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The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intended for medical diagnostic purposes only. It may be used for the detection of sounds from the heart, and lungs with the use of selective frequency ranges. It has been tested for use on adults undergoing a physical assessment.

Steth IO is an acoustic device that is used in conjunction with a smartphone to collect heart and lung sounds. Steth IO attaches to the back of the smartphone and contains an acoustic wave guide that channels sound from the Steth IO chest piece to the smartphone's microphone, while also acting as a protective covering for the phone. The Steth IO smartphone application software performs real-time analysis so the user can hear the sounds using headphones, and visualize the sound using the on-screen phonocardiogram. The device is capable of recording sound and phonocardiogram data, allowing healthcare providers to capture biological sounds and send the data to other healthcare providers or for review at a later time. Steth IO is intended for use as a diagnostic aid, enabling the healthcare provider to identify sounds and any abnormalities that may be present.

I am sorry, but the provided text does not contain a study or specific acceptance criteria with reported device performance for the Steth IO device. The document is primarily a 510(k) premarket notification summary to the FDA, which focuses on establishing substantial equivalence to a predicate device.

It outlines:

• Device Name: Steth IO
• Regulation Number: 21 CFR 870.1875
• Regulation Name: Stethoscope
• Regulatory Class: Class II
• Product Code: DQD
• Intended Use: "The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, and lungs with the use of selective frequency ranges. It has been tested for use on adults undergoing a physical assessment."
• Predicate Device: 3M Littmann Electronic Stethoscope, Model 3200 (K083903) used in conjunction with Zargis StethAssist phonocardiogram software.
• Comparison to Predicate: A table (Table 2-1.1) highlighting differences in features and functionalities, but not specific performance metrics against acceptance criteria. It discusses how the differences do not affect safety or efficacy.
• Compliance to Standards: A list of quality, risk management, process-related, technical/product-specific, labeling, and biocompatibility standards the device complies with.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or details about the study design (retrospective/prospective).
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance.
5. Standalone (algorithm only) performance.
6. The type of ground truth used (e.g., pathology, outcomes data).
7. Sample size for the training set.
8. How ground truth for the training set was established.

Therefore, I cannot provide the requested table and study details based on the given input.

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