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The ICS Chartr EP 200 with VEMP is indicated for auditory evoked potential testing as an aid in assessing hearing loss and lesions in the auditory pathway. The Vestibular Evoked Myogenic Potential is indicated for vestibular evoked potential testing as an aid in assessing vestibular function in adult patients. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.

"Vestibular Evoked Myogenic Potentials (VEMPs) are short latency electromyograms (EMGs) evoked by high level acoustic stimuli recorded from surface electrodes over the tonically contracted sternocleidomastoid (SCM) muscle." Akin FW & Murnane OD (2001).
The ICS Chartr EP 200 with VEMP is used to test the auditory and vestibular functions of children and adults in a hospital, in an Ear, Nose and Throat Clinic or in an Audiology office. The ICS Chartr EP 200 system measures evoked potentials from the patient using repeated auditory stimuli and averaging EEG or EMG activity in order to abstract the response from the noise resulting in an analysis of the auditory/vestibular system functions.

The ICS Chartr EP 200 is a PC-based system, which consists of software modules for installation on a PC, an isolation transformer, a hardware platform, pre-amp, a mains adapter, stimulation devices and recording devices. The stimulation and recording devices are connected to the preamp, which is connected to the hardware platform, which is connected to the PC via a USB cable - no hardware installation inside the PC is required. The PC and hardware platform are powered from the isolation transformer which is powered from the mains.

One added item as compared to the standard EP200 is the VEMP monitor. The Chartr EP (USB) VEMP monitor assesses the level of tonic EMG and displays if the level is adequate or inadequate. The monitor light will display the following based on the EMG level: Low (blue) -EMG level is below the Min value- Good (green) - EMG level is between Min value and the Max value - High (amber) - EMG level is above the Max value

Summary: VEMP is an evoked potential (EP) just like ABR obtained using any commercially available EP system. The unique feature with the ICS Chartr EP 200 is the ability to perform EMG monitoring during VEMP data collection.

The VEMP function of the EP 200 does not make a diagnosis. The diagnosis is made by a medical professional.

The provided text describes a 510(k) premarket notification for the ICS Chartr EP 200 with VEMP, an auditory and vestibular evoked potential testing device. It does not contain information about an AI/ML medical device. Therefore, a comprehensive answer to the user's request for acceptance criteria and study proving an AI/ML device meets them cannot be wholly extracted from the given text.

However, I can extract the information relevant to the device's validation and substantial equivalence, and then address the remaining points by stating the information is not present in the provided document.

Here's an attempt to answer the user's request based only on the provided text, highlighting what is available and what is not:

Based on the provided FDA 510(k) summary for the ICS Chartr EP 200 with VEMP:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in a quantitative table format for performance metrics relevant to an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating the reproducibility of VEMP waveforms and comparing the new device's features and safety/effectiveness to a predicate device.

The closest equivalent to "reported device performance" in the context of this device is the correlation values for VEMP waveform reproducibility.

2. Sample sized used for the test set and the data provenance

• Test Set Sample Size:
  • 60 normal cVEMP subjects
  • 58 pathologic cVEMP subjects
  • 20 normal oVEMP subjects
• Data Provenance: Studies were collected at two different facilities, one in the USA and one in Canada. The document states these were "clinical studies," implying they were prospective, but does not explicitly state "retrospective" or "prospective."

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

This information is not present in the provided text. The device assesses auditory and vestibular function, and the "ground truth" seems to be the VEMP waveform itself and its reproducibility, rather than a clinical diagnosis established by experts. The diagnosis is stated to be made by a medical professional.

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

This information is not present in the provided text. The study focuses on correlation and reproducibility of waveforms, not on classification or diagnostic accuracy adjudicated by multiple readers.

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

• MRMC Study: No, an MRMC study was not done. This device is an evoked potential testing system, not an AI-powered diagnostic algorithm assisting human readers.
• Effect Size of AI assistance: Not applicable, as this is not an AI/ML device.

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

• Standalone Performance: Not applicable in the context of AI/ML. The device's "performance" is its ability to reliably acquire and display VEMP waveforms. The clinical conclusion and diagnosis are explicitly stated to be made by a medical professional. "The VEMP function of the EP 200 does not make a diagnosis. The diagnosis is made by a medical professional."

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

The "ground truth" implicitly used for the reproducibility study is the VEMP waveform itself and its consistency across repeated measurements. The study aimed to demonstrate that the device could reliably produce these waveforms. For patients with disorders, the "pathologic" status serves as a descriptor for that cohort, with results indicating lower correlation due to the nature of their conditions (absent or abnormal VEMPs).

8. The sample size for the training set

This information is not present in the provided text. This is not an AI/ML device that requires a "training set" in the machine learning sense. Clinical studies presented were to confirm reproducibility, not to train an algorithm.

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

This information is not present in the provided text, as it is not an AI/ML device with a training set and corresponding ground truth.

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Type 1053 FreeFit is intended for audiologists, hearing instrument dispensers, ENTs, speech therapists and other health care professionals. The intended use is that the user is able to visualize the amplified signal recorded in the ear(s) of persons with a hearing loss together with reference information such as target curves in order for the user to have an objective basis for adjusting the Hearing Instrument settings.

The GN Otometrics Type 1053 FreeFit is a PC-based system that contains hardware and software for one or more applications. The applications are controlled from selfcontained software modules installed on a common software platform. The following applications are available: Real ear measurement system (i.e., audio fitting system) and Simulator system.

As a real ear measurement system, the Type 1053 FreeFit plays calibrated sound files and measures the sound pressure level in the ear canal. The difference between the measured sound level outside the ear and in the ear canal gives the gain from the hearing aid. This allows for adjusting hearing aids and demonstrating hearing aid features like noise suppression. The Type 1053 FreeFit system also shows target curves that the hearing aid dispenser can use as guidelines for adjusting the hearing aid.

The real ear measurement system consists of a neckset, a charger unit with mains adapter, two probes connected to the neckset, software for installation on a PC (i.e., OTOsuite Probe Microphone Measurements (PMM)) and hardware for connection to a PC. The neckset is connected to the PC via a Bluetooth radio link (i.e. no physical connection to the PC).

The FreeFit Neckset is the actual measuring device. It contains 2 probes (one for each ear) each with 2 microphones used for measuring the sound level outside and inside the ear. Digital signal processing in form of Fast Fourier Transformations takes place inside the device and the obtained frequency spectra are transmitted to the OTOsuite via Bluetooth. The microphones measuring outside the ear are used for calibrating the sound level. Measurements inside the ear canal (near the eardrum) are conducted with a biocompatible silicone tube guiding the sound waves to the microphone. And the probes contain an o-ring also in biocompatible material for fastening at the ear (pinna).

The FreeFit Charger is used to charge the FreeFit neckset via an inductive coil system. The charger includes a power adaptor connected to mains and providing DC input to the charger stand.

OTOsuite PMM is a software platform required for measuring with the Type 1053 FreeFit, displaying the results and controlling the played sound files and levels. OTOsuite runs on most windows based PCs.

The Type 1053 FreeFit also has the capability to act as a hearing loss simulator and a hearing instrument simulator. These applications are commonly used to demonstrate the level of hearing loss suffered by a patient and the degree to which that loss can be overcome by use of a hearing instrument.

The simulator consists of software for installation on a PC (i.e., OTOsuite Counseling and Simulation (C&S)) and hardware for connection to a PC (i.e., headphones).

OTOsuite C&S is a software application that is required for simulating hearing loss and hearing instruments as part of the counseling process.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly define specific numerical acceptance criteria for the Type 1053 FreeFit device in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to a predicate device (SpeechLink 100 Type 1053) and compliance with various established international and national standards.

Therefore, the table will reflect the general nature of the "acceptance" as described in the document, which primarily focuses on demonstrating equivalence and compliance rather than specific performance thresholds.

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

The document does not specify a sample size for any "test set" in the context of patient data or clinical trials. The testing described is primarily non-clinical, involving comparisons against a predicate device and compliance with technical standards.

• Sample Size for Test Set: Not applicable / Not specified for patient or clinical data. The "test set" here refers to the device itself being tested in a laboratory setting for compliance with standards.
• Data Provenance: Not applicable for patient or clinical data. The data provenance relates to engineering and testing against technical standards.

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

This information is not applicable as the document describes non-clinical performance data and compliance with technical standards for a sound measurement system, not a diagnostic or AI-driven system that would require expert-established ground truth from patient data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable for the reasons stated above. There's no mention of human adjudication in the context of device performance testing against technical standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, and therefore, there is no information on the effect size of human readers improving with or without AI assistance. The device described is a Real Ear Measurement System, which is a tool for audiologists to measure sound pressure levels, not an AI diagnostic or interpretive tool for "readers" to analyze cases.

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

The document describes the device as a "PC-based system that contains hardware and software." The "FreeFit Neckset is the actual measuring device," and "Digital signal processing... takes place inside the device." The "OTOsuite PMM is a software platform required for measuring... displaying the results and controlling the played sound files and levels."

This strongly suggests a standalone performance assessment was indeed central to verifying compliance with standards. The device's ability to accurately measure sound pressure levels and perform signal processing (Fast Fourier Transformations) and calculate gain curves without human intervention in the measurement process itself is the core of its function. The "improved calibration scheme" leading to "significantly greater measurement accuracy" is a direct measure of its standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance testing is defined by established technical standards and methods for acoustical measurement. Specifically:

• ANSI S3.46-1997: "Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids." This standard dictates how real-ear measurements should be performed and what constitutes accurate measurement.
• EN/IEC 61669: "Electroacoustics - Equipment for the measurement of real-ear acoustical characteristics of hearing aids." Similar to ANSI S3.46, this standard provides a framework for accurate acoustical measurements.

The device's performance is gauged against the requirements and specifications outlined in these standards, which serve as the "ground truth" for its functional accuracy.

8. The Sample Size for the Training Set

Not Applicable. The Type 1053 FreeFit is a measurement device that performs digital signal processing based on established acoustical principles. It is not an AI/ML device that requires a "training set" in the conventional sense to learn patterns or make predictions. Its "learning" is based on its engineering design and adherence to scientific principles.

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

Not Applicable. As established in point 8, there is no training set in the context of AI/ML. The "ground truth" for the device's design and operation is rooted in the principles of electroacoustics and signal processing, validated by compliance with relevant international and national standards.

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The ICS Chartr EP 200 is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

The ICS CHARTR EP 200 is a PC-based system, which consists of software modules for installation on a PC, an isolation transformer, a hardware platform, pre-amp , a mains adapter, stimulation devices and recording devices, The stimulation and recording devices are connected to the pre-amp, which is connected to the hardware platform, which is connected to the PC via USB cable - no hardware installation inside the PC is required.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ICS CHARTR EP 200 device:

The provided text is a 510(k) summary for the ICS CHARTR EP 200, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a novel clinical study. As such, many of the requested data points for a traditional clinical study are not present in this document.

The "Effectiveness" section explicitly states: "The ICS CHARTR EP 200 is an Auditory Evoked Response device for replacement of an existing product of a technology type that is available and accepted in the market." This indicates that the regulatory pathway is based on similarity to already approved devices, not on proving new performance metrics.

1. A table of acceptance criteria and the reported device performance

Based on the 510(k) summary, formal "acceptance criteria" in the sense of specific performance targets (e.g., sensitivity, specificity, accuracy for a diagnostic device) and corresponding "reported device performance" from a dedicated study are not explicitly stated or provided.

Instead, acceptance is demonstrated by showing substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable because the device's technical characteristics and intended use are similar to those of devices already on the market.

The closest we get to "acceptance criteria" are the compliance with recognized electrical safety and EMI/EMC standards, and the statement of "Indication for use EP."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This document does not describe a clinical study with a "test set" sample size or data provenance in the way one would for a new diagnostic or prognostic device's performance evaluation. The device type (auditory evoked potential system) is well-established, and the focus is on demonstrating safety and efficacy through equivalence to existing technology, rather than a de novo clinical trial.

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

Not applicable/Not provided. Since there's no clinical study described with a "test set" and corresponding "ground truth" to be established by experts for performance evaluation, this information is not present.

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

Not applicable/Not provided. As there is no clinical study described that involved expert adjudication of a test set, this information is not available.

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/Not provided. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, particularly in image interpretation. The ICS CHARTR EP 200 is an auditory evoked potential system, not an AI-assisted diagnostic imaging device, and the submission is a 510(k) for substantial equivalence, not a new technology requiring such a study.

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

Not applicable/Not provided. The device is an Auditory Evoked Potential System, which is inherently a human-in-the-loop diagnostic tool, used by clinicians to perform tests and interpret results. It is not an "algorithm only" device in the context of standalone performance evaluation like an AI diagnostic tool.

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

Not applicable/Not provided. As no dedicated performance study is described, no specific "ground truth" for evaluating the device's diagnostic accuracy is mentioned in the document.

8. The sample size for the training set

Not applicable/Not provided. The device is not an AI/machine learning product that requires a "training set" in the conventional sense. Its development is based on established principles of auditory evoked potential measurement and engineering standards.

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

Not applicable/Not provided. As there is no "training set" for an AI algorithm described, the method for establishing its ground truth is not relevant or mentioned.

Summary of the Study and Device Performance as Presented in the 510(k):

The provided document, a 510(k) summary, demonstrates the device's substantial equivalence to legally marketed predicate devices primarily through comparison of:

• Intended Use: Identical to predicates for auditory evoked potential testing.
• Technological Characteristics: Similar to predicates, with minor differences (e.g., external hardware, USB connection, lack of OAE/ASSR features present in some, but not all, predicates).
• Safety Standards: Compliance with recognized international and national electrical safety and EMI/EMC standards (EN 60601 series, UL, CAN/CSA).
• Quality Management Systems: Compliance with ISO 9001 and ISO 13485.

The submission relies on the established safety and effectiveness of the predicate devices in the market, rather than a new clinical study to establish performance against novel acceptance criteria. The "study" here is essentially the detailed comparison showing that the new device's features, intended use, and adherence to safety standards are sufficiently similar to approved devices.

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The Focus VNG/ENG is a nystagmograph that is intended to measure, record, and display involuntary movements (nystagmus) of the eyeball.

The Focus VNG/ENG is a PC-based system, which consist of software modules for installation on a PC, an isolation transformer, a hardware platform, a mains adapter, stimulation devices and recording devices.

The stimulation and recording devices are connected to the hardware platform, which is connected to the PC via a USB cable - no hardware installation inside the PC is required.

The provided 510(k) summary for the Focus VNG/ENG type 1068 does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the way one might expect for a new AI/ML-based device.

Instead, this submission leverages the substantial equivalence pathway, common for traditional medical devices. This means the device's "effectiveness" is primarily demonstrated by its similarity to a legally marketed predicate device (ICS Medical CHARTR ENG/VNG Diagnostic System, K991497) and its compliance with relevant safety standards.

Therefore, many of the requested sections below will indicate "Not applicable" or "Not provided in this document" because the nature of the submission does not involve a performance study against specific, quantified acceptance criteria for an AI algorithm.

Here's a breakdown based on the available information:

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

• EN 60601-1-1:2001 (Medical Electrical Equipment. Part 1: General requirements for safety. 1. Collateral standard: Safety requirements for medical electrical systems)
• EN 60601-1-2:2001 (Medical Electrical Equipment. Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests)
• EN 60601-2-40:1998 (Medical electrical equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment)
• ISO 9001:2000 (Quality Management Systems – Requirements)
• ISO13485:2003 (Quality management systems Requirements for regulatory purposes) |
  | Technological Characteristics: Key components and interfaces are comparable or offer improvements over the predicate in a way that doesn't raise new safety or effectiveness questions. | Differs from predicate (CHARTR ENG/VNG) in:
• External hardware platform with USB interface: (Predicate has built-in hardware, integrated in computer)
• Software: (No specific performance difference described, assumed to perform similarly)
• Video goggles: (Not detailed, but implies recording/stimulation mechanism is comparable) |

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

• Not applicable / Not provided in this document. This submission is based on substantial equivalence to a predicate device, not on a clinical performance study with a test set of patient data to evaluate algorithmic performance. The effectiveness is inferred from the predicate's established performance and the new device's comparable design and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable / Not provided in this document. No "ground truth" establishment for a test set is described, as it's not an AI/ML performance study.

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

• Not applicable / Not provided in this document. No test set or adjudication method 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 / Not done. This is not an AI-assisted diagnostic device, but a measurement and recording device for a physiological signal. No MRMC study or human reader improvement with AI assistance is mentioned.

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

• Not applicable / Not done. This device is a complete system (hardware and software) intended for use by a clinician, not a standalone algorithm. Its effectiveness is based on its function as a nystagmograph, not as an AI algorithm.

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

• Not applicable / Not provided in this document. As it's not a performance study of an AI algorithm, no specific ground truth for performance evaluation is described. The "ground truth" for its function as a nystagmograph is implicitly the established medical understanding of involuntary eye movements and the ability of such devices to measure them.

8. The sample size for the training set:

• Not applicable / Not provided in this document. This is a hardware and software system, not an AI/ML model that requires a training set.

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

• Not applicable / Not provided in this document. No training set or ground truth establishment for a training set is described.

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The SpeechLink 100 is a hearing aid calibrator and analysis system that is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid.

The SpeechLink is a PC-based system that contains hardware and software for one or more applications. The applications are controlled from self-contained software modules installed on a common software platform. The following applications are available: Audio fitting system and Simulator system.

The fitting system consists of a neckset, a charger unit with mains adapter, two probes connected to the neckset, software for installation on a PC and hardware for connection to a PC. The neckset is connected to the PC via a Bluetooth radio link, i.e. no physical connection to the PC.

The simulator consists of software for installation on a PC and hardware for connection to a PC.

The provided document outlines the acceptance criteria and a study demonstrating the SpeechLink 100 type 1053 device's performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state a specific numerical sample size for the test set. It refers to "Speech mapping recordings" being measured, implying multiple recordings were taken.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

• Not applicable. The study compares the device's measurements against a predicate device and a technical standard and does not involve human expert interpretation of results to establish ground truth in the traditional sense of medical image analysis or diagnosis.

4. Adjudication Method for the Test Set:

• Not applicable. As noted above, the comparison is against a predicate device's measurements and technical standard tolerances, not against adjudicated expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study compares the device against another device and a technical standard, not human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

• Yes, a standalone performance assessment was conducted. The study directly compares the measurements from the SpeechLink 100 with those from the Audioscan Verifit VF-1, and assesses its compliance with a technical standard. This is an evaluation of the device's (or its underlying algorithm's) performance in generating measurements without human intervention in the measurement process itself.

7. Type of Ground Truth Used:

• The ground truth in this context is established by:
  • The measurements obtained from the predicate device (Audioscan Verifit VF-1).
  • The tolerances defined by the IEC 61669 (2001-01) Electroacoustics - Equipment for the measurement of real-ear acoustical characteristics of hearing aids standard.

8. Sample Size for the Training Set:

• Not applicable. The provided document details a performance study comparing the device to a predicate and a standard, not a machine learning model's training process.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. The provided document details a performance study comparing the device to a predicate and a standard, not a machine learning model's training process.

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The OTOflex 100 type 1012 is an auditory impedance tester that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes.

The OTOflex system consists of a charger unit, a handheld unit with built-in Bluetooth interface, a probe, a contra earphone, and software for installation on a PC. The probe and contra earphone is connected to the handheld unit. The handheld unit can be operated as a standalone device, as a desktop device when placed in the charger, or as a PC-based system from the software via a Bluetooth radio link. The handheld unit is powered from batteries that are recharged when the unit is placed in the mains powered charger unit and two transducers for contra stimulus presentation are available: Probe and Insert phone.

The provided text is a 510(k) summary for the OTOflex 100 type 1012 auditory impedance tester. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a clinical trial report would.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies is not available within this document. The document primarily highlights safety compliance, technological characteristics compared to a predicate, and adherence to relevant standards.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing: Specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) for measuring tympanic membrane mobility, acoustic reflex, or eustachian tube function are not detailed in this 510(k) summary. The acceptance criteria are primarily framed as compliance with recognized standards and similarity to predicate devices.

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

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified in the document. This is a 510(k) submission, which relies on demonstrating substantial equivalence to existing devices and compliance with standards, rather than presenting new clinical study data with test sets of patients.

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

• Number of Experts: Not applicable/Not specified. This information is typically relevant for studies involving subjective assessments or expert consensus in fields like image interpretation, which is not the primary focus for an auditory impedance tester 510(k).
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified. This concept is usually associated with studies where multiple readers or experts make assessments that need to be reconciled for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary.
• Effect Size of Human Reader Improvement with AI vs. Without AI Assistance: Not applicable, as this device is a standalone diagnostic instrument, not an AI-assisted interpretation tool for human readers.

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

• Yes, this submission describes the device's standalone performance in terms of its ability to meet performance standards (EN 61027, ANSI S3.39) and its technological characteristics. The OTOflex 100 is an auditory impedance tester, and its "performance" is its intrinsic capability to perform the measurements as specified, rather than an "algorithm" performance in the AI sense.

7. The Type of Ground Truth Used

• For this type of device, "ground truth" is derived from its ability to accurately and reliably perform physical measurements according to specified engineering and performance standards.
  • Effectiveness: Compliance with product performance standards for impedance/admittance instruments: EN 61027 and ANSI S3.39. These standards define the expected accuracy and performance characteristics for such devices.
  • Safety: Compliance with various electrical and medical device safety standards (e.g., EN 60601-1 series).
• There is no mention of expert consensus, pathology, or outcomes data being used as "ground truth" in the context of this 510(k) submission for this specific device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. This device is not described as involving machine learning or AI models that would require a "training set" of data in the typical sense. Its design and performance are based on established engineering principles and adherence to recognized standards.

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

• Ground Truth Establishment for Training Set: Not applicable, as no training set for a machine learning model is mentioned or implied.

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