CARDIOVIEW TRANSTELEPHONIC SOFTWARE by MICROMEDICAL, INC.

CardioView is a computerized, enhanced electronic Transtelephonic System designed for clinical indications to allow physicians or other health care providers to remotely view and analyze patient ECG data. This system is suited for small to medium health care monitoring facilities. If offers a 12 lead ECG remote monitoring system which is more comprehensive than conventional single lead transtelephonic Software. Both devices use a remote user input device that retains the ECG signal and transmits it over the telephone lines. Both devices can use a switched telephone network. Both devices use a modern at the Host site to communicate with the remote device and uplink the data into the Computer. Both devices use a DOS based Computer which runs in Windows "" to display data. Both devices: output a display that resembles a conventional ECG display. Both devices retain a electronically stored sample. Both act on that sample using mathematical computations. Both use a proprietary algorithm. Both use computer programming in a Windows "" environment.

AI/ML Overview

This K955891 filing for the CardioView Transtelephonic Software, Part Number 268-400-004, is a 510(k) premarket notification. In this type of submission, the primary goal is to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets specific performance acceptance criteria through a dedicated study.

Therefore, the provided text does not contain the detailed information requested about acceptance criteria, a specific study proving those criteria, or the methodology for ground truth establishment, sample sizes for training/test sets, or MRMC studies.

The document focuses on comparing the CardioView to its predicate device, CardioMagic™ Software (K925639), to establish that it is as safe and effective as the already marketed device.

Here's a breakdown of why each section of your request cannot be fully answered from the provided text:

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

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "acceptance criteria" for a 510(k) submission are generally that the device is "as safe and effective" as the predicate device.
Reported Device Performance: Instead of specific performance metrics, the document lists functional similarities to the predicate device. These are qualitative comparisons rather than quantitative performance results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. There is no mention of a specific test set, its size, or its provenance. The demonstration of substantial equivalence relies on functional and technological comparison.

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)

Not applicable/Not provided. Since there's no described test set with independently established ground truth, this information is absent. The "ground truth" for a 510(k) is implicitly the established safety and effectiveness of the predicate device.

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

Not applicable/Not provided. No test set or independent adjudication process 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

No MRMC study was done or mentioned. CardioView is described as a "computerized, enhanced electronic Transtelephonic System" to "remotely view and analyze patient ECG data," implying it's a tool for physicians, but not an "AI assistance" in the modern sense that would typically warrant an MRMC study comparing human performance with and without AI. Its function is to facilitate viewing and analysis, not to interpret or diagnose.

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

Not explicitly described as a standalone study. While the device uses a "proprietary algorithm" and performs "mathematical computations," its purpose is to "allow physicians or other health care providers to remotely view and analyze patient ECG data." This implies human-in-the-loop use. The document doesn't present an evaluation of the algorithm's performance in isolation from a human user.

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

Not applicable/Not provided in the traditional sense. For a 510(k), the "ground truth" is established by showing that the new device functions similarly to and is as safe and effective as the predicate device, which is already legally marketed. There isn't an independent "ground truth" for ECG interpretation specifically detailed in this document for CardioView.

8. The sample size for the training set

Not provided. No training set is mentioned as this is a 510(k) based on substantial equivalence, not a de novo clearance requiring extensive performance data from an AI/ML model trained on a dataset.

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

Not applicable/Not provided. No training set or ground truth establishment for it is mentioned.

Summary of what the document does provide regarding "acceptance" and "proof":

The document aims to demonstrate that CardioView meets the criteria for substantial equivalence to CardioMagic™ Software (K925639). The "proof" is presented through a series of direct comparisons on various aspects:

Intended Use: Both are for clinical applications allowing physicians to remotely view and analyze ECG data.
Technology & Functionality:
- Both use a remote user input device to transmit ECG signals over telephone lines.
- Both can use a switched telephone network.
- Both use a modem at the host site to communicate and uplink data.
- Both use a DOS-based computer running Windows for data display.
- Both output a display resembling a conventional ECG.
- Both retain electronically stored samples.
- Both act on samples using mathematical computations.
- Both use a proprietary algorithm.
- Both use computer programming in a Windows environment.
Limitations: Neither claims to be laboratory analysis equipment; both are for remote convenience and easy response.
Design & Manufacturing: CardioView conforms to Good Manufacturing Procedures.
Safety & Effectiveness: MICROMEDICAL INC. states that the device is "safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy." They also maintain an in-house reporting system for adverse events.

Essentially, the "study" is the comparison of the new device's specifications and functionality against a legally marketed predicate device to argue that it does not raise new questions of safety or effectiveness.

Summary

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K955891

OCT - 8 1996

Exhibit 14 Summary of Safety & Effectiveness for CardioView *** Transtelephonic Software, Part Number 268-400-004

CardioView is a computerized, enhanced electronic Transtelephonic System designed for clinical andications to allow physicians or other health care providers to remotely view and analyze patient ECG data. This system is suited for small to medium health care monitoring facilities. If offers a 12 lead ECG remote monitoring system which is more comprehensive than conventional single lead transtelephonic Software.

As such, this device is a Class II device, having Classification Name: Monitor, Electrograph, Product Code: 74FYW as described in 21 CFR Part 870.2340. MICROMEDICAL INC. has determined that this device is substantially equivalent to a predicate medical device which is currently in commerce and has been submitted to the FDA via K925639 as an electronic Transtelephonic Software and is identified as CardioMagic™ Software, marketed by Instromedix.

A determination of substantial equivalence is based upon:

Both the CardioView and CardioMagic are electronic Transelechonic Software for clinical applications to allow physicians or other health care providers to remotely view and analyze patient ECG data.

Both devices use a remote user input device that retains the ECG signal and transmits it over the telephone lines. Both devices can use a switched telephone network. Both devices use a modern at the Host site to communicate with the remote device and uplink the data into the Computer. Both devices use a DOS based Computer which runs in Windows "" to display data.

Both devices: output a display that resembles a conventional ECG display. Both devices retain a electronically stored sample. Both act on that sample using mathematical computations. Both use a proprietary algorithm. Both use computer programming in a Windows "" environment.

Neither device have claims or, are offered as, laboratory analysis equipment. Both are for remote convenience and easy response.

The CardioView has benefited from design, development, testing and production procedures that conform to Good Manufacturing Procedures. This device has performance characteristics substantially equivalent to its predicate device yet includes improvements to facilitate the various clinical applications for which it is intended.

This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy MICROMEDICAL INC. continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

CERTIFICATION:

I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.

M/ba

Mr. Malcom Castle President MICROMEDICAL INC. 255 Revere Drive, Suite 111 Northbrook, IL 60062 Tel 708 205 0099 Fax 708 441 0905

Regulation Number and Section

§ 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).