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K Number
K983182
Device Name
ALOE THERAPY ORAL RINSE
Manufacturer
CARRINGTON LABORATORIES, INC.
Date Cleared
1998-12-10

(90 days)

Product Code
OLR,MGQ
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Carrington Laboratories Caraloe Oral Rinse provides fast pain relief and is recommended for the conning of a lives of oral wounds, mouth sore injuries and ulcers of the oral mucosa, including canker son s and traumatic ulcers such as those caused by braces and ill-fitting dentures. Safe if swallowed

Device Description

Caraloe Oral Rinse

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Carrington Laboratories Caraloe Oral Rinse, dated December 10, 1998. It primarily addresses the regulatory status and allowed labeling claims for the device. As such, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document lacks the following information which would be necessary to answer the prompt directly:

  • A table of acceptance criteria and the reported device performance: This document states the device is "substantially equivalent" but does not define specific performance metrics or acceptance thresholds.
  • Sample size used for the test set and the data provenance: There is no mention of any specific test set, its size, or its origin.
  • Number of experts used to establish the ground truth for the test set and their qualifications: No information about expert review or ground truth establishment is provided.
  • Adjudication method for the test set: Not applicable as no test set is described.
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
  • If a standalone study was done: The document describes regulatory clearance, not a standalone performance study in the context of an algorithm.
  • The type of ground truth used: Not applicable as no ground truth is described.
  • The sample size for the training set: There is no mention of a training set as this is about a medical device, not an AI/algorithm.
  • How the ground truth for the training set was established: Not applicable.

Instead, the document focuses on:

  • Indications for Use: "The Carrington Laboratories Caraloe Oral Rinse provides fast pain relief and is recommended for the conning of a lives of oral wounds, mouth sore injuries and ulcers of the oral mucosa, including canker son s and traumatic ulcers such as those caused by braces and ill-fitting dentures." (There appears to be a typo "conning of a lives" which likely meant "comforting of").
  • Regulatory Class: Unclassified
  • Product Code: MGQ
  • Limitations on Labeling: The device may not be labeled for use on third-degree burns, as having an accelerating effect on wound healing, as a long-term/permanent/no-change dressing/artificial skin, or as a treatment/cure for any type of wound.
  • Basis for Clearance: Substantial equivalence to devices marketed prior to May 28, 1976.

Therefore, I cannot provide the requested table and study details based on the provided text.

N/A