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510(k) Data Aggregation
(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.
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(56 days)
The CG-2211 SelfCheck ECG Transmitter and LifeWatch Heart Screening Service are intended for self-testing by patients who are concerned about their heart rhythm (i.e. during or after exercise) or who experience the following symptoms that are suggestive of abnormal heart rhythms, and who would like to monitor these symptoms:
- Skipped Beats
- Pounding heart (Palpitations)
- Heart Racing or Irregular Pulse
- Lightheadedness or Faintness
- History of Arrhythmias
The CG-2211 SelfCheck is a personal single lead event ECG transtelephonic transmitter. The device is intended for self-testing by patients and records a limited period of heart activity. The recording is activated by patient, when symptom is experienced. The CG-2211 SelfCheck transmits the recorded data to a receiving station, where data is displayed for analysis and evaluation by physician. The transmission includes the time, when the event recording was activated by patient.
This 510(k) summary does not contain a specific study demonstrating that the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices and lists various validation and environmental tests conducted to verify compliance with design specifications. There is no mention of a clinical study with a test set, ground truth, or expert review for performance evaluation against specific acceptance criteria.
Therefore, many of the requested sections regarding acceptance criteria and a study to prove they are met cannot be filled from the provided document.
Here's a summary of the information that can be extracted or inferred from the document, along with explanations for the missing information:
Acceptance Criteria and Study Information
| Feature | Description from Document |
|---|---|
| 1. Table of Acceptance Criteria & Reported Performance | Not provided in the document. The document states that "laboratory testing was conducted to verify and validate the CG-2211 compliance with all the design specifications." It then lists various types of validation, environmental, and safety tests performed (e.g., High and Low Temperature and Humidity Test, Frequency Response Test, EMC Test, System Noise Test, etc.). However, it does not specify what the acceptance criteria for these tests were (e.g., "Frequency response within X dB from Y Hz to Z Hz") nor does it report the quantitative performance results against these criteria. The conclusion section generally states that "CG-2211 SelfCheck ECG Transmitter constitutes a safe and reliable means for recording and transmitting standard ECG for the purpose of cardiac condition diagnosis," but this is a qualitative summary, not performance data against specific metrics. |
| 2. Sample Size (Test Set) and Data Provenance | Not provided. The document does not describe a clinical test set or any data provenance for performance evaluation. The "validation tests" mentioned appear to be engineering/laboratory tests, not clinical performance studies with patient data. |
| 3. Number & Qualifications of Experts for Ground Truth | Not applicable/provided. Since no clinical test set or ground truth method is described, there's no information on experts or their qualifications. |
| 4. Adjudication Method (Test Set) | Not applicable/provided. No adjudication method is mentioned for a test set. |
| 5. Multi-Reader Multi-Case (MRMC) Study & Effect Size | Not performed/provided. The document does not describe an MRMC study or any assessment of human reader improvement with/without AI assistance. The device is a "SelfCheck ECG Transmitter" that sends data for a physician's analysis, implying human interpretation is always part of the workflow, and the document focuses on the device's ability to transmit data, not on interpretation aid. |
| 6. Standalone Performance (Algorithm Only) | Not performed/provided. The device itself is an ECG transmitter. Its primary function is to record and transmit ECG data for a physician to analyze. There is no mention of an internal algorithm performing interpretation or diagnosis in a standalone capacity. |
| 7. Type of Ground Truth Used | Not applicable/provided. As no clinical performance study involving diagnostic accuracy is described, no ground truth type is mentioned. The "validation tests" refer to engineering and safety verifications. |
| 8. Sample Size for Training Set | Not applicable/provided. This device is an ECG transmitter and does not appear to involve AI or machine learning algorithms that would require a "training set" in the context of diagnostic interpretation. The document describes a hardware device that records and transmits data. |
| 9. How Ground Truth for Training Set was Established | Not applicable/provided. As no training set for an AI/ML algorithm is mentioned, the method for establishing ground truth is not relevant here. |
Key Takeaway:
The provided 510(k) summary for the CG-2211 SelfCheck ECG Transmitter focuses on substantial equivalence to predicate devices and engineering/safety compliance rather than a clinical performance study with defined acceptance criteria for diagnostic accuracy. The device's function is to transmit ECG data for professional analysis, not to provide automated diagnostics itself. Therefore, the details requested about performance studies, data sets, experts, and ground truth, typical for AI-powered diagnostic devices, are not present in this document.
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