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K Number
K092025
Device Name
FLUID FILLED TEETHER - GEL
Manufacturer
KIDS II
Date Cleared
2011-01-27

(570 days)

Product Code
KKO
Regulation Number
872.5550
Type
Abbreviated
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

All teethers instruct consumer to: .

  • Clean before use with a damp cloth and mild soap. Air dry. o
  • o Not dishwasher safe
  • Freezer safe ◆

Teether acts as an aid in relieving an infant's gums due to teething. .

Device Description

Fluid Filled Teether - Gel

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as requested. The document is an FDA 510(k) clearance letter for a "Fluid Filled Teether - Gel" (K092025), which indicates that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classification, general controls, and compliance requirements.

However, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details about sample sizes for test sets, data provenance, or retrospective/prospective nature.
  3. Information on the number or qualifications of experts used to establish ground truth.
  4. Adjudication methods.
  5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
  6. Standalone algorithm performance.
  7. The type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is a regulatory approval, not a technical study report detailing performance metrics and study methodologies.

§ 872.5550 Teething ring.

(a)
Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.(b)(1)
Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.