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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
• 2. Bone contouring, osteoplasty

B. Periodontal surgeries

• 1. Bone contouring & alveoplasty around living teeth

2. Removal of exostosis

C. Bone grafting

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

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

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.

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.

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.

Ask a specific question about this device

The E-CUBE is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills(Gates-Glidden).

The E-CUBE is an AC-powered device that includes a hand-held motor and controller for regulation of speed and direction of rotation or a contra-angle attachment for dental implant surgery.

The provided document describes a 510(k) summary for the Saeshin E-CUBE, a dental handpiece. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, design, and adherence to safety standards.

However, the document does not contain any information regarding specific acceptance criteria for device performance, nor details of a study that proves the device meets such criteria in terms of clinical performance or accuracy.

Instead, the document highlights:

• Substantial Equivalence: The E-CUBE is deemed substantially equivalent to predicate devices (X-Smart Easy, K092614, and STRONG Implant Handpiece, K092412) in terms of intended use, materials, design, and use concept.
• Biocompatibility Testing: Biocompatibility of patient contact parts was demonstrated through cytotoxicity, sensitization, and irritation testing according to ISO 10993-1.
• Safety Standards: The device conforms to IEC 60601-1 (Medical electric equipment, Part 1: General requirements for safety) and IEC 60601-1-2 (electromagnetic compatibility).

Therefore, I cannot provide the requested table or detailed study information as it is not present in the provided text. The document focuses on regulatory compliance and equivalence to established devices rather than reporting on a specific performance study with defined acceptance criteria and clinical outcomes.

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