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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 and teeth bone for e.g. impacted third molars and complicated extractions

Device Description

The STRONG Dental Handpieces; ACL(B)-03C and ACL(B)-03F are gear driven handheld dental handpieces with Gear Ratio of 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 for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the STRONG Dental Handpieces (models ACL(B)-03C and ACL(B)-03F). The intention is to demonstrate substantial equivalence to a predicate device (K100192).

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

Key Takeaway: This submission is for a medical device (dental handpieces), not for an AI/ML powered device. Therefore, many of the typical questions regarding AI/ML study design, such as information about training sets, test sets, ground truth establishment by experts, adjudication methods, and MRMC studies, are not applicable here. The evaluation focuses on non-clinical bench testing and biocompatibility to prove substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Test Standards based on ISO 14457)	STRONG Dental Handpieces (ACL(B)-03C) Performance	STRONG Dental Handpieces (ACL(B)-03F) Performance
Visual Inspection of General Design (Section 7.2 of handpiece standard)	Complies	Complies
Extraction Force (minimum)	≥ 45 N	≥ 22 N
Reported Extraction Force (Mean)	51.2 N	32.2 N
Eccentricity (maximum total indicated run-out)	≤ 0.08 mm	≤ 0.08 mm
Reported Eccentricity (Mean)	0.014 mm	0.012 mm
Resistance to Sterilizing Procedure (Deterioration) (after 250 cycles of 132°C for 4 min)	No deterioration detected	No deterioration detected
Resistance to Sterilizing Procedure (Extraction Force) (after 250 cycles)	> 45 N (Reported: 51.2 N)	> 22 N (Reported: 32.2 N)
Resistance to Sterilizing Procedure (Max. Speed) (±10% rpm from initial)	35,000 rpm (Reported: 35,120 rpm)	35,000 rpm (Reported: 35,090 rpm)
Resistance to Sterilizing Procedure (Noise)	< 70 dB (Reported: 55 dB)	< 70 dB (Reported: 54 dB)
Temperature Rise (max. at touchable surface, compared to environment)	≤ 20°C (Reported: 10°C)	≤ 20°C (Reported: 6°C)
Resistance to Corrosion (after 10 autoclave cycles at 132°C for 4 min, 22kPa)	No signs of corrosion	No signs of corrosion
Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity)	Compliant (previously cleared via K100192)	Compliant (previously cleared via K100192)

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

Test Set Sample Size: The document does not specify the exact number of units or distinct samples for each bench test (e.g., how many handpieces were tested for extraction force or eccentricity). It refers to "ACL(B)-03C and ACL(B)-03F samples" which were compliant.
Data Provenance: The tests are non-clinical bench tests performed by the manufacturer, Saeshin Precision Co., Ltd. The biocompatibility test report was issued by the Korea Testing & Research Institute. This data is retrospective in the sense that the tests were conducted prior to the 510(k) submission. The country of origin for the testing institution (Korea Testing & Research Institute) is Korea.

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

Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus is not relevant. The "ground truth" for the device's performance is established by adhering to recognized industry standards (e.g., ISO 14457, ISO 10993, ISO 17665-1) and performing objective physical measurements and analyses.

4. Adjudication Method for the Test Set

Not Applicable. As this involves objective physical testing against predetermined standards, there is no expert adjudication process in the manner of diagnostic interpretation. The results are compared directly to the specified numerical or qualitative criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not Applicable. This device is a dental handpiece, not an AI/ML powered diagnostic or therapeutic device. No human-in-the-loop performance or reader studies are mentioned or relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not Applicable. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical bench tests, the "ground truth" is adherence to international standards and specifications (e.g., ISO 14457 for dental handpieces, ISO 10993 for biocompatibility, ISO 17665-1 for sterilization). The performance of the device is directly measured against these established quantitative and qualitative criteria.
For biocompatibility, the predicate device (K100192) having previously cleared the same materials is also cited as "ground truth" for material safety.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a "training set."

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

Not Applicable. Not an AI/ML device.

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