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cardiette microtei is a 12 lead ECG acquirer fitted with a display and keyboard. The electrical heart activity is detected by means of two or more electrocardiograph electrodes and the device can acquire and transmit an ECG trace in analogue (via sound coupling) or digital formal (USB port or via the wireless Bluetooth channel) to a remote PC.

The equipments are intended for use in routine ecg recording in physician practice and/or hospital. Intended use for non interpretive applications covers the full range of patient population with no limitations with respect to age, sex and race of the patient.

The equipment is intended to be used by trained medical personnel or physicians.

cardiette microtel does not include ecg interpretation tools and/or analysis programs. The device is intended to transmit ECG waveforms to a PC. Analysis program on a PC is a separate product not marketed with the Cardiette Microtel.

The hardware and the software of the equipment, except for the paper recorder routines and interpretation program, are the same of the predicated device.

Indication for use of cardiette microtel has not been changed, except for the ecg interpretation program not present on this device, with respect to the predicate device CARDIOLINE AR600, AR1200, AR2100 (ref. K051534 CARDIOLINE AR600, AR1200, AR2100).

cardiette microtel is an electrocardiograph providing the following characteristics:

• · standard and/or rechargeable internal AA batteries
• · simultaneous acquisition and storage of the 12 standard leads acquired from a 10 wire cable, or 7 leads (6 peripheral + 1 precordial) acquired from a 5 wire cable.
• · storege of 10 second ECG of acquired ECG signals (in 12 and 7 lead formats)
• · storage of up to 40 ecg recordings (optional)
• · digital filters for AC interference suppression and base-line drift
• · transmition of the ECG in an analogue format via sound coupling or in digital format (SCP format) via the USB port and also via the wireless Bluetooth channel
• · graphic LCD display for user interface and ECG visualisation (the ecg trace may be used only to evaluate the quality of the acquired ecq)
• · functional keyboard for patient identification input data (disabled in the basic product), ECG recording and ECG sending operations

The information provided is for a 510(k) premarket notification for the "cardiette microtel" electrocardiograph. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically associated with novel devices.

Therefore, many of the requested sections below cannot be fully populated as this is not a study proving the device meets new acceptance criteria, but rather a demonstration that it is substantially equivalent to an existing device.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in the typical format of a clinical study, as the submission focuses on substantial equivalence to a predicate device. Instead, performance characteristics of the "cardiette microtel" are compared directly to those of the predicate devices (CARDIOLINE AR 600, AR 1200, AR 2100) in Table 5.7.1. The "acceptance criteria" here is implicitly that the microtel's performance should be substantially similar to the predicate, with any differences not raising new questions of safety or effectiveness.

USB (optional)
Blue Tooth (only for microtel bt version). |
| DISPLAY | |
| Size: None/120 x 32 pixels (AR 600) | Backlit single-colour LCD 128x64 pixels |
| Nº of displayed channels: none (AR 600) | 1 |
| Traces speed: N/a (AR 600) | 12,5 mm/s |
| Sensitivity: N/a (AR 600) | 5 mm/mV |
| Keyboard | |
| Type i keys: Membrane 21 functional keys (AR 600) | Silicon rubber 20 functional keys |
| SW options | |
| ECG Interpretation: Interpretation Program HES EKG (AR 600) | No |

The main "performance" aspects derived from the comparison are that the microtel (the new device) lacks a thermal printer and ECG interpretation software, and has different interfaces (sound couple, USB, Bluetooth) and a display compared to the AR 600 predicate. These differences are described as not raising new questions of safety or effectiveness, as the intended use (acquisition and transmission of ECG signals) remains equivalent for non-interpretive applications.

2. Sample size used for the test set and the data provenance

The document describes no clinical test set in the traditional sense for evaluation of diagnostic accuracy or clinical performance. This is a 510(k) submission based on substantial equivalence to an existing device (CARDIOLINE AR 600, AR 1200, AR 2100). The "tests" mentioned are non-clinical: full safety tests and Electromagnetic Compatibility (EMC) tests according to various EN and IEC standards (EN60601-1, IEC 601-2-25, IEC 601-2-51, EN60601-1-2, ETSI EN 301 489-17, ETSI EN 300 328). The sample size for these engineering tests is not specified, but it would typically involve a small number of manufactured units of the device.

There is no mention of patient data (retrospective or prospective) from any country of origin in the context of performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set requiring expert ground truth establishment is described in this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No clinical test set 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

Not applicable. This device is an electrocardiograph that acquires and transmits ECG signals, and explicitly does not include ECG interpretation tools or analysis programs. Therefore, no AI assistance or MRMC study involving human readers is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device does not include an algorithm for interpretation or analysis. Its function is to acquire and transmit raw ECG signals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No clinical performance testing against a ground truth is described. The relevant "ground truth" for this submission are the engineering standards (EN60601-1, IEC 601-2-25, IEC 601-2-51, EN60601-1-2, ETSI EN 301 489-17, ETSI EN 300 328) for safety and EMC, to which the device demonstrated compliance.

8. The sample size for the training set

Not applicable. The device does not employ any machine learning or AI algorithms that would require a "training set."

9. How the ground truth for the training set was established

Not applicable. No training set is described.

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CARDIOLINE AR 600 and AR 1200 and AR 2100 are a family of electrocardiograph recorders provided with a program for automated ecg analysis and with a graphic LCD display.

The equipments are intended for use in routine ecg recording in physician practice and/or hospital. The electrical heart activity is detected by means of two or more electrocardiograph electrodes and is recorded on thermal paper.

Intended use for non interpretive applications covers the full range of patient population with no limitations with respect to age, sex and race of the patient.

The interpretation program is intended to provide a diagnostic support to the physician for the ecg evaluation on rhythm and morphology.

Interpretation Statements must be overviewed and approved by trained Physician's. Interpretation statements just represent a partial qualitative and quantitative information of the general patient cardiovascular condition: no therapy or drugs can be subministrated based solely on Interpretation statements.

The equipments are intended to be used by trained medical personnel or physician's.

CARDIOLINE AR 600, AR 1200 and AR 2100 is a family of electrocardiographs providing the following characteristics:

• Mains and internal battery operation
• Manual acquisition of the 12 Standard Leads
• Simultaneous acquisition of the 12 Standard Leads
• Storage of 10 seconds of acquired ecg signal
• Storage of up to 40 ecg recordings (optional)
• Multichannel Ecg printout on thermal paper
• Copy function of the stored ecg
• High resolution digital thermal printer
• Digital filters for AC interference suppression and base-line drift
• Time and date printout
• Possibility to send acquisition data to a Personal Computer or Workstation via Infrared serial interface
• Interpretation Program Hannover Ecg System (HES) providing the following additional informations (optional):
  • Representatives Templates of each lead including markers on fiducial A points
  • Summary of mean measurements A
  • Summary of measurements performed on each lead A
  • A Rythm Analysys Statements
  • Rythm graphical representation A
  • Signal noise detection and information A
  • A Specific findings on QRS complex
  • A Conduction statements
  • QRS T Diagnostic Statements A
  • Summary of measurements performed on each lead
  • Arrhythmia monitoring detection
  • A Heart Rate Variability
• graphic LCD display for user interface and ECG visualisation
• Patient input data for Interpretation, identification and filing purposes

More specifically, the equipments family is based on 3 model variants characterized by different print and display capabilities.

The CARDIOLINE AR 600, AR 1200, and AR 2100 electrocardiographs incorporate the Hannover ECG System (HES) interpretation program. The submission states that this program has not been changed and its performance is established through prior validation and publication.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format for the interpretive program to be met by the new device. Instead, it relies on the established performance of the unchanged HES program within the predicate device. The comparison table (Table 5.7.1) primarily focuses on technical specifications of the recorder and display components, demonstrating similarities and some differences between the new devices and the predicate.

For the interpretive program (HES), the study cited serves as the evidence of its quality and accuracy. The "reported device performance" for the interpretive program is qualitative, implying it meets the standards of a high-quality, accurate ECG interpretation system as demonstrated in the cited study.

Acceptance Criteria (Implied for the HES interpretive program): The interpretive program's quality and accuracy are considered acceptable, as demonstrated by the published study "The Diagnostic Performance of Computer Programs for the Interpretation of Electrocardiograms" in the New England Journal of Medicine.

Reported Device Performance (for HES interpretive program): "The results shown in this study have demonstrated the quality and accuracy of the HES program with respect to other commercially available programs."

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

• Sample Size for Test Set: The document does not explicitly state the sample size for the test set used in the cited "The Diagnostic Performance of Computer Programs for the Interpretation of Electrocardiograms" study. It merely refers to the study as evidence of the program's performance.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that the study was published in "New England Journal of Medicine."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not provide details about the number of experts, their qualifications, or how the ground truth was established within the cited study. It focuses on the study's overall conclusion regarding the HES program's quality and accuracy.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used in the cited study.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study regarding how much human readers improve with AI vs without AI assistance for the CARDIOLINE AR devices. The study cited is focused on the standalone diagnostic performance of computer programs, including HES.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The entire premise of citing "The Diagnostic Performance of Computer Programs for the Interpretation of Electrocardiograms" is to establish the standalone performance (algorithm only) of the Hannover ECG System (HES) interpretation program. The document states: "The measurements and interpretation program has not been changed. It has been intensively tested and validated by the developer Medizinische Hochschule Hannover. Test results have been published on the New England Journal of Medecine..."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of ground truth used in the cited study.

8. The Sample Size for the Training Set

The document does not provide the sample size for the training set used for the HES program. The focus is on the validation of the already developed program.

9. How the Ground Truth for the Training Set was Established

The document does not provide details on how the ground truth for the training set was established for the HES program.

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