(46 days)
The indications for use of the assistive listening device in this submission is to amplify sound for individuals with impaired hearing. The device is indicated for individuals with hearing loss in the following category(ies). (Check appropriate space(s)): Severity: Slight, Mild, Moderate. Configuration: Gradually Sloping, Flat.
Specific Indications: FOR IMPROVED SIGNAL TO NOISE RATIO THROUGH PLACEMENT OF A REMOTE MICROPHONE NEAR A DESIRED SOUND SOURCE. SEVERE TO PROFOUND LOSS - USED IN CONJUNCTION WITH PERSONAL HEARING AID VIA TELECOIL OR DIRECT AUDIO INPUT.
To improve the signal to noise ratio for a listener in a variety of environments where background noise, poor acoustics, and distance from a desired sound source contribute to hearing difficulty.
Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the listener. This includes: Low gain amplification for Attention Deficit Disorders, Learning Disabilities, Central Auditory Processing Disorders, amplification for mild to moderate conductive and sensorineural hearing loss, and amplification moderate to severe conductive and sensorineural hearing loss when used in conjunction with a personal hearing aid.
HEARING HELPER PERSONAL FM SYSTEM Models PFM300 & PFM 358. WILLIAMS SOUND, HEARING HELPER PERSONAL FM SYSTEM, Model PFM 300 / PFM 350.
The provided text is a 510(k) premarket notification for a hearing assistance device, the Williams Sound, Hearing Personal FM System Model PFM 300/350. This type of regulatory submission historically focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria as one might find for a novel or high-risk device.
Based on the information provided, it is not possible to describe specific acceptance criteria and a study proving the device meets them in the way modern device submissions or clinical trials would. Here's why and what can be extracted:
- Type of Device and Submission: This is a Class II group hearing aid or group auditory trainer. The document is a 510(k) premarket notification, which primarily establishes "substantial equivalence" to a legally marketed predicate device. This process typically involves comparing technical characteristics and indications for use, rather than extensive clinical efficacy studies with predefined acceptance criteria and statistical power calculations.
- Date: The letter is dated January 10, 2017, but refers to the original 510(k) submission from 1997 (K970974) and a correction letter from 1997. Regulatory requirements and expectations for performance studies have evolved significantly since 1997.
Therefore, the following points address what can be inferred or what is not present in the provided text regarding acceptance criteria and a detailed study:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred/Typical for 510(k)) | Reported Device Performance (From Document) |
|---|---|
| Substantial Equivalence: | The FDA has "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." (Page 0). This is the primary "performance metric" for a 510(k) in the absence of specific clinical efficacy claims requiring trials. |
| Indications for Use: | General Indications (Page 2): "amplify sound for individuals with impaired hearing." Indicated for hearing loss severity: Slight, Mild, Moderate. Indicated for hearing loss configuration: Gradually Sloping, Flat. Specific Indications (Page 2): "FOR IMPROVED SIGNAL TO NOISE RATIO THROUGH PLACEMENT OF A REMOTE MICROPHONE NEAR A DESIRED SOUND SOURCE." "SEVERE TO PROFOUND LOSS - USED IN CONJUNCTION WITH PERSONAL HEARING AID VIA TELECOIL OR DIRECT AUDIO INPUT." Further Indications (Page 3): "To improve the signal to noise ratio for a listener in a variety of environments where background noise, poor acoustics, and distance from a desired sound source contribute to hearing difficulty." "Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the listener. This includes: Low gain amplification for Attention Deficit Disorders, Learning Disabilities, Central Auditory Processing Disorders, amplification for mild to moderate conductive and sensorineural hearing loss, and amplification moderate to severe conductive and sensorineural hearing loss when used in conjunction with a personal hearing aid." |
| Safety and Effectiveness: | The FDA states, "You may, therefore, market the device, subject to the general controls provisions of the Act." This implies the device is deemed safe and effective for its intended use based on the substantial equivalence review, but no specific outcome measures or performance thresholds are explicitly stated in this document. |
Here are the answers to the specific questions, based on the provided document:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not mentioned. The document describes a 510(k) premarket notification for substantial equivalence, which typically relies on comparisons of technical characteristics and indications of use to a predicate device, rather than a clinical "test set" with human subjects. If any testing was done, it would likely be engineering bench testing for acoustic performance rather than human performance testing that would require a "test set" in the clinical sense.
- Data Provenance: Not mentioned. It's highly unlikely that clinical data from a human test set was a primary component of this 1997 510(k) submission for this type of device, given the regulatory landscape at the time and the nature of substantial equivalence.
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 mentioned. As there is no clinical "test set" described, there would be no ground truth established by experts in this context. The "ground truth" for a 510(k) is the predicate device's established safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. No clinical test set or adjudication method 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
- No. This is a hearing assistance device, not an AI-powered diagnostic tool, and the concept of "human readers" or "AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a hardware hearing system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a 510(k), the "ground truth" for the submission is the established safety and effectiveness profile of the predicate device. The applicant demonstrates that their new device is "substantially equivalent" to this predicate, meaning it performs similarly and raises no new questions of safety or effectiveness. No specific clinical ground truth (like pathology or outcomes data) is typically required for this type of device and submission.
8. The sample size for the training set
- Not applicable/Not mentioned. This is a hardware device; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set."
§ 874.3320 Group hearing aid or group auditory trainer.
(a)
Identification. A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.