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The Steth IO Spot is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data, whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Steth IO Spot is intended for use on individuals undergoing physical examination. The Steth IO Spot is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis or emergency use.

OTC use: Steth IO Spot can be used by a patient to be examined during a video call and to submit a non-emergent-examination for review by their healthcare provider.

Rx-only use: Steth IO Spot may be prescribed by a licensed medical provider to monitor medical conditions that require the use of a stethoscope.

The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C) port of the smartphone and can be utilized to auscultate patients during physical examination. The sound is then analyzed by the Steth IO Spot software telemedicine application (app) installed on the smartphone. This analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present. A web portal (i.e., the Steth IO Portal) may also be used to access recorded patient data and to hold telemedicine calls.

The Steth IO Spot device has two main components:

• Steth IO Spot device: The Steth IO Spot device is capable of transmitting your heart, lung or other biological sounds to the mobile device. This device needs to be connected to the smartphone's lightning port/USB-Type C port.
• Steth IO Spot Software (Telemedicine App): The Steth IO smartphone application software performs real-time analysis to hear the sounds using headphones. The app is available for download from a designated software repository.

A chest piece, consisting of a bell and diaphragm, and an integrated microphone is placed on the patient and the sound is transmitted to a smartphone via lightning port/USB-C port. The device is capable of recording sound data, allowing the patient-user at one location to share audio data with their healthcare provider on site or at a different location on the network.

The provided document describes the Steth IO Spot, an electronic stethoscope. While it details various performance tests (functional, biocompatibility, electrical safety, EMC, software verification and validation), it focuses on demonstrating substantial equivalence to a predicate device (Eko CORE) rather than proving the device meets specific acceptance criteria based on clinical efficacy or diagnostic accuracy.

Therefore, the information required to construct the comprehensive table of acceptance criteria and a study proving those criteria (especially regarding diagnostic performance, human reader improvement with AI, standalone AI performance, and detailed ground truth establishment), as typically seen for AI-driven diagnostic devices, is not fully available in this regulatory submission document. This document is for a medical device that amplifies, filters, and transmits sounds, which is different from an AI-driven diagnostic tool that analyzes sounds for specific medical conditions.

However, I can extract the available information and highlight what is missing based on your request.

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance studies for the Steth IO Spot:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Eko CORE) by comparing technological characteristics and showing that the device performs comparably or better in functional aspects relevant to its core purpose (amplifying, filtering, and transmitting sounds). It does not describe a study that validates a diagnostic AI model's performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device as an electronic stethoscope for sound data acquisition and transmission, the "acceptance criteria" presented are primarily functional and safety-related, rather than diagnostic performance metrics (e.g., sensitivity, specificity for disease detection).

2. Sample Size Used for the Test Set and Data Provenance

• Heart Rate Accuracy Test: Not explicitly stated, but "side-by-side comparison test" implies a test set was used. The provenance (country, retrospective/prospective) is not mentioned.
• Frequency Audio Response Test: Not explicitly stated.
• Human Factors Usability Testing: "Two separate studies were conducted." Sample size (number of participants) is not explicitly stated. Provenance (country, retrospective/prospective) is not mentioned beyond the "intended use environment (e.g., hospital setting, office setting, etc.)" for professionals and "home setting" for lay users.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Heart Rate Accuracy Test: The ground truth was established using an "EKG (gold standard)." This implies an objective measurement rather than expert interpretation of the device's output. The expertise for establishing the EKG ground truth itself is not detailed.
• Frequency Audio Response Test: No mention of experts; this is an engineering performance test against specifications and a predicate device.
• Human Factors Usability Testing: Evaluated "intended users" (healthcare professionals and patient-users/lay-users), but it's about usability, not a diagnostic ground truth established by experts.

4. Adjudication Method for the Test Set

• Not applicable for the described tests, as they are primarily technical performance or usability assessments rather than diagnostic accuracy studies requiring adjudication of discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done according to the provided text. This document describes a device for sound acquisition and transmission, not an AI that interprets or aids in diagnosis. Therefore, there's no discussion of human readers improving with or without AI assistance.

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

• Not explicitly applicable in the context of diagnostic AI. The "Steth IO Spot Software (Telemedicine App)" performs "real-time analysis to hear the sounds," but the document does not state that this analysis includes automated diagnostic interpretations. Its role is primarily for amplification, filtering, transmission, and recording of sounds for human clinicians to interpret. The "analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present," implying it's an aid for the human, not a standalone diagnostic algorithm being evaluated for accuracy.

7. The Type of Ground Truth Used

• Heart Rate Accuracy Test: "EKG (gold standard)" for heart rate.
• Frequency Audio Response Test: Objective measurements against a predicate device and engineering specifications.
• Human Factors Usability Testing: User task completion and satisfaction (functional ground truth).

8. The Sample Size for the Training Set

• Not applicable. The document describes a medical device, not an AI model trained on sound data for diagnostic purposes. The software mentioned (Steth IO Spot Software) primarily handles real-time audio processing for listening and transmission, not deep learning for diagnosis.

9. How the Ground Truth for the Training Set was Established

• Not applicable. See point 8.

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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.

Ask a specific question about this device