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The proposed Mortara RScribe Electrocardiograph is a non-invasive prescription device.

• The device is indicated for use to acquire, analyze, display, transmit and print electrocardiograms.
• The device is indicated for use to provide interpretation of the data for consideration by a physician.
• The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
• The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
• The device is indicated for use on adult and pediatric populations.
• The device is not intended to be used as a vital signs physiological monitor.
• The device is not designed for out of hospital transport.
• The device is not designed for use in highly invasive environments, such as an operating theatre.

The proposed Mortara Instrument RScribe is an electrocardiograph that combines proprietary hardware and an off-the-shelf personal computer. The RScribe is intended to be used with the Mortara Wireless Acquisition Module (WAM) or Mortara Acquisition Module (AM12) patient cables. The RScribe acquires ECG waveforms from the WAM or the AM12 patient cable.

The system is based on the following components:

• The RScribe is compatible with proprietary detachable patient applied lead sets. The RScribe acquires ECG waveforms from the Mortara Wireless Acquisition Module (WAM) or Mortara Acquisition Module (AM12) patient cables. The received ECG data will be first analyzed to determine the quality of the ECG then the record will be analyzed using the latest VERITAS™ Resting Interpretation criteria (adults / pediatric, K082946) used in other Mortara Electrocardiographs. The analyzed ECG will be displayed on the PC screen and will include measurements performed by the interpretation algorithm and the text of the automatic analysis. The user will have the possibility to edit the patient demographic data and, also the interpretation text.
• RScribe allows the user to schedule new exams and viewing of the existing schedule. The system controls user access and authentication, submits demographic and visit information to the repository. It also allows the user to view scheduled modality procedures, select the appropriate exams and enter patient demographics and download modality worklist when necessary.
• After the exams are saved, the reports will be generated (Report Generator) upon request of the modality application. The request includes the template file and data necessary to generate the report. User is also able to print the report and/or export it to a pdf file. The Report Viewer will provide the possibility to open saved reports and read the data directly from the report file. It allows the user to print to a selected windows printer, Mortara Z200+ printer, the ability to zoom the previewed final report, enable/disable the display and print of grid and navigation of the report pages.
  The received ECG data will be first analyzed to determined the quality of the ECG then the record will be analyzed using the Mortara Resting Interpretation (adults and pediatric). The analyzed ECG will be displayed on the PC screen and it will include measurements performed by the interpretation algorithm and the text of the automatic analysis. The user will have the possibility to edit the patient demographic data and, in some versions of the product, also the interpretation text.

The user will be able to store the record on the local hard disk or on a networked server. In addition, printouts will be possible as well as file export in several formats (DICOM, UNIPRO32, XML, FDA-XML, etc).

Additional to the above mentioned features, the RScribe will be capable of being interfaced with Hospital Information System (or similar) in order to receive patient demographics.

The user interface of the RScribe will also be customizable in order to better fit the customer workflow. RScribe implements the latest VERITAS™ Resting Interpretation criteria (adult/pediatric) (ELI 350 K082946).

The provided text is a 510(k) summary for the RScribe Electrocardiograph. It describes the device, its intended use, and indications for use, butdoes not include a detailed study or acceptance criteria with specific performance metrics beyond stating that it uses the "latest VERITAS™ Resting Interpretation criteria."

Therefore, I cannot populate the table or answer all of your questions directly from the provided text. The document focuses on regulatory approval based on substantial equivalence to predicate devices, not on presenting novel performance data against specific acceptance criteria.

However, I can extract the information that is present and indicate where information is missing.

Here's a breakdown of what can and cannot be answered:

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 mentioned.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not mentioned.

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 mentioned.
• Qualifications of Experts: Not mentioned. The document refers to "physician over-read" as part of the intended use, but not for ground truth establishment for a specific study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not mentioned.

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: Not mentioned. The filing is a Special 510(k) for changes to an existing device, relying on substantial equivalence, not typically requiring new clinical performance studies like an MRMC study unless significant changes to the interpretation algorithm or intended use are made.
• Effect Size of Human Reader Improvement: Not applicable, as an MRMC study is not mentioned.

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

• Standalone Performance Study: Not explicitly described as a distinct study in this document. The device uses the "VERITAS™ Resting Interpretation criteria," which is an algorithm, and its performance would have been established for that algorithm previously (K082946). The RScribe, as detailed, integrates this existing algorithm.

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

• Type of Ground Truth: Not mentioned for any specific study related to this filing. For the VERITAS™ algorithm (K082946), it would typically involve expert consensus of cardiologists, but this document does not provide details.

8. The sample size for the training set

• Sample Size for Training Set: Not mentioned. This would be relevant for the VERITAS™ algorithm (K082946), not specifically for this filing.

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

• Ground Truth Establishment for Training Set: Not mentioned. This would be relevant for the VERITAS™ algorithm (K082946), not specifically for this filing.

Summary from the document:

This 510(k) notification (K120865) for the RScribe Electrocardiograph is a "Special 510(k)," which indicates modifications to an already cleared device. The key aspect for the device's analytical performance is its reliance on the "latest VERITAS™ Resting Interpretation criteria (adults/pediatric) (K082946)," which was previously cleared. The focus of this filing is on the integration of this existing algorithm into new hardware/software (PC-based system), and its equivalence to other Mortara devices already on the market that use the same interpretation algorithm. The document emphasizes the acquisition, display, printing, storage, and transmission capabilities, along with user interface customization. The "study" proving its acceptance is primarily the demonstration of substantial equivalence to its predicate devices (Mortara Instrument ELI PC Electrocardiograph (K0933339) and Mortara Instrument ELI 230 Electrocardiograph (K100127)), particularly by implementing an already cleared interpretation algorithm. Therefore, explicit detailed performance studies with dedicated acceptance criteria, sample sizes, and expert reviews specifically for this filing are not presented in this summary, as they would have been part of the original clearance (K082946) for the VERITAS™ algorithm.

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The device is indicated for use to acquire, analyze, display, transmit, print, record and store electrocardiograms.
The device is indicated for use to provide interpretation of the data for consideration by a physician.
The device is indicated for use in a clinical setting, or mobile environment (including prehospital, emergency services, ambulance and patient transport), by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
The device is indicated for use on adult and pediatric populations.
The device is not intended to be used as a vital signs physiological monitor.

The ELI 10 is a multi-channel, portable electrocardiograph. The ELI 10 simultaneously acquires data from up to 12 leads. Once the data is acquired, it can be reviewed, stored, transmitted and/or printed (using an external, optional printer). The ELI 10 is designed to be installed on a transport cart. The ELI 10 is able to acquire, analyze, display, transmit, print, record and store electrocardiograms acquired through its internal Mortara front-end amplifier. The size of the screen will allow preview of the technician to assess the quality of the acquired ECG. The ELI 10 utilizes a monochrome LCD for display of ECG waveforms, menu options and status information. A custom keyboard is part of the ELI 10 design and allows patient data entry as well as control of the functions and options available for the unit. The ELI 10 custom keyboard includes alphabetic, numeric, symbol, cursor control and special function keys. When an ECG is acquired, a preview will be displayed in this window. The ECG format used to display the waveforms will the configured printing format. Gain, speed and filter are applied to both screen and printout at the same time (Printing function available only through an external optional printer). The ELI 10 will offer storage capability in order to retrieve or transmit stored records. Transmission can be achieved using one of the optional communication media designed in the unit: Modem, LAN, VolvaN, GSM/GPRS, and/or USB port.

Here's a breakdown of the acceptance criteria and the study details for the Mortara ELI 10 Electrocardiograph's Pediatric Criteria for the VERITAS™ Interpretive Algorithm, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table format for the interpretive algorithm. Instead, it describes a "clinically acceptable" performance. The primary criterion implicitly is that the performance of the algorithm should be similar to or considered acceptable by a cardiologist.

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

• Sample Size for Test Set: Approximately 1300 15-lead ECGs (standard 12 leads plus V3R, V4R, and V7).
• Data Provenance:
  • Country of Origin: Not specified, but collected from "various pediatric cardiology centers."
  • Retrospective or Prospective: Retrospectively collected ("randomly collected").

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

• Number of Experts: Singular expert ("a cardiologist").
• Qualifications of Experts: "a cardiologist" (no further specific experience or specialization, beyond being a cardiologist).

4. Adjudication Method for the Test Set

The adjudication method appears to be a single blind reading by "a cardiologist" of raw ECGs without the automatic interpretation.

• Method: A single cardiologist performed a "blind reading" of the ECGs without the algorithm's interpretation.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess the effect size of human readers improving with AI vs. without AI assistance. The study described compares the algorithm's interpretation to a single cardiologist's interpretation.

6. Standalone (Algorithm Only) Performance

Yes, a standalone (algorithm only) performance assessment was done. The study specifically states: "The same ECGs were interpreted by the VERITAS Pediatic ECG Interpretation algorithm. The performance obtained by the algorithm is considered clinically acceptable." This indicates the algorithm's performance was evaluated independently against the ground truth established by the cardiologist.

7. Type of Ground Truth Used

The ground truth used was expert consensus / expert reading. Specifically, it was the "blind reading" performed by a cardiologist.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions that the VERITAS Interpretive Algorithm was "included within the cleared 510(k) Premarket Notification (K082946)" and that "ELI 10 utilizes the same VERITAS Interpretive Algorithm as the ELI 350 (K082946)". This suggests the pediatric criteria were an addition to an existing, previously validated algorithm, but the training data for the base algorithm or this specific pediatric update is not detailed here.

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. It only describes the process for the validation/test set.

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The ELI 230 Electrocardiograph is a non-invasive prescription device.

• The Mortara ELI 230 Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use for patients of any age, diseased or non-diseased.
• The device is indicated for use to provide interpretation of the data for consideration by a physician.
• The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
• The device is indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis.
• The device is not intended to be used as a vital signs physiological monitor.
• The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The ELI 230 is a multi-channel diagnostic electrocardiograph intended for acquiring and printing ECG's of adult and pediatric patients. The ELI 230 utilizes previously cleared predicate Mortara technology and design features from the Mortara electrocardiograph device family, together with other current industry techn allo dest to achieve a highly reliable electrocardiograph. The device is not intended to be used as a vital signs nhysiological monitor. The ELI 230 is intended to be used by a licensed health care practitioner in a hospital or clinical setting.
The ELI 230 is a standard 12-lead, electrocardiograph that is intended to be used with the Mortara Wireless Acquisition Module (WAM) or Mortara Acquisition Module (AM12) patient cables. The ELI 230 acquires ECG waveforms from the WAM or AM12 patient cables.
The ELI 230 incorporates a similar user interface to that of the Mortara ELI 250 Electrocardiograph (K031182), The LCD on the ELI 230 is a QVGA color (320 x 240), 2.4" active matrix, TFT. Although sightly smaller than the ELI 250, the LCD displays waveforms as well as menus and configuration screens. As in the ELI 250, the user will use soft-keys to select functions displayed on screen. a group of five keys are available on the ELI 230 keyboard and they are located underneath the LCD. The ELI 230 implements the latest VERITAS™ Resting Interpretation criteria (adult/pediatric) (cleared in ELI 350 K082946).
The ELI 230 has a custom keyboard which includes symbol, cursor control and special function keys. The ELI 230 has a Main Configuration menu, divided in multiple pages, that includes all the default settings and user preferences (print speed, filters, etc.) The ELI 230 user will use soft-keys to select functions displayed on the LCD screen. A group of five keys and an On/Off key are available on the keyboard, and they are located near the LCD.
The ELI 230 prints on thermal roll paper oriented in the "landscape" mode. The printer is entirely controlled by software. When a print job is started the printer voltage is enabled, the 20 KHz chopper is enabled and the target speed is set. The 1 msec timer will step the motor phases every millisecond until the target speed is reached. ECG printout speed choices allowed are 5, 10, 25 and 50 mm/s. The outer dimensions of the ELI 230 are approximately 8 inches (width, left-to-right) x 12 inches (depth, front-to-back) x 3 inches (height, top-tobottom). The housing of the ELI 230 is ABS polycarbonate. Provisions for mounting the EU (230 to, a cre will be made.
The ELI 230 operates from a standard AC connection and also has the capability of being operated directly from a sealed lead-acid battery. The battery is only removable / replaceable through disassembly of the united when operating from the battery, remaining charge will be monitored. When the battery charge is low, an indication will be made to the operator. When the battery charge is depleted to its lowest allowed level, the unit will automatically power down. The battery is charged by an internal power supply when connected to the AC line. The unit will indicate when the battery is being charged and when it has reached full charge. When the blite has been discharged to a pre-defined, low-voltage limit, the internal power supply will be capable of re-dataging. the battery to 90% of its full charge level within 8 hours.

The provided document is a 510(k) premarket notification for the Mortara ELI 230 Electrocardiograph. It describes the device, its intended use, and indications for use, and claims substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study that proves the device meets such criteria.

The document states: "The ELI 230 implements the latest VERITAS™ Resting Interpretation criteria (adult/pediatric) (cleared in ELI 350 K082946)." This implies that the device is leveraging previously cleared interpretation criteria, rather than presenting new performance data for interpretation within this specific 510(k). To find the detailed acceptance criteria and performance study for the VERITAS™ Resting Interpretation criteria, one would need to refer to the 510(k) notification K082946 for the ELI 350.

Therefore, based solely on the provided text for K100127, I cannot complete the requested tables and information. The document focuses on showing substantial equivalence based on previously cleared technology and design features, and does not include new clinical performance data for the interpretation algorithm.

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