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The ScanX Swift 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

The ScanX Swift View 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

The ScanX Swift 2.0 and ScanX Swift View 2.0 are dental devices that scan photostimulable phosphor storage plates that have been exposed in place of dental 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. The device is an intraoral Plate Scanner, which is designed to read out all cleared plates of the sizes 0, 1, 2, 3, and 4. The phosphor plates are made of rigid photostimulable material. Intraoral phosphor plate x-ray (also known as phosphor storage plate or PSP x-ray) eliminates the need for traditional film processing for dental radiography. Phosphor storage plates can convert existing film based imaging systems to a digital format that can be integrated into a computer or network system. The intraoral Plates are put into the mouth of the patient, exposed to X-rays and then are read out with the device. The read-out-process is carried out with a 639nm 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 x-ray 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 an Ethernet link 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 has to 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 cover and starts the read out process. After the read out process the picture is transmitted to the connected PC, the picture can be viewed and the IP is erased and ready to use for the next acquisition. The main difference between the two models is on the ScanX Swift View 2.0 the display is larger, has touch capability, and can show a preview of the scan image. The device firmware is based on the predicate firmware and is of a moderate level of concern.

The provided text is a 510(k) summary for a medical device (ScanX Swift 2.0, ScanX Swift View 2.0), which focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria for a specific clinical endpoint or a study proving a device meets such criteria.

Instead, it discusses the technological characteristics, safety, and performance of the device in comparison to a predicate device based on non-clinical testing and engineering principles. The document explicitly states:

• "Summary of clinical performance testing: Not required to establish substantial equivalence."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor details about sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.

However, I can extract information related to non-clinical performance testing and technical characteristics, which are used to establish substantial equivalence.

Here's an analysis based on the available information:

Key Takeaways from the Document:

• Device Type: Phosphor Storage Plate (PSP) scanner for dental X-ray images.
• Purpose: Scan exposed PSPs, process digital images, and display/store them.
• Approval Basis: Substantial equivalence to a predicate device (ScanX Edge K202633).
• No Clinical Study: Clinical performance testing was explicitly stated as "Not required to establish substantial equivalence." This means the FDA cleared the device based on non-clinical data and comparison to a legally marketed predicate.

Information Related to Device Performance and Equivalence (Non-Clinical):

The document compares the subject devices (ScanX Swift 2.0, ScanX Swift View 2.0) to the predicate device (ScanX Edge) based on various technical specifications and non-clinical performance metrics.

1. Table of "Acceptance Criteria" (Technical Specification Comparison) and Reported Device Performance (as listed for the subject devices):

Since no acceptance criteria are explicitly stated as pass/fail for a clinical endpoint, I will present the comparative technical specifications as the basis for demonstrating equivalence and "performance" in this context. The "acceptance criteria" here are effectively the predicate device's performance, and the subject device's performance is compared against it for substantial equivalence.

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

• Not explicitly stated for performance testing. The document refers to non-clinical performance testing (MTF, DQE, noise power spectrum) in accordance with IEC 6220-1:2003, which would involve imaging phantoms or test objects.
• Data Provenance: Not specified, but given the manufacturer is German (DURR DENTAL SE), the non-clinical testing likely occurred in a controlled lab environment, presumably in Germany or where their R&D facilities are located. These tests are inherently "prospective" in the sense that they are conducted to characterize the specific device.

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

• Not applicable. The submission states no clinical performance testing was required. For non-clinical tests like MTF/DQE, ground truth is established by the design of the test phantom and the known physical properties being measured.

4. Adjudication method for the test set (for clinical studies):

• Not applicable. No clinical studies were performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states: "Summary of clinical performance testing: Not required to establish substantial equivalence." Therefore, no MRMC study was performed.

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

• The device itself is a standalone imaging acquisition and processing system. The performance metrics (MTF, DQE) are inherently standalone measurements of the device's image quality output.
• The ScanX Swift View 2.0 model has a "Stand-Alone-Mode" where it can operate without a connection to a computer, generate image data, and store it on a USB stick. This is a functional feature, not a separate performance study.

7. The type of ground truth used:

• For the non-clinical image quality performance metrics (MTF, DQE, noise power spectrum), the ground truth is established by physical standards and phantoms as defined by the IEC 6220-1:2003 standard. These involve known patterns and controlled radiation exposures to objectively measure the imaging system's capabilities.

8. The sample size for the training set:

• Not applicable. As this is a 510(k) for a hardware device (PSP scanner) and not an AI/ML algorithm requiring a training set in the typical sense, there is no mention of a "training set" for image processing algorithms. The image processing algorithms used within the device are stated to be "the same as cleared in K192743 for the imaging software VisionX," implying they are established and validated algorithms, not newly trained ones for this specific device.

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

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

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

The ScanX Edge is a dental device that scans photostimulable phosphor storage plates that have been exposed in place of dental 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. The device is an intraoral Plate Scanner, which is designed to read out intraoral Plates of the sizes 0, 1 and 2. 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 X-rays and then are read out with the device. The read-out-process is carried out with a 635nm Laser. The laser beam is moved across the surface of the plate by an oscillating MEMS mirror. The laser beam stimulates the top coating of the plates, which consists of x-ray 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 an Ethernet link 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 has to 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 cover and starts the read out process. After the read out process the picture is transmitted to the connected PC, the picture can be viewed and the IP is erased and ready to use for the next acquisition.

The provided text describes the Dürr Dental SE ScanX Edge device (K202633) and its substantial equivalence to a predicate device, the ScanX Intraoral View (K170733). However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria with performance data from a specific study.

Instead, the document focuses on demonstrating that the ScanX Edge maintains similar performance characteristics and safety profiles compared to a previously cleared device. It references technical testing and standards compliance rather than a clinical performance study with defined acceptance criteria and performance metrics for the device itself.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a dedicated study as that information is not present in the provided text. I will extract the available performance specifications and the context of their assessment.

Here's a breakdown of the information that can be extracted from the document, with explanations for what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not present a specific study that defines acceptance criteria and then reports performance against those criteria. Instead, it compares the ScanX Edge's technical specifications to those of its predicate device, often stating that the values are "similar." These comparisons are made against established standards for general X-ray imaging devices.

Note: The document states that the "lower DQE did not adversely affect image quality as shown by our SSD testing," implying that despite a numerically lower DQE, the overall image quality was deemed acceptable, likely within the context of substantial equivalence to the predicate in dental applications.

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

• Sample Size for Test Set: Not specified. The document refers to "MTF and DQE image performance testing" and "SSD testing" but does not provide details on the number of images or cases used for these tests.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective. Implicitly, as Dürr Dental SE is a German company, some testing might have occurred in Germany, but this is not stated for the performance data.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

The performance testing referenced (MTF, DQE, noise power spectrum) are objective technical measurements performed on the device itself, often using phantoms or controlled inputs, not human interpretation of clinical images. Therefore, the concept of "ground truth established by experts" as typically applied in diagnostic AI studies is not directly applicable here for these specific technical metrics. The "SSD testing" mentioned in relation to DQE might involve human assessment, but details are not provided.

4. Adjudication method for the test set

Not applicable/Not specified for the referenced technical performance tests (MTF, DQE). These are objective measurements rather than subjective assessments requiring adjudication.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document.
• Effect Size: Not applicable, as no MRMC study was performed.

This device is described as an "Extraoral source x-ray system" for scanning phosphor plates and displaying digital images. It is not an AI algorithm intended to assist human readers in diagnosis. Therefore, an MRMC study assessing AI assistance is outside the scope of this device's function as described.

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

A "standalone" performance assessment was done in the sense that the intrinsic physical image quality metrics (MTF, DQE, theoretical resolution) of the device were measured and reported. These metrics reflect the device's inherent capability to produce high-quality images, independent of human interpretation or assistance. However, it's not an algorithm that performs a diagnostic task.

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

The ground truth for the MTF, DQE, and theoretical resolution measurements are based on physical properties and standardized test methods as outlined in IEC 62220-1:2003 ("Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the input properties of digital X-ray imaging devices"). This typically involves using phantoms and known physical inputs rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This device is a hardware imaging system, not an artificial intelligence algorithm that requires a training set.

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

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

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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 Intraoral View is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

The ScanX Intraoral View is a dental device that scans photostimulable phosphor storage plates that have been exposed in place of dental 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.

The provided document is a 510(k) premarket notification for a dental imaging device called ScanX Intraoral View. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria from an AI/algorithm performance perspective.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI/algorithm, a study proving device performance against such criteria, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment in the context of an AI/algorithm.

The document describes the device as a scanner that processes digital images from Phosphor Storage Plates (PSPs) and displays them on a computer monitor. It is not an AI/ML powered device, but rather a digital radiography system. The performance testing summarized focuses on:

• Safety testing: Electrical safety (IEC 61010-1), Electromagnetic Compatibility (EMC) (EN 61326-1), and Laser safety (IEC 60825-1).
• Imaging performance: Theoretical resolutions, MTF (Modulation Transfer Function), and DQE (Detective Quantum Efficiency) were measured with reference to IEC 62220-1:2003, as recommended by the FDA guidance for Solid State X-ray Imaging Devices.
• Software validation and risk analysis were performed.
• Cybersecurity was addressed per FDA guidance.

The document explicitly states: "Summary of clinical performance testing: Not required to establish substantial equivalence." This further confirms that no clinical study (which would typically assess performance against clinical acceptance criteria) was conducted or presented in this 510(k) submission.

In summary, the provided text does not describe an AI/ML-based device or a study proving its performance against acceptance criteria in the way your detailed questions imply for an AI/ML product.

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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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S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.

S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

The indications for use of the S-scan system, as described in its labeling, are the same as those of the unmodified S-scan system cleared via K063207.

The changes performed on the modified S-scan device, with respect to the cleared version - S-scan K063207 -, are due to the improvement of the system performance. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• 1. A device that locks the patient table in the current position, unless the user disconnects the coil cable.
• 2. A limb protection for patient table.
• 3. Modified pulse sequences.
• 4. A new software release.

The provided text is a 510(k) summary for the S-scan System, a Magnetic Resonance Imaging (MRI) device. It details modifications to an existing device (K063207) and compares its technological characteristics to several predicate devices.

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets these criteria, or any performance metrics from such a study.

The submission focuses on establishing substantial equivalence to previously cleared devices based on technological characteristics and intended use, rather than presenting new performance study data for approval. Therefore, I cannot complete the requested tables and information based on the input provided.

Here's a breakdown of what is present in the document, and what is not:

What is present:

• Device Name: S-scan System, Nuclear Magnetic Resonance Imaging
• Intended Use: Produces transversal, sagittal, coronal, and oblique cross-section images of limbs, joints, and the spinal column for diagnostic information when interpreted by a medical expert.
• Predicate Devices: S-scan (K063207), G-scan (K042236), Siemens Magnetom C! (K043030), Esaote Dynamic MRI Software (K061429), Siemens Syngo Multimodality Workstation (K010938).
• Modifications to the S-scan (K063207):
  • Device that locks the patient table.
  • Limb protection for the patient table.
  • Modified pulse sequences.
  • A new software release.
• Technological Characteristics Comparison: Detailed lists of pulse sequences and their parameters for the modified S-scan compared to the predicate S-scan (K063207), G-scan (K042236), and Siemens Magnetom C! (K043030). Also details image processing functions, networking functions, system access management, and accessories compared to predicate devices.

What is NOT present (and therefore cannot be provided in the requested format):

• Table of Acceptance Criteria and Reported Device Performance: No acceptance criteria or performance metrics are stated. The submission relies on demonstrating substantial equivalence to predicates, implying that if the technological characteristics and intended use are similar, the performance is also considered similar.
• Study details (Sample size, data provenance, number of experts, adjudication method, MRMC, standalone performance, ground truth type, training set size, ground truth for training set): The document does not describe any specific performance study conducted to assess the diagnostic accuracy or clinical effectiveness of the modified S-scan device. The "study" here is essentially a technical comparison for substantial equivalence.

In summary, the provided 510(k) summary focuses on demonstrating that the modified S-scan device is substantially equivalent to existing cleared devices based on its technological characteristics and intended use, rather than providing the results of a clinical performance study with specific acceptance criteria.

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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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Ask a specific question about this device

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

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

The provided document is an FDA 510(k) clearance letter for the SCANX Scanner. It states that the device is "substantially equivalent" to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than requiring new clinical trials to establish safety and effectiveness and detailed performance metrics as would be found in a PMA submission or a detailed study report.

Therefore, I cannot provide the requested information based on the given text. The document confirms the regulatory clearance but lacks the technical and performance data asked for in your prompt.

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