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The TM2000 EasyTrace Plus Transtelephonic Receiving Center system is intended to support a remote monitoring, i.e. receiving, storing, displaying, measuring, updating, printing and re-transmitting of patient ECG and Spirometric parameters and other relevant data.

The TM2000 EasyTrace Plus Telemedicine Receiving Center is intended for supporting transtelephonic monitoring of Electrocardiography (ECG) and Spirometric parameters of patients.

The TM2000 EasyTrace Plus Transtelephonic Receiving Center system comprises a receiver, a PC with associated equipment, and a package of software tools.

The provided text describes the TM2000 EasyTrace Plus Transtelephonic Receiving Center and its substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study demonstrating the device meets specific performance criteria.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document focuses on regulatory compliance (510(k) summary, substantial equivalence, applicable standards, risk analysis, design controls) and the general features and intended use of the device. It does not list specific performance metrics (e.g., accuracy, sensitivity, specificity, signal-to-noise ratio for ECG/Spirometry) that the device was tested against, nor does it provide quantitative results.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified.

Explanation: The document mentions "testing was conducted to verify the system compliance with all its design specifications" in the context of design controls. However, it does not detail the nature of this testing, the size of any test datasets used, or where such data originated (e.g., real patient data, simulated data, country of origin, retrospective/prospective collection).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Explanation: Given the absence of detailed performance data and a specific clinical study, there is no information regarding experts involved in establishing ground truth for any test sets. The focus is on the device's technical specifications and regulatory adherence rather than its clinical performance validation with expert-adjudicated data.

4. Adjudication Method:

• Adjudication Method: Not specified.

Explanation: As no performance study with a test set and ground truth is described, there is no mention of an adjudication method like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study Done?: No.
• Effect Size (AI vs. without AI assistance): Not applicable, as no MRMC study is mentioned.

Explanation: The device is described as a "Transtelephonic Receiving Center" for ECG and Spirometric parameters, implying a system for receiving, storing, displaying, and re-transmitting data for human review. There is no indication of AI assistance for interpretation or a comparative effectiveness study involving human readers.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study Done?: No.

Explanation: The document does not describe any standalone performance metrics for an algorithm that interprets ECG or Spirometry data. The device's function is centered on data management and display, not automated diagnostic algorithms.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not specified.

Explanation: Without a described performance study, there's no mention of how ground truth (e.g., expert consensus, pathology, outcomes data) would have been established for any test data.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable.

Explanation: Since this device is described as a data receiving and management system and not an AI/ML-based diagnostic algorithm, the concept of a "training set" is not relevant to the information provided.

9. How Ground Truth for the Training Set Was Established:

• How Ground Truth for Training Set Was Established: Not applicable.

Explanation: As above, the device does not appear to involve machine learning or AI models that would require a training set with established ground truth.

Summary of what the document does provide:

• Intended Use: Remote monitoring (receiving, storing, displaying, measuring, updating, printing, and re-transmitting) of patient ECG and Spirometric parameters and other relevant data.
• Device Classification: Class II (21 C.F.R. Par. 870.2920).
• Applicable Standards: A comprehensive list of medical device, quality management, and software standards (e.g., EN1441, IEC 601-1, ISO/IEC Guide 51, FDA guidances).
• Features: Runs on MS Windows, manual patient/physician entry, analog/digital receiving, data processing, ECG/Spirometric event recording, receiving/viewing/printing from Card Guard transmitters, large storage capacity.
• Substantial Equivalence: Claimed to be substantially equivalent to Telemedicine 2000, the Transtelephonic Receiving Center, K992164.
• Design Controls and Hazard Analysis: Mentions a formal design and production process, QA/QC policy, and a "moderate level of concern" system determination through rigorous design evaluation, System Safety, and Risk analysis.
• Conclusion: The system is "a safe and reliable means" for its intended use, presenting "no adverse health effect or safety risks to patients when used as intended."

In conclusion, the provided text serves as a 510(k) summary focused on regulatory compliance and substantial equivalence to a predicate device, rather than a detailed report of a performance study with specific acceptance criteria and outcome data.

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