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The HyperLight Portable X-ray Unit is a diagnostic X-ray system which is intended to be used by trained dentists and 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.

Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.

HyperLight Portable X-ray Unit of Changzhou Sifary Medical Technology Co., Ltd., is a handheld x-ray device. The technology of portable x-ray devices was originally developed in the 1950s and was originally designed to be used in situations where there was no access to fixed x-ray units. With new technological possiblities arising, the use of portable handheld devices are becoming more mainstream.

The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the handheld device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors. The intraoral x-ray detectors are not part of the subject device. The functions of the HyperLight Portable device are supported by software. The software package is of Moderate level of concern and it's not based on the predicate system.

This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient. The handheld x-ray device is a choice model to assist doctors with special need patients, nursing home patients in the office that cannot be easily moved, as well as other special situations. The choice of an x-ray generator is a matter of functional utility in the dental operatory and personal preference by the medical professional.

This document is a 510(k) premarket notification for a medical device (HyperLight Portable X-ray Unit). It does not contain information about an AI/ML algorithm or a study related to its performance against acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (MobileX Portable X-ray System) based on technical characteristics, indications for use, and non-clinical performance data (electrical safety, EMC, software validation, biocompatibility, usability, risk assessment, and clinical comparison).

Therefore, I cannot provide the requested information about acceptance criteria, study details for an AI/ML algorithm, 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.

The document discusses the following:

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

• The document provides a "Comparison of Technological Characteristics with Predicate" table, which acts as a comparison against a predicate device, not against specific quantitative acceptance criteria for an AI/ML algorithm.
• It lists characteristics like size, source to skin distance, cone diameter, user interface, backscatter radiation protection, exposure switch, electrical information (exposure time, time accuracy, mA, kVp, waveform, total filtration), and performance standards.
• For example, for "Exposure time," the subject device's reported performance is "0.02 ~ 2.0 seconds in .01-.40s increments (20 steps)" compared to the predicate's "0.01 ~ 1.3 seconds in 0.01 or 0.05 increments." This is a comparison, not an acceptance criterion with a pass/fail threshold.

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

• Not applicable. The document describes non-clinical performance data, primarily engineering and safety tests, and a comparison to a predicate device. There is no mention of a test set with patient data for an AI/ML algorithm, nor data provenance (country of origin, retrospective/prospective).

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

• Not applicable. No AI/ML algorithm performance study is described that would require expert-established ground truth.

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

• Not applicable. No AI/ML algorithm performance 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. No MRMC study or AI assistance for human readers is mentioned.

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

• Not applicable. No AI algorithm is the focus of this 510(k) submission. The device is a portable X-ray unit.

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

• Not applicable. There is no AI/ML algorithm requiring ground truth from clinical data. The "ground truth" for this submission are
  established engineering standards (e.g., IEC standards for electrical safety, EMC, etc.) and the characteristics of the predicate device.

8. The sample size for the training set:

• Not applicable. No AI/ML algorithm training is mentioned.

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

• Not applicable. No AI/ML algorithm training is mentioned.

In summary, this document is a regulatory submission for a physical medical device (X-ray unit) based on substantial equivalence, not an AI/ML device requiring clinical performance validation against acceptance criteria.

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The CuringPen Dental 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 380~515nm waveband of visible light.

This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.

The CuringPen Dental Curing Light is designed to polymerize all photo-activated dental materials in the wavelength range of 380-515 nm per ISO 10650:2018. It is a cordless pen-style, LED light polymerization device, and must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.

This document describes the premarket notification for the CuringPen Dental Curing Light. The information provided is for a traditional 510(k) submission, demonstrating substantial equivalence to a predicate device, not an AI/ML software device study. Therefore, many of the requested categories related to AI/ML software performance studies are not applicable.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where relevant for AI/ML specific criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not an AI/ML study involving a test set of data. This is a medical device clearance.

• Test Set Sample Size: Not Applicable for an AI/ML test set. The performance testing was conducted on the device itself.
• Data Provenance: Not Applicable. The testing was conducted internally or by accredited labs on the physical device.

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

This is not an AI/ML study.

• Number of Experts: Not Applicable.
• Qualifications of Experts: Not Applicable. Performance was measured against established physical and electrical properties, and biological safety standards.

4. Adjudication Method for the Test Set

This is not an AI/ML study.

• Adjudication Method: Not Applicable. Performance was measured objectively against engineering and biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, a multi-reader, multi-case comparative effectiveness study was not done. This device is a dental curing light, not an AI/ML diagnostic or assistive tool for human readers.
• Effect Size of Human Readers' Improvement with AI: Not Applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• Standalone Study: Not Applicable. This is a physical device, not an algorithm. Performance tests were conducted on the device itself (standalone in terms of being tested independently).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established engineering standards, physical measurements, and biological safety standards.

• Engineering Standards: ISO 10650:2018 (dental curing lights), IEC 60601 series (electrical safety and EMC).
• Biocompatibility Standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization, irritation).
• Specific Device Performance: Measured irradiance, wavelength, depth of cure, heat generation.

8. The Sample Size for the Training Set

This is not an AI/ML study.

• Training Set Sample Size: Not Applicable. There is no AI/ML model being trained.

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

This is not an AI/ML study.

• Ground Truth for Training Set: Not Applicable.

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E-connect S is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the position of the tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.

This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The E-connect S is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The E-connect S can be used for enlargement and preparation of root canals and can also be used as an apex locator.

The motor drives the file to rotate at a certain speed and torque through the contra angle gearing. The rotating file will cut the root canal wall along the direction of the root canal. The speed and torque of the motor are controlled by the central processor and are configurable to accommodate different files. With built-in apex locator, this device monitors the file tip position in the root canal during root canal treatment.

The components of the E-connect S include a charge base, handpiece, contra angle, insulating sleeve, file clip, lip hook, measuring wire, adapter, and spray nozzle. The contra angle is compatible with files shafts conforming to ISO 1971-1, Type 1. The key panel on the handpiece is used to control/adjust the power, memory settings, operation modes (motor/apex,) and adjust the parameters. The body of the handpiece is to be covered with a FDA cleared barrier sleeve.

The provided document is a 510(k) summary for the E-connect S Endo Motor with built-in Apex Locator. It details the device's performance data and comparison to a predicate device, but it does not contain information about an AI/algorithm-only study, a multi-reader multi-case (MRMC) comparative effectiveness study, or details on ground truth establishment for a training set. The study described focuses on non-clinical performance evaluations and comparative testing against a predicate device.

Here's the information extracted and organized, with an emphasis on what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a table format with pass/fail metrics. Instead, the document describes performance tests against recognized standards and a comparative test against a predicate device. The most relevant performance criterion discussed is the accuracy of the root apex locator function.

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

• Sample Size: Not specified for any of the non-clinical tests or the comparative root canal measurement test. The document states "Comparative Root Canal Measurement Performance Test to evaluate the root canal length measurement accuracy to the predicate device," but the number of cases or samples used in this test is not provided.
• Data Provenance: Not specified. The document does not mention the country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) summary, it's typically a report of manufacturer-conducted tests.

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

• Not applicable / Not specified. The document describes non-clinical performance and comparative testing. It does not mention any ground truth established by experts for a test set in the context of clinical or diagnostic performance. The apex locator accuracy is a technical measurement, not an expert-driven clinical ground truth.

4. Adjudication Method for the Test Set

• Not applicable / Not specified. There is no mention of adjudication methods as no expert-based ground truth or clinical test set adjudication is described.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There were no clinical tests performed for the E-connect S device." The performance data section describes non-clinical tests and a comparative evaluation of the root canal measurement accuracy to the predicate device, not a human reader study.

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

• Partially applicable. The "apex locator function" is a standalone algorithm/device function. Its accuracy is reported as -0.5mm to +0.5mm for Apex position. This is a direct measurement of the device's technical performance without human interpretation or intervention in the measurement itself outside of proper device usage. The study compared this measurement accuracy to that of the predicate device.

7. The Type of Ground Truth Used

• Technical/Instrumental Measurement. For the apex locator function, the "ground truth" would be an objective, precise measurement of the actual root canal length, likely established under controlled laboratory conditions or cadaveric/ex vivo studies using highly accurate reference methods (e.g., direct physical measurement, micro-CT). The document does not detail how this "ground truth" was specifically established but refers to the "Accuracy of the root apex locator function." For other performance aspects, the ground truth refers to conformance to established international standards (e.g., IEC 60601, ISO 10993).

8. The Sample Size for the Training Set

• Not applicable / Not specified. This device is a motor and apex locator, not an AI/machine learning algorithm that requires a "training set" in the traditional sense of medical imaging or diagnostic AI. The document does not describe any machine learning components that would necessitate training data.

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

• Not applicable / Not specified. As there is no described training set for an AI/ML algorithm, the method for establishing its ground truth is not relevant here.

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