(20 days)
This air-conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderate.
The device is powered by a standard hearing aid battery (type 10A). The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The ability of the hearing aid dispenser to program digitally the fitting parameters of the ReSound® CC4 hearing device is the same as in the ReSound® IC4. The ability to change the characteristics of the sound processing and to adjust the volume via an optional remote control is the same as that offered by the commercial device, the ReSound® IC4. The algorithm used by the ReSound® computerized fitting system to compute sets of fitting parameters is similar to that used for the ReSound® IC4 with adjustments made for the acoustic differences between the IC4 and the ReSound® CC4.
This document (K964115) is a 510(k) premarket notification for a hearing aid, the ReSound® CC4 Personal Hearing System™. It is seeking substantial equivalence to a predicate device, the ReSound® Personal Hearing System™ ED4-C (K951067).
The information provided in this 510(k) summary is insufficient to answer many of the questions asked, as it is focused on establishing substantial equivalence based on design and operational similarities, rather than a clinical performance study with acceptance criteria and detailed reporting of device performance against a ground truth.
Here's an attempt to address your prompts based on the available information, with significant caveats where information is missing:
1. A table of acceptance criteria and the reported device performance
Based on the document, there are no explicitly stated acceptance criteria in terms of clinical performance metrics (e.g., accuracy, sensitivity, specificity) for the new device. The acceptance criteria for this 510(k) are implicit: that the new device is substantially equivalent to the predicate device in its intended use, technology, and performance specifications.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Intended Use (compensate for mild to moderate hearing loss) | "This air-conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderate." (Same as predicate) |
| Device Type (air-conduction hearing instrument) | "This air-conduction hearing instrument..." (Same as predicate) |
| Power Source (standard hearing aid battery) | "The device is powered by a standard hearing aid battery (type 10A)." (Same as predicate) |
| Manufacturing/Materials/Techniques | "The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices." (Implied similar to predicate/industry standard) |
| Programmability (fitting parameters) | "The ability of the hearing aid dispenser to program digitally the fitting parameters of the ReSound® CC4 hearing device is the same as in the ReSound® IC4." (Same as predicate) |
| Remote Control Functionality | "The ability to change the characteristics of the sound processing and to adjust the volume via an optional remote control is the same as that offered by the commercial device, the ReSound® IC4." (Same as predicate) |
| Fitting Algorithm | "The algorithm used by the ReSound® computerized fitting system to compute sets of fitting parameters is similar to that used for the ReSound® IC4 with adjustments made for the acoustic differences between the IC4 and the ReSound® CC4." (Similar to predicate with necessary adjustments for acoustic differences) |
| Overall Performance Specifications, Functions, Operations | "The performance specifications, functions and operations of the ReSound® CC4 Personal Hearing System™ is substantially equivalent to that described in the predicate device 510(k) Premarket Notification." (Substantially equivalent to predicate) |
The document does not describe a study that proves the device meets specific performance-based acceptance criteria. Instead, it asserts substantial equivalence based on design and functional similarities to a previously cleared device. There is no mention of a clinical trial or performance study against a specific ground truth for the CC4 device in this summary.
The remaining questions cannot be answered from the provided text as they pertain to clinical performance studies, which are not described in this 510(k) summary. This document focuses on demonstrating substantial equivalence, not on presenting novel clinical performance data with a test set, expert ground truth, or a multi-reader study.
Here's why each cannot be answered:
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. No clinical performance test set is described.
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. No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or adjudication process 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 provided. This is a hearing aid, not an AI diagnostic imaging device for human readers/interpreters. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. While a hearing aid has "standalone" performance, the 510(k) doesn't describe a formal study of its performance in this context against a clinical outcome. Its function is to amplify sound, and its "performance" is implicitly tied to its effect on the user's hearing, which is not detailed in a clinical study here. The "algorithm" mentioned refers to the fitting system's software, not an AI for diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth defined for a performance study.
8. The sample size for the training set
- Not applicable / Not provided. No training set for a machine learning algorithm in the context of clinical performance is described. The "fitting system algorithm" is likely a rule-based or signal processing algorithm, not a machine learning model requiring a "training set" in the typical sense.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No training set or ground truth establishment is described.
In summary: This K964115 document demonstrates substantial equivalence for a hearing aid based on similarities in intended use, technology, and performance specifications to a predicate device. It does not contain the details of a clinical performance study with explicit acceptance criteria and corresponding performance metrics against a defined ground truth, as would be expected for a device requiring such data to demonstrate safety and effectiveness.
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.