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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.

Ask a specific question about this device