(177 days)
The pePER is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.
The pePER is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms and the transmission of these recordings by telephone to a receiving system. The pePER stores the ECG after the `record' button is depressed. The recording period is preset up to 40 seconds with 2 recordings stored. The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the pePER.
Here's a breakdown of the acceptance criteria and study information for the pePER device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K060297) details the pePER's compliance with safety, EMC, and device standards, and its substantial equivalence to a predicate device (HEARTCARD® K010945). It does not present specific quantitative acceptance criteria for performance efficacy in detecting or transmitting cardiac events, nor does it report specific performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the device's adherence to relevant standards and its demonstrated equivalence to the predicate device in electrical characteristics and data transmission.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 and related amendments | "The pePER meets the set requirements and is in compliance for this device type." (Implicitly, passes all tests under these standards) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 and CISPR 11:1997/IEC 55011 | "The pePER meets the set requirements and is in compliance for this device type." (Implicitly, passes all tests under these standards) |
| Diagnostic ECG Device Standards | Compliance with AAMI EC11:1991 | "Testing was performed, where applicable, in accordance with AAMI EC11:1991. The pePER meets the set requirements and is in compliance for this device type." |
| Functional Equivalence (Electrical Characteristics & Data Transmission) | Equivalence to HEARTCARD® (K010945) in main electrical and transmission characteristics. | "The results of data transmissions and the measurements of the main functional characteristics of the pePER Transtelephonic ECG Recorder, when compared to the HEARTCARD® (K010945), indicate that the pePER is substantially equivalent." (A detailed "Characteristics Comparison and Transmission Validation" document is appended, but not provided in the excerpt) |
| Risk Management | Identification and mitigation of failure modes, with acceptable risk levels. | "A risk analysis is appended... The analysis identifies possible failure modes. For failure modes considered to be of medium or high probability of occurrence, system design features and procedures used to mitigate the associated hazard are listed." (Implicitly, all identified risks are appropriately managed) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a separate "test set" in the context of clinical performance evaluation (e.g., a set of patient ECGs used to evaluate the device's diagnostic accuracy). The testing described relates to electrical safety, EMC, and functional characteristics against a predicate device.
- Sample Size for Functional Testing: Not explicitly stated as a number of "samples" in the clinical sense. The comparison was based on "data transmissions and the measurements of the main functional characteristics."
- Data Provenance: Not applicable in the sense of patient data. The testing was technical in nature, comparing the pePER to the HEARTCARD® device. The manufacturing entity is based in Australia ("Medical Monitors Limited, Eastgardens NSW 2036, Australia").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided because the submission primarily focuses on technical equivalence and compliance with engineering standards rather than a clinical performance study requiring expert adjudication of ground truth for a test set of patient data.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication is described.
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
An MRMC comparative effectiveness study was not conducted or described. The pePER is a "Personal Event Recorder" intended to capture and transmit ECGs for physician review, not an AI-powered diagnostic tool that assists human readers. The submission focuses on the device's technical specifications and equivalence to a predicate device, not on AI-assisted interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The pePER is a hardware device for recording and transmitting ECGs. It does not perform automated diagnostic interpretation or analysis in a "standalone" algorithmic sense that would require such a study. The physician reviews the transmitted ECGs.
7. The Type of Ground Truth Used
The concept of "ground truth" in the diagnostic performance sense (e.g., pathology, outcomes data) is not used or described in this submission. The "truth" or reference for the device's performance is its adherence to industry standards (electrical, EMC, diagnostic ECG device) and its functional equivalence to a legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. The pePER is a physical device, and this submission does not describe an artificial intelligence algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of an AI algorithm or a training set.
§ 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).