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The SAVI Wireless PM500, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.

The SAVI Wireless Model PM500, is a small, auto triggered, hand-held device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpitations are examples of these symptoms. This device may be worn for a period of days or weeks - whatever time is necessary to capture and record the ECG.

The device consists of the SAVI Wireless event monitor, patient cable, and off the shelf cellular telephone. The device can be used with accessories, including a belt clip, lanyard, and PC interface cable.

The provided text describes a 510(k) premarket notification for the SAVI Wireless Model PM500, a cardiac event/loop recorder. It primarily focuses on demonstrating substantial equivalence to a predicate device (CardioPAL SAVI Model PM410) rather than presenting a study with specific acceptance criteria and performance data for the subject device itself.

Based on the document:

1. Table of acceptance criteria and the reported device performance:
   The document does not explicitly define acceptance criteria as a separate, quantitative set of metrics that the SAVI Wireless Model PM500 device needed to meet. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device. The performance is reported qualitatively by comparing features and stating that "there are no differences in their technological characteristics, thereby not raising any new issues of safety or effectiveness."

   Feature	Predicate Device (CardioPAL SAVI PM410)	Subject Device (SAVI Wireless PM500)
   ECG Storage	20 Minutes	20 Minutes
   On Board Analysis	Yes	Yes
   ECG Input	1-Ch 2-Wires, 1-Ch 3-Wires, 2-Ch 3-Wires, 2-Ch 5-Wires	1-Ch 2-Wires, 1-Ch 3-Wires, 2-Ch 3-Wires, 2-Ch 5-Wires
   User Interface	Audio Beeper, 2x16 LCD, 3 Buttons	Audio Beeper, 2 Buttons, Cellular Telephone
   PC Interface	Trans-telephonic, USB	Cellular Network, Bluetooth, USB
   Case	Plastic	Plastic
   EC38 Type	Type 3	Type 3
   Battery	1 AA	1 AA, 1 Rechargeable

   Reported Device Performance: The document asserts that the subject device has "identical indications for use" and that "bench testing... demonstrates that there are no differences in their technological characteristics." The "study" proving this involved non-clinical tests.

2. Sample size used for the test set and the data provenance:
   The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical test set with human patients or their data was used for this specific 510(k) submission. The testing performed was "derived from the risk assessment which evaluated the effects of the feature changes" and included IEC 60601-1, IEC 60601-1-2 (electrical safety and electromagnetic compatibility), and environmental and software validation testing. These are bench tests, not clinical performance tests on a sample set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no clinical test set with associated ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no clinical test set was used.

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 applicable. This device is an ECG recorder, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The document describes "On Board Analysis: Yes" for both the predicate and subject devices, suggesting some level of automated analysis. However, it does not provide details or results of any standalone performance study of this "on board analysis" algorithm, nor does it define its specific function beyond general "on board analysis" in the context of an event/loop recorder which relies on subsequent physician review. The 510(k) submission focused on hardware safety and equivalence, not algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable, as no clinical performance study requiring ground truth was conducted. The ground truth for the non-clinical tests would be defined by the specifications and standards (e.g., successful completion of IEC 60601-1 tests).

8. The sample size for the training set:
   Not applicable, as no clinical data training set is mentioned or implied for a machine learning algorithm. The "on-board analysis" capability is not further detailed as an AI/ML component in this document.

9. How the ground truth for the training set was established:
   Not applicable, as no training set is mentioned.

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