(87 days)
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."
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.