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The ScanX Touch/ScanX Duo Touch is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

The ScanX Touch is a device that scans photostimulable phosphor storage plates that have been exposed in place of X-ray film and allows the resulting images to be displayed on a personal computer monitor and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. Two models are available: The Scanx® Touch processes one imaging plate while ScanX® Duo Touch processes two at a time. The ScanX Touch also includes an RFID Phosphor Plate identification system which requires that the Phosphor Plate has an RFID tag attached to the non-imaging side of the Plate. ScanX allows multi room dental clinics to produce digital radiographs within seconds using a flexible PSP (Phosphor Storage Plates). The workflow is supported by a touch screen, for job handling (ScanManager, Patient information), preview and standalone work. ScanX produces the digital diagnostic quality intraoral image by scanning PSPs, which have been exposed to X-rays. ScanX can also work independently. If the IT network goes down, the user can still scan and save X-ray images. The images are temporarily placed in the internal memory and are later transferred to the office database. This makes the device ideally suited to provide a mobile solution when it is necessary to visit the patient outside the office. Additionally, ScanX allows computer storage, processing, retrieval and display of the processed images utilizing a user supplied software (e.g. DBSWIN) and computer. An additional feature of ScanX consists of an in-line plate eraser function that removes the latent image from the plate immediately after scanning. This design provides an efficient one-operation scanning and erasing process leaving the user with a PSP ready for the next X-ray procedure

The provided text describes the Air Techniques ScanX Touch/ScanX Duo Touch, a device for scanning and processing digital images from Phosphor Storage Plates (PSPs) in dental applications. The information focuses on demonstrating substantial equivalence to a predicate device (ScanX Intraoral View, K170733) rather than a comprehensive study proving the device meets specific performance acceptance criteria for a novel AI algorithm.

Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable or cannot be extracted from this document as it pertains to a traditional medical device clearance, not an AI-driven one.

Here's a breakdown of the information that can be extracted, aligning with the closest relevant details provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily framed around demonstrating substantial equivalence to the predicate device in terms of image quality and functional specifications. The "acceptance criteria" here are implicitly meeting or exceeding the predicate's performance in key imaging metrics.

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

• Sample Size: The document mentions that "Test images were acquired on the new device and on the predicate device." However, a specific number of images or cases used for this comparison is not provided.
• Data Provenance: Not explicitly stated, but the testing was conducted by Air Techniques, Inc. likely within their facilities or through contracted labs (e.g., UL). There's no mention of country of origin for the data or whether it was retrospective or prospective in detail beyond the acquisition of "test images."

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

• Number of Experts: "a licensed dentist" (singular)
• Qualifications: "licensed dentist" (no further details such as years of experience or specialization are given).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The evaluation was a single-reader assessment where a licensed dentist answered specific questions in the affirmative regarding the images. There was no mention of a consensus process among multiple experts.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The evaluation involved a single licensed dentist.
• Effect Size of Human Readers with/without AI: Not applicable, as this device itself is not an AI algorithm but an imaging hardware and processing system. The study did not assess human reader performance with or without AI assistance.

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

• Standalone Performance: Not applicable. The device is hardware for image acquisition and initial processing. The "standalone" testing referred to in the document relates to the device's ability to operate and save images independently if the IT network goes down, not an AI algorithm's standalone diagnostic performance.

7. The Type of Ground Truth Used

• Type of Ground Truth: "Expert assessment/satisfaction." A licensed dentist evaluated the images for representativeness, diagnostic usefulness, and absence of misleading artifacts, and comparability to the predicate. This is a subjective expert evaluation rather than an objective "ground truth" derived from pathology or definitive outcomes data.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document does not describe an AI algorithm that was "trained." The device is an image acquisition and processing system.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set or an AI algorithm that requires one.

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Disposable Barrier Envelopes are intended to be used as a disposable barrier for Air Techniques Phosphor Storage Plates. This device is non-sterile and intended for single patient use only.

The ScanX barrier envelopes are made from one layer of clear blown polyethylene film and one layer of black blown polyethylene film heat sealed along three edges. An adhesive strip along the fourth edge is used for temporary barrier. Barrier Envelopes are used with Air Techniques' intraoral Phosphor Storage Plates. Barrier Envelopes are non-sterile, and disposable, single use only- discarded after each use.

The provided document is a 510(k) premarket notification for "ScanX Barrier Envelopes" and describes the acceptance criteria and study results demonstrating that the device meets these criteria.

Here's an analysis of the requested information:

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

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

The document lists standards (e.g., ISO 10993, ASTM) that were followed for testing. These standards specify methodologies and may include sample size requirements within their procedures. However, the exact sample sizes used for each specific test in this study (e.g., "how many barrier envelopes were tested for tensile strength?") are not explicitly reported in this summary.

Regarding data provenance: The tests are material and mechanical property tests of a medical device (barrier envelopes), not clinical data involving patient information. Therefore, 'country of origin of the data' and 'retrospective or prospective' study design are not applicable in the typical sense for these types of non-clinical performance studies. The testing would have been conducted in a laboratory setting.

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 product (ScanX Barrier Envelopes) is a physical barrier device for dental phosphor storage plates. The "ground truth" for its performance is established through objective, standardized laboratory testing of its physical properties (e.g., tensile strength, resistance to penetration, biocompatibility) and its impact on image quality, as outlined by the listed ASTM and ISO standards. It does not involve human expert interpretation of medical images or diagnoses in the way an AI-driven diagnostic device would.

Therefore, this question (number of experts, qualifications, etc.) is not applicable to this type of device and study. The "ground truth" is derived from the results of the physical and chemical tests themselves, performed by qualified technicians in accredited labs according to the specified standards.

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

This concept is primarily relevant for studies involving human interpretation (e.g., reading medical images) where discrepancies between readers need to be resolved. Since this study involves objective laboratory measurements of physical properties, adjudication methods are not applicable. The results are quantitative measurements or pass/fail determinations based on predefined criteria within the respective standards.

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, an MRMC comparative effectiveness study was not conducted for this device. This type of study is specifically designed to evaluate the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The ScanX Barrier Envelope is a physical accessory, not an AI diagnostic tool, so such a study would be irrelevant.

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

This question is also not applicable. The device is not an algorithm; it's a physical product. The "standalone performance" here refers to its ability to meet the specified physical and biological safety standards, which was indeed evaluated through the non-clinical tests listed.

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

The "ground truth" for the ScanX Barrier Envelopes is based on objective, quantitative measurements and qualitative assessments derived from adherence to recognized national and international standards (ASTM, ISO) for material properties, barrier effectiveness, biocompatibility, and image quality. This is not clinical ground truth (like pathology or outcomes data) but rather engineering and safety ground truth.

8. The sample size for the training set

The concept of "training set" is specific to machine learning and AI algorithms. Since this device is not an AI algorithm, there was no training set in that context. The development and testing of the barrier envelopes would involve material science, engineering, and manufacturing processes, not AI model training.

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

As there was no AI model training set, this question is not applicable.

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The ScanX D5000 series scanners, with and without battery option are devices that read photostimulable phosphor plates that have been exposed in place of x-ray film and allow those images to be displayed on a personal computer display and stored for later recovery in a computer's memory. It will be used by physicians, dentists, veterinarians, and authorized medical auxiliary personnel for this purpose. These scanners are not intended to be used for mammographic images.

The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Air Techniques, Inc. ScanX D5000 Series Scanner with and without Battery":

Overview:
This 510(k) summary describes a new device, the ScanX D5000 series scanner, which reads photostimulable phosphor plates. The primary claim for regulatory clearance is substantial equivalence to previously cleared predicate devices (ScanX 10/12 and Dental ScanX Scanner) and a predicate portable X-Ray system ("Any Ray" for the battery component). The document focuses on demonstrating that the D5000 series is "identical in concept, design, and function" to its predicates, with specific modifications detailed.

Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" in the format one might expect for a quantitative performance study (e.g., target sensitivity/specificity). Instead, it relies on demonstrating substantial equivalence to predicate devices through a comparison of characteristics. The "reported device performance" is implicitly that it functions identically or equivalently to the predicate devices.

Here’s a table summarizing the relevant characteristics and how they relate to demonstrating equivalence (which serves as the "acceptance criteria" here):

Study Details:

The provided document describes a substantial equivalence determination rather than a traditional performance study with a test set of images, ground truth, or expert readers. This is a common approach for 510(k) submissions when a device is highly similar to existing cleared devices.

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

   • No explicit "test set" of images or patient data is mentioned. The study is a comparison against predicate device specifications and functionalities.
   • Data provenance: Not applicable in the sense of patient data. The comparison is against the specifications and performance of existing, legally marketed devices from Air Techniques, Inc.

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

   • Not applicable. No "ground truth" for a test set of images was established by experts in this type of submission. The "ground truth" is effectively the established performance and safety of the predicate devices.

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

   • Not applicable. There was no test set requiring adjudication.

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

   • No MRMC study was done. This device is a scanner, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a hardware/firmware device that produces images for human interpretation, not a standalone diagnostic algorithm.

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

   • The "ground truth" is implied to be the established safety and effectiveness of the predicate devices based on their prior clearance and market performance. The submission argues that the new device, despite some differences (like plate size, in-line erase, and battery option), maintains the same fundamental performance characteristics for image acquisition. For the battery component, the "ground truth" is the safety and performance certification (UL 2054, UL 1642) of the battery itself and its equivalence to a predicate portable X-ray system.

7. The sample size for the training set:

   • Not applicable. There is no machine learning or AI component requiring a "training set" in the context of this 510(k) submission.

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

   • Not applicable, as there was no training set.

Conclusion from the document:

Air Techniques, Inc. concludes that the ScanX D5000 Series scanners are "safe and effective and substantially equivalent to the predicate devices as described herein," based on the detailed characteristic comparison and specific validation for new features like the battery and reconfigured firmware (mitigated through product and process validation located in Exhibit 7, though Exhibit 7 is not provided in the input). The FDA's letter concurs with the substantial equivalence finding.

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Spectra Fluorescence Caries Detection Aid System is indicated as an aid in the detection and diagnosis of dental caries.

The Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain any explicit acceptance criteria or reported device performance metrics from a clinical study. It only states that "Clinical testing was performed and established the effectiveness of the device to its claims."

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

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).

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

Not specified in the provided document.

4. Adjudication Method:

Not specified in the provided document.

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

Not mentioned or described in the provided document. Therefore, no effect size of human reader improvement with AI assistance can be reported.

6. Standalone Performance Study:

A standalone performance study of the algorithm (without human-in-the-loop performance) is not explicitly mentioned or described. The document refers to "the effectiveness of the device," which, given the device description as an "aid," implies human involvement.

7. Type of Ground Truth Used:

Not specified in the provided document.

8. Sample Size for the Training Set:

Not specified in the provided document.

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

Not specified in the provided document.

Summary of what is available in the document:

The provided 510(k) summary (K090169) for the Spectra Fluorescence Caries Detection Aid System focuses primarily on regulatory compliance and substantial equivalence to a predicate device (Inspektor Pro K040063). While it states that clinical testing was performed to establish effectiveness, it lacks any detailed information about the methodology, results, acceptance criteria, or specific performance metrics of that study. This means that nearly all the specific information requested in your prompt regarding acceptance criteria and study details is not present in the provided text.

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The RinsEndo is used for root canal irrigation/ disinfection.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "RinsEndo". This document confirms that the device is substantially equivalent to a legally marketed predicate device for its indicated use (root canal irrigation/disinfection) and allows it to be marketed.

However, the document does NOT contain any information regarding:

• Acceptance criteria for the device's performance.
• The specifics of any study performed to prove the device meets acceptance criteria.
• Device performance results.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study details or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for training was established.

This 510(k) letter is an administrative document about market clearance, not a technical report detailing the performance evaluation studies. Therefore, I cannot extract the requested information from the provided text.

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The Accent Sensor is a digital x-ray sensor system for human and non human use in dental, medical and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues. Accent replaces standard X-ray film and/or phosphor plate technology.

The X-ray tube (not part of this product) is pointed at the sensor and activated. The X-ray energy is detected by the sensor and transmitted as data to the computer to which it is connected. The software (not part of this product) interprets the image as a gray scale image and displays it on the computer monitor for diagnosis.

This document is a 510(k) premarket notification letter from the FDA for a device named "Accent," an extraoral source x-ray system. The letter discusses the substantial equivalence of the device to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance, sample sizes used in studies, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth sources, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory approval letter, not a study report or a summary of performance data.

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The ScanX 14 is a device that reads photostimulable phosphor plates that have been exposed in the place of x-ray film and allow those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by physicians and authorized medical auxiliary personnel for this purpose.

The ScanX 14 is a device that reads photostimulable phosphor plates that have been exposed in the place of x-ray film and allow those images to be displayed on a CRT and stored for later recovery in a computer memory.

The provided document is a 510(k) clearance letter from the FDA for a device named "ScanX 14." It states that the device is substantially equivalent to a predicate device for its intended use, which is reading photostimulable phosphor plates and displaying/storing the images.

Critically, this document is an FDA clearance letter and an "Indications for Use" statement. It does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the input text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or training sets.
3. Number or qualifications of experts.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. How ground truth for training or test sets was established.

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The Acclaim system is primarily a tool to provide visual information to dental patients so that they can better understand the necessity and quality of the health care they receive.

Not Found

This is a notification about the clearance of the Acclaim system, a dental operative unit, and accessories. Due to the nature of the document, there is no information regarding the acceptance criteria, study details, or device performance as it would be found in a clinical study report. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed devices.

The key information provided is:

• Trade/Device Name: Acclaim
• Regulation Number: 21 CFR 872.6640
• Regulation Name: Dental Operative Unit and Accessories
• Regulatory Class: I
• Product Codes: NRD and EAY
• 510(k) Number: K042266
• Indications for Use: The Acclaim system is primarily a tool to provide visual information to dental patients so they can better understand the necessity and quality of the healthcare they receive. This is the same intended use as previously cleared for the VistaCam Omni IC, 510(k) number K974204.

Since this is a Class I device and a 510(k) clearance, a full clinical study with specific acceptance criteria and detailed performance metrics is often not required, especially if the device is found to be substantially equivalent to a predicate device. The substantial equivalence is typically based on technological characteristics and intended use.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided FDA clearance letter.

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The A/T X-Ray 70 is an extra oral device designed to expose intra oral x-ray recording media (film, plates, sensors) for the purpose of radiographic examination and diagnosis of diseases of the teeth.

The A/T X-Ray 70 is an extra oral device designed to expose intra oral x-ray recording media (film, plates, sensors).

The provided text is a 510(k) clearance letter from the FDA for a dental X-ray device and an associated "Statement of Indications for Use." It does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies. This document is purely administrative pertaining to regulatory clearance.

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