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Traus SSG10 Surgical System is an electrical appliance intended to cut, shave, bone & tissue resection, grinding, and drilling in the cranium and spine. Shaver handpiece is not intended for use in neurosurgical procedures.

Traus SSG10 Surgical System is composed of a control box, micro motor and a foot controller as an electric bone surgery machine. A signal for operating a foot controller, a handpiece, etc.., is transmitted when a power source is inputted to a control box (main body) to control functions such as rotational speed, torque and water injection amount.

It is a mechanism for puncturing, and cutting bones and human tissues through rotation and reciprocating motion by connecting handpieces and attachments to a micro motor. Three modes (Drill, Saw, Shaver) can be set, and the handpiece and attachment for each mode can be used in many surgical areas.

The provided text is a Premarket Notification (510(k)) from the FDA for the Traus SSG10 Surgical System. This type of document is for demonstrating substantial equivalence to a predicate device, not typically a detailed study proving acceptance criteria for new or innovative device features.

Therefore, the document does not contain the detailed information requested for acceptance criteria or a study proving those criteria, particularly in the context of an AI/ML medical device. The device in question is an "Electric Cranial Drill Motor," which is a traditional hardware device, not an AI/ML powered one.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on demonstrating substantial equivalence to a predicate device based on general features and safety/EMC standards, not specific performance metrics against defined acceptance criteria.
2. Sample size used for the test set and the data provenance: Not provided. Performance testing mentioned is "bench testing" to assure operation within predefined design specifications, but no details on sample size, data origin, or retrospective/prospective nature are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is not an AI/ML device. Performance is assessed against engineering specifications.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Information that can be extracted or inferred from the document regarding "acceptance" in a general sense:

The "acceptance criteria" for devices seeking 510(k) clearance are primarily about demonstrating substantial equivalence to a legally marketed predicate device regarding safety and effectiveness. This is achieved by showing conformance to recognized standards and comparable performance.

Implicit Acceptance Criteria (based on 510(k) process):

Study Proving Device Meets Acceptance Criteria (as described in the document):

The "study" or evidence provided is a collection of non-clinical tests and conformance to standards, rather than a single, formal "study" with specific statistical endpoints to prove new performance claims.

• Non-clinical Performance Data:
  • (1) Electrical Safety and Electromagnetic Compatibility (EMC): Conducted according to IEC 60601-1:2005/AMD2:2020 and IEC 60601-1:2015+A1:2021. This demonstrates adherence to recognized safety standards.
  • (2) Software Verification and Validation Testing: Conducted in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) and IEC 62304, for a "moderate level of concern." This ensures the software operates as intended and mitigates risks.
  • (3) Performance Testing (Bench Test): This testing was performed to "assure that the SSG10 operates safely and within the predefined design specifications." The report references "performance criteria such as RPM." Although the maximum RPM (40,000rpm) is lower than the predicate (80,000rpm), the testing results reportedly showed this difference "does not raise any problems in the safety and effectiveness."
  • (4) Sterilization: Validated in conformance to ISO 17665-1:2006.
  • Biocompatibility: Materials tested and confirmed safe per ISO 10993 series (1, 5, 10, 12).

Key Takeaway: The document outlines the evidence used to support a substantial equivalence determination, focusing on compliance with established safety and performance standards for a medical device that is not an AI/ML technology. It does not contain the specific AI/ML-related study details requested.

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Traus SSG30 Surgical System is an electrical appliance intended to cut, shave, bone & tissue resection, grinding, and drilling in the cranium and spine. Shaver handpiece is not intended for use in neurosurgical procedures.

Traus SSG30 Surgical System, is available to apply surgical operation by various handpieces incorporating a micro motor and a handpiece. The technological characteristics and operating parameters of OSSEODUO Shaver and Drill System is very similar to the predicate device. With respect to the functional aspects, Traus SSG30 Surgical System, Bone surgery Engine Unit, uses the same fundamental technology as the predicate device. Traus SSG30 Surgical System consists of a control box (main unit), foot controller, micro motor and handpieces. Traus SSG30 Surgical System is composed of a control box, micro motor and a foot controller as an electric bone surgery machine. A signal for operating a foot controller, a handpiece, etc... is transmitted when a power source is inputted to a control box (main body) to control functions such as rotational speed, torque and water injection amount. It is a mechanism for puncturing, and cutting bones and human tissues through rotation and reciprocating motion by connecting handpiece and attachments to a micro motor. Three modes (Drill, Saw, Shaver) can be set, and the handpiece and attachment for each mode can be used in many surgical areas.

The provided text describes the 510(k) premarket notification for the "Traus SSG30 Surgical System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria through clinical performance data, especially concerning AI/ML aspects.

The document explicitly states: "Clinical Data: No clinical performance testing was performed."

Therefore, I cannot fulfill all parts of your request as the information required for a study proving the device meets acceptance criteria, particularly for AI/ML performance, is not present in this regulatory submission. This submission primarily focuses on functional equivalence, electrical safety, software verification, and sterilization validation.

However, I can extract information related to the acceptance criteria that were tested (non-clinical) and the methods described:

Summary of Acceptance Criteria and Device Performance (Based on Non-Clinical Data Provided):

Information Not Available / Not Applicable for this Device's Clearance:

As stated previously, this submission is for a Traditional 510(k) of a physical surgical system, not an AI/ML-driven device that requires performance studies related to diagnostic accuracy or human-AI collaboration. Therefore, many of your specific questions are not applicable to the context of this FDA clearance.

• Sample sized used for the test set and the data provenance: Not applicable for a traditional surgical system's non-clinical performance tests like electrical safety or mechanical RPM. The "test set" here refers to physical bench tests and software V&V, not a clinical data set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and electrical systems is typically defined by engineering specifications and standards, not expert consensus on images or clinical outcomes.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For non-clinical tests, ground truth is based on engineering specifications, physical measurements, and industry standards (e.g., IEC, ISO).
• The sample size for the training set: Not applicable (not an AI/ML device).
• How the ground truth for the training set was established: Not applicable.

Conclusion from the Document:

The 510(k) summary concludes: "The non-clinical data support the safety of the device and software and software verification and validation demonstrate that the SSG30 device should perform as intended in the specified use conditions. The clinical data demonstrate that the SSG30 device performs comparably to the predicate device that is currently marketed for the same intended use Based on the available information, the subject device and the predicates are similar indication for use, operational principal, performance data. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification that we conclude that substantially equivalent with predicate device."

This explicitly indicates that substantial equivalence was primarily demonstrated through non-clinical performance and a comparison of technical specifications to a predicate device, without clinical performance testing.

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This air-powered dental handpiece is intended for removal of carious material, cavities and crown preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures. It is designed for use by a trained professional in the field of general dentistry.

The TRAUS Air Dental handpieces are air driven dental handpieces for the use by a trained dental professional. The devices are air-powered handpieces that are reusable and designed accordance with international standard. The devices can be sterilized by the prevacuum steam autoclave methods that have been validated. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high-speed turbine. They also receive cooling water for cutting through one port and light for illumination through another port.

Using in combination with dental unit chair, it is possible to use by installing the instrument at air handpiece according to purpose. It is possible to change the rotation speed by adjusting the flowing air.

The provided document is a 510(k) premarket notification for a dental handpiece (TRAUS Air Dental Handpiece) and does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device.

The document discusses the substantial equivalence of the TRAUS Air Dental Handpiece to a predicate device (Maxima PRO 45L) based on technical characteristics and non-clinical performance data. It explicitly states: "No clinical performance testing was performed."

Therefore, I cannot provide the requested information, such as:

1. Table of acceptance criteria and reported device performance: This document does not establish performance criteria in the way an AI/ML device study would (e.g., sensitivity, specificity, AUC). Instead, it compares the technical specifications and operational principles of the new device to a predicate device.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance: These are all concepts relevant to clinical or AI/ML performance studies, which were explicitly stated as "not performed."
3. Type of ground truth: Not applicable as it's a mechanical device with no AI component requiring ground truth.
4. Sample size for training set, how the ground truth for the training set was established: Not applicable as there is no training set for an AI/ML model.

The "Non-clinical Performance Data" section (page 6) details bench tests conducted to ensure conformity to ISO standards (ISO 14457, ISO 17665-1, ISO 9168) and demonstrate substantial equivalence. These are engineering and sterilization validation tests, not performance studies as typically understood for AI/ML devices.

In summary, the provided text describes a 510(k) submission for a conventional dental handpiece, and thus does not contain the information requested about acceptance criteria and a study for an AI/ML driven device.

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The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills (Gates-Glidden).

The TRAUS ENDO is an AC-powered device that includes a power unit, charging station and contra-angle handpieces, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, which are used for grinding, cutting, and polishing work in dental oral use. It is used for endodontic surgery with 600-1,000 rpm.

The provided text is a 510(k) summary for a medical device called "TRAUS ENDO," which is a dental handpiece. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific performance acceptance criteria through clinical trials or algorithm performance evaluations.

Therefore, the information requested about acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth establishment, training set details), and specific performance metrics (like effect size or standard performance values) for proving the device meets acceptance criteria cannot be found in this document.

This type of 510(k) submission generally relies on demonstrating the new device is as safe and effective as a legally marketed predicate device, often through:

• Comparison of technological characteristics: Showing similarities in design, materials, and operating principles.
• Performance testing to standards: Demonstrating compliance with relevant electrical safety, biocompatibility, and sterilization standards (as listed in Section 12). These are typically engineering tests, not clinical studies involving human or animal subjects for performance evaluation.
• Verification/Validation: Ensuring the device design meets specified requirements and user needs.

Based on the provided text, I can extract the following information related to "performance data" (which in this context refers to engineering and quality assurance tests, not clinical performance):

1. A table of acceptance criteria and the reported device performance:

The document states that "The following tests were conducted, and the device passed all of the tests based on predetermined Pass/Fail criteria." However, it does not explicitly list the specific quantitative acceptance criteria or the numerical results for these tests. It only lists the types of tests performed.

Note: The document also references assessments for Biocompatibility (ISO 10993) and Reprocessing Validation (cleaning, sterilization per ISO 17665-1) that were performed on previously cleared predicate devices with the same materials and processes.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The tests mentioned (Software, Temperature, Eccentricity) are typically performed on a limited number of manufactured units or prototypes to demonstrate compliance with standards, not on a "test set" in the context of a large-scale clinical performance study.
• Data Provenance: Not explicitly stated, but these are likely internal lab tests performed by the manufacturer (Saeshin Precision Co., Ltd.) to engineering standards. There is no mention of country of origin for any "data" beyond the manufacturing location. The study is not a retrospective or prospective clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to the "performance data" presented in this 510(k) summary. The tests performed are engineering and quality assurance tests that do not involve human expert interpretation for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as the "performance data" refers to technical-compliance testing, not human-read interpretation of data requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a dental handpiece, not an AI-assisted diagnostic tool. No MRMC study or AI-related effectiveness study was conducted or reported in this document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is hardware (a dental handpiece) and its accompanying components. It is not an algorithm, and its performance is not measured in a standalone computational manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The concept of "ground truth" as typically applied to diagnostic AI models is not applicable here. The "ground truth" for the engineering performance tests (Temperature, Eccentricity) would be the specific quantitative limits defined by the ISO/IEC standards (e.g., maximum allowable temperature, maximum allowable eccentricity), and the "truth" of the software passing would be its adherence to specified functional requirements.

8. The sample size for the training set:

This is not applicable. The device is not an AI model requiring a training set.

9. How the ground truth for the training set was established:

This is not applicable. The device is not an AI model.

In summary, the provided document is a regulatory submission for a Class I medical device based on substantial equivalence, which primarily relies on demonstrating compliance with recognized standards and similarity to predicate devices rather than comprehensive clinical performance studies involving large datasets or AI components.

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TRAUS SIP20 is intended for use in dental surgery, implantology, for treatment of dental hard tissue and mechanial rotating root canal preparation.

TRAUS SIP20 is an AC-powered device that includes a hand-held motor, contra angle handpiece and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental surgery.

This document describes a 510(k) premarket notification for a dental handpiece, the TRAUS SIP20. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove a device meets specific acceptance criteria through extensive clinical studies like those for novel AI devices or high-risk medical devices.

Therefore, the requested information regarding acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert involvement, and MRMC studies, as typically applied to AI/ML clinical evaluations, is not present in this document. This submission primarily relies on comparing the new device's design and performance to an already cleared predicate device, demonstrating that any differences do not raise new questions of safety or effectiveness.

Here's how to address your request based on the provided document:

Overview of Device and Study Type

The TRAUS SIP20 is a dental handpiece for use in dental surgery and implantology. The "study" proving its performance is a substantial equivalence evaluation, primarily through non-clinical bench testing and comparison to predicate devices, rather than a clinical trial with acceptance criteria for diagnostic performance (e.g., sensitivity, specificity).

1. Table of Acceptance Criteria and Reported Device Performance

This type of comprehensive table with explicit acceptance criteria for diagnostic performance (e.g., accuracy, precision) is not applicable to this document as it's a 510(k) submission for a non-AI dental handpiece. The "performance" is demonstrated by showing equivalence in intended use, design, and adherence to safety standards.

Instead, the document highlights:

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

• Sample Size for Test Set: Not applicable in the context of clinical diagnostic performance. The "test set" for this device relates to the number of units or components tested during bench testing (e.g., for electrical safety, EMC, performance per ISO 14457). The specific sample size for these non-clinical tests is not detailed in the summary but would be part of the full submission.
• Data Provenance: Not explicitly stated as "data" in the sense of patient images or outcomes. The data provenance would be the location where the safety and performance bench tests were conducted, likely within the manufacturer's R&D or a certified testing lab (e.g., in Republic of Korea).
• Retrospective or Prospective: Not applicable. This is a non-clinical, bench-testing and design comparison submission.

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

• Not applicable. This submission does not involve "ground truth" established by human experts for diagnostic purposes akin to image interpretation. The "truth" for this device is based on engineering specifications, adherence to standards, and physical performance measurements.

4. Adjudication Method for the Test Set

• Not applicable. There is no expert adjudication process described as this is not a diagnostic device relying on human interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was NOT done. This type of study is typically performed for AI-powered diagnostic tools to assess how AI assistance impacts human reader performance. This device is a mechanical dental handpiece, not an AI diagnostic tool.

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

• Not applicable. This device is a mechanical tool. There is no "algorithm only" performance to evaluate in this context. While it has firmware (software with "MODERATE level of concern"), its "standalone performance" refers to its function as a controlled rotary instrument, evaluated through bench tests, not diagnostic accuracy.

7. The Type of Ground Truth Used

• Not applicable in the common sense of diagnostic "ground truth" (e.g., pathology, clinical outcomes, expert consensus on images). The "ground truth" for this device's performance are engineering specifications, established international standards (e.g., ISO, IEC), and physical measurements from bench tests.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning, therefore, there is no "training set."

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

• Not applicable. No training set exists for this device.

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TRAUS SUS20, Piezo Surgery Engine Set, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation.

TRAUS SUS20 has the function of piezo surgery by using ultrasonic mechanical vibration. TRAUS SUS20 consists of a control box (main unit), a piezo handpiece and a foot controller.

This document is a 510(k) Summary for the TRAUS SUS20, a piezo surgery engine set. It details the device's characteristics and its substantial equivalence to a predicate device, TRAUS SUS10. Since this is a submission for a medical device (bone cutting instrument), the "acceptance criteria" and "device performance" in this context refer to demonstrating substantial equivalence to a legally marketed predicate device, rather than a quantifiable performance metric (like sensitivity or specificity) for a diagnostic AI. The study presented here is primarily a comparison of technical characteristics and compliance with recognized standards, and not a clinical study involving human subjects or AI-specific performance metrics.

Here is an analysis based on your request, as much as can be extracted from the provided text for a non-AI medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are generally met by demonstrating compliance with recognized standards and substantial equivalence to a predicate device. "Device performance" is shown through bench testing of key operational parameters.

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

This document describes a premarket notification (510(k)) for a conventional medical device, not an AI device or a diagnostic test involving a "test set" of patient data in the typical sense.

• Sample Size: Not applicable. The "test set" refers to the physical device components and their performance in bench tests (e.g., electrical safety, EMC, performance parameters) and comparison with a predicate device. The performance tests would use a sample of the manufactured device.
• Data Provenance: Not applicable in the context of patient data. The provenance of the data for this submission would be internal testing reports, external testing laboratory reports (for standards compliance), and comparison data from the predicate device (TRAUS SUS10, K151171) and a reference device (Compact Piezo LED, K151023) from Saeshin Precision Co., Ltd. and Mectron Spa, respectively. Given the context of a 510(k) submission, this data is generally prospective in terms of the testing done for the new device, but relies on existing data for the predicate devices.

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

Not applicable for this type of device submission. "Ground truth" in the context of diagnostic AI refers to clinically validated diagnoses from expert readers, pathology reports, or robust outcome data. For the TRAUS SUS20, the "ground truth" for the performance tests would be the established scientific and engineering principles behind accurate measurement and functional operation, validated by qualified engineers and technicians performing the tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where human readers independently interpret images/data and then reconcile disagreements, which is not relevant for this device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for diagnostic devices, particularly in medical imaging, to assess reader performance with and without an AI aid across multiple cases and readers. The TRAUS SUS20 is a surgical instrument, not a diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical surgical engine set, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology or outcomes data is not directly applicable. The "truth" for this device rests on:

• Engineering Specifications and Standards: The device performs according to its design specifications (e.g., vibration frequency, output power) and meets recognized international standards for electrical safety, EMC, and biocompatibility.
• Predicate Device Equivalence: The functional and safety characteristics are demonstrated to be substantially equivalent to an already legally marketed device.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning system, and therefore does not have a "training set" in the computational sense.

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

Not applicable, as no training set exists for this device.

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The TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN 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 TRAUS Dental Handpieces; TRAUS CRB46LN and TRAUS CRB46NN are gear driven hand-held dental handpieces with Gear Ratio of 20:1. 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.

The provided text is an FDA 510(k) Premarket Notification for a dental handpiece. It details the device's indications for use, technological characteristics, and comparison to a predicate device to establish substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop performance study.

The "studies" mentioned are:

• Biocompatibility testing (following ISO standards) to ensure material safety.
• Bench testing (to ISO 14457) to ensure mechanical performance and compliance.
• Sterilization validation (following FDA guidance, ASTM, and ISO standards) to confirm effective reprocessing.

These are standard engineering and safety tests for a medical device like a dental handpiece, not performance studies assessing diagnostic accuracy or human performance with or without AI assistance. The device in question is a physical dental instrument, not a software algorithm for diagnostic image analysis.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them in the context of AI/human-in-the-loop performance, as the provided text does not contain this information for this type of device.

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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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TRAUS SUS10, Piezo Surgery and Implant Engine Unit, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation (for ultrasonic surgery), and implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation (for dental implant surgery).

TRAUS SUS10, Piezo Surgery and Implant Engine Unit, combines the function of piezo surgery by using ultrasonic mechanical vibration and the function of dental implant motor surgery into one device. TRAUS SUS10 includes a control box (main unit), foot controller and dental handpieces. The dental handpieces of TRAUS SUS10 are supplied with two types: Piezo handpiece and Dental implant motor handpiece incorporating an implant motor and an angle handpiece. When the AC power is connected to the control box by the power cord, the control box has a program for ultrasonic surgery mode which be able to select options such as power (output intensity) and boost (vibration frequency), and for implant motor surgery mode which be able to select options such as speed, torque and gear ratio, and includes the memory function for input and output settings.

The provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI-powered medical device. Instead, it is a 510(k) premarket notification for a medical device called "TRAUS SUS10 Piezo Surgery and Implant Engine Unit," which is a dental surgery device.

The document discusses:

• The device's intended use and technological characteristics.
• Comparison to predicate devices to establish substantial equivalence.
• Non-clinical test summaries covering electrical safety, EMC, software validation, biocompatibility, sterilization validation, and mechanical performance testing.
• A explicit statement that "No clinical studies were considered necessary and performed."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them, as the provided text does not describe such a study or and the device is a piece of surgical equipment, not an AI or software-only device.

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