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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 ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.

The optional Spirometry module is indicated for use in clinical situations to assess a patient's pulmonary health status and evaluate symptoms, signs, or abnormal laboratory test results.

The Welch Allyn CP 100™ electrocardiograph features a full alphanumeric key board, an LCD display, full-size user-programmable reports, and the ability to operate on either battery or AC power. ECG tests sent to a memory card are compatible with the Welch Allyn CardioPerfect™ workstation, which in turn can connect with other electronic patient-information systems, such as billing and medical records. The CP 100™ electrocardiograph is specifically intended for acquiring and printing ECG signals from adult 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 Welch Allyn CP 200™ electrocardiograph can display, print, save, and send ECGs electronically. It features a full alphanumeric keyboard, a color display to preview ECGs and edit settings, storage for up to 50 ECG and 50 spirometry records, full-size user programmable reports, and the ability to operate on either battery or AC power. For centralized ECG data storage, the CP 200™ electrocardiograph can connect to a Welch Allyn CardioPerfect™ workstation, which in turn can connect with other electronic patient-information systems, such as billing and medical records. The CP 200 electrocardiograph is specifically intended for acquiring, viewing, storing, and printing ECG signals from adult and pediatric patients. It will be used in clinical settings by trained health care 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 electrocardiograph provides and optional interface to a pulmonary function device. Communication of ECG and spirometry data with a central data-management system is optional.

Here's an analysis of the acceptance criteria and the supporting study information for the Welch Allyn CP 100™ and CP 200™ Electrocardiographs, based on the provided text:

Acceptance Criteria and Device Performance for Welch Allyn CP 100™ and CP 200™ Electrocardiographs

The provided documentation details two main aspects of acceptance criteria and performance: the ECG interpretation algorithm and the spirometry functionality.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a specific table of acceptance criteria in the format of pass/fail thresholds for the device's diagnostic performance. Instead, it relies on demonstrating equivalence to predicate devices and adherence to established standards.

For the ECG Interpretation Algorithm (MEANS interpretive software):

For the Spirometry Functionality (CP 200™ only):

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

For the ECG Interpretation Algorithm:
The document refers to a 1996 independent validation study of the MEANS algorithms, stating that the specificity and sensitivity from that study were presented for a prior submission (K962854). However, the sample size for this test set is not specified in the provided text. The data provenance is implied to be from a validation study performed by the Department of Medical Informatics of Erasmus University Rotterdam in 1996. It's implicitly retrospective to the development of the 1996 MEANS algorithms.

For the Spirometry Functionality:
The spirometry functionality was validated by Robert O. Crapo, M.D. The test report, dated March 2, 2007, confirmed that the device meets ATS standard requirements. The specific sample size (number of patients or tests) used for this validation is not specified. The data provenance is from a study conducted at the Pulmonary Laboratory at LDS Hospital in Salt Lake City, Utah. It appears to be a prospective validation as part of the device's development/submission process.

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

For the ECG Interpretation Algorithm:
The document mentions "The Department of Medical Informatics of Erasmus University Rotterdam independently validated the MEANS algorithms in 1996." It does not specify the number of experts involved or their specific qualifications (e.g., "cardiologist with X years of experience").

For the Spirometry Functionality:
The spirometry functionality was validated by one expert: Robert O. Crapo, M.D., Medical Director of the Pulmonary Laboratory at LDS Hospital in Salt Lake City, Utah. His qualifications as a Medical Director of a pulmonary laboratory indicate expertise in respiratory medicine.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (such as 2+1 or 3+1) for either the ECG interpretation algorithm validation or the spirometry functionality validation. For the ECG, it states "independently validated," but details of how ground truth was established by experts are not provided. For spirometry, Dr. Crapo's single validation implies a direct comparison against the ATS standard.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not explicitly mentioned or performed according to the provided text. The ECG algorithm's role is described as "guidance" for qualified physicians, but no study on its impact on human reader performance is detailed.

6. Standalone Performance Study

For the ECG Interpretation Algorithm:
Yes, a standalone performance study was done for the MEANS algorithm. The document states, "The Department of Medical Informatics of Erasmus University Rotterdam independently validated the MEANS algorithms in 1996." This validation assessed the algorithm's specificity and sensitivity directly, independent of a human-in-the-loop scenario.

For the Spirometry Functionality:
Yes, a standalone performance study was done for the spirometry functionality. "The spirometry functionality of the CP 200™, including the custom software, was validated by Robert O. Crapo, M.D." This validation confirmed the device's accuracy and precision against the ATS standard on its own.

7. Type of Ground Truth Used

For the ECG Interpretation Algorithm:
The type of ground truth used is implied to be expert consensus or expert interpretation from the validation study performed by the Department of Medical Informatics of Erasmus University Rotterdam. Specific details on how this consensus was achieved (e.g., against clinical diagnosis, pathology, or subsequent outcomes) are not provided.

For the Spirometry Functionality:
The ground truth for spirometry performance was established against the "Standardization of Spirometry: 1994 Update and 2005 version" published by the American Thoracic Society (ATS). This represents a recognized standard for accuracy and precision in spirometry measurements.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the MEANS interpretive algorithm or any other components of the devices. It only refers to the validation of existing algorithms.

9. How the Ground Truth for the Training Set Was Established

Since a training set nor its sample size is mentioned, the document does not provide information on how the ground truth for any training set was established. The focus is on the validation of pre-existing and adopted algorithms (MEANS, and the spirometry component based on Medikro D9 and ATS standards).

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The Welch Allyn Printing Electrocardiography and Spirometry Products (Subject Devices) are intended for use by trained operators in health facilities. The subject Devices will provide the following diagnostic functions:

• Acquiring, viewing, storing and printing ECG waveforms patients using ECG . Front End modules 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, . graphical presentations and interpretive statements on an advisory basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings.
• Using the optional Spirometry module and associated accessories 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 able to understand the instructions for performing the test, such as with children greater than three (3) years of age.

The Welch Allyn Multi-Channel Electrocardiographs, the low cost CP 100 or full-featured CP200. Both feature full alphanumeric keyboards for easy and fast entry of patient demographics, user-programmable report formats printed on patient chart size thermal paper, ECG measurement, advanced filters for optimal ECG trace quality and battery or AC operation.

Here's a breakdown of the acceptance criteria and study information for the Welch Allyn CP 100/200 Electrocardiography and Spirometry Products, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria for the device's performance. Instead, it describes the intended functions of the device. Since specific numerical targets are not mentioned, I will infer the performance criteria from the device's stated functions.

Study Information

The provided 510(k) premarket notification does not contain details of a specific performance study (e.g., clinical trials, bench testing with detailed results) that "proves" the device meets acceptance criteria.

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices. This means that the device's design, intended use, technology, and performance are sufficiently similar to approved devices that it raises no new questions of safety or effectiveness. The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the devices... are substantially equivalent."

Therefore, many of the specific study-related questions cannot be directly answered from the provided text.

1. Sample size used for the test set and the data provenance: Not mentioned in the provided text, as a specific "test set" for a new performance study is not described. The substantial equivalence determination would have involved a comparison of design and functional specifications, potentially using literature or prior predicate device data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as no specific ground truth establishment for a new test set is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned, as no specific test set or adjudication process is described.
4. 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: Not mentioned. This type of study is typically done for AI-driven diagnostic aids. While the device includes an "optional algorithm to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis," the document does not suggest a new MRMC study was conducted to evaluate its impact on human readers. Such a study might have been conducted for the predicate device's interpretive algorithm or would be part of a separate submission if the algorithm itself was novel and required performance validation.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned. For the interpretive algorithm, its "advisory basis" implies it's not strictly standalone for diagnosis. The 510(k) process for substantial equivalence often means that the algorithm's performance is either comparable to or directly inherited from the predicate device's validated algorithm, or its performance is evaluated in a non-clinical context against established standards rather than a formal standalone clinical study described here.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For substantial equivalence, ground truth for comparing device characteristics is often based on engineering specifications, recognized standards, and the performance characteristics of the predicate devices.
7. The sample size for the training set: Not mentioned. Training sets are relevant for machine learning algorithms. While an "optional algorithm" is mentioned, details about its development (including training data) are not part of this 510(k) summary, which focuses on substantial equivalence rather than novel algorithm validation.
8. How the ground truth for the training set was established: Not mentioned.

Summary of Substantial Equivalence:

The core of this 510(k) submission is the claim of substantial equivalence to two predicate devices:

• PageWriter Trim Series Cardiograph (K031422) for electrocardiography.
• Spirometer System (Medikro D9 Spirometer) (K971336) for spirometry.

The FDA's approval indicates they found no new questions of safety or effectiveness compared to these legally marketed devices, implying that the Welch Allyn CP 100/200 meets an acceptable level of performance based on comparison to its predicates, rather than through a new, detailed clinical performance study described within this document.

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