(20 days)
The ERA 3000 is intended for use during invasive pacemaker procedures in the following activities:
Temporary External Pacing . Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO modalities during implantable pacemaker procedures or physician evaluations.
Lead Threshold Determination . Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time.
Pacemaker Function Test . Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, A/V delay, and rate/interval.
The ERA 3000 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. It can also operate as a temporary external pulse generator during the above mentioned procedures. The ERA 3000 utilizes a touch-proof configuration to help prevent hazardous connection between patients and electrical power sources.
The ERA 3000 Pacing System Analyzer (Model: ERA 301.4) underwent a Special 510(k) notification (K042708) to update its software to correct several anomalies. The original predicate device was BIOTRONIK's ERA 3000 Pacing System Analyzer (#K022360, cleared 01-27-03).
The provided text does not contain details of specific acceptance criteria or an explicit study proving the device meets these criteria. The document primarily focuses on the device modification (software update), its general description, indications for use, and regulatory classification.
Therefore, many of the requested details cannot be extracted from the provided text.
However, based on the information provided, here's what can be inferred or stated as not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available | Not Available |
| (Specific performance metrics and thresholds for the software update are not described in the provided text.) | (Specific reported performance data for the software update is not described in the provided text.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not available.
- Data Provenance: Not available. The document mentions the manufacturing sites (Germany and Switzerland) but provides no information about where any testing or data collection took place.
- Retrospective or Prospective: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not available.
- Qualifications of Experts: Not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not available.
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
- MRMC Study: No. This device is a pacing system analyzer, not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study to assess human reader improvement with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The document describes a software update for a "Pacing System Analyzer designed to test the electrical performance of the pulse generator and the pacing lead system." While the device operates automatically, the text does not explicitly detail a "standalone performance" study in the context of a new algorithm's evaluation, but rather refers to corrections of "anomalies" in existing software. The update is for an existing device's functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not available. The "anomalies" corrected by the software update would imply that the "ground truth" for the original software's performance (and the corrected version) would relate to the accurate measurement and analysis of pacing parameters (e.g., impedance, capture threshold, pulse amplitude, width, A/V delay, rate/interval). However, the method for verifying these corrections is not described.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a software update to correct anomalies, not a machine learning algorithm requiring a separate training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As it's not a machine learning algorithm, there is no training set in the typical sense.
§ 870.3600 External pacemaker pulse generator.
(a)
Identification. An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.
(2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (
i.e., battery power, AC mains connections, or both).(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;
(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;
(iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (
e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.
(4) Appropriate software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;
(ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;
(iii) The labeling must list all pacing modes available in the device;
(iv) Labeling must include a detailed description of any special capabilities (
e.g., overdrive pacing or automatic mode switching); and(v) Appropriate electromagnetic compatibility information must be included.