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The i-Scope 200 is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.

i-scope 200 digital stethoscope is a new advanced product compared to conventional stethoscopes that removes noise from tube of standard stethoscope. It dose not cause pain to the ear despite long-term use due to newly introduced soft materials applied in earphone. i-scope 200 digital stethoscope is intended for medical diagnostic purposes only. It is used for the amplification of heart, lung and other body sounds with selective frequency filtering. This product is not designed, sold, or intended for any other use.

The provided document is a 510(k) summary for the i-Scope 200, a digital stethoscope. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance studies or specific acceptance criteria with quantifiable metrics. Therefore, much of the requested information cannot be extracted from this document, particularly regarding specific numerical performance, ground truth establishment, or multi-reader studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

Acceptance Criteria and Study Information for i-Scope 200:

1. Table of Acceptance Criteria and Reported Device Performance:
   The document does not provide a table of acceptance criteria or specific numerical performance metrics for the i-Scope 200. The claim for substantial equivalence is based on "same intended use and similar technological characteristics" to predicate devices, rather than meeting pre-defined quantitative performance thresholds.

2. Sample Size used for the test set and the data provenance:
   This information is not provided in the document. The traditional concept of a "test set" for performance evaluation, as would be used for AI/ML devices, is not discussed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided. The concept of ground truth establishment by experts for a test set is not relevant to this type of 510(k) submission, which focuses on substantial equivalence to predicate devices.

4. Adjudication method for the test set:
   Not applicable; no specific test set or adjudication process is described.

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. The i-Scope 200 is a digital stethoscope, a hardware device for amplifying body sounds. It is not an AI-assisted diagnostic software, and therefore, an MRMC comparative effectiveness study with or without AI assistance is not described or relevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. The i-Scope 200 is a standalone device in that it functions independently to amplify sounds, but it does not involve algorithms for automated diagnosis or a "human-in-the-loop" concept in the way AI/ML devices do. Its performance is based on sound amplification and filtering capabilities.

7. The type of ground truth used:
   Not applicable. The document does not describe a performance study that would require a ground truth for diagnostic accuracy.

8. The sample size for the training set:
   Not applicable. As this device is a hardware digital stethoscope and not an AI/ML algorithm requiring a training set, this information is not provided.

9. How the ground truth for the training set was established:
   Not applicable. No training set is described for this device.

Summary based on available information:

The K062364 submission for the i-Scope 200 is a traditional 510(k) notification focused on demonstrating substantial equivalence to existing legally marketed predicate devices (3M Littmann Electronic stethoscope, Model 4000 (K003723) and JABES electronic stethoscope (K031446)).

The primary "acceptance criterion," implicitly, is that the device shares the "same intended use and similar technological characteristics" as its predicates. This is the basis for the FDA's clearance. The document highlights:

• Intended Use: "amplification of heart, lung and other body sounds with selective frequency filtering" for "medical diagnostic purposes only" and "on any patient undergoing a physical assessment." This is stated to be the same as the predicate devices.
• Technological Characteristics: The i-Scope 200 is described as a "new advanced product compared to conventional stethoscopes that removes noise from tube of standard stethoscope" and uses "newly introduced soft materials applied in earphone" for comfort. These are presented as similar to, or improvements upon, the predicate technology, rather than requiring new performance thresholds.

The submission is notably devoid of specific performance data, clinical study results, or quantitative metrics. This is common for predicate-based 510(k) submissions of devices like stethoscopes, where equivalence in function and safety, without raising new questions of effectiveness, is the core of the review.

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