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The CASE 8000 exercise testing system is a diagnostic device intended to monitor and record electrocardiographic data from the patient during exercise, as well as perform resting ECG analysis.

The intended use of the CASE 8000 exercise testing system is to acquire, process, record, archive, analyze, and output data during a period of physiologic stress or during a resting ECG condition. The CASE 8000 exercise testing system has the ability to calculate prognostic scores. A user selectable option can provide printout of prognostic scores on select reports. A vector loops report is also available.

Ancillary functions include control of an external device (typically a treadmill or ergometer) and communications with centralized electronic/digital storage system.

This device uses a computerized analysis program, which can be used as a tool in ECG tracing interpretation.

The device records 12 lead ECG data taken in resting and exercise modes, as well as real-time rhythm and median morphology recordings. The device can perform a 12 lead interpretive analysis on the resting ECG, providing the user with statements of morphology, rhythm and conduction.

The CASE 8000 exercise testing system is intended to be used by trained operators under the direct supervision of a licensed health care practitioner when exercise or resting ECG records are required.

The CASE 8000 exercise testing system is intended to be used primarily in hospital based exercise testing laboratories, but can be used in clinics, physician offices, outreach centers or wherever exercise testing is performed. This device is not intended for use with high frequency surgical units.

The CASE 8000 system is not intended to be used as a vital signs physiological monitor.

This equipment will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulator.

The CASE 8000 exercise testing system is a PC-based device capable of being operated as a stand-alone system or in conjunction with a centralized electronic/digital storage system such as the MUSE CV Information System - K980495 (MUSE). Major components include a CPU, display, modem, mouse, printer, keyboard, power supply, acquisition module and a cart. It is intended to be used primarily in hospital based exercise testing laboratories. It can also be used in clinics and outreach centers or wherever exercise testing is performed.

The primary application of the device is to acquire, process, record, archive, analyze and output data during a period of physiologic stress or during rest. Ancillary functions include control of an external exercise device, typically a treadmill or ergometer, and communication with a centralized electronic/digital storage system such as the MUSE.

When used in conjunction with MUSE, the CASE 8000 exercise testing system is capable of bringing computerized information management to the exercise laboratory. Demographic and order information can be downloaded to the system to simplify order management and data entry operation. Results from previous tests can be reviewed on the system after network download from the MUSE. New results can be quickly sent to the MUSE for long term storage.

The provided text describes the GE Marquette Medical Systems' CASE 8000 exercise testing system and its 510(k) submission (K991014) to the FDA. However, the document does not contain specific acceptance criteria or a detailed study report that quantitatively proves the device meets such criteria.

The "Test Summary" section {2} mentions general quality assurance measures applied during development but lacks concrete metrics, study designs, sample sizes, or performance results. The "Conclusion" states "The results of these measures demonstrate that the CASE 8000 exercise testing system is as safe, as effective, and performs as well as the predicate devices," but provides no data to support this.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set information.

Based on the provided text, the following information is either not available or only vaguely mentioned:

1. Table of acceptance criteria and the reported device performance: Not provided. The document states the device "complies with the voluntary standards as detailed in Section 9 Specific Standards and Guidances of this submission" and that "the results of these measures demonstrate that the CASE 8000 exercise testing system is as safe, as effective, and performs as well as the predicate devices." However, no specific performance metrics or their comparison against acceptance criteria are presented.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
5. 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: Not provided. The device performs "12SL Analysis" which is a computerized interpretive analysis on resting ECGs, but no MRMC study details are given. The document does not describe AI assistance for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device performs a "12 lead interpretive analysis on the resting ECG" {2}. This implies standalone algorithmic performance, but no specific study or metrics for this standalone performance are provided.
7. The type of ground truth used: Not explicitly stated. For the 12-lead interpretive analysis, it would typically be compared against expert cardiologist interpretations, but this is not confirmed or detailed in the document.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

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