(18 days)
The Articulate G1 Series Hearing Aids are wearable, sound-amplifying devices that are intended to compensate for impaired hearing. The intended use of the Articulate series hearing aids is identical to that of the legally marketed predicate devices.
The Articulate G1 Series Hearing Aids amplify and deliver sounds via air conduction to the external ear of persons with hearing losses. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. In the non-programmable Articulate models, the potentiometers of the circuit are used by the hearing aid dispenser to manually modify the amplification characteristics of the incoming signal. In the programmable Articulate models, the amplification characteristics are contained in digitally programmable memory; the programming port allows direct programming of the circuit and adjustment of device parameters through the interface to a personal computer and proprietary Articulate Programming Software.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Articulate G1 Series Hearing Aids:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Met all applicable specifications developed by the manufacturer. | The devices met all applicable specifications developed by the manufacturer in accordance with test methods outlined in ANSI S3.22-1996, "Specification of Hearing Aid Characteristics". |
| Compliance with ANSI S3.22-1996 "Specification of Hearing Aid Characteristics" | The performance characteristics were evaluated in accordance with ANSI S3.22-1996. |
Study Information
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Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Performance data" was evaluated, but it does not specify the number of hearing aids tested or where the test data came from (e.g., patient trials, lab-simulated environments).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here refers to whether the devices meet technical specifications, not a clinical diagnosis or assessment requiring expert consensus.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The assessment is against established technical specifications (ANSI S3.22-1996), not subjective human interpretation.
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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 a hearing aid, not an AI-powered diagnostic tool. The study described is a performance/compliance test, not a comparative effectiveness study involving human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in the sense that the device's technical performance was measured directly against specifications. This is an evaluation of the device as a standalone product, not an algorithm's performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is defined by the applicable specifications developed by the manufacturer in accordance with ANSI S3.22-1996, "Specification of Hearing Aid Characteristics". This is a technical standard/specification.
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The sample size for the training set: Not applicable. This is not a machine learning or AI-driven device that requires a training set. The performance evaluation is against a fixed set of technical specifications for hardware.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device and study.
§ 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.