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The AT-10Plus is a 12-channel, ECG Device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-10Plus can be used as a diagnostic aid for heart function and heart conditions. The AT-10Plus is designed for indoor use. The device provide an optional interface to the SP-250 for pulmonary function data.

The AT-10Plus is a 12-channel, ECG device used for the recording, analysis and evaluation of ECG recordings. It has dimensions of 348x288x87mm and weighs 4.2 Kg. It operates in temperatures from +10° - 40° C and storage temperatures from -10° - +50° C, with relative humidity between 25% - 95% (non condensing). It supports Standard / Cabrera leads and has a battery capacity of 2 hrs of normal use. The frequency range of the digital recorder is 0 to 150Hz. It has an Alphanumerics, LCD Display 800x600dots. The Myogram Filter is 25Hz or 35Hz programmable. Paper speeds are 5/10/12.5/25/50 mm/s. The printing process uses a High resolution thermal printhead 8dots per mm 200dots per inch(amplitude axes) 40dots per mm / 1000 dots per inch time axes, 25mm/s. It uses Thermoreactive, Z-folded, 210mm chart paper and has 6 recording tracks, positioned at optimal with on 80 mm / 3.2 inch automatic baseline adjustement. It has 6 channel representation of 12 simultaneously acquired standard leads automatic lead programs. It also provides an optional interface to the SP-250 for spirometry.

This 510(k) summary describes a device, the CARDIOVIT AT-10Plus, that is an Electrocardiographie Device. The submission focuses on demonstrating substantial equivalence to a predicate device (CARDIOVIT AT-102, K031557) through non-clinical testing and comparison of technical specifications, rather than clinical performance studies with specific acceptance criteria that are typically seen for novel diagnostic algorithms.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as they relate to clinical performance, is largely not applicable (N/A) in the context of this 510(k) submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance

The core "acceptance criteria" in this 510(k) are related to safety, effectiveness, and technical specifications, demonstrating substantial equivalence to the predicate device.

• Dimensions: 348x288x87mm (vs 380x328x100mm)
• Weight: 4.2 Kg (vs 5.0 kg)
• Control panel: Alphanumerics, LCD Display 800x600dots (vs LCD Display)
• Paper speed: 5/10/12.5/25/50 (vs 5/10/25/50mm/s direct) |

Study Details Based on the Provided Document:

1. A table of acceptance criteria and the reported device performance: See table above. The primary acceptance criterion here is meeting relevant electrical safety standards and demonstrating equivalent technical specifications and intended use to the predicate device.

2. Sample size used for the test set and the data provenance: N/A. This 510(k) relies on non-clinical engineering and software testing, and a comparison of technical specifications, not a clinical "test set" of patient data for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment for a patient-data test set is not described as part of this submission. The "experts" involved would be those assessing compliance with electrical safety standards and reviewing software documentation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. No clinical test set requiring 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: N/A. This device is an electrocardiograph, not an AI-assisted diagnostic tool that would involve human readers and a comparative effectiveness study of this nature.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. The submission does not describe a standalone algorithm performance study. The device's "analysis" function is intrinsic to its role as an ECG device, and its safety and effectiveness are established through reference to the predicate and compliance with standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A for clinical performance. The "ground truth" for the non-clinical tests is regulatory standards (e.g., EN60601-1, IEC 601-2-25) and engineering specifications of the predicate device.

8. The sample size for the training set: N/A. This is not a machine learning or AI device that would have a "training set" in the typical sense.

9. How the ground truth for the training set was established: N/A. Not applicable for this device type and submission.

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