an equivalency claim, not a de novo study with strict acceptance criteria).
Acceptance Criteria and Study Details for RhythmStat XL System
1. Table of Acceptance Criteria and Reported Device Performance
Note: The submission does not explicitly state numerical acceptance criteria in the format typically seen in more recent device studies. Instead, it relies on a comparative assessment of "measurable comparability" and "equivalent quality" to predicate devices. The "performance" described is the outcome of this comparative assessment against a qualitative benchmark.
| Acceptance Criteria (Implicitly Derived) | Reported Device Performance |
|---|---|
| ECG waveforms produced by the RhythmStat XL System must be measurably comparable to those produced by predicate devices (Micromedical BIOLOG and Instromedix LifeSigns Receiving Center) in terms of amplitude and duration of QRS segments. | The RhythmStat XL System's ECG waveforms were analyzed for the amplitude and duration of the first ten QRS segments, and the total duration of all QRS segments. These measurements were compared to those obtained from the Micromedical BIOLOG and Instromedix LifeSigns Receiving Center. The system "demonstrated acceptable performance, producing ECG waveforms which were measurably comparable" to the waveforms of the predicate devices. |
| ECG waveforms produced by the RhythmStat XL System must be of equivalent quality to those produced by predicate devices (Micromedical BIOLOG and Instromedix LifeSigns Receiving Center). | The RhythmStat XL System "produced ECG waveforms which were... of equivalent quality to the waveforms of the Micromedical and Instromedix products." The method for assessing "quality" beyond the QRS measurements is not explicitly detailed but is implied to be part of the comparative evaluation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "Subjects were tested" and that "ECG recordings were obtained with the BIOLOG, then played back to and recorded by the PSION/RhythmStat XL". This implies recordings from at least one subject were used, but the number of unique subjects or recordings is not quantified.
- Data Provenance: The study was conducted by Data Critical Corporation. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective. Given the testing methodology described (obtaining recordings with one device and playing them back to others), it suggests a controlled, prospective setup within the company's testing environment rather than a large-scale clinical study with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified. The analysis of QRS segments ("amplitude and duration of the first ten QRS segments were analyzed and measured, along with the total duration of all QRS segments") does not explicitly state who performed these measurements or whether expert review was involved in establishing a "ground truth" beyond the measurements themselves. The document states the PSION displays the signal "to the physician," but this pertains to the intended use, not necessarily the ground truth establishment for the performance study.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. The study describes a direct comparison of physical output (ECG printouts) by measurement, rather than an expert review process requiring adjudication of disagreements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on direct device output comparison, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
- Standalone Performance Study: Yes, a standalone performance assessment was conducted for the RhythmStat XL System in the context of comparing its output (ECG waveforms) to predicate devices. The system's output was directly measured and compared without human interpretation being explicitly part of the performance evaluation method, although it implicitly aims to produce output suitable for human interpretation.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this study is the direct measurement of QRS amplitude and duration from ECG printouts produced by the predicate devices. The predicate devices' outputs serve as the reference standard for "measurable comparability" and "equivalent quality." This is a measurement-based comparative standard rather than an expert consensus, pathology, or outcomes data ground truth.
8. Sample Size for the Training Set
- Sample Size for Training Set: The document does not mention a training set. This system is described as a receiving and reporting system, not an AI/machine learning algorithm that typically requires a training set. If there's internal calibration or development data, it's not disclosed as a "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as no training set is mentioned in the context of an AI/machine learning algorithm.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).