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The QSCREEN device is a hand-held, portable hearing screener intended for recording and automated evaluation of Otoacoustic Emissions (OAE) and Auditory Brainstem Responses (ABR). Distortion Product Otoacoustic Emission (DPOAE) and Transient Evoked Otoacoustic Emission (TEOAE) tests are applicable to obtain objective evidence of peripheral auditory function. ABR tests are applicable to obtain objective evidence of peripheral and retro-cochlear auditory function including the auditory nerve and the brainstem. QSCREEN is intended to be used in subjects of all ages. It is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable.

The QScreen is a hand-held and portable audiometric examination device offering test methods for the measurement of Otoacoustic Emissions (OAE) including transitory evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE) and Auditory Evoked Responses like Auditory Brainstem Responses (ABR) in patients of all ages. It has a touch screen display and can be used with different accessories, such as its Docking Station, Ear Coupler Cable, Ear probe, Insert earphone, and Electrode cable.

QScreen is a battery powered device which is charged by the Docking Station wirelessly and communicates with the Docking Station via Bluetooth. The Docking Station can be connected to a personal computer (PC) via USB cable on which patient and test data can be reviewed and managed with the optional software. Additionally, device and user profile configurations can be conducted with the software. Printing the data is also possible and carried out by a label printer that can be connected to the Docking Station. The QScreen device also contains a camera on the back side to read linear bar codes and QR codes. All materials that come into contact with human skin are selected to be biocompatible.

The operating system on the QScreen is a self-contained firmware. The user is guided by the menu on the touch screen through the measurement. The results are evaluated on the base of signal statistics. The device offers an automatically created result, which can have the values "PASS" (Clear Response), "REFER" (No Clear Response) or "INCOMPLETE" (Test aborted).

The provided text is a 510(k) summary for the PATH MEDICAL GmbH's QScreen device. It states that "No clinical performance data was collected for the subject device QScreen. Substantial equivalence was shown through bench testing and compliance to international standards..." As such, the document does not contain the information required to answer the prompt regarding acceptance criteria and the study that proves the device meets the acceptance criteria (specifically clinical performance data).

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document explicitly states that no clinical performance data was collected to demonstrate the device meets acceptance criteria via a clinical study. Instead, substantial equivalence to a predicate device (Sentiero) was shown through:

• Bench testing: This included tests for "frequency, timing and sound level of the stimulus as well as noise resistance and the lowest response signal detectable by the device."
• Compliance to international standards: IEC 60645-6:2009 (OAE) and IEC 60645-7:2009 (ABR).
• Biocompatibility testing: According to ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation).
• Electrical safety and electromagnetic compatibility (EMC) testing: According to IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2:2014, IEC 60601-2-40: 2016.
• Software Verification and Validation Testing: According to FDA's guidance and IEC 62304:2015.
• Usability Testing: According to EN 62366:2015.
• Mechanical and Acoustic Testing: Including maximum sound level, push, drop, and mould stress relief tests, and frequency content, timing, sound level, and repetition rate of stimuli.
• Literature Review: Citing publications on ABR algorithm and automated infant screening.

The comparison to the predicate device focuses on technical characteristics, intended use (where QScreen is a subset of Sentiero's functionality), and accessories, stating that these differences "do not raise different question of safety or effectiveness."

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