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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 Spirometer is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening. These measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's previous values. The device is designed to test pulmonary function and obtain spirometric indices for:

• adult and pediatric patients 12 years and older,
• hospital and clinic use only.

The Welch Allyn CP150™ Electrocardiograph with Spirometry Option 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 and it provides an optional interface to a pulmonary function device that allows the user to acquire, view, store, and print measures and waveforms of pulmonary function. Its features include a 7" color touch screen display for ECG and Spirometry preview and user-friendly interface, full-size user-programmable reports, and the ability to operate on either battery or AC power.

Communication of ECG and spirometry data with a central data-management system is optional.

The CP150™ Electrocardiograph with Spirometry is able to connect 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 CP150™ Electrocardiograph is specifically intended for acquiring and printing ECG signals from adults and pediatric patients. It will be used in clinical settings by trained healthcare providers.

The optional interpretation algorithm analyzes these ECG signals to generate measurements and interpretive statements. The interpretive results are intended only as guidance for qualified physicians and must not be relied upon as diagnoses.

The CP 150™ spirometry option allows the user to acquire, view, store, and print measures and waveforms of pulmonary function including, but not limited to, maximal volume and flow of air that can be moved in and out of a patient's lungs. These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases. The spirometer should only be used with patients who are able to understand the instructions for performing the test.

The provided text describes a 510(k) premarket notification for the Welch Allyn CP150™ Electrocardiograph with Spirometry Option. While it lists various standards the device was tested against for safety and effectiveness, it does not explicitly state specific acceptance criteria or provide a study demonstrating the device meets quantitative performance metrics for either the ECG or spirometry functions.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K131573 for the Electrocardiograph and K133428 for the Spirometer component) by detailing software and hardware modifications made to integrate the spirometry option. The non-clinical tests mentioned are predominantly related to compliance with general medical device standards (risk management, electrical safety, EMC, software lifecycle, and specific standards for electrocardiographs and spirometry).

Therefore, based solely on the provided text, a table of acceptance criteria and reported device performance, information about sample sizes, ground truth establishment, expert involvement, and MRMC/standalone study details cannot be fully extracted.

However, I can describe what is mentioned regarding testing and equivalence:

Acceptance Criteria and Device Performance (Based on available information):

Further Specifics Not Explicitly Stated in the Provided Text:

1. Sample sizes used for the test set and data provenance: Not mentioned. The document primarily refers to compliance with standards rather than specific performance studies with human or simulated data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
3. Adjudication method for the test set: Not mentioned.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
   • An "optional interpretation algorithm" for ECG is mentioned, but no MRMC study or its results are detailed. The algorithm provides "computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information." This implies it is an assistive tool, but its impact on human reader performance is not quantified here.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • The ECG interpretation algorithm is presented as a component providing "guidance for qualified physicians" and "must not be relied upon as diagnoses." This suggests its performance is not intended to be standalone for diagnosis, and no standalone performance metrics are provided.
6. The type of ground truth used: Not mentioned for any specific performance validation studies. The general context implies that ground truth for ECG interpretation would eventually be clinical diagnosis confirmed by a physician, and for spirometry, accurate physical measurements.
7. The sample size for the training set: Not mentioned.
8. How the ground truth for the training set was established: Not mentioned.

Summary of Study Type:

The submission K141582 is a Special 510(k) Premarket Notification. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device, especially when modifications do not affect the fundamental scientific technology or intended use (as described in section 3.2.1 of the FDA's "Guidance for Industry and FDA Staff: The 510(k) Program").

In this case, the study presented is a demonstration of compliance with recognized performance and safety standards and a comparison of technological characteristics to existing predicate devices (Welch Allyn CP150 Electrocardiograph K131573 and Medikro Spirometer K133428). The "study" proving the device meets acceptance criteria primarily consists of:

• Engineering analysis and documentation of hardware and software modifications.
• Verification and Validation (V&V) activities to ensure these modifications support the intended functionality and maintain safety and effectiveness.
• Compliance testing against the listed international and national standards (e.g., ISO 14971, IEC 60601 series, IEC 62304, ANSI/AAMI EC11, ATS/ERS 2005).

The submission does not provide details of a clinical performance study using patient data to derive performance metrics like sensitivity, specificity, accuracy, or reader agreement. Instead, it relies on the established safety and performance of its predicate devices, asserting that the implemented changes maintain this level of performance.

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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.

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.

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