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The evadri Bladder Control System is intended to provide electrical stimulation or electromyographic or pressure biofeedback for the treatment of urinary and fecal (electromyographic biofeedback) incontinence.

The evadri Bladder Control System is an office based instrument that is intended to be used by physicians, nurse clinicians, and physiotherapists in an office, clinic, or hospital. The evadri office prisitials, maros marse entronyography or pressure biofeedback from pelvic musculature. The device also provides electrical stimulation to the pelvic musculature. The modalities of biofeedback and electrical stimulation are intended for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of incontinence.

I am unable to provide a description of the acceptance criteria and study as the provided text does not contain that information. The document is a 510(k) summary for a medical device (evadri Bladder Control System), which primarily focuses on describing the device, its intended use, and its substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results.

The document includes:

• Sections 1-6: Details about the sponsor, device name, predicate devices, detailed description of the evadri Bladder Control System (including technological characteristics for stimulation and biofeedback).
• Section 7: A conclusion stating that the device is safe and effective and substantially equivalent to identified predicate devices.
• FDA Letter: A letter from the FDA confirming the 510(k) clearance and the device's substantial equivalence.
• Statement of Intended Use: A reiteration of the device's intended use.

There is no mention of specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement in a performance study within the provided text.

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The intended use of the SmartTrOAE device is to measure otoacoustic emissions, which allow the operator to get information on cochlear function without requiring a subjective response from the person being tested with the device. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

SmartTrOAE is an otoacoustic emissions testing device that is capable of measuring transient and spontaneous otoacoustic emissions produced by the inner ear.

This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive study protocol and results for the SmartTrOAE device independently.

However, I can extract the available information regarding acceptance criteria and device performance based on similarity to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in terms of specific thresholds for performance metrics. Instead, it demonstrates substantial equivalence by comparing the technological characteristics of the SmartTrOAE to the predicate device, ILO88 (K890124). The implicit acceptance criterion is that the SmartTrOAE's performance in these listed parameters is similar enough to the predicate to be considered substantially equivalent.

2. Sample size used for the test set and the data provenance:

This document does not report on a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The substantial equivalence is based on comparing technical specifications and intended use with a predicate device. There is no mention of a clinical study with a test set for the SmartTrOAE's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This document does not report on any ground truth establishment by experts for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This document does not report on an adjudication method for a test set.

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:

This document does not report on an MRMC comparative effectiveness study. The SmartTrOAE is an otoacoustic emissions testing device, which typically provides objective measurements (otoacoustic emissions) and does not involve "human readers" in the interpretation of complex images or data that an AI might assist with.

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

This document does not explicitly detail a standalone performance study. The device itself is an "otoacoustic emissions testing device," implying it takes objective measurements. The intended use "without requiring a subjective response from the person being tested" suggests a standalone measurement capability. However, detailed performance metrics from such a study are not provided. The comparison is solely based on technical specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This document does not describe a type of ground truth used as it does not present a formal clinical study for the SmartTrOAE. The basis for equivalence is the similarity in technical characteristics and intended use to a legally marketed predicate device.

8. The sample size for the training set:

This document does not report on a training set sample size. This type of device (otoacoustic emissions) typically uses established physiological principles and signal processing, rather than machine learning models that require a "training set" in the conventional sense of AI/ML devices.

9. How the ground truth for the training set was established:

This document does not report on the establishment of ground truth for a training set.

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The intended use of the Scout Sport Otoacoustic Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. This intended use is identical to that of the predicate device.

The Scout Sport is a small device measuring 8.5"x4"x2.5" (LxWxD) and weighing 1.45 lbs (0.65 Kg), which is connected to a PC computer through a standard RS-232 serial data communications cable. -The Sport contains a single printed circuit board with all electronics necessary for a complete, self-contained auditory testing system. Control commands are sent to this unit from the computer, and data is returned to the computer from the Sport device. The new Scout Sport OAE device duplicates the functions of the Ariel DSP board hardware and software in a different hardware package. The Scout Sport is battery-powered, using rechargeable batteries and an external charger connected to the AC power. In addition to the charger connector, there are two other connectors on the box. One connector is a 6-pin mini-din which allows for serial communication to the computer. The other connector is a 7-pin mini-din which connects to the Etymotic ER-10C ear probe. There is a single momentary pushbutton switch on the unit, used to perform a RESTART function by the user. A 2-row x 16-character LCD display on the Sport is used to communicate various operational messages to the user.

The provided document describes the Bio-logic Scout Sport OAE, a medical device for measuring otoacoustic emissions (OAE). The document asserts that the Scout Sport performs equivalently to its predicate device, the Bio-logic Scout (formerly EMAV) OAE Instrument (K944735), with some improvements. The primary focus of the document is to demonstrate the safety and effectiveness of the Scout Sport, particularly its equivalence to the predicate device despite hardware configuration changes.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a formal table of quantitative acceptance criteria with specific thresholds for performance metrics. Instead, it focuses on demonstrating equivalence to the predicate device and highlights areas of improvement.

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