(119 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated in Document | The device analyzes ECG records using the "latest VERITAS™ Resting Interpretation criteria (adults/pediatric, K082946) used in other Mortara Electrocardiographs." This implies its performance is expected to be comparable to other Mortara devices using the same VERITAS™ algorithm. |
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.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).