(77 days)
The Page Writer 2001 Model 1770A is intended to provide acquisition, digitization and recording of couventional diagnostic 12 simultaneous lead ECG wavelorms and ECG Data, The Page Writer 200i Model M1770A also displays ECC waveforms and records patient information entered through the alphanimeric keyboard. Additionally, it measures and provides interpretation. The Page Writer 200i Model M1770A interpreted FCC7 with measurements and diagnostic statements is offered to the physician un an advisory basis only, and the physician is asked to overread and validate (or change) the ECG interpretation.
In addition, the PageWriter 2001 Model M.1770A with ACI-TIPI Model M1791A is intended to provide the cardiologist with an additional tool to aid in assessment of acute cardiac ischemia.
The ACI-TIPI Model M1791A is an optional software application for the commercially available predicate PageWriter 200i M1770A interpretive · cardiograph. This optional software application is used to provide the cardiologist with an additional tool to aid in the assessment of acute cardiac ischemia. The ACI-TIPI application regression formula for ACI combines patient data (age, sex, and chest pain status) with measurements from the ECG. The computation yields a probability index of acute cardiac ischemia in the range of 0-100%. This index is intended to be used with the currently established data in evaluation of the subject patient population. As an index, the physician can correlate values with their current diagnostic results and then use the index to support their diagnosis, or to initiate further action. For example, the physician can use the index as part of the diagnostic data set used to assess a patient. This index is never used alone or in place of other pertinent information normally used in acute ischemia determinations.
The provided document is a 510(k) summary for the Hewlett-Packard PageWriter 200i Interpretive Cardiograph Model M1770A with the Acute Cardiac Ischemia Time Insensitive Predictive Instrument (ACI-TIPI) Model M1791A Application. It describes the device, its intended use, and its equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.
The submission focuses on establishing substantial equivalence based on:
- The interpretive cardiographic functions being identical to a previously cleared PageWriter 200i (K935772).
- The ACI-TIPI application being identical to one cleared for use with a PageWriter XLi (K951978).
- Nonclinical testing to verify that the addition of the ACI-TIPI application did not adversely alter the functionality of the host cardiograph.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results.
- Standalone performance study results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document serves as a regulatory submission demonstrating substantial equivalence to existing devices rather than a detailed performance study achieving specific acceptance criteria.
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