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The CardioPerfect Workstation software and associated accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals, as identified below, for the purpose of assisting the clinician in the diagnosis and monitoring of various diseases and/or treatment regimens. The CardioPerfect Workstation software also provides non-diagnostic functions such as patient management, data security, search tools for patient and/or test records and support for exporting data to Electronic Medical Record systems.

The CardioPerfect Workstation and associated accessories are intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients, subject to any specific contraindications identified below.

Stress Electrocardiograph - Intended Use: Using the optional ECG module and associated accessories the user can acquire, view, store and print ECG waveforms.

Resting Electrocardiograph - Intended Use: The same as defined for stress ECG plus the ability to use optional algorithms (MEANS) to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis. These are presented for review and interpretation by the clinician.

Spirometry - Intended Use: Using the optional spirometry module and associated accessories to acquire, view, store and print measures and waveforms of pulmonary function. The spirometer should only be used with patients able to understand the instructions for performing the test.

Ambulatory Blood Pressure - Intended Use: Using the optional ABP module and associated accessories the user can acquire, retrieve, view, store and print patient ambulatory blood pressure history.

Indications for Use:

Electrocardiograph - Indications for Use: Indications for electrocardiography range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department.

Spirometry - Indications for Use: Indications for spirometry include, but are not limited to, the following: Shortness of breath, Chronic cough, Occupational exposure to dust or chemicals, Assist in the diagnosis of Bronchitis, Assist in the diagnosis of Asthma, Wheezing, Assist in the monitoring of bronchodilator.

Ambulatory Blood Pressure - Indications for Use: Indications for ambulatory blood pressure measurement (as listed in Journal of Hypertension 2003, 21 :821-848, E. O'Brien et. at.) include, but are not limited to, the following: suspected "white coat" hypertension, Suspected nocturnal hypertension, To establish dipper status, Resistant hypertension, Elderly patient, To monitor antihypertensive drug treatment, Type 1 diabetes, Hypertension of pregnancy, Evaluations of hypotension, Autonomic failure, Masked hypertension.

CardioPerfect Workstation software is used to create a computer platform on which ECG, ABP, & Spirometry applications can operate within inherent capabilities of an off-theshelf desktop or laptop personal computer utilizing a Windows operating system.

The provided text describes the Welch Allyn CardioPerfect Workstation Software (CPWS) Version 1.6.2 and its comparison to a predicate device. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and a detailed study proving device performance against those criteria.

The document states that the major difference between version 1.6.2 and the predicate version 1.5.0 is the inclusion of interpretive ECG software for pediatric patients through the PEDMEANS interpretive ECG algorithm. It then asserts that the performance of this algorithm in CPWS 1.6.2 is equivalent to its implementation in the CP 100™ and CP 200™ ECG devices (cleared under K072449).

Let's break down what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states:
"The MEANS algorithms were verified and found to be consistent with the requirements of IEC 60601-2-51:2003, particular requirements for safety, including essential performance, of recording and analyzing single channel and multi-channel electrocardiographs."

This implies that the acceptance criteria for the MEANS algorithms (including PEDMEANS) are aligned with IEC 60601-2-51:2003. However, the document does not list specific performance metrics (e.g., sensitivity, specificity, accuracy for specific arrhythmias) or numerical thresholds that constitute the acceptance criteria from this standard. It only states that the algorithms were "consistent with" these requirements.

It also notes that "All requirements of the recognized and applicable standards are in compliance: EC11 (AAMI/ANSI), UL 60601-1. IEC 60601-1. IEC 60601-1-1. IEC 60601-1-2. IEC 60601-1-4 and IEC 60601-2-25." These are primarily safety and general electrical equipment standards, not direct clinical performance metrics.

Therefore, a table of specific acceptance criteria and reported numerical performance cannot be fully constructed from the provided text. The "reported device performance" is broadly stated as "equivalent" and "consistent with requirements."

Based on the available information, here's what can be provided:

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

• Implementation and performance of PEDMEANS in CPWS 1.6.2 is equivalent in every respect to its implementation in CP 100™ and CP 200™ ECG devices (cleared per K072449). |
  | Compliance with recognized standards (General Safety/Electrical) | - In compliance with: EC11 (AAMI/ANSI), UL 60601-1, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-25. |
  | Risk Management | - Activities conducted in accordance with ISO 14971 and comply with IEC 60601-1-4. |

For the remaining points, the provided text contains limited to no information:

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

• Not explicitly stated for the "verification" or "equivalence" studies. The document mentions the PEDMEANS algorithm was developed by P. Rijnbeek, 2007, in a thesis at Erasmus University Rotterdam, which might imply data from the Netherlands, but no specific test set details are given.

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 explicitly stated. The document refers to "the requirements of IEC 60601-2-51:2003" and the "PEDMEANS Interpretive ECG algorithm developed by P. Rijnbeek" but does not detail how ground truth was established for their specific verification/equivalence study.

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

• 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:

• Not mentioned. The document focuses on the algorithm's performance against standards and its equivalence to a previously cleared implementation, not on human-AI collaboration.

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

• This is the most likely scenario, given the mention of "interpretive algorithm" and "consistency with requirements" of a standard for recording and analyzing ECGs. The intended use states the algorithm provides "interpretive statements on an advisory basis," which are "presented for review and interpretation by the clinician." This implies a standalone algorithmic assessment, with the clinician in the loop for final diagnosis. However, the details of the standalone performance metrics are not provided.

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

• Not explicitly stated for the verification or equivalence studies. For ECG interpretation, ground truth is typically established by expert cardiologists.

8. The sample size for the training set:

• Not mentioned.

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

• Not mentioned.

Summary of Study Information:

The document indicates that the device meets acceptance criteria through:

• Verification of MEANS algorithms (including PEDMEANS) against IEC 60601-2-51:2003. This standard outlines requirements for the "safety, including essential performance, of recording and analyzing single channel and multi-channel electrocardiographs." The specific performance metrics within this standard that were met are not detailed in the submission.
• Demonstration of "equivalence in every respect" of the PEDMEANS algorithm's implementation and performance in CPWS 1.6.2 to its previous clearance in CP 100™ and CP 200™ ECG devices (K072449). This implies that the prior clearance established the performance, and the current submission leverages that. No new, specific, detailed study results for CPWS 1.6.2 are provided beyond this statement of equivalence.
• Compliance with various other safety and electrical standards (EC11, UL 60601-1, IEC 60601-1 series, IEC 60601-2-25) and risk management standards (ISO 14971).

In essence, the submission relies on standards compliance and a claim of equivalence to a previously cleared implementation of the same pediatric ECG interpretive algorithm, rather than presenting a new, detailed clinical performance study with specific metrics for CPWS 1.6.2 itself.

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