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The eKuore One Wireless electronic interface for stethoscope is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One Wireless is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application.

It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.

The equipment consists of a stethoscope attachment, which will let the sound flow through the stethoscope's tube, so the stethoscope can continue working as usual, and the sound will be collected by a little hole in the piece, where a microphone will be placed. Then, this piece will be covered by a plastic case. A Bluetooth module is placed for a wireless transition of the data to a mobile (Android/IOS) or tablet. The eKuore One Wireless electronic interface for stethoscope gets the power supply from an internal rechargeable battery.

The application allows the user to visualize audio streaming received from the stethoscope. The connection is established between the smartphone application and the selected device, and after this event, the selected device starts to stream audio to the smartphone application.

The application also allows the user to record the current audio streaming, storing it in the internal storage of the Android/iOS device. The recordings can be viewed, shared and deleted after that.

The application does not store or collect any personal data of the users or patients. The only generated artifacts generated with the use of the application, the auscultations stored in the internal storage of the Android/iOS device, can only be identified by its name, which is a combination of the time and date when the auscultation was performed, which is insufficient to identify uniquely a patient or gets its personal information.

The provided text is a 510(k) Premarket Notification for the "eKuore One Wireless Electronic Interface for Stethoscope" and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to diagnostic accuracy, sensitivity, specificity, or other clinical efficacy metrics. Instead, the document discusses technical characteristics and regulatory compliance to demonstrate equivalence to a previously cleared device.

Therefore, most of the requested information regarding acceptance criteria and clinical study details cannot be extracted from this document.

Here's what can be gathered, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail metrics for clinical performance. The document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and regulatory compliance.

• Reported Device Performance: The document lists technical characteristics of the eKuore One Wireless electronic interface for stethoscope and compares them to a predicate device. This is not "performance" in the sense of diagnostic accuracy or clinical outcomes.

  Elements of Comparison (as per provided text)	eKuore One Wireless electronic interface for stethoscope (Candidate Device)	Eko electronic stethoscope system (Reference Device)	Comparison
  Regulatory data
  Regulatory Class	Class II	Class II	Identical
  Device Classification name	Electronic Stethoscope	Electronic Stethoscope	Identical
  Regulation Number	21 CFR 870.1875	21 CFR 870.1875	Identical
  Classification Product code	DQD	DQD	Identical
  FDA Clearance	Pending	K151319	-
  USE
  Intended use	Diagnostic decision support... record heart sounds, cardiac murmurs, bruits, respiratory, and abdominal sounds.	Diagnostic decision support... record heart sounds, cardiac murmurs, bruits, respiratory, and abdominal sounds.	Similar (Predicate also amplifies sound)
  Characteristics
  Principles of operation	Microphone & electronics for digitalization/codification, wireless (Bluetooth) to mobile.	Dispositive introduced in acoustic stethoscope, sound amplification, audio transmission to smartphone via Bluetooth.	Similar (Both acquire and transmit sound to a mobile app)
  Clinical conditions	Human body sounds related	Human body sounds related	Identical
  Use	Electronic stethoscope	Electronic stethoscope	Identical
  Compatibility	-Littmann 3M Cardiology III/IV -Littmann 3M classic II/III	-Littmann 3M Cardiology II/III -Welch Allyn Harvey Elite -ADC601 lines of analog stethoscopes	Similar (Both compatible with Littmann 3M Cardiology III)
  Prescription/OTC	Prescription use	Prescription use	Identical
  Intended for Direct Connection to Patient	No	No	Identical
  Use environment	Clinical	Clinical	Identical
  Type of users	Health-care personnel	Health-care personnel	Identical
  Target population	All types of patients	All types of patients	Identical
  Cleaning & Maintenance	Detach, alcohol wipe cleaning of eKuore One. Stethoscope cleaned between each patient.	Stethoscope and CORE cleaned between each patient. External parts with 70% isopropyl alcohol wipes.	Identical
  Technical equivalence
  Sound track transfer function	Yes	Yes	Identical
  Signal transmission for visualization	Bluetooth transmission to compatible smartphones/tablets	Bluetooth transmission to compatible smartphones/tablets	Identical
  Energy Source	Rechargeable Lithium Ion Battery	Rechargeable Lithium Ion Battery	Identical
  System required	Android and iOS	Android and iOS	Identical
  Hardware and software platforms	Mobile devices or tablets	Mobile devices or tablets	Identical
  Connections	Micro USB connector only to charge internal battery	Micro USB connector only to charge internal battery	Identical
  Frequency range	20 Hz to 2 KHz	20 Hz to 2 kHz	Identical
  Signal Input Method	Sound collected via a Transducer. MEMS	Sound waves collected via a Transducer. Electro microphone	Identical
  Audio Output Method	Earbuds and 3.5mm Jack when connected with smartphone/tablets	Earbuds and 3.5mm Jack when connected with smartphone/tablets	Identical
  Signal Storage	Allows signal storage depending on technical features of connected device.	Allows signal storage depending on technical features of connected device.	Identical
  Performance requirements	Temp range: -20℃ to +45℃ Humidity range: 0% to 90%	The operating range is 10℃ to 40℃, and 0% to 90% relative humidity	Similar
  Biological Equivalence
  Materials	Cover: ABS and EPDM; Pushbutton: PMMA; Gasket: EPDM	Body: ABS (Acrylonitrile Butadiene Styrene).	Similar
  Contact with human tissues or body fluids	Does not contact patient's body. Attached stethoscope does.	Does not contact patient's body. Attached stethoscope does.	Identical
  Sterility	Sterility considerations are not applicable	Sterility considerations are not applicable	Identical

2. Sample size used for the test set and the data provenance: Not provided. The submission relies on non-clinical test data and comparison to a predicate device, not a clinical test set for diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such clinical test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 document does not describe an AI device or a comparative effectiveness study. The device is a "Wireless Electronic Interface for stethoscope" which electronically filters and transfers sounds.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is an electronic interface for a stethoscope, meant to be used by healthcare professionals. It's not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical performance study requiring ground truth is described.

8. The sample size for the training set: Not applicable, as no machine learning algorithm requiring a training set is described.

9. How the ground truth for the training set was established: Not applicable.

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