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K Number
K972058
Device Name
LORIPRO, LORIPRO II
Manufacturer
LORI MEDICAL LABORATORIES, INC.
Date Cleared
1997-08-15

(74 days)

Product Code
ESD
Regulation Number
874.3300
Type
Traditional
Panel
Ear Nose & Throat
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The indication for use of the air conduction hearing alos in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(fes). (Check appropriate space(s)); Severity: X1. Slight X2. Mild X3. Moderate X4. Severe 5. Profound Configuration: X1. High Frequency - Precipitously Sloping X2. Gradually Sloping X3. Reverse Slope X4. Flat 5. Other Other X1. Low tolerance To Loudness X2. Normal Dynamic Range 3. ______

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) notification for "Loripro and Loripro II Hearing Aids" (K972058) does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is an FDA letter granting substantial equivalence for the device, based on its indications for use. It primarily focuses on regulatory classification, general controls, and an advisory about potential electromagnetic interference.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

Here's a breakdown of why this information isn't available based on your request:

  1. A table of acceptance criteria and the reported device performance: Not included in the document.
  2. Sample sized used for the test set and the data provenance: Not included in the document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not included in the document.
  4. Adjudication method for the test set: Not included in the document.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not included in the document.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not included in the document.
  7. The type of ground truth used: Not included in the document.
  8. The sample size for the training set: Not included in the document.
  9. How the ground truth for the training set was established: Not included in the document.

The document is purely a regulatory letter concerning the substantial equivalence of the device to previously marketed hearing aids, allowing it to proceed to market. It does not elaborate on the specific performance studies or acceptance criteria that would have been submitted as part of the 510(k) application itself.

§ 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.