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The ER36 Series OAE Test System is indicated for testing of cochlear function in infants, children, and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. Otoacoustic emissions are low level audio frequency sounds that are produced by the cochlea as part of the normal hearing process.

Available evidence suggests that otoacoustic emissions are generated by the cochlea's outer hair cells and that the presence of OAE's is an indication that the outer hair cells are viable. Clinical evidence indicates that these emissions normally occur with normal hearing, or at most, mild hearing loss (usually 30-40dB HL). The majority of hearingimpaired individuals will be identified by a simple OAE test.

The ER36 Series OAE Test System is a battery powered, hand-held microprocessor-controlled instrument designed to measure otoacoustic emissions. The ER36 is connected by a 1 meter, thin flexible cable to the ER36 MicroProbe OAE Test Probe (Ear Probe). The Ear Probe incorporates a field replaceable Probe Tip (9-lumen tube) that is inserted and acoustically sealed to the test ear canal with a compliant ear tip. The ER36 provides otoacoustic emissions measurements by two methods: distortion product otoacoustic emissions (DPOAE), and transient-evoked otoacoustic emissions (TEOAE). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. Otoacoustic emissions are low level audio-frequency sounds that are produced by the cochlea as part of the normal hearing process.

This document describes the ER36 Series OAE Test System, an audiometer device for measuring otoacoustic emissions. However, it does not include acceptance criteria or the details of a study demonstrating its performance against those criteria. The provided text is a 510(k) premarket notification summary from the FDA, which focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance efficacy data from clinical trials.

The document discusses:

• Substantial Equivalence: The primary goal of this submission is to demonstrate that the ER36 Series OAE Test System is substantially equivalent to a legally marketed predicate device (ERO•SCAN™ OAE Test System, K010165). This means it has the same intended use, indications for use, and principle of operation, and that modifications do not raise new questions of safety or effectiveness.
• Modifications: It lists modifications from a prior device version (ER34), including updated electronic components, ergonomic changes, battery power change, and addition of Bluetooth and USB connectivity.
• Risk Analysis: A risk analysis was performed according to ISO 14971:2007, and residual risks were deemed acceptable.
• Design Verification: Design verification activities were performed "to ensure the modified device was substantially equivalent to the predicate device and that it met performance specifications." This testing was based on risk analysis and design controls.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it is not present in the provided text. The document states that "Design verification activities were performed... that it met performance specifications," but it does not detail those specifications (acceptance criteria) or the specific results of the studies used to demonstrate compliance.

To answer your request, I would need a different document that specifically outlines the performance study and its results to demonstrate how the device meets predefined acceptance criteria.

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The ER35 ERO•SCAN Pro Hearing Test System is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacoustic emissions (OAEs), tympanometry, and acoustic reflex.

The ER35 is a microprocessor-controlled instrument designed to screen otoacoustic emissions, tympanic membrane performance, and acoustic reflex. Test information is stored in memory, displayed on a graphic LCD, and can be printed by a printer or stored on a computer. The product is manufactured and delivered completely assembled to the retailer using materials and techniques widely used by manufacturers of hearing devices.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in the format requested. Instead, it describes the ER35 ERO-SCAN Pro Hearing Test System, its intended use, and indicates that performance testing was conducted to support its substantial equivalence to predicate devices.

Here's an analysis of what can be extracted and what information is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated as specific numerical targets for performance metrics (e.g., sensitivity, specificity, accuracy). The document states that "Certain performance specifications may vary compared to predicate devices, but in these cases, sufficient performance testing has been done to support substantial equivalence determination." This implies the acceptance criteria were based on demonstrating comparable performance to predicate devices, rather than predefined quantitative thresholds.
• Reported Device Performance: Not provided in the document. The text only says "Performance data collected supports a substantial equivalence determination."

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

• Sample Size (Test Set): Not specified. The document only mentions "Subjects tested included both male and female participants, an appropriate age range, and variable audiometric profiles (i.e., subjects with normal range hearing and impaired hearing function)."
• Data Provenance: Not specified. It's unclear if the study was prospective or retrospective, or the country of origin of the data.

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 specified. The document does not describe how ground truth was established, nor the involvement or qualifications of experts for this purpose.

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

• Not specified.

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: Not mentioned or applicable. This device is an audiometer, not an AI diagnostic tool primarily requiring human interpretation of images or complex data where AI assistance would be a factor. The "study" referenced is performance testing of the device itself.
• Effect size of human readers with/without AI assistance: Not applicable to this device.

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

• Yes, a standalone performance assessment was done. The "performance testing" referenced pertains to the ER35 device itself, which performs measurements of otoacoustic emissions, tympanometry, and acoustic reflex. This is inherently a standalone assessment of the device's measurement capabilities. The text states: "Non-clinical and clinical validation was performed in accordance with recognized consensus standards for this type of device. The ER35 has been demonstrated to be in compliance with the following performance and safety standards..."

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

• Not explicitly stated. Given the nature of the device (measuring cochlear and middle ear function), the "ground truth" would likely be established through recognized clinical diagnostic methods or reference standards for otoacoustic emissions, tympanometry, and acoustic reflex, possibly involving expert clinical assessment or other validated diagnostic equipment. The document mentions "variable audiometric profiles (i.e., subjects with normal range hearing and impaired hearing function)," implying clinical classifications were used.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device that requires a training set. The device is a physical instrument for measurement.

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

• Not applicable for the same reason as point 8.

Summary of what is available and what is missing:

The document describes the submission as a 510(k) for an updated medical device (an audiometer) demonstrating substantial equivalence to predicate devices. The "study" mentioned is "performance testing" conducted to show compliance with medical device standards (ANSI S3.39-1987 (R2007), IEC 60601-1:2000, ANSI S3.6-2004, IEC 60645-5:2004) and to support substantial equivalence.

It does not provide the granular detail requested common for AI/ML device evaluations, such as specific performance metrics (sensitivity, specificity, AUROC), sample sizes for test sets, details on ground truth establishment by experts, or MRMC studies. The key statement regarding performance is: "Certain performance specifications may vary compared to predicate devices, but in these cases, sufficient performance testing has been done to support substantial equivalence determination. Non-clinical and clinical validation was performed in accordance with recognized consensus standards for this type of device."

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The ER35 is intended to be a test instrument that measures otoacoustic emissions and tympanic membrane performance (tympanometry).
The ER35 ERO-SCAN Pro Hearing Test System (ER35) is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacoustic emissions (OAEs) and tympanometry.

The ER35 is a microprocessor-controlled instrument designed to screen otoacoustic emissions and tympanic membrane performance (tympanometry). Test information is stored in memory, displayed on a graphic LCD, and can be printed by a dot matrix printer or stored on a computer. The product is manufactured and delivered completely assembled to the retailer using materials and techniques widely used by manufacturers of hearing devices

The provided document describes the ER35 ERO-SCAN Pro Hearing Test System, a device intended to measure otoacoustic emissions and tympanic membrane performance. The submission is a Traditional 510(k) Premarket Notification.

Here's an analysis of the provided information regarding acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to performance standards rather than defining specific acceptance criteria for a new clinical study. The "performance" discussed is related to compliance with existing standards.

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

The document does not mention any specific sample sizes for a test set or clinical study. The submission relies on demonstrating substantial equivalence to existing devices and compliance with recognized performance standards. Therefore, information on data provenance (country of origin, retrospective/prospective) for a test set is also not provided.

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

This information is not applicable as the document does not describe a clinical study that required expert-established ground truth. The device performance is assessed against recognized standards and equivalence to predicate devices, not through a new ground truth determination of a specific condition.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a clinical study requiring an adjudication method.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study would typically assess the improvement of human readers with AI assistance, which is not relevant to this device's function or the nature of its 510(k) submission.

6. Standalone Performance Study

The document does not describe a standalone (algorithm only without human-in-the-loop performance) study. The ER35 is described as a "microprocessor-controlled instrument" designed for screening, implying it performs measurements rather than an "algorithm only" function in the AI sense. Its performance is linked to its compliance with established standards for such instruments.

7. Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically understood for diagnostic algorithms is not directly applicable to this 510(k) submission. The "truth" or "performance" is benchmarked against established performance standards for audiometers and immittance meters (ANSI S3.39-1987, IEC 60645-5, ANSI S3.6-2004) and the demonstrated performance and technical specifications of legally marketed predicate devices.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is expected for a device like the ER35, which is an instrument measuring physiological responses, rather than an AI/Machine Learning model that requires a training set.

9. How Ground Truth for the Training Set Was Established

This information is not applicable as there is no mention of a training set or an AI/Machine Learning model that would require a ground truth for training.

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The ERO.SCAN Otoacoustic Emissions Test Instrument is a hand-held auditory test instrument designed to evoke or stimulate the generation of distortion product otoacoustic emissions (DPOAEs), utilizing pure-tone stimulus presentation, for the purpose of determining the presence of cochlear function in adults, children and infants.

The ERO.SCAN Otoacoustic Emissions Test Instrument is a hand-held device designed to provide an objective measure of outer hair cell function through the measurement of otoacoustic emissions (OAEs). The ERO.SCAN system has both receivers and microphone built into the screener. The DSP board is housed in a hand-held device.

The provided text describes a 510(k) premarket notification for the ERO•SCAN Otoacoustic Emissions Test Instrument, seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical trials that establish device performance against specific acceptance criteria.

Therefore, the document does not contain information about explicit acceptance criteria in the form of performance metrics (like sensitivity, specificity, accuracy) with corresponding acceptance thresholds, nor does it detail a study designed to prove the device meets such criteria through a traditional clinical validation process. Instead, it focuses on comparing the technological characteristics of the ERO•SCAN device to its predicate, the Etymotic Research Cub Dis Otoacoustic Emissions Test Instrument.

However, we can infer "accepted" performance characteristics by examining the "Performance Characteristics" listed for both the predicate and the ERO•SCAN device in the comparison table, as these are implicitly deemed acceptable for an Otoacoustic Emissions Test Instrument.

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

Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly the performance characteristics of the predicate device. The "reported device performance" is the ERO•SCAN's characteristics.

Note: The differences in Frequency Range and Stimulus Intensity Range between the predicate and the ERO•SCAN describe variations in their technical specifications, which are deemed acceptable for the intended use through the substantial equivalence argument, rather than being "failures" to meet a criterion. The core functionality and safety aspects (like maximum output) are maintained or improved.

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

The document does not describe a clinical study with a test set of patient data. The substantial equivalence argument is based on a technical comparison of device specifications and principles of operation.

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. No clinical test set requiring expert ground truth establishment is described.

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

Not applicable. No clinical test set 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. This device is an Otoacoustic Emissions Test Instrument, a diagnostic tool, not an AI-assisted interpretation system for human readers. No MRMC study is mentioned.

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

The device is a standalone instrument for measuring otoacoustic emissions. Its performance is inherent to its design and technical specifications, which are compared to the predicate. It's not an "algorithm only" in the sense of a software-based AI interpreting data externally. The "Software algorithms are essentially equivalent" to the predicate, implying that the underlying computational methods for processing signals are similar or the same as an already accepted device.

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

For this type of device and submission, the "ground truth" for demonstrating safety and effectiveness implicitly relies on the established safety and effectiveness of the predicate device. The comparison focuses on technical and functional equivalence, ensuring the new device operates on the same principles and provides similar, safe, and effective measurements. There isn't a "ground truth" derived from patient outcomes or expert consensus specifically for validating the ERO•SCAN's diagnostic accuracy in the way a new imaging algorithm might be evaluated.

8. The sample size for the training set

Not applicable. This document describes a medical device seeking substantial equivalence, not a machine learning model requiring a training set.

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

Not applicable. This document describes a medical device seeking substantial equivalence, not a machine learning model requiring a training set.

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