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• removing supra and subgingival calculus and stains
• periodontal pocket lavage with simultaneous ultrasonic tip movement
• scaling and root planning
• releasing crowns, bridges, inlays and posts as well as condensing gutta percha
• plugging for amalgam condensation
• amalgam burnishing
• preparing, cleanig, and irrigating root canals
• preparing approximal cavites
• cementing inlays and onlays
• retrograde preparation of root canals

The purpose of the device is to remove plaque from the surface of the tooth through using ultrasonic vibration generated by the electricity(24 V ~) and water supply received in a dental chair and other dental devices.

The product is provided in the form of parts that can be installed and used inside a dental chair and other dental devices. The control of the water supply is made from the dental chair and other dental devices.

The provided text is a 510(k) summary for a dental ultrasonic scaler, the "Compact S." It focuses on demonstrating substantial equivalence to a predicate device, the "CLEANSE S+," rather than presenting a performance study with acceptance criteria in the manner typically used for new AI/ML-driven medical devices.

Therefore, many of the requested details, such as the sample size for the test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or not present in this document. This document is a regulatory submission for a physical medical device, not a software-based diagnostic AI.

Here's an attempt to extract and describe what's available based on the provided text, and point out what is missing:

Device Name: Compact S, Compact S (LED)
Device Type: Ultrasonic Scaler (Dental)

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific quantitative acceptance criteria for clinical performance against which the device was tested to demonstrate accuracy. Instead, it relies on demonstrating functional and technological equivalence to a predicate device and compliance with relevant electrical and safety standards.

Study Information Pertaining to Device Performance:

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

• Test Set Sample Size: Not applicable. This submission relies on bench testing and comparison to a predicate device, not a clinical test set with patient data for diagnostic accuracy.
• Data Provenance: Not applicable. (No patient data was used).

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

• Not applicable. No ground truth based on patient data with expert consensus was established as this was not a clinical performance study for an AI/ML device.

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

• Not applicable. No test set involving human interpretation requiring adjudication was used.

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. This device is a physical ultrasonic scaler, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This is a physical device, not an algorithm. Bench tests were performed on the device itself.

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

• For functional and safety testing: Ground truth was based on engineering specifications, regulatory standards (like IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, ISO 17665-1/2, IEC 62304, ISO 10993-1), and the performance characteristics of the predicate device. For example, "Maximum output power with load" was tested against a specified value (24VA).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device and does not involve a training set.

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

• Not applicable.

Summary of Approach:

This 510(k) submission demonstrates substantial equivalence by showing that the "Compact S" device is fundamentally the same as its predicate, "CLEANSE S+," with minor structural modifications (removal of exterior case, keypad) that do not affect safety or performance. The primary method of proving this was through:

• Bench Testing: Non-clinical performance testing for electrical safety, EMC, basic/essential performance, software validation, sterilization/cleaning validation, and biocompatibility.
• Comparison to Predicate: Demonstrating that the indications for use, core functional characteristics (frequency range, water supply pressure, handpiece output), and main components are either identical or acceptably similar to the predicate device.
• No Clinical Testing: The submission explicitly states, "No clinical testing was conducted to support this submission," as substantial equivalence was established through non-clinical data and comparison to the predicate.

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The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.

This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside

The provided text is a 510(k) summary for the DMETEC SmarThor Ultrasonic Surgery device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria, performance metrics, and detailed study design as might be done for a novel device or AI/software.

Therefore, the following information is extracted or inferred based on the nature of a 510(k) submission for this type of device (an ultrasonic bone-cutting instrument).

Here's a breakdown of the information based on your request, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device (EMS Piezon Master Surgery). The performance is reported by comparing the specifications of the SmarThor to the predicate device.

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

• Test Set Sample Size: Not applicable in the context of this 510(k) submission. No specific "test set" of cases or patients was used for evaluating performance in the way an AI/software study would. The evaluation is based on non-clinical bench testing and comparison of specifications to a predicate device, as well as biocompatibility testing on biological samples.
• Data Provenance:
  • Non-clinical tests (biocompatibility, electrical safety, EMC, software validation): These tests would have been performed by DMETEC CO., LTD. in Korea (country of origin). These are "prospective" tests conducted specifically for this submission.

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

• Not applicable. This 510(k) does not involve expert-established ground truths for performance evaluation in the way a diagnostic AI would. The "ground truth" for compliance with standards (e.g., biocompatibility) is defined by the standard itself, and the comparison to the predicate relies on published specifications and post-market experience.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical "test set" requiring adjudication by experts.

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

• No, an MRMC study was not done. This device is a physical instrument, and its 510(k) submission relies on demonstrating substantial equivalence through technical specifications, non-clinical bench testing, and comparison with a predicate device, not through a comparative effectiveness study involving human readers and interpretations.

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

• Not applicable. This is a medical device (ultrasonic surgery instrument), not an AI algorithm. Its performance is inherent in its physical and electrical characteristics.

7. The Type of Ground Truth Used

• For non-clinical tests (biocompatibility, electrical safety, EMC): The ground truth is established by the requirements and methodologies defined in the cited international standards (e.g., ISO 10993-5:2009, IEC 60601-1, IEC 60601-1-2).
• For comparison to the predicate: The ground truth is the published technical specifications and intended use of the legally marketed predicate device (EMS Piezon Master Surgery), as well as its established safety and effectiveness through "post-market experience."

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

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A device intended for use surgical procedure Including osteotomy, osteoplasty, Periodontal surgery and implantation

This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside

Here's an analysis of the provided text regarding the acceptance criteria and study for the DMETEC Ultrasonic Surgery Machine:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (EMS Piezon Master Surgery) rather than defining explicit, quantitative acceptance criteria for de novo performance. The acceptance criteria are implicitly met by showing that the DMETEC device is "similar in functions and efficiency" and has "similar specification and performance" to the predicate.

Here's a table comparing the DMETEC device's reported performance against the predicate, which serves as the de facto "acceptance criteria" through substantial equivalence:

Note: The differences, particularly in supply voltage and output power, are acknowledged, but the submission argues for substantial equivalence based on the overall functional similarity and safety.

Study Information

The document does not describe a classic clinical study with an explicit test set and detailed performance metrics as one might expect for novel technology. Instead, it relies on demonstrating substantial equivalence through non-clinical testing and comparison to post-market experience of the predicate device.

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

   • No specific sample size for a clinical "test set" is mentioned in the context of device performance evaluation.
   • Data provenance: The document mentions "post market experience" of the predicate device. This suggests retrospective data from the market performance of the EMS Piezon Master Surgery. No specific country of origin is mentioned for this "post market experience."

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

   • Not applicable. There is no mention of a defined "test set" requiring expert ground truth establishment for clinical performance.

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

   • Not applicable, as no clinical test set requiring adjudication is described.

4. 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. This device is a surgical instrument, not an imaging or diagnostic AI device. Therefore, MRMC studies and "human readers" improving with/without AI are not relevant.

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

   • Not applicable. This is a physical surgical instrument, not an algorithm.

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

   • The "ground truth" for substantial equivalence appears to be derived from documented performance and safety records of the predicate device (EMS Piezon Master Surgery), as well as compliance with recognized standards (IEC 60601-1, ISO 10993). For biocompatibility, lab tests (in vitro cytotoxicity, skin sensitization, oral mucosa irritation) served as the basis for assessing safety.

7. The sample size for the training set:

   • Not applicable. As this isn't an AI/machine learning device, there is no "training set."

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

   • Not applicable, for the same reason as above.

Summary of Non-Clinical Tests Conducted:

• Biocompatibility Tests:
  • In vitro cytotoxicity test (ISO 10993-5 criteria: evaluated as Grade 0, no cell lysis or toxicity).
  • Skin sensitization test (scores were zero, 0% sensitization rates at 24 hours).
  • Oral mucosa irritation test (no mortality, no body weight changes, no differences between saline and test group).
• Electric Safety and Electromagnetic Compatibility:
  • Tested according to EN 60601-1 and IEC 60601-1-2. Device met the requirements.
• Software Validation:
  • A software validation report indicated the device "performs as it should" and is substantially equivalent.

Overall Conclusion of Studies:

The manufacturer concludes that the DMETEC Ultrasonic Surgery Machine (Surgy Star, AIC Surgery) is substantially equivalent to the predicate device based on:

• Similar intended use.
• Similar specifications and performance, despite some numerical differences (e.g., output power).
• Successful completion of non-clinical tests (biocompatibility, electrical safety, electromagnetic compatibility, software validation) demonstrating safety.
• Comparison to the post-market experience of the predicate device to infer similar functions and efficiency.

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Intended for use during dental procedures to:
-Remove supra and subgingival calculus and stains

• Remove ouple and Subge with simultaneous ultrasonic tip movement
• Scaling and root planning
• Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
• Plugging for amalgam condensation
• Amalgam burnishing
• Preparing, cleaning, and irrigating root canals
• Preparing approximal cavities
• Cementing inlays and onlays
• Retrograde preparation of root canals

The Cleanse S+ is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls for water flow and ultrasonic intensity, displays, and ultrasonic generator. The device is connected directly to a water supply for irrigation during use. A footswitch used for on/off control is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord. Instruments (stainless steel tips) designed for specific dental procedure are attached to the distal end of the handpiece.

This submission pertains to the Cleanse S+ Ultrasonic Scaler.

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

The provided text does not contain explicit "acceptance criteria" for performance metrics in the traditional sense, nor does it report specific quantitative performance outcomes that would be measured against such criteria. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, intended use, and non-clinical testing for safety standards.

The closest to a "performance" comparison is the table detailing "OUTPUT CHARACTERISTICS" between the Cleanse S+ and the predicate EMS miniPiezon.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. No clinical or performance testing involving a "test set" of patient data was conducted or described.
• Data Provenance: Not applicable. The submission states, "No clinical testing was conducted." The non-clinical tests relate to electrical safety and electromagnetic compatibility standards (IEC 60601-1, EN 55011, EN 60601-1-2).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical testing was performed, and therefore no "ground truth" was established by experts for a test set.

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

Not applicable. No clinical testing was performed 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

Not applicable. This device is an ultrasonic scaler, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an ultrasonic scaler, not an algorithm.

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

Not applicable. No clinical testing was performed. The "ground truth" for demonstrating safety and effectiveness was based on adherence to recognized electrical and electromagnetic compatibility standards and comparison to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This device is an ultrasonic scaler. No training set for an algorithm was used.

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

Not applicable. No training set for an algorithm was used.

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The Skylight LED Curing Light is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding, and sealing materials that are photo-polymerized in the 440-490 nm waveband of visible light.

Skylight by DMETEC Co., Ltd is classified as an Ultraviolet Activator for polymerization(21 C.F.R. 872.6070) because it is a device intended for the photo-polymerization light cured dental materials.

The Skylight is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 440 to 490 nm waveband of spectrum with a power density comprised 1,000W/cif, 13-11mm light quide.

These power densities are sufficient for photo-polymerization in the 440-490nm waveband of visible light cured (VLC) dental materials of restorative composite, orthodontic brackets, orthodontic bonding and sealing.

The exposure time can be set by one second to 99 seconds with 3 modes of operation: Standard, Pulse, and Soft Start. It has also memory storage functions for 5 exposure programs set by the practitioner.

The provided텍스트 describes a 510(k) summary for the "Skylight LED Curing Light." It includes information about the device, its intended use, and a comparison to a predicate device, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document explicitly states:

• "No clinical testing was conducted" This means there are no studies regarding human performance, MRMC, or standalone performance against a ground truth.

Therefore, I cannot provide the requested table or detailed information on the acceptance criteria and study as that information is not present in the provided text.

Based on the available text, here's what can be inferred riguardo testing, though it doesn't directly address acceptance criteria or performance against a ground truth in the way typically associated with AI/diagnostic device studies:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of measurable performance targets (e.g., accuracy, sensitivity, specificity). The closest concept to "acceptance" is the determination of substantial equivalence based on non-clinical testing and comparison to a predicate device.
• Reported Device Performance:
  • Power Density: Comprised of 1,000 W/cm² with a 13-11mm light guide.
  • Waveband: 440 to 490 nm.
  • Exposure Time: Can be set from one second to 99 seconds.
  • Operating Modes: Standard, Pulse, and Soft Start (3 modes).
  • Memory Storage: For 5 exposure programs.
  • Performance Claim: "These power densities are sufficient for photo-polymerization in the 440-490nm waveband of visible light cured (VLC) dental materials of restorative composite, orthodontic brackets, orthodontic bonding and sealing." This is a functional claim, not a measurement of diagnostic accuracy.

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

• Not applicable. No "test set" in the context of an AI/diagnostic study was used. The testing described is non-clinical, focusing on electrical safety and electromagnetic compatibility standards.

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

• Not applicable. No ground truth was established by experts for a test set in the context of an AI/diagnostic study.

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

• Not applicable.

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:

• No. The document explicitly states: "No clinical testing was conducted."

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

• No. The device is a physical light-curing unit, not an algorithm.

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

• Not applicable.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

• Not applicable. This device is not an AI/ML algorithm.

Summary of Study (Based on Provided Text):

The study performed was non-clinical testing to demonstrate safety and effectiveness, and to establish substantial equivalence to a predicate device (Mini L.E.D by SATELEC).

• Tests Conducted: In accordance with several EN (European Norm) standards related to electrical safety (EN 60601-1), electromagnetic compatibility (EN 60601-1-2, EN 61000-3-2, EN 61000-3-3, EN 55011).
• Purpose: To show that the device meets the requirements of these standards and does not pose safety hazards, thus supporting its safety and effectiveness in the intended environment.
• Conclusion: The tests "demonstrated safety and effectiveness of the Skylight LED curing light in the intended environment of use" and "None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards."

This type of submission focuses on validating the device against established engineering and safety standards, rather than proving diagnostic performance against a medical ground truth or evaluating human performance with the device.

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