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REXTAR PRO is a portable X-ray system to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for adult patients.

The REXTAR PRO is an X-ray device offering a lightweight, compact portable X-ray generator. The generator is a high frequency X-ray generator, with a high Output at 70kV / 2mA. The battery-powered device is a Ripple-free HF type of generating device. The REXTAR PRO X-ray function is controlled by Touch Screen and Button for convenience. The handheld device features a main body (X-ray tube head), rechargeable battery (handset), charger, and charger AC/DC power supply. REXTAR PRO uses a high-quality shielding material for shielding (using domestically produced 99.9% purity lead. The RETAR PRO minimizes the exposure of the users from X-ray scattering by adding a backscatter shield. The REXTAR PRO's uses a GRID Tube and is a specialized X-ray tube that improves the quality of the x-ray beam by controlling the flow of electrons through the GRID placed between the cathode and anode. It's application of the Focal Spot 0.2mm GRID Tube for clearer, high-quality imaging helps with the diagnosis for accurate procedures and minimizes patient radiation exposure.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance or clinical effectiveness. The document provided is a 510(k) premarket notification review for the Rextar Pro, an extraoral source X-ray system, and focuses primarily on establishing substantial equivalence to a predicate device (REXTAR X, K132041) based on technical characteristics and safety standards.

The document discusses non-clinical performance testing for safety and electrical compatibility, specifically referencing:

• IEC 60601-2-65: Particular requirements for basic safety and essential performance of dental intra-oral X-ray equipment.
• IEC 60601-1: General requirements for basic safety and essential performance.
• IEC 60601-1-2: Electromagnetic disturbances—requirements and tests.
• FDA software guidance: Content of Premarket Submissions for Device Software Functions.
• Leakage Radiation Test: Measurements made at 15 different points around the device.

The conclusion states that the REXTAR PRO's radiation emitting level at the operator's perspective is fairly minimal compared to NCRP requirements (occupational radiation exposure to adults working with radioactive material to 5,000 mR (50 mSv) per year).

However, none of the requested information regarding diagnostic performance (e.g., sensitivity, specificity, AUC), sample sizes for test sets, expert qualifications, ground truth establishment for diagnostic evaluation, or MRMC studies are present in the provided text. The document confirms the device is intended for "producing diagnostic x-ray images using intraoral image receptors" but does not detail how the diagnostic quality or effectiveness of these images by the Rextar Pro itself was assessed against specific acceptance criteria.

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XERO a is an Hand-held intraoral dental x-ray equipment to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients. This equipment is used in a professional healthcare facility environment.

XERO a is an Hand-held intraoral dental x-ray equipment to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients. This equipment is used in the professional healthcare facility environment. But the image detectors (an integral part of a complete dental system) are not part of the device. The operation principle of the device involves emitting x-ray source when a high voltage is supplied to the X-ray tube assembly, which frees electrons from the cathode. They hit anode to produce X-rays. The device acquires images by emitting X-rays continuously on the human tooth. And the functions of the dental generator XERO a are supported by firmware. This is of basic firmware documentation level, and there is no external data exchange port in the device. Moreover, the XERO a is not wireless. The subject dental system is not a cyber device.

The provided text describes the 510(k) premarket notification for the XERO - C and XERO α intraoral dental X-ray equipment. However, the document does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case (MRMC) studies, or standalone algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Vatech Co., Ltd.'s EzRay Air Portable, K200182) through:

• Technological characteristics comparison: Showing similar design, mechanical features, electrical specifications, and adherence to relevant safety standards.
• Non-clinical data summary: Listing compliance with international and FDA-recognized consensus standards for medical electrical equipment safety, electromagnetic compatibility, usability, and specific requirements for dental X-ray equipment.
• Statement on clinical data: Explicitly stating that clinical studies are unnecessary to validate the safety and effectiveness of the device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/algorithm. This information is not present in the provided 510(k) summary.

The device described is a medical imaging device (X-ray equipment), not an algorithm or AI software for image analysis that would typically have the kind of performance metrics and study designs you've asked about.

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The Lucas Lifecare's Life Ray handheld is indicated for use only by a trained and qualified dentist or dental technicians for both adult and pediatric subjects for producing diagnostic dental images using various intraoral image sensors/receptors.

LifeRay™ is a battery-operated, handheld, dental X-ray device. LifeRay™ employs a 100 kHz highfrequency DC X-ray generator. This oil-cooled and shielded tube head is energized by a rechargeable lithium-ion battery pack. The battery is housed under to enable portability. The battery gets charged when the device is docked into its cradle, which is powered through an AC - DC power supply. To focus exposure on the specified zone of the subject, and limit radiation leaking elsewhere out of the device, a shielded beam-limiting cone is engaged to the tube head. This restricts the X-ray field to 60 mm diameter, compatible to dental image receptors. An additional transparent, circular backscatter shield is provided which shall be permanently mounted around the exit of the beam limiting cone to arrest radiation scattering back from the subject, so clinicians can perform in proximity. A wrist lanyard facilitates secure grip, and an inclination display aids in consistent repeatability of radiographs. LifeRay™ employs a fixed tube current of 2.6 mA, but has three selectable tube voltages: 60, 65, or 70 kVp. Exposure duration can be set between 10 ms to 1 s in steps of 10 ms. All these presets can be selected from the home screen of the display through a practical keypad to achieve the best radiograph results.

The provided document describes the FDA 510(k) premarket notification for the LifeRay™ Intraoral Handheld X-ray device. However, it does not contain specific acceptance criteria, reported device performance data, sample sizes for test or training sets, details about ground truth establishment (number/qualifications of experts, adjudication methods), or information about MRMC studies or effect sizes for AI assistance.

The document focuses on demonstrating substantial equivalence to a predicate device (KaVo NOMAD Pro 2 Handheld X-ray System K173319) based on technological characteristics and non-clinical test data adhering to various IEC standards.

The only mention of "clinical performance data" is qualitative: "Clinical radiographic images using of LifeRay™ and the predicate device have been reviewed and compared to determine the substantial equivalence. Both intraoral X-ray systems generate adequate anatomical details using an intra oral sensor. Difference in edge definition and grayscale of bony structures for both images were negligible. Both intraoral X-ray systems generate sufficient X-ray levels to obtain acceptable edge definition and grayscale of bony and soft tissue images." This is a general statement, not a scientific study with quantitative metrics, defined acceptance criteria, or statistical analysis.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the format you asked, as the document does not contain this level of detail. It is a regulatory submission focused on substantial equivalence rather than a detailed performance study report.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Study for Performance (Information Not Provided in Document)

The document does not describe specific acceptance criteria tied to quantitative performance metrics for diagnostic image quality, nor does it detail a formal study that proves the device meets such criteria through quantitative measures. The "Clinical Performance Data" section is a qualitative statement of comparability.

Information that could not be extracted from the provided document:

1. A table of acceptance criteria and the reported device performance: This is absent. The document only offers a qualitative statement about image quality being "adequate" and "negligible" differences compared to the predicate.
2. Sample sizes used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified, as no formal ground truth establishment for a diagnostic performance study is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no such study 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: Not applicable. This device is an X-ray generator, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no formal diagnostic performance study with ground truth is detailed. The "clinical performance data" section refers to a review and comparison of images, implying subjective assessment rather than a structured ground truth process.
8. The sample size for the training set: Not applicable, as this is a hardware device, not an AI model.
9. How the ground truth for the training set was established: Not applicable, as this is a hardware device, not an AI model.

What the document does provide regarding the "study" context:

The document focuses on "Non-Clinical Test Data" and "Clinical Performance Data" used to establish Substantial Equivalence to a predicate device.

• Non-Clinical Test Data: This section details compliance with various international standards related to electrical safety, electromagnetic compatibility, radiation protection, X-ray tube assemblies, and dental intra-oral X-ray equipment. These are engineering and safety standards, not diagnostic performance metrics based on clinical images.
  • IEC 60601-1 Edition 3.2 2020-08 (General Safety)
  • IEC 60601-1-2 Edition 4.1 2020 (Electromagnetic Disturbances)
  • IEC 60601-4-2 Edition 1.0 2016-05 (Electromagnetic Immunity)
  • IEC 60601-1-3 Edition 2.1 2013-04 (Radiation Protection)
  • IEC 60601-2-28 Edition 3.0 2017 (X-ray Tube Assemblies)
  • IEC 60601-2-65 Edition 1.2 2021 (Dental Intra-oral X-ray Equipment)
  • IEC 62133-2: Edition 1.0 2017: (Lithium System)
  • IEC 62304 Edition 1.1 2015-06 (Software Life Cycle Processes - Note: The device is explicitly stated as not being a "cyber device" or subject to cybersecurity risks, and "not capable of network connection" which implies minimal software functionality on device itself)
• Clinical Performance Data:
  • Description: "Clinical radiographic images using of LifeRay™ and the predicate device have been reviewed and compared to determine the substantial equivalence. Both intraoral X-ray systems generate adequate anatomical details using an intra oral sensor. Difference in edge definition and grayscale of bony structures for both images were negligible. Both intraoral X-ray systems generate sufficient X-ray levels to obtain acceptable edge definition and grayscale of bony and soft tissue images."
  • Nature: This is a qualitative, comparative assessment, likely performed by the manufacturer or their chosen evaluators, rather than a blinded, multi-reader study with predefined metrics.
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Implicitly, it was likely internal testing by the manufacturer.

Summary Table of What could be extracted:

• "Both intraoral X-ray systems generate adequate anatomical details using an intra oral sensor."
• "Difference in edge definition and grayscale of bony structures for both images were negligible."
• "Both intraoral X-ray systems generate sufficient X-ray levels to obtain acceptable edge definition and grayscale of bony and soft tissue images."
  Quantitative Performance (from specifications for comparison):
• Exposure Time: 0.01s -1.0s (vs predicate 0.02s-1.0s)
• mA: 2.6 mA fixed (vs predicate 2.5 mA fixed)
• kVp: Adjustable 60, 65, 70 (vs predicate 60 kVp fixed) |
  | Sample Size (Test Set) | Not specified. (The document states "Clinical radiographic images...have been reviewed and compared," implying a set of images, but no quantity is given.) |
  | Data Provenance | Not specified (e.g., country of origin, retrospective/prospective). |
  | Experts for Ground Truth | Not specified. No formal ground truth establishment process for diagnostic accuracy is described. The "review and comparison" could have been done by internal personnel. |
  | Adjudication Method | Not applicable, as no formal study with expert reads and ground truth adjudication is presented. |
  | MRMC Comparative Study | Not applicable. This device is a hardware X-ray generator, not an AI diagnostic assistant. |
  | Standalone Performance | Not applicable. This is a hardware device, its "performance" is in generating X-rays of a certain quality, which is indirectly assessed via the qualitative image comparison and directly via compliance with safety/performance standards. |
  | Type of Ground Truth Used | Not applicable in the traditional sense of a diagnostic accuracy study. The "clinical performance" here refers to image comparability for the purpose of demonstrating substantial equivalence, not establishing diagnostic accuracy against a verified ground truth. |
  | Training Set Sample Size | Not applicable. This is a hardware device, not an AI model. |
  | Training Set Ground Truth Method | Not applicable. This is a hardware device, not an AI model. |

In conclusion, for a handheld intraoral X-ray device seeking 510(k) clearance, the emphasis is on demonstrating safety, effectiveness, and substantial equivalence to a legally marketed predicate device, primarily through engineering and hardware performance standards (Non-Clinical Test Data) and general qualitative image comparability (Clinical Performance Data) rather than rigorous clinical diagnostic accuracy studies common for software algorithms or novel diagnostic tools.

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The device is a diagnostic X-ray system, which is intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.

The device is a diagnostic X-ray system, which is intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors.

I am sorry, but the provided text from the FDA 510(k) clearance letter for the Remex-GR100 does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it describe an AI component.

The document is a standard FDA clearance letter for an extraoral X-ray system, confirming its substantial equivalence to predicate devices and outlining the regulatory requirements for the manufacturer. It specifies the device's indications for use: "intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects."

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

To answer your questions, I would need a different document, such as a summary of the clinical or performance testing data submitted to the FDA for the device, or a specific study report.

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The Handheld Dental X-ray System, model XVbeam2000, is indicated for use only by a trained and qualified dentist or dental technician as an extraoral X-ray source to produce diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

The subject device Handheld Dental X-ray System, model XVbeam2000, is a battery-operated, portable extraoral X-ray source system that is designed to generate X-rays to produce diagnostic quality intraoral X-ray images utilizing intraoral image receptors. The device can be used with three receptor types: film, digital intraoral X-ray sensors, and phosphor plates. The subject device is designed for use in a dental office or similar environments (hospital ward etc.) where appropriate safeguards are implemented. The subject device XVbeam2000 is an X-ray device with a DC generator. The handheld device features a main body (X-ray tube head), rechargeable battery (handset), charger, and charger AC/DC power supply. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient. The power is supplied by a rechargeable Lithium-Ion battery core pack built into a handset. This facilitates portability of the device.

The provided text is a 510(k) summary for a medical device (XVbeam2000 Handheld Dental X-ray System). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria through clinical trials or performance studies that would typically generate the requested information.

Therefore, the requested information about acceptance criteria for device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly available in the provided document. The document focuses on demonstrating substantial equivalence through non-clinical performance testing and compliance with recognized standards.

However, I can extract the information that is present and note where the requested information is not provided.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Compliance with Standards)

The document states that "The test results show that all of the performance specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence."

While specific numerical acceptance criteria and reported device performance for individual metrics are not tabulated, the document generally indicates that the device met the requirements of several FDA-recognized consensus standards for medical electrical equipment and X-ray systems.

Here's a table summarizing the general approach taken, as specific performance criteria and reported values are not detailed in the provided text:

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The Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral dental X-ray source to produce X-ray images using intraoral image receptors.

These are hand-held portable battery operated x-ray generators for dental purposes. The Portable Dental X-Ray is an X radiation controlled emissions generator system, i.e., once put into service, is intended to be moved from one location to another by a person, used together with appropriate capture devices to generate intraoral radiological images for dental assessment, diagnosis and treatment. This equipment has exposure programs that can be applied to a variety of patients and has predefined exposure parameters depending on the type of patient. The operator is free to change these parameters depending on the situation. The equipment's human-machine interface consists of a control panel located on the top of the equipment, a local trigger button and a remote trigger (hard wired). The triggers are "dead-man" triggers, meaning they release and interrupt the exposure. The Portable Dental X-Ray was designed to be used in adult and children patients by trained dentists and dental technicians to produce X-ray images for diagnosis. The Portable Dental X-Ray is indicated for the production of intraoral medical images of teeth, mandible and oral structures; it assists in the diagnosis of diseases, planning of surgical treatment and monitoring. It is exclusively for dental use, and must be used and handled by qualified and trained health professionals according to the User Manual.

The provided text is an FDA 510(k) summary for a portable dental X-ray system. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/algorithm-based medical device.

Therefore, many of the requested details about acceptance criteria, study design for AI evaluation (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), are not present in this document.

The document primarily covers non-clinical testing for safety, EMC, and basic performance of the X-ray system itself, not an AI algorithm.

However, based on the information provided, here's what can be extracted and what information is missing:

Information Present in the Document (Related to Device Performance Testing, Not AI):

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

  • The document primarily lists performance characteristics of the device and compares them to a predicate, rather than defining "acceptance criteria" in a quantitative, pass/fail sense for an AI.
  • For the X-ray device itself, non-clinical tests were performed.
  • Accepted Performance (device characteristics vs. predicate):
    • Indications for Use: Same as predicate.
    • Models: Proposed device has two (60 kV 2.5 mA, 65 kV 2.5 mA); predicate has one (60 kV 2.5 mA). "ALMOST IDENTICAL"
    • Timer Range: Proposed device 0.01 to 1 sec (0.01 sec steps); predicate 0.02-1.00 sec (0.01 sec steps). "Slightly greater range of steps."
    • Duty Cycle: Both 1:60. "SAME"
    • Waveform: Both DC. "SAME"
    • mA: Both 2.5 mA fixed. "SAME"
    • Where Used: Both Dental offices. "SAME"
    • Operating Temp. Range: Proposed device +10°C to +35°C; predicate -5°C to +40°C.
    • Supply Voltage (for battery charging): Proposed device 100-240 V~, 50-60 Hz; predicate 110/120V or 220/240V. "SAME (Charger is UL listed)"
    • Battery: Proposed device Rechargeable Lithium-ion, 21.6V - 2.50Ah; predicate Rechargeable Lithium-ion, 22.2V; 1.7 A-hr.
    • Electrical Safety Standards: Both ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, etc. "SAME"
    • EMC: Both IEC60601-1-2 Ed. 4. "SAME"
    • X-Ray Performance: Both 21 CFR 1020.30, 1020.31; IEC 60601-1-3; IEC 60601-2-65. "SAME"

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

  • Not applicable as this is not an AI/algorithm dataset evaluation.
  • However, for the non-clinical bench testing: "Bench Testing was performed to confirm compliance with the FDA Radiation Safety requirements of the Code of Federal Regulations including: accuracy and reproducibility specifications (kV, ma, time) and aluminum equivalence." The sample size for these bench tests (e.g., number of exposures, equipment tested) is not specified.

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

  • For the X-ray device itself, "Image Evaluation: Using a digital image receptor (cleared in K230732) images were acquired and were found to be of diagnostic quality for dental applications." This implies a qualitative assessment by an unnamed expert or group. The ground truth for "diagnostic quality" is not explicitly defined (e.g., against a gold standard).
  • For radiation safety, compliance was against regulatory standards (CFR).

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

  • Not applicable as this is not an AI/algorithm that requires a training set.

Information NOT Present in the Document (and likely not relevant to this specific 510(k) as it's for an X-ray generator, not an AI/CADe system):

• 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 for an X-ray generator submission.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 8. The sample size for the training set: Not applicable as this is not an AI/algorithm driven device.

In summary: The provided FDA 510(k) summary is for a Portable Dental X-Ray generator, not an AI-powered diagnostic device. Therefore, the detailed requirements for AI acceptance criteria and study designs are not addressed in this document. The document focuses on demonstrating the substantial equivalence of the X-ray generator's basic performance, safety, and electromagnetic compatibility to a legally marketed predicate device.

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x-mind dc (and Owandy-RX DC under trademark Owandy Radiology) is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device.

The device is operated and used by dentists, radiologists and other legally qualified health care professionals.

x-mind dc consists of the following parts:

• 1 X-ray control unit (timer)
• 2 Wall plate and horizontal bracket
• 3 Pantograph type arm (scissor arm)
• 4 X-ray source assembly (tubehead)
• 5 Collimator cone (Beam Limiting Device)

The timer is the control panel used to manage the exposure settings and to safely use the tubehead. It allows easy and clear selection, with the help of clear and visible signals, of the exposure settings, perform personal settings and display alarms of the device in case of incorrect operation or eventual failures.

The horizontal bracket it is available in 3 different lengths and represents the support for the scissor arm. The pantograph arm, being adjustable in height and depth, allows the precise positioning of the tubehead. The tubehead of the device contains the X-ray tube, the high voltage board and the high frequency generator. It is the component of the device which emits the X-rays.

The collimator cone represents the part of the device in contact with the patient and it allows the correct focal spot to skin distance, ensures the dimension, direction and centering of the X-ray beam.

x-mind dc can be used with conventional chemical films (D, E, F speed films), phosphor plates (PSP), RVG digital detectors (CCD or CMOS).

The provided text outlines the 510(k) summary for the x-mind dc (and Owandy-RX DC) device, which is an extraoral source X-ray system intended for intra-oral radiographic exams. The core of the summary demonstrates substantial equivalence to a predicate device, Endograph DC (K130109), and a reference device, PHOT-X II, MODEL 303 (K042260).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the device in the sense of performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm. Instead, it details the device's technical specifications and compliance with various international and national standards and regulations. The "acceptance criteria" here are implicitly the successful adherence to these standards, demonstrating safety and essential performance comparable to the predicate device.

To frame this in the requested format, we can list key technical specifications and their comparison to the predicate/reference devices, which serve as the "performance" verification. The ultimate "acceptance criterion" is the determination of substantial equivalence by the FDA.

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DVAS is an extra-oral source x-ray system to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic dental radiographic examination and diagnosis of teeth, jaw, and other oral structures using intra-oral image receptors. It is intended for both adult and pediatric subjects.

DVAS, the extra-oral source x-ray system for dentistry is the standard X-ray equipment used to acquire intraoral images of patients during dental diagnosis such as dental caries, periodontal diseases, dental root fracture, and other oral and dental pathologies. DVAS is used to provide anatomic X-ray images of a patient at hospitals or dental clinics using a cone for X-ray exposure. The doctor or dentist can check the acquired X-ray images with chemical films or a PC monitor. DVAS can be used Digital I/O Sensor, Image plate (CR), Film as a Image receptor. The image receptors are not part of this submission.

The provided text is a 510(k) summary for the DVAS (DVAS-M, DVAS-W) extra-oral source x-ray system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the device itself in a clinical setting.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (e.g., sensitivity, specificity, or reader improvement) is not present in the provided document. The document primarily addresses engineering and regulatory compliance.

However, I can extract information related to safety, EMC, performance data comparison, and software validation, which are forms of acceptance criteria for a medical device.

Here's a breakdown of the available information based on your request, highlighting what is implicitly or explicitly stated regarding "acceptance criteria" and "proof":

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of clinical performance acceptance criteria (e.g., specific sensitivity or specificity thresholds) because it is a 510(k) submission focused on substantial equivalence to a predicate device, not clinical efficacy trials for novel AI algorithms.

However, it does describe compliance with various standards and successful completion of validation testing as its "performance criteria" for regulatory clearance.

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

The document does not mention a "test set" in the context of clinical images or patient data for evaluating a diagnostic algorithm. The testing described is primarily engineering and regulatory compliance testing, not a clinical performance study involving diagnostic accuracy metrics.

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

Not applicable. No clinical test set needing expert ground truth establishment is mentioned in this submission.

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

Not applicable. No clinical test set needing adjudication is mentioned.

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 MRMC study is mentioned. This device is an X-ray system (hardware), not an AI diagnostic algorithm, so such a study would not be relevant for this type of submission.

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

Not applicable. This is an X-ray system, not a standalone algorithm.

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

Not applicable. For the engineering and regulatory compliance tests, the "ground truth" would be the specifications and requirements of the relevant standards (e.g., IEC 60601 series, 21 CFR 1020.30/31).

8. The sample size for the training set

Not applicable. This document does not describe the development or testing of an AI algorithm that would require a training set of data.

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

Not applicable. No training set for an AI algorithm is mentioned.

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