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The Strong Dental Handpiece, ACL(B)-46EP is intended for 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 and teeth bone for e.g. impacted third molars and complicated extractions.

Not Found

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The document is a 510(k) clearance letter from the FDA for a medical device called "STRONG Dental Handpieces". It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general controls provisions of the Act that the manufacturer must comply with. It also includes an "Indications for Use" section for the device.

Therefore, I cannot provide the requested information based on the given input.

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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.

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The STRONG Dental Handpieces. ACL(B)-03C and ACL(B)-03F. 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 and teeth bone for e.g. impacted third molars and complicated extractions

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.

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

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The STRONG Dental Handpieces is indicated for wide range of dental procedures.

• AT II for the application in the area of the front teeth, root tip resection, bone . removal, osteotomia on the upper and lower jaw, preprosthetic surgical modellation, sequestrotomia, fenestration on the alveolar appendix, apical ventilation, bone modellation, bone smoothing.
• ACL-01, ACL(B)-01C and ACL-02C for the osteotomia on the upper and lower ● jaw, germectomia, sequestrotomia.

The STRONG Dental Handpieces; AT-II, ACL-01C, ACL(B)-01C and ACL-02C is The STRONG Dental handpieces with transmission ratio of 1:1. It can be driven by torque adjustable electrical motors for surgery treatment. It is attached to drive via ISO 3964 coupline. The head clamp accepts instrument complying with ISO 1797-1. It has contra-angle(AT-II has straight-angle) attachment for difficult to reach 1797-1. It has contra digities for restorations, such as fillings, and for cleaning teeth.

The provided text is a 510(k) summary for a dental handpiece, focusing on establishing substantial equivalence to predicate devices rather than presenting a performance study against specific acceptance criteria for an AI/machine learning device. Therefore, a direct answer to the request to describe acceptance criteria and a study proving device performance in the context of AI/machine learning is not possible from this document.

The document discusses the device's indications for use and compares its characteristics to predicate devices. It states:

• "The STRONG Dental Handpieces has the same device characteristics as the predicate The Surgical Contra-Angle handpieces Types WS-56E, Surgical Straight Handpieces Types S-11; intended use, material, design and use concept are similar. And they also comply to ISO 3964 coupling and ISO 1797-1 shank."
• "Based on the comparison of intended use and technical features, the STRONG Dental Handpieces are substantially equivalent to the predicate devices."

This indicates that the "study" conducted for this medical device was a substantial equivalence comparison to predicate devices, not a clinical or performance study with acceptance criteria as one would expect for an AI/ML diagnostic or measurement tool.

Therefore, the requested information cannot be extracted from the provided text for the following reasons:

1. Acceptance Criteria and Reported Device Performance: This document does not outline specific, quantifiable acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) nor does it report performance against such criteria. The device is a mechanical tool (dental handpiece), and its acceptance is based on design, materials, and intended use being equivalent to already approved devices.
2. Sample Size and Data Provenance: Not applicable, as this is not a study involving data analysis or patient data.
3. Experts for Ground Truth and Qualifications: Not applicable.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not applicable, as there is no AI assistance involved with this device.
6. Standalone Performance: Not applicable, as there is no AI algorithm.
7. Type of Ground Truth: Not applicable.
8. Training Set Sample Size: Not applicable, as there is no AI model to train.
9. Ground Truth for Training Set Establishment: Not applicable.

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