(34 days)
The Welch Allyn CP150TM Electrocardiograph is intended for use by trained operators in health facilities. The electrocardiograph provides the following diagnostic functions: Acquiring, viewing, storing and printing ECG waveforms using ECG Front-End modules (patient cables) and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.Using optional algorithms to generate measurements, data presentations and graphical presentations, and interpretative statements on an advisory basis. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the result of physical examination, the ECG tracings, and other clinical findings.
The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
The 12-lead optional interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
The Welch Allyn CP150™ Electrocardiograph is an electrocardiograph 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. Its features include a 7" color touch screen display for ECG preview and user-friendly interface, full-size user-programmable reports, and the ability to operate on either battery or AC power.
The CP150™ Electrocardiograph is able to connect either via USB cable or via wired ethernet (RJ45 connector) across the ethernet network, which in turn can connect with other electronic patient-information systems, such as billing and medical records. The USB port can also be used to connect other accessory devices.
The provided document describes the Welch Allyn CP150™ Electrocardiograph and its substantial equivalence to predicate devices (Welch Allyn CP100™ and CP200™ Electrocardiographs, K072449). The information focuses on non-clinical performance testing and device comparison, rather than a clinical study evaluating diagnostic accuracy or reader performance with an AI algorithm. Therefore, many aspects of your request (e.g., sample size for test set, number of experts, MRMC study, standalone performance for AI, training set details) are not directly addressed in the provided text.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents "Additional performance Bench Testing" with specific criteria and conclusions. These primarily relate to the device's physical and electrical reliability and compliance with various standards, not diagnostic accuracy of an interpretation algorithm.
| Report DIR -- Description | Objective of the Test | Pass/Fail Criteria (Acceptance Criteria) | Conclusions (Reported Device Performance) |
|---|---|---|---|
| 60048998 --- CP150 Connectors Reliability | To verify the reliability of all connectors of CP150. | • AC power inlet: 50 connect/disconnect cycles. | |
| • ECG (DB15): 50 connect/disconnect cycles. | |||
| • Ethernet (RJ45): 100 connect/disconnect cycles. | |||
| • mini USB (USB B): 100 connect/disconnect cycles. | |||
| • USB: 400 connect/disconnect cycles. | PASS: The connectors meet the requirements of TRS and reliability plan. | ||
| 60048999 --- CP150 Battery Capacity Test | To verify the battery capacity for number of standard use cycles available without re-charging the battery. | The device shall have the capacity to complete 25 ECGs over a 12 hour period with a single fully charged battery. Each ECG test is assumed taken in 15 minutes cycle with two copies of ECG prints. | PASS: The battery meets the requirements of TRS. |
| 60049000 --- CP150 Battery Door & Connector | To verify the reliability of Battery Door and Battery Connector for number of standard use (insert/remove) cycles. | TRS 4.8 4.8: The battery connector shall have a useable life shall be at least 10 connect/disconnect cycles and the door needs to pass 230 cycles of opening/closing. | PASS: The battery door and battery connector meet the requirements of TRS. |
| 60049001 --- CP150 Power Button Test | To verify the reliability of Power Button by number of presses. | Reliability Plan 8.5: The test should meet zero failures for a total of 48,909 presses on 1 unit. | PASS: The Power Button meets the requirements of reliability plan. |
| 60049002 --- CP150 LCD Touchscreen Test | To verify the reliability of LCD Touchscreen by applying mechanical touches on the screen. | Reliability Plan 8.5: All the functional tests must pass for a total of 1,687,688 touches on 3 units. | PASS: The test results shows the LCD touchscreen meets the requirements of Reliability plan. |
| 60049003 --- CP150 Environment Test | To verify the device shall operate at temperature between 10.0C and 40.0C and at a relative humidity of 15% to 95% (non condensing). For printing the humidity is limited to 30% to 70% (non-condensing). | All the intermediate verification test was passed for following conditions: | |
| Acquiring ECG with Printing: | |||
| • +5°C / 30% RH for 6 hours | |||
| • +5°C / 70% RH for 6 hours | |||
| • +45°C / 30% RH for 6 hours | |||
| • +45°C / 30% RH for 6 hours | |||
| Acquiring ECG without Printing: | |||
| • +5°C / 10% RH for 6 hours | |||
| • +5°C / 95% RH for 6 hours | |||
| • +45°C / 10% RH for 6 hours | |||
| • +45°C / 95% RH for 6 hours | PASS: The test results shows the CP150 meets the environmental test requirements of Reliability plan. | ||
| --- CP150 Barcode scanner verification | To verify that the device will have the ability to input barcode alphanumeric inputs via a bar code scanner. | Scanned results should match the sample serial number in the box. | PASS: The test results shows the bar code scanner meets the requirements of Reliability plan. |
| 50052441 --- 60601-1 Safety test | Test the device per 60601-1 to ensure that the device meets the safety requirements for medical devices. | Devices pass criteria of 60601-1. | PASS: Devices are compliant with 60601-1 standard. |
| 50052442 --- 60601-1-2 Electromagnetic Compatibility test | Test the device per 60601-1-2 to ensure that the device meets the requirements for Electromagnetic Compatibility. | Devices pass criteria of 60601-1-2. | PASS: Devices are compliant with 60601-1-2 standard. |
| 50052441 - 60601-1-4 Medical Electrical Equipment - Part 1-4 | Test the device per 60601-1-4 to ensure that the device meets the requirements for Programmable Electrical Medical Systems. | Devices pass criteria of 60601-1-4. | PASS: Devices are compliant with 60601-1-4 standard. |
| AAMI EC-11 Diagnostic electrocardiographic devices | Test the device per to ensure that the device meets the AAMI standard requirements for Diagnostic electrocardiographic devices. | Devices pass criteria of AAMI EC-11. | PASS: Devices are compliant with AAMI EC-11. |
| 60601-2-25 Medical electrical equipment - Part 2-25 | Test the device per to ensure that the device meets the 60601-2-25 requirements for the basic safety and essential performance of electrocardiographs. | Devices pass criteria of 60601-2-25. | PASS: Devices are compliant with 60601-2-25. |
| 60601-2-51 Particular Requirements For Safety | Test the device per to ensure that the device meets 60601-2-51 the requirements for Safety, Including Essential Performance, Of Recording And Analysing Single Channel And Multichannel Electrocardiographs. | Devices pass criteria of 60601-2-51. | PASS: Devices are compliant with 60601-2-51. |
| 14971 Medical Devices - Application of Risk Management to Medical Devices | Test the device per to ensure that the device meet the requirements for the Application of Risk Management to Medical Devices. | Devices pass criteria of 14971. | PASS: Risk Analysis Summary. |
| 60051724-- Welch Allyn mobile stand - Large Platform Cart (LPC) Safety test | To verify the LPC meet the safety requirements per 60601-1. | The device can be installed as per assembly instruction and the LPC pass criteria of 60601-1. | PASS: the LPC is compliant with 60601-1 standard and can be used with the subject device. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." The performance tests conducted are non-clinical bench tests (e.g., connector cycles, battery capacity, touchscreen presses) and compliance testing against various medical device standards (e.g., IEC 60601 series, AAMI EC-11). Therefore, there isn't a "test set" in the context of clinical data for diagnostic performance.
The provenance of non-clinical test data is implied to be internal Welch Allyn testing or third-party certified labs.
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 or ground truth established by experts for diagnostic performance is described. The device is tested against engineering and safety standards. The "optional interpretation algorithm" mentioned is noted as providing "guidance for qualified physicians" and "must not be relied upon as diagnoses," implying that human expert interpretation remains the gold standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication process for diagnostic performance 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 comparative effectiveness study is mentioned. The submission focuses on the technical characteristics and safety of the device itself and its substantial equivalence to predicate devices, not on the comparative effectiveness of its optional interpretation algorithm with or without human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions an "optional interpretation algorithm" that "provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information." This indicates that the algorithm is not intended for standalone use as a diagnostic tool. No standalone performance study for the algorithm is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by the technical specifications and regulatory standards (e.g., number of cycles for reliability tests, passing criteria for IEC 60601 standards). No clinical ground truth from expert consensus, pathology, or outcomes data is mentioned as being used for device validation in this submission.
8. The sample size for the training set
Not applicable. Since no clinical studies were used and the focus is on hardware and software updates for substantial equivalence, details about an algorithm's training set are not provided. The algorithm itself is noted to be "also used in Welch Allyn's Cardioperfect Workstation, and this modification to the PEDMEANS was covered in the submission K082478 for the Cardioperfect Workstation." This suggests the algorithm's development and validation (and likely training) occurred prior to this submission and was part of a different submission.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as point 8. The document does not provide details about the training set for the interpretation 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).