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K Number
K171436
Device Name
STRONG Dental Handpieces
Manufacturer
Saeshin Precision Co., Ltd.
Date Cleared
2018-01-05

(234 days)

Product Code
EGS
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K092412
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The STRONG Dental Handpieces, ACL(B)-611, ACL(B)-631, ACL(B)-651 and ACL(B)-04C are intended for a wide range of dental procedures including:

  • A. Implant placement, including
    1. Preparation of the osteotomy site
    1. Bone contouring, osteoplasty

B. Periodontal surgeries

    1. Bone contouring & alveoplasty around living teeth
  1. Removal of exostosis

C. Bone grafting

    1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
    1. Harvesting autogen living bone
    1. Sinus elevation & grafting of alveolar sockets

D. Removal and sectioning of teeth bone for e.g. impacted third molars and complicated extractions

Device Description

The STRONG Dental Handpieces; ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-65| and ACL(B)-04C are gear driven hand-held dental handpieces with Gear Ratio of 20:1, 16:1, 64:1, 32:1 and 1:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the "STRONG Dental Handpieces" based on the provided FDA 510(k) summary (K171436):

1. Table of Acceptance Criteria and Reported Device Performance:

The document for the "STRONG Dental Handpieces" focuses on demonstrating substantial equivalence to a predicate device (K143418) rather than defining specific, quantitative acceptance criteria for de novo performance. The acceptance criteria are implicitly that the new device meets the same performance and safety standards as the predicate, as evidenced by similar technical specifications and successful bench testing against relevant standards.

Acceptance Criteria CategorySpecific Criteria (Implicit for Substantial Equivalence)Reported Device Performance
Intended UseIdentical to predicate deviceIdentical to predicate device
Device DesignSimilar to predicate deviceSimilar to predicate device
Composition of MaterialsSimilar to predicate deviceSimilar to predicate device (with minor variations noted)
Technical SpecificationsComparable to predicate device (within acceptable ranges for variations)See detailed comparison table in Section 8 of the summary (e.g., Gear Ratio, Length, Diameter, Max Speed, Torque, Shank Conformance, Coupling Dimension)
BiocompatibilityCompliance with ISO 10993-1 (Cytotoxicity, Sensitization, Irritation)Materials previously cleared and test reports demonstrate compliance.
Bench TestingConformity to ISO 14457 (Dentistry - Handpieces And Motors)All models compliant with ISO 14457:2012.
SterilizationValidation per FDA Guidance, ASTM F2314, ISO 15883-5, ISO 17665-1, ISO 17665-2 for steam sterilization protocol.Sterilization method validated according to listed standards for the specified protocol (Steam Heat 132 ℃ / 4 min. with sterilization bag and 30 min dry time).

2. Sample Size Used for the Test Set and Data Provenance:

  • Test Set Description: The studies involved "ACL(B)-611, ACL(B)-62l, ACL(B)-63l, ACL(B)-65l and ACL(B)-04C samples."
  • Sample Size: The exact number of samples tested for each model in the bench tests is not specified in the provided document. It states "samples were compliant," implying multiple units were tested per model.
  • Data Provenance:
    • Country of Origin: Korea (Saeshin Precision Co., Ltd. is based in Republic of Korea; Biocompatibility testing done by Korea Testing & Research Institute).
    • Retrospective or Prospective: The testing appears to be prospective bench testing specifically conducted for this 510(k) submission to demonstrate compliance. Biocompatibility data leverages previous clearance (K092412) for similar materials, which would be considered retrospective in terms of the initial material assessment, but the application to the current device is part of the prospective submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

  • This document describes testing for a Class I dental handpiece, not an AI/Software as a Medical Device (SaMD) that typically involves expert ground truth for interpretation.
  • Therefore, there is no mention of experts establishing ground truth in the context of interpretation for image analysis or clinical diagnosis. The "ground truth" for this device's performance is established by direct measurement and compliance with engineering and biocompatibility standards.
  • Experts involved would typically be in engineering, materials science, and microbiology for the bench and sterilization testing, but their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set:

  • Not applicable for this type of device and testing. Adjudication methods like "2+1" are relevant for clinical studies where multiple human readers interpret data, and discrepancies need to be resolved, often in the context of AI performance evaluation. This document describes bench testing against defined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

  • No MRMC study was done. This type of study is typically performed for diagnostic imaging AI algorithms to compare human reader performance with and without AI assistance. The "STRONG Dental Handpieces" are mechanical devices, and such a study is not relevant to their evaluation.

6. Standalone Performance Study (Algorithm only):

  • Not applicable. This device is a mechanical dental handpiece, not an algorithm or software. The performance described is for the physical device itself.

7. Type of Ground Truth Used:

  • The "ground truth" for this device's acceptance is based on:
    • Engineering Standards: Compliance with ISO 14457:2012 for dental handpieces, and ISO 3964, ISO 1797-1 for coupling and shank conformity.
    • Biocompatibility Standards: Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10.
    • Sterilization Standards: Compliance with FDA Guidance for Reprocessing, ASTM F2314, ISO 15883-5, ISO 17665-1, ISO 17665-2.
    • Direct Measurement: Technical specifications for revolution, gear ratio, weight, size, torque, etc., are directly measured and compared against the predicate and design specifications.

8. Sample Size for the Training Set:

  • Not applicable. This device is a mechanical product, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

  • Not applicable. As there is no training set, this question is not relevant.

§ 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.