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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

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.

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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, AAI, A00, or ODO 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 confiquration to help prevent hazardous connection between patients and electrical power sources.

The provided text describes the ERA 3000 Dual Chamber Pacing System Analyzer and its indications for use, but does not contain information about acceptance criteria, device performance, or any studies conducted to prove device performance.

Therefore, I cannot provide the requested information in the format specified. The document is primarily a 510(k) summary for regulatory clearance, outlining the device's purpose, predicate devices, and an FDA clearance letter. It does not include the results of performance studies or validation data.

Ask a specific question about this device