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Ai Ray Dental X-Ray Device is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients.

Ai Ray Dental X-Ray Device is a super capacitor-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The Portable Dental X-ray Device is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable supercapacitor to allow for the use of the Portable Dental X-ray Device where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility.

This document describes the Ai Ray Dental X-Ray Device, an extraoral diagnostic dental X-ray source. The information provided focuses on the device's substantial equivalence to a predicate device, the EzRay Air Portable (Model: VEX-P300).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Ai Ray Dental X-Ray Device are based on its compliance with various international and FDA standards for medical electrical equipment, radiation protection, and software lifecycle processes. The reported device performance is demonstrated by its adherence to these standards and its substantial equivalence to the predicate device.

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

The document does not provide details on a specific "test set" for performance evaluation in the context of clinical data. Instead, it refers to Non-Clinical Performance Testing to verify substantial equivalence, focusing on compliance with established standards.

• Sample Size for Test Set: Not applicable in the context of clinical data for this submission. Performance was validated through compliance with standards.
• Data Provenance: Not applicable for clinical data. The device itself is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd. in China.

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

As no clinical data or test set requiring expert ground truth for comparison was used for this 510(k) submission, this information is not applicable. The device's performance was evaluated against technical and safety standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication of ground truth was described.

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

No. The document explicitly states: "No clinical data was required to demonstrate substantial equivalence." Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, this device is a physical X-ray device, not an AI algorithm. Its performance is related to its ability to generate X-ray images, not to interpret them or to function as a standalone AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptance is its compliance with technical and safety standards (e.g., IEC 60601 series, FDA regulations 21 CFR 1020.30, 21 CFR 1020.31) and its substantial equivalence to a legally marketed predicate device. This is primarily assessed through non-clinical performance testing to verify the device's technical specifications and safety parameters.

8. The Sample Size for the Training Set

Not applicable. As this device is a physical X-ray generator, it does not involve a "training set" in the context of machine learning or AI algorithms.

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

Not applicable, as there is no training set for this device.

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Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

The Implanter is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The submission consists of: - the control unit - a motor with cable with light (sterilizable: SPM58L) - a wired foot control (MF4) - and as an attachment the surgical contra-angle handpieces (with LED:WP-1L/without LED:WP-1). Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display. The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning. The control unit is intended to be used with the motor SPM58L. To run the Implanter according to its intended use, Guilin Woodpecker provides two different surgical handpieces.

The provided text is a 510(k) Summary for a medical device called "Implanter incl. Accessories." It details the device's indications for use, comparisons to a predicate device, and non-clinical testing performed to demonstrate substantial equivalence.

However, the document states, "No clinical data is needed to demonstrate substantial equivalence." This means there was no study conducted to prove the device meets acceptance criteria using performance metrics like sensitivity, specificity, or reader improvement with AI assistance.

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets them in the format requested, as that type of study was explicitly not conducted or deemed necessary for this 510(k) submission.

The document focuses on demonstrating substantial equivalence to an already legally marketed device (the predicate device) through non-clinical testing, rather than proving a specific performance level of a novel AI algorithm.

Below is a breakdown of the information that is available in the provided text, focusing on the nearest equivalents to your requested points:

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

Since this is a 510(k) submission focused on substantial equivalence through non-clinical testing, there are no specific performance acceptance criteria like sensitivity/specificity or reader improvement from an AI study. Instead, the acceptance criteria are implicit in the conformity to established medical device standards and FDA guidance documents and the demonstration that technological differences do not impact safety or effectiveness compared to the predicate device.

The "reported device performance" is demonstrated through the satisfactory completion of these non-clinical tests.

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

This information is not provided in the document. The testing described is non-clinical, likely bench testing performed by the manufacturer (Guilin Woodpecker Medical Instrument Co., Ltd. in China) or a contracted lab. Details on specific sample sizes for each non-clinical test (e.g., how many handpieces were tested for lifecycle, how many components for biocompatibility) are not included in this summary.

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)

This information is not applicable/not provided. The device is an "Implanter incl. Accessories" (a dental handpiece and motor system), not an AI diagnostic imaging device. Therefore, there is no "ground truth" established by clinical experts in the context of diagnostic interpretation. The "ground truth" for non-clinical testing refers to established engineering standards, physical measurements, and chemical analyses.

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

This information is not applicable/not provided. Adjudication methods like "2+1" typically refer to the process of resolving discrepancies among multiple human readers in a clinical study involving subjective interpretation. Since this is non-clinical testing of a physical medical device, such an adjudication method is not relevant.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data is needed to demonstrate substantial equivalence." This type of study is relevant for AI-powered diagnostic aids, which this device is not. It is a mechanical dental instrument.

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

Not Applicable. This device is a mechanical dental instrument, not an AI algorithm. Its performance is inherent in its physical and functional specifications.

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

As explained in point 3, the concept of "ground truth" in the clinical diagnostic sense (like expert consensus or pathology for imaging) is not applicable here. The "ground truth" for this device's non-clinical testing refers to:

• Established national and international engineering standards (e.g., IEC 60601-1, ISO 14457, IEC 62304, ISO 10993 series, IEC 62471).
• FDA guidance documents specific to medical electrical equipment, software, biocompatibility, reprocessing, and dental handpieces.
• Objective physical and chemical measurements (e.g., power output, torque, speed range, material composition analysis, sterilization efficacy, electromagnetic compatibility).

8. The sample size for the training set

This information is not applicable/not provided. This device is a mechanical medical instrument, not an AI model that requires a training set.

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

This question is not applicable. Since there is no AI model or training set, there is no ground truth established for a training set.

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The Dental Air Polishing Handpiece, AP-H Plus is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.

The Dental Air Polishing Handpiece, AP-H Plus is intended for patients suffering from periodontal disease.

The Dental Air Polishing Handpiece, AP-H Plus is indicated for the non-surgical removal of subgingival plaque in pockets up to 4 mm after initial periodontal treatment.

The Dental Air Polishing Handpiece, AP-H Plus is an air driven dental handpiece for the use by a trained professional in the field of supragingival and the subgingival treatment. The devices are air-powered handpieces that are reusable.

The proposed Dental Air Polishing Handpiece, AP-H Plus device is similar in design to the predicates AIR-FLOW handy 3.0 PLUS (K151912) . The proposed Dental Air Polishing Handpiece, AP-H Plus device and the predicates connect to a standard air turbine connection on a dental operative unit and deliver a mixture of water, air, and prophylaxis powder to a treatment site. The subject Dental Air Polishing Handpiece is comprised of a supragingival handpiece (model: AP - 1 Plus) a subgingival handpiece (model: AP - 2 Plus), spray head, nozzle, powder storage chamber, and tail cord connector.

This document is a 510(k) Pre-Market Notification from the FDA regarding a dental device, which generally does not contain the detailed performance data or clinical study results required for medical imaging AI/ML devices. Therefore, a complete description of the acceptance criteria and study that proves the device meets the criteria, as requested, cannot be fully provided from the given information.

However, I can extract the information related to performance testing that was deemed sufficient for substantial equivalence for this device, which might be interpreted as meeting "acceptance criteria" for the specific context of this device's regulatory pathway.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria (e.g., sensitivity, specificity, AUC) or direct reported device performance in the manner typically seen for diagnostic AI/ML models. Instead, it indicates compliance with recognized standards.

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

Not applicable. The document describes performance testing against engineering and biocompatibility standards, not a "test set" of clinical cases or data.

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

Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert consensus on clinical findings) is not relevant for the type of testing described here.

4. Adjudication Method for the Test Set:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done, as this is not an AI/ML device for diagnostic interpretation. The device is a "Dental Air Polishing Handpiece."

6. Standalone (Algorithm Only) Performance:

No, as this is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used:

For the performance testing, the "ground truth" would be the established requirements and specifications of the referenced international standards (e.g., ISO 20608, ISO 10993, ANSI AAMI ST79). For example, for biocompatibility, the ground truth is whether the device materials elicit a cytotoxic, irritant, or sensitizing response according to the defined protocols in the ISO 10993 series.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that undergoes a "training set" process.

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

Not applicable.

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D-Laser Blue and D-Laser 16 are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; implant recovery; gingivectomy; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining: incisions and draining of abscesses: tissue retraction for impressions: papillectory; vestibuloplasty ; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening: D-Laser Blue and D-Laser 16 are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy: D-Laser Blue and D-Laser 16 are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

The dental diode laser systems, D-Laser Blue and D-Laser 16, realize oral soft tissue surgery, periodontal disease, endodontic disease, pain treatment, soft laser therapy and other oral diseases by vaporizing, carbonizing and solidifying the tissue by laser. The device features include: Using a capacitive touch screen which has the clear display and is easy to operate; Builtin large-capacity rechargeable lithium battery with longer time of endurance; The handpiece sleeve and the fiber tip can be autoclaved to prevent from cross infection; Preset more than 20 treatment procedures to reduce the difficulty of use; A secure protection mechanism that automatically shuts down the device after 5 minutes of inactivity.

The D-Laser Blue and the D-Laser 16 respectively consist of a main unit, a laser transmission system and a power adapter. The main unit includes a semiconductor laser, a power supply system and a control device, a safety protection device and a display device.

The D-Laser Blue employs the diodes with wavelengths of 976nm, 650nm and 450nm, and the device emits laser output energy in the infrared, red and blue spectra respectively. The D-Laser 16 employs the diodes with wavelengths of 976nm and 650nm, and the device emits laser output energy in the infrared, red spectra respectively.

The provided text does not contain typical acceptance criteria and a study design for evaluating a medical device's performance in terms of diagnostic accuracy (e.g., sensitivity, specificity). Instead, this document is a 510(k) summary for laser surgical instruments (D-Laser Blue and D-Laser 16), primarily focusing on demonstrating substantial equivalence to legally marketed predicate devices.

The "acceptance criteria" presented are primarily comparisons of technological characteristics, indications for use, and a list of non-clinical tests confirming compliance with various electrical, safety, and biocompatibility standards. The study mentioned is a non-clinical comparison of cutting efficiency.

Therefore, many of the requested fields (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and training set ground truth establishment) are not applicable to the type of information presented in this 510(k) summary.

Here's an attempt to extract and format the available information according to your request, with "N/A" for criteria not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like the D-Laser Blue and D-Laser 16, substantial equivalence is often demonstrated by showing that the proposed device has the same intended use and similar technological characteristics to a predicate device, or that any differences do not raise new questions of safety or effectiveness. The "acceptance criteria" here are largely met by demonstrating these similarities and confirming compliance with relevant standards and functional tests.

Examples of comparisons and reported findings:

• Product Code: Matches GEX, ILY.
• Regulation Number & Classification: Matches 21 CFR 878.4810, Class II.
• Surgical IFU: Matches predicate devices.
• Laser Periodontic IFU: Matches predicate devices.
• Tooth Whitening IFU: Matches predicate devices.
• Low Level Laser Therapy IFU: Matches predicate devices.
• Application: Dental Laser (Matches).
• Laser Classification:
  • D-Laser Blue: 976 nm (Class IV), 650 nm (Class II), 450 nm (Class IV). Predicate: 970 nm (Class IV), 660 nm (Class II), 445 nm (Class IV). Accepted based on reference devices.
  • D-Laser 16: 976 nm (Class IV), 650 nm (Class II). Predicate: 970 nm (Class IV), 660 nm (Class II). Accepted based on reference devices.
• Laser Type: Solid state diode (Matches).
• Laser Wavelength:
  • D-Laser Blue: 976 nm (+/-20 nm), 650 nm (+/-20 nm), 450 nm (+/-20 nm). Accepted based on range compatibility with predicate/reference devices (e.g., K103753, K163128, K071687, K930210).
  • D-Laser 16: 976 nm (+/-20 nm), 650 nm (+/-20 nm). Accepted based on range compatibility with predicate/reference devices (e.g., K103753, K163128, K071687).
• Optical Power:
  • D-Laser Blue: 976 nm (0.2-4W CW, 7W peak), 650 nm (25-200 mW CW), 450 nm (0.2-3W CW, 4W peak). Accepted based on predicate/reference devices (e.g., K163128, K071687, K180044).
  • D-Laser 16: 976 nm (0.3-7W CW, 16W peak), 650 nm (25-200 mW CW). Accepted based on predicate/reference devices (e.g., K163128, K071687, K170500).
• Emission Modalities: Continuous Wave, Chopped (1 Hz - 20 kHz). Accepted based on reference device K163128.
• Pulse Duration: Chopped Mode (5 µsec - 0.9 sec). Accepted based on reference device K163128.
• Aiming Beam: 650±20 nm, Pmax

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The MT2 dental electric motor consists of main unit, motor tail, power adapter and power cord. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment. The Dental Electric Motor can be used with ISO E-type a straight, right-angle or contra-angle handpiece attachment of equal, gear-reducing, or gear increasing speed.

The contra-angle handpieces (model: WJ-15, WJ-15L) are driven by a micro-motor to rotate at a specified speed, so as to drive the dental bur. It is applicable to drilling and grinding in dental surgery.

The MT2 dental electric motor consists of main unit, motor, motor tail, power adapter and power cord. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, rightangle or contra-angle handpiece attachment of equal, gear-reducing, or gear increasing speed.

Dental Electric Motor (model: MT2) is a control unit, which is connected to an AC power supply and a handpiece hose, that drives a DC electric micromotor, and turns on or off or regulates the speed of the motor by the foot control of the dental unit. The foot switch is not included in the control unit. It is used together with a handpiece attachment. It provides a low voltage DC power supply for the handpiece attachment with light.

The device is for prescription use.

The provided text describes a 510(k) premarket notification for a Dental Electric Motor (model MT2). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive trials. Therefore, the information typically requested in your prompt (e.g., effect size with AI assistance, expert qualifications for ground truth in a test set, MRMC studies) is generally not applicable to this type of regulatory submission for this device.

Based on the provided text, here's a breakdown of the available information:

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

The document doesn't explicitly present acceptance criteria in a table format with corresponding device performance metrics in the way you might expect for a diagnostic or AI-powered device. Instead, substantial equivalence is claimed based on comparing the technological characteristics of the subject device to predicate and reference devices, and conformity to recognized standards.

The "acceptance criteria" for this submission are primarily demonstrating that the device meets relevant safety and performance standards and that any differences from a predicate device do not raise new questions of safety or effectiveness.

Table: Comparison of Subject Device to Predicate/Reference Devices (from text, modified for clarity to show "acceptance criteria" indirectly)

The "Remarks" column (e.g., "Identical," "Similar," "Different") from the original table serves as the performance outcome relative to the implied acceptance criterion of substantial equivalence. Where "Different" or "Similar" is noted, the document explicitly states in "Discussion 2" that these differences do not affect the identical principles of operation or cause new risks.

Non-clinical Tests Performed:

• Biocompatibility testing (ISO 10993-5, ISO 10993-10)
• Electric safety and EMC testing (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60)
• Bench testing (implied by the comparison and discussion of differences not affecting performance)
• Sterilization validation (ANSI/AAMI/ISO 17665-1:2006 and FDA Reprocessing Guidance)
• Software validation (per FDA Software Guidance for Moderate level of concern)
• Conformity to Dentistry-Handpieces and motors standard (ISO 14457: 2017)

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

This information is not applicable as the submission is for a traditional 510(k) for a mechanical dental device, not a diagnostic device or an AI/ML product typically requiring test sets of patient data. The "tests" mentioned are non-clinical engineering and bench tests, not clinical studies with patient samples. The manufacturer is Guilin Woodpecker Medical Instrument Co., Ltd. in China.

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)

This information is not applicable. Ground truth experts are typically used for diagnostic or AI/ML device evaluations. This document details non-clinical testing against engineering standards and a comparison to predicate devices, not clinical ground truth establishment.

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

This information is not applicable. Adjudication methods are relevant for clinical trials or diagnostic studies, not for the non-clinical engineering tests performed for this 510(k).

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 information is not applicable. This device is a dental electric motor, not an AI-assisted diagnostic tool.

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

This information is not applicable. This device does not involve an algorithm or AI.

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

This information is not applicable in the clinical sense. For the non-clinical tests, the "ground truth" is defined by the requirements of the cited international and national standards (e.g., IEC, ISO, ANSI/AAMI), which specify test methods and acceptable performance limits for parameters like electrical safety, biocompatibility, and sterilization effectiveness.

8. The sample size for the training set

This information is not applicable. This device is a mechanical dental instrument, not an AI/ML system requiring a training set.

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

This information is not applicable. As above, no AI/ML system or training set is involved.

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i-Polish is a cordless prophylaxis handpiece equipped with control buttons and wireless foot control for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.

The Cordless Prophy system is a cordless handpiece which is intended for use by dental professionals for cleaning and polishing teeth. This is a general hygiene procedure that is performed on people of all ages in a professional dental operatory.

The Cordless Prophy System is comprised of a cordless, battery-powered handpiece, a removable and autoclavable outer sheath, an AC powered battery charging station, a battery-powered wireless foot control and an AC adapter. Accessories to the Cordless Prophy System include three style of Disposable Prophy Angle (DPA), which is cleared as Class I, Product code ESG, under premarket notification K030603.

Additionally, the handpiece of Cordless Prophy System must be used with a Disposable Sleeve, which is cleared as Class II, Product Code PEM, under premarket notification K151123.

The handpiece features a removable outer sheath that is to be cleaned and steam sterilized prior to first use and after each patient use.

The i-Polish has two speed control mode for operation:

• . Foot control mode: One is using it with the wireless foot control, where the amount of vertical actuation on the wireless foot control correlates to the speed of the handpieces supplied to the DPA, the corresponding variable speed range of the DPA is controlled and adjusted through varying pressure on the foot control. The adjustable range is 500 rpm to 4000 rpm;
• . Handpiece control mode: And the other uses a Centralized control button located on the handpieces for six constant speed level, 500 rpm, 1500 rpm, 1500 rpm, 2000 rpm, 3000 rpm and 4000 rpm.

The provided text is a 510(k) summary for the Guilin Woodpecker Medical Instrument Co., Ltd. i-Polish Cordless Prophy System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving acceptance criteria for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not available in this document.

However, I can extract information related to the device's performance, comparisons to predicate devices, and non-clinical testing.

Here's the information that can be extracted or inferred from the provided text, acknowledging that most of your request pertains to a different type of submission:

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

The document does not explicitly present "acceptance criteria" in the format of specific quantitative benchmarks. Instead, it details the device's technical specifications and compares them to a predicate device to argue for "substantial equivalence." The "performance" is described through these specifications and compliance with various safety and performance standards.

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

This document describes a premarket notification for a medical device (Cordless Prophy System) and focuses on demonstrating substantial equivalence through technical comparisons and non-clinical testing. It does not involve a "test set" of patient data as would be used for an AI/software device. The tests performed are engineering and biocompatibility evaluations.

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. This is not an AI/software device relying on expert-annotated ground truth for performance evaluation on a test set.

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

Not applicable. This is not an AI-assisted diagnostic or interpretive device.

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

Not applicable.

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

Not applicable. The "ground truth" here is compliance with engineering standards, physical specifications, and performance characteristics for a dental handpiece, as demonstrated through non-clinical testing (e.g., electrical safety, EMC, biocompatibility).

8. The sample size for the training set

Not applicable. There is no AI/machine learning component requiring a training set mentioned in this document.

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

Not applicable.

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The dental scaler and air polisher, Model PT-A, is intended for use in dental (gum) therapy and polishing. The device polishes the teeth and removes calculus deposits and stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. By attaching the ultrasonic handpiece with different scaling tips, the device could fulfill the following functions: 1 Scaling Removal of supragingival calculus; Removal of stains 2 Endo Preparation, cleaning and irrigation of root canals: Retrograde preparation of root canals Condensing gutta-percha; Removal of crown, bridges and restorations 3 Restorative - Cavity preparation; Luting inlays and onlays; Condensing of amalgams 4 Perio Scaling and root planing; Periodontal treatments By using air polishing handpiece attached with corresponding nozzles, the device could fulfill the following functions - · Removing dental plaque - · Surface preparation before bonding/cementation of inlays, crowns and veneers - · Tooth surface preparation before placing the composite restoration - · Cleaning before sticking orthodontic brackets - · Effectively removing plaque for orthodontic patients - · Cleaning the implant fixture before loading - · Stain removal for shade determination - · Removing plaque before fluoride treatment - · Removing plaque before whitening procedure

The dental scaler and air polisher, Model PT-A, mainly consists of ultrasound scaler system and air polishing system. More specifically, it mainly contains a control module, a display panel with function keys, water bottle, powder tank, scaling handpiece, air polishing handpiece, scaling tips, sand blasting nozzle, foot pedal and power adapter. The device generates ultrasonic waves intended for dental applications such as scaling, root canal irrigation and periodontal preparation. For the ultrasonic system, a sinusoidal electrical signal is generated and delivered to the 'piezoelectric ceramic' located inside the ultrasonic handpiece. The electrical signal is converted into mechanical vibrations and propagated to the distal end of the handpiece. For air polishing system, the powder tank is driven by air pressure to flow into the nozzle attached with the air polishing handpiece and mixed with air and water to blast the teeth. By attaching the ultrasonic handpiece with appropriate scaling tips, the device could fulfill scaling, restorative, endodontal treatment. However, by attaching the corresponding nozzle to the air polishing handpiece, the device could remove calculus, stains, plaques and polish the teeth. The device is powered by a power adapter with input of 110V~ 50Hz/60Hz 800mA and output of 25V~ 50Hz/60Hz 2.8A. The ultrasonic handpiece, air polishing handpiece with or without non-disposal stainless steel sand blasting nozzles, and scaling tip are provided non-sterile, which will be sterilized by the user before use.

The provided text is a 510(k) summary for a dental scaler and air polisher. This type of regulatory document is typically focused on demonstrating "substantial equivalence" to a predicate device, rather than proving a device meets specific performance acceptance criteria through a detailed clinical study in the way a diagnostic AI device might.

Therefore, the document does not contain the kind of information requested in the prompt regarding acceptance criteria and performance studies for a diagnostic AI device. The device described (a dental scaler and air polisher) is a physical medical device, not a software or AI-driven diagnostic tool.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance: While there's a comparison table to a predicate, it focuses on features, intended use, and technical specifications, not specific quantifiable performance metrics with predefined acceptance thresholds.
• Sample size and data provenance (test set): No test set of clinical data is described.
• Number of experts and qualifications for ground truth (test set): Not applicable as there's no diagnostic test set requiring expert ground truth.
• Adjudication method (test set): Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned, as it's not relevant for this type of device submission.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

Instead, the document details physical and electrical specifications, biocompatibility, and sterilization validation, and compares these aspects to a predicate device to demonstrate substantial equivalence. The "Non-clinical Testing" section mentions adherence to various international standards (e.g., IEC 60601-1, ISO 10993-5, ISO 18397) to ensure safety and effectiveness, but these are general compliance requirements rather than specific performance acceptance criteria for a diagnostic algorithm. It also states that "Performance comparison test performed on subject device and predicate device aims to support the substantial equivalence of the subject device to the predicate device. Test's setup and execution was in accordance with applicable standards. Results of the testing demonstrate the compliance to the standards and comparable performance between subject device and predicate device." However, the exact metrics and acceptance criteria for these performance comparisons are not detailed in this summary.

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i-Scan Imaging Plate Scanner is intended to be used for scanning and processing digital images exposed on IP Imaging Plate in dental applications.

i-Scan Imaging Plate Scanner is a dental device that scans IP imaging plates that have been exposed in place of dental X-ray film and allows the resulting images to be displayed on a personal computer and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out intraoral Plates of the size 0, 1, 2 and 3. Intraoral plate scanners are state of the art since 2002 and are available in various designs from many companies around the world. The intraoral plates are put into the mouth of the patient, exposed to Xrays and then are read out with the device. The read-out-process is carried out with 651-665 nm laser. The laser beam is moved across the plate by an oscillating MEMS mirror. The laser beam stimulates the top coating of the plates, which consists of Xray sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier Tube/ PMT) and transferred into an electrical output signal is digitalized and is the data for the digital X-ray image. The data is transmitted via WIFI to a computer. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he must use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection over and starts the read-out process. After the read out process the picture is transmitted to the connected computer, the picture can be viewed, and the IP is erased and ready to use for the next acquisition.

The provided document, a 510(k) summary for the i-Scan Imaging Plate Scanner, does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML medical device. This device is an X-ray imaging plate scanner, not an AI-powered diagnostic or assistive tool.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information provided in this document.

However, I can extract information related to performance testing and comparison with a predicate device, which are relevant to the device's substantial equivalence determination.

Here's a breakdown of the available information based on your request, with "Not Applicable (N/A)" for criteria not found or relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it compares the subject device's technical specifications to those of a predicate device (Duerr Dental AG ScanX Intraoral View). The performance testing conducted was against international standards for X-ray imaging devices.

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Endo Motor, Ai-Motor and Endo Radar Plus are cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the file tip inside the canal.

The Endo Motor Series includes a cordless hand-piece with charging adapter. The device has a chuck for holding rotary instruments such as dental files, and is mainly used in Endodontic surgeries. The device can enlarge the root canal by filing the dentin and measuring the root canal length, and may also be used for cutting and grinding for the preparation of root canal surgery. The rotary speed and the torque range can also be adjusted.

The provided document, K203320, is a 510(k) premarket notification for an "Endo Motor" device. This device is a dental handpiece with root canal measurement capability. The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device through non-clinical testing and comparison of technical specifications. It does not present a study proving the device meets specific acceptance criteria based on clinical performance metrics (e.g., accuracy, sensitivity, specificity) of an AI/algorithm-driven device.

The document states that "Performance Comparison Testing of Root Canal Measurement Passed," but it does not provide details on the acceptance criteria or how this testing was conducted (e.g., sample size, ground truth, expert involvement).

Therefore, I cannot fully answer your request for information regarding acceptance criteria and the study proving the device meets them, as the provided document lacks the empirical data and methodology typically found in studies for AI/algorithm-driven devices concerning clinical performance.

However, I can extract the information provided about the non-clinical testing performed to support substantial equivalence:

Acceptance Criteria & Device Performance (Based on Non-Clinical Testing for Substantial Equivalence)

The document primarily relies on non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical performance study with explicit acceptance criteria for an AI/algorithm.

Detailed Answers to Specific Questions:

1. A table of acceptance criteria and the reported device performance
See table above. Note that for "Performance Comparison Testing of Root Canal Measurement," while it states "Passed," no quantitative acceptance criteria or specific performance metrics are provided in the document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable / Not provided. The document primarily reports non-clinical engineering and biological tests, and a comparison of technical specifications to a predicate device. There is no mention of a clinical "test set" with a specified sample size or data provenance in the context of root canal measurement performance.

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 / Not provided. There is no mention of expert involvement for establishing ground truth for any performance study in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Not provided. No test set or adjudication method is described.

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 device is an "Endo Motor," a physical dental handpiece. It is not an AI/software device that would involve "human readers" or AI assistance in the way described for an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The description implies that the device's "root canal measurement capability" is integral to the motor's function. While there's a "Performance Comparison Testing of Root Canal Measurement Passed," the document does not provide details on whether this was a true "standalone" algorithm performance evaluation with explicit metrics, or simply a functional test. Given the regulatory class (Class I, reserved) and the nature of the device (a physical handpiece), it is highly unlikely that a rigorous clinical standalone performance study, as typically seen for AI/ML devices, was conducted or required.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not provided. For the "Performance Comparison Testing of Root Canal Measurement," the document does not specify how the "ground truth" for root canal length was established.

8. The sample size for the training set
Not applicable / Not provided. This device is not described as an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
Not applicable / Not provided. This device is not described as an AI/ML device that requires a training set.

In summary, the provided FDA 510(k) document (K203320) focuses on demonstrating "substantial equivalence" of a physical dental device (Endo Motor) through a comparison of design, intended use, and non-clinical testing results against a predicate device. It does not contain the kind of clinical performance study details (e.g., acceptance criteria for diagnostic accuracy, sample sizes of test/training sets, ground truth establishment by experts, MRMC studies) typically associated with AI/algorithm-driven medical devices. The "Performance Comparison Testing of Root Canal Measurement" is mentioned as "Passed," but without any specifics provided in this document regarding its methodology or quantitative results.

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