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K Number
K173920
Device Name
LS OIL
Manufacturer
J. Morita USA, Inc.
Date Cleared
2018-10-11

(293 days)

Product Code
EKX
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

LS OIL is a lubricant and is intended for use to lubricate dental handpieces.

Device Description

LS OIL is a lubricant intended for use with dental handpieces. It is comprised of the same paraffin oil and oiliness improver (fatty acid ester) as the previouslycleared LS SPRAY reference device. LS OIL is used after clinical use of dental handpieces before sterilization. It is directly added to the devices from its nozzle by dropping into inside of the handpieces. The LS OIL goes through the hollow of the devices and lubricates their components (gears, bearing, and rotating parts).

AI/ML Overview

I am sorry, but the provided text does not contain the information needed to answer your request about acceptance criteria and a study proving device performance as it relates to an AI/ML device.

The document is a 510(k) Premarket Notification for a dental handpiece lubricant called "LS OIL." It discusses:

  • Device Name: LS OIL
  • Intended Use: Lubricating dental handpieces
  • Comparison to a Predicate Device and Reference Device: PANA-SPRAY and LS SPRAY, respectively.
  • Technological Characteristics: Paraffin oil and fatty acid ester composition.
  • Non-clinical Testing: Viscosity, solubility, density, color, performance testing (sound/vibration after simulated use), shelf life, and biocompatibility (cytotoxicity, irritation, sensitization).
  • No Clinical Testing.

There is no mention of:

  • AI or machine learning algorithms.
  • Acceptance criteria for an AI/ML device's performance (e.g., sensitivity, specificity, AUC).
  • A test set, training set, or data provenance for an AI/ML model.
  • Experts establishing ground truth for AI/ML performance.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) studies.
  • Standalone AI performance.
  • Effect size of human reader improvement with AI assistance.
  • Ground truth types in the context of diagnostic AI.

Therefore, I cannot extract the requested information as it is not present in the provided text.

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.