(15 days)
A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). Severity: X 1. Slight X 2. Mild X 3. Moderate Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat Other 1. Low Tolerance To Loudness B. Specific Indications (Only if appropriate.) : (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
Not Found
The provided document K973972 is a 510(k) clearance letter for the Perfect Ear/Mini Canal and Perfect Ear/CIC hearing aids. It makes a determination of substantial equivalence (SE) to a predicate device already on the market.
It is important to understand that a 510(k) summary for a substantially equivalent device generally does not contain detailed information about the acceptance criteria and the comprehensive study results of the type requested.
The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical studies similar to those for a PMA (Premarket Approval) submission.
Therefore, many of the requested details about specific acceptance criteria, detailed study designs, sample sizes for test and training sets, ground truth establishment, and MRMC studies are not available in this document.
However, I can extract the information that is present in the document which relates to performance and indications for use.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Indication) | Reported Device Performance (from "Indications For Use" - Page 3) |
|---|---|
| Amplifies sound for individuals with impaired hearing. | The indication for use...is to amplify sound for individuals with impaired hearing. |
| Effective for various severities of hearing loss. | Indicated for individuals with: - Slight, Mild, Moderate hearing loss (Severity categories). |
| Effective for various configurations of hearing loss. | Indicated for individuals with: - High Frequency, Gradually Sloping, Reverse Slope, Flat hearing loss (Configuration categories). |
| Compatibility with specific psychoacoustic indications (e.g., improved speech intelligibility in background noise) if supported by clinical data. | No specific psychoacoustic indications beyond general amplification are made in this document. The document explicitly states: "(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)" Since these are not listed under "Specific Indications," it implies such claims were not made or supported in this submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Not specified in this document. A 510(k) submission primarily relies on comparisons to a predicate device. If performance data was submitted, its details (sample size, provenance) are not included in this high-level summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not specified in this document. The concept of "ground truth" as typically applied to AI/diagnostic device validation where expert labeling is used is not directly relevant to this 510(k) for a hearing aid, which usually relies on established audiological metrics and comparison to a predicate device.
4. Adjudication Method for the Test Set
- Not specified in this document.
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 and not specified in this document. An MRMC study is typically for evaluating diagnostic imaging or AI-assisted diagnostic tools. This device is a hearing aid, which is a therapeutic/assistive device. The document does not describe AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not specified in this document. This device is hardware (hearing aid) and its performance is evaluated in direct interaction with the user, not as a standalone algorithm without human-in-the-loop performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a hearing aid, the "ground truth" would generally relate to audiological measurements (e.g., audiograms, speech understanding tests) that define the patient's hearing loss and the device's ability to ameliorate it. The document does not detail the specific types of ground truth data used in the comparison to the predicate device, but it would indirectly involve these audiological assessments.
8. The Sample Size for the Training Set
- Not applicable and not specified in this document. This 510(k) for a hearing aid does not describe a machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable and not specified in this document. As there's no mention of a training set for an AI model, this question is not relevant to the information provided.
In summary: The provided document is a 510(k) clearance letter confirming substantial equivalence. It focuses on the general indications for use of the hearing aid. It does not contain the detailed study design, acceptance criteria (beyond general indications), or statistical results that would typically be associated with clinical trials or AI/diagnostic device validation studies.
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Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 1997
Don Campbell President Perfect® Ear Incorporated PO Box 526050 Longwood, Fl 32752
Re: K973972
Perfect Ear/Mini Canal/(PE-M, PE-ML, PE-MD) Perfect Ear/CIC/(PE-CIPE-CID Hearing Aids Dated: October 8, 1997 Received: October 20, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Campbell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
While your device has been deemed substantially equivalent to other legally marketed hearing aids, please be advised that electromagnetic interference from digital cellular telephones, as well as from other sources is increasingly becoming a concern. Typically, this interference takes the form of a buzzing sound that can range from annoying to very loud and may render a hearing aid temporarily ineffective for the wearer. Because electromagnetic interference may affect your device, you may be asked to test for electromagnetic compatibility in the future. In this interim period, we encourage you to modify your device labeling to inform practitioners and users of the potential for electromagnetic interference. Please be aware that a 510(k) submission is required for any claims that infer that your device is compatible with potential sources of electromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
hoLliau Yi
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510(k) Number (if known):_ MINI-CANAL PE-ML. PE-MI Device Name: VE-M COMPLETELY - IN.CANAL Indications For Use:
- A. General Indications:
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies).
| Severity: | Configuration: | Other |
|---|---|---|
| X 1. Slight | X 1. High Frequency- Precipitously Sloping | 1. Low ToleranceTo Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | |
| 4. Severe | X 4. Flat | |
| 5. Profound | 5. Other |
B. Specific Indications (Only if appropriate.) : (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted device (per 21 CFR 801.420
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number | K973972 |
§ 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.