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Nanox.ARC X is a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients.

This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, physicists.

Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions.

This device is not intended for mammographic, angiographic, cardiac, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.

Nanox.ARC X is a stationary, floor-mounted, stand-alone digital tomosynthesis system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, from a single tomographic sweep. It serves as an adjunct to conventional radiography, for adult patients in recumbent positions. The system is intended for use in professional healthcare settings such as hospitals, clinics, and imaging centers by trained radiographers, radiologists, and physicists

The Nanox.ARC X includes a secured, dedicated off-the-shelf handheld operator console, a multisource, tiltable arc gantry with five identical tubes, a motorized patient table, and a flat panel detector of a scintillator-photodetector type. The image reconstruction service and DICOMization services can be hosted either locally or as part of the secured Nanox.CLOUD, according to customer preference. Nanox.CLOUD also hosts a protocol database service package.

The Nanox.ARC X X-ray tubes are operated sequentially, one at a time, generating multiple low-dose images acquired from different angles, during a single sweep, dividing the overall power requirements among the tubes. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions.

The acquired projection imaging data is anonymized and automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis image result reduces the effect of overlying structures and provides depth information on structures of interest. The resultant images are re-identified and sent using the DICOM protocol.

Here's an analysis of the provided FDA 510(k) clearance letter for Nanox.ARC X, focusing on the acceptance criteria and the study that proves the device meets those criteria.

Key Observation: The provided document is a 510(k) Clearance Letter. These letters primarily address the "substantial equivalence" of a new device to a predicate device, rather than providing detailed clinical efficacy trial results as would be found in a Premarket Approval (PMA) application or a de novo classification request. This type of clearance often relies heavily on non-clinical bench testing and technological comparisons to demonstrate that the new device is as safe and effective as a legally marketed predicate.

Therefore, the information regarding in-depth clinical studies (like MRMC studies, specific ground truth methods, or detailed acceptance criteria for diagnostic accuracy) is limited or absent in this document because it's not typically required for a 510(k) clearance based on substantial equivalence to an existing device with similar technological characteristics. The focus is on demonstrating that the modifications to the predicate device (Nanox.ARC) do not negatively impact its safety or effectiveness.

Acceptance Criteria and Device Performance Assessment

Based on the provided document, the "acceptance criteria" are primarily framed around demonstrating that the modified device (Nanox.ARC X) is as safe and effective as its predicate (Nanox.ARC), despite minor technological changes. The proof relies heavily on non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary focused on substantial equivalence and technological comparison, the "acceptance criteria" are inferred from the types of non-clinical tests performed to ensure the new device functions as intended and is as safe and effective as the predicate. The "reported device performance" are the general conclusions drawn from these tests.

Note: The level of detail provided in a 510(k) letter doesn't include specific quantitative metrics for each test, only a general statement that the system "functioned as intended" and overall safety/effectiveness are similar to the predicate.

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

• Test Set Sample Size: Not explicitly stated in terms of patient data. The testing described primarily involves bench testing, phantom studies, and system-level verification and validation. There is no indication of a clinical test set involving human patients as one might expect for a diagnostic accuracy study.
• Data Provenance: Not applicable in the context of clinical patient data for this 510(k) pathway, as no clinical tests were performed. The "data" comes from the results of the various non-clinical bench tests.

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

• Number of Experts: Not applicable. Since no clinical tests were performed on human patients and no diagnostic accuracy claims are being established through reader studies, there was no need for expert ground truth establishment for a clinical test set.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring expert adjudication was conducted.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was explicitly NOT done. The document states: "No clinical tests were performed for the subject device." This type of study would be a clinical test.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was done.

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

• Standalone Performance: The document does not describe a standalone diagnostic accuracy study of an AI algorithm. The device is a tomographic X-ray system, not an AI diagnostic algorithm, although it does include "image reconstruction service" and "DICOMization services." These are intrinsic functionalities of the imaging system itself, not separate AI components whose standalone diagnostic performance would be evaluated. The "Software Verification and Validation" likely covers the functional correctness of these reconstruction algorithms.

7. The Type of Ground Truth Used for the Test Set

• Type of Ground Truth: Not applicable for a clinical test set. The "ground truth" for the non-clinical tests would be the established engineering specifications, phantom measurements, and functional requirements against which the device's performance was measured (e.g., a known phantom structure for image quality, or expected electrical parameters for qualification).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This 510(k) is for a hardware device (X-ray system) with associated software for image reconstruction. It is not an AI/ML algorithm that undergoes a distinct "training" phase on a specific dataset for diagnostic interpretation. The image reconstruction algorithms are typically deterministic or based on established physics and signal processing, not on deep learning models trained on large image datasets.

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

• Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the context of an AI/ML diagnostic algorithm for which ground truth would be established. The "ground truth" for the development of image reconstruction algorithms would be based on mathematical models, physical principles of X-ray interaction, and calibrated phantom data to optimize image quality and accuracy.

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Nanox.ARC is a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients.

This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists.

Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions.

This device is not intended for mammographic, cardiac, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.

Nanox.ARC is a stationary, floor-mounted, stand-alone digital tomosynthesis system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, from a single tomographic sweep. It serves as an adjunct to conventional radiography, for adult patients in recumbent positions. The system is intended for use in professional healthcare settings such as hospitals, clinics, and imaging centers by trained radiologists, and physicists.

The Nanox.ARC includes a secured, dedicated off-the-shelf handheld operator console, a multisource, tiltable arc gantry with five identical tubes, a motorized patient table, and a flat panel detector type. The image reconstruction service and DICOMization services can be hosted either locally or as part of the secured Nanox.CLOUD, according to customer preference.

Nanox.CLOUD also hosts a protocol database service package.

The Nanox.ARC X-ray tubes are operated sequentially, one at a time, generating multiple low-dose images acquired from different angles, during a single sweep, dividing the overall power requirements among the tubes. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions.

The acquired projection imaging data is anonymized and automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis reduces the effect of overlying structures and provides depth information on structures of interest. The resultant images are re-identified and sent using the DICOM protocol.

The provided text is a 510(k) summary for the Nanox.ARC device. It mentions a "Clinical Sample Data evaluation" and confirms that the device can "generate diagnostic-quality images for the expanded Indications for Use," but it does not provide specific details on acceptance criteria or the study design and results as requested in the prompt.

Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes (for test/training), ground truth details, expert qualifications, or adjudication methods directly from the provided text. The document states that "The non-clinical performance testing conducted on the predicate device submitted under K222934 remain applicable to the subject device," implying that some of the detailed testing justification might reside in the predicate device's 510(k) submission (K222934).

However, I can extract the information that is present:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., sensitivity, specificity, image quality scores).
• Reported Device Performance: "Nanox.ARC System functioned as intended" and "generate diagnostic-quality images for the expanded Indications for Use. This includes the evaluation of complex and abnormalities of various sizes and shapes."

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

• Sample Size (test set): Not specified. The document mentions "clinical sample data" but not the number of cases.
• Data Provenance: Not specified.

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 specified.

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

• Not specified.

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

• An MRMC study is not mentioned. The device is described as an imaging system intended to produce tomographic images, with "adjunctive to conventional radiography." This phrasing suggests human interpretation of the images produced by the device, but not necessarily an AI-assisted interpretation workflow and its comparative effectiveness.

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

• The document implies the device generates images for human interpretation ("trained radiographers, radiologists, and physicists"). A standalone algorithm performance (without human-in-the-loop) is not discussed.

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

• Not specified. The document uses terms like "diagnostic-quality images" and "evaluation of complex and abnormalities," which generally implies comparison against established diagnostic standards, likely expert-interpreted images or clinical findings, but the specific type of ground truth (e.g., expert consensus, pathology, follow-up) is not detailed.

8. The sample size for the training set

• Not specified.

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

• Not specified.

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Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists. Digital Tomosynthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions. This device is not intended for mammographic, cardiac, pulmonary, intra-abdominal, intra-cranial, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.

Nanox.ARC is a tomographic and solid-state X-ray system (product codes IZF and MQB) intended to produce tomographic images of the human musculoskeletal system from a single tomographic sweep, as an adjunct to conventional radiography, on adult patients.

Nanox.ARC is a floor-mounted tomographic system that consists of a user control console, a multisource, tiltable arc gantry with five alternately-switched tubes, a motorized patient table, a flatpanel detector of a scintillator-photodetector type, and Protocols database and Image processing software packages.

Nanox.ARC utilizes several small-sized X-ray tubes that are independently and electronically switched, thereby dividing the overall power requirements over multiple tubes. Nanox.ARC utilizes a tilting imaging ring with five X-ray tubes, operated sequentially, one at a time, used to generate multiple low-dose X-ray projection images acquired from different angles during a single spherical (non-linear) sweep. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions.

The acquired projection imaging data is automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis image result reduces the effect of overlying structures and provides depth information on structures of interest. The image reconstruction service, as well as the system's protocol database and DICOMization services, can be hosted either locally or as part of the Nanox.CLOUD, according to customer preference. The resultant images are sent using the DICOM protocol.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly list specific quantitative acceptance criteria in a table format with separate reported device performance values for each criterion. Instead, it states that "Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device."

The "Table 2: Non-clinical Performance Data" lists various tests performed and reports a "PASS" for each, indicating that the device met the acceptance criteria for those specific tests.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Study Details:

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

   • Clinical Sample Evaluation (for image quality): Nine (9) Digital Tomosynthesis image cases were acquired from healthy adult human subjects (patients).
   • Phantom Performance Exams: Twelve (12) Digital Tomosynthesis phantom performance exams (total cases = 9 human + 12 phantom = 21 cases).
   • Data Provenance: From a clinical study conducted at Shamir Medical Center in Israel. The study appears to be prospective as it states "image cases were acquired from healthy adult human subjects (patients) from a clinical study conducted at Shamir Medical Center in Israel."

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

   • Number of Experts: One (1)
   • Qualifications: An ABR-certified radiologist.

3. Adjudication method for the test set:

   • Adjudication Method: Not explicitly stated, but with only one radiologist reviewing, there was no multi-expert adjudication mentioned (e.g., 2+1, 3+1). If only one expert makes the determination, it's effectively "none" in terms of reaching a consensus among multiple experts.

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:

   • MRMC Study: No, an MRMC comparative effectiveness study was not conducted. The clinical sample evaluation involved a single ABR-certified radiologist evaluating the diagnostic quality of the Nanox.ARC images themselves, "against a reference comparison which was the standard of care radiographies." This was a direct comparison of images, not a study on human reader performance with or without AI assistance.

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

   • Standalone Performance: Yes, the described "Bench Testing" and "Non-clinical Performance Data" table largely represent standalone algorithm and system performance without human intervention in the diagnostic interpretation loop. The "Image Quality" and "Phantom Validation" tests also assessed the device's output directly. The clinical sample evaluation by the radiologist was to evaluate the diagnostic quality of the images produced by the device, effectively assessing the device's standalone output for clinical utility.

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

   • Type of Ground Truth: For the clinical sample evaluation, the diagnostic quality of the Nanox.ARC images was evaluated by an ABR-certified radiologist "against a reference comparison which was the standard of care radiographies." This implies the "ground truth" was essentially the interpretive diagnostic quality determined by a single expert, compared to standard of care imaging. For the phantom studies, the ground truth would be based on the known physical properties and measurements within the phantoms.

7. The sample size for the training set:

   • Training Set Sample Size: The document does not provide any information regarding the sample size used for the training set of the Nanox.ARC system's image reconstruction or processing algorithms.

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

   • Training Set Ground Truth: The document does not provide any information on how ground truth was established for the training set.

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The product is intended as an X-Ray source for diagnosis. Operators of the Nano-x Cart X-Ray System are healthcare professionals familiar with and responsible for the X-Ray examinations being performed.

Indication for Use – The device is designed to perform radiographic X-Ray examinations of hands, wrists, and fingers, on adult patients.

Limitations for use – This device is not intended for general radiographic X-Ray examinations other than the indicated use, or for mammographic, angiographic, interventional, or fluoroscopic applications. This device is not intended for pediatric use.

The Nanox Cart X-Ray system is a mobile X-Ray system designed to perform radiographic X-Ray examinations of hands, wrists, and fingers, on adult patients. The system facilitates X-ray examinations in situations where it is not possible to transport the patient to a ward with fixed equipment.

The Nanox Cart X-Ray system consists of a mobile system enclosure; an X-Ray tube assembly consists of the X-ray Tube, Cooling Fluid, electronics, and casing; a pulse generator and a highvoltage generator; a microprocessor that provides increased exposure consistency and efficient operation; and a touch-based screen LCD which provides a simple and user-friendly interface and technique selection.

The Nanox Cart is specified and designed to operate only with a Flat Panel Digital X-ray Detector Model EVS3643, manufactured by DRTECH Inc. (K162552)

The intended operators of the Nanox Cart X-ray System are healthcare professionals familiar with and responsible for the X-ray examinations being performed.

To minimize electrical, mechanical, and radiation hazards, the Nanox Cart X-ray System adheres to recognized and established industry practices and standards.

Here's a summary of the acceptance criteria and study information for the Nanox Cart X-ray System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of quantitative acceptance criteria from a clinical performance study. Instead, it relies on a qualitative assessment from a phantom imaging study. The implicit acceptance criterion from the phantom study is:

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

• Sample Size: The document refers to the use of "commercial products manufactured by Kyoto Kagaku" as phantoms. It doesn't specify a numerical sample size for the test set of phantoms. It states "The phantoms represent different hands."
• Data Provenance: The study was a phantom imaging study, not involving human subjects. The phantoms were "commercial products manufactured by Kyoto Kagaku." The study was conducted by Nano-x Imaging Ltd. (Israel).

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

• Number of Experts: Three experts ("clinical evaluations of three experts")
• Qualifications of Experts: Not specified in the document.

4. Adjudication Method

The document states, "Professional evaluation of the output and professional comparison between the Nanox Cart X-Ray system and predicate device's output demonstrate that the outcome images of the Nanox Cart X-Ray system are as good as an X-Ray system available in market. Based on the clinical evaluations of three experts it can be concluded that the Nanox Cart X-Ray system operates as intended and generates images that are as good as images produced by the predicate Device."

This suggests a consensus or independent review by the three experts, but a specific adjudication method (e.g., 2+1, 3+1) is not detailed. It appears to be a qualitative assessment leading to a conclusion of "as good as."

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 comparative effectiveness study was mentioned. The device is an X-ray system, not an AI-powered diagnostic tool, so reader improvement with AI assistance is not applicable in this context.

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

This is not applicable as the device is an X-ray imaging system, not an algorithm, and is used with a human operator. The performance evaluation focused on the quality of the generated X-ray images.

7. The Type of Ground Truth Used

The ground truth for the phantom study was implicitly the inherent properties and known structures of the commercial phantoms. The evaluation by experts compared the generated images against a qualitative standard of "as good as" images from a predicate device or other market-available systems. This is more akin to expert consensus on image quality rather than a definitive pathology or outcomes data from patients.

8. The Sample Size for the Training Set

No training set is mentioned as this device is an X-ray imaging system, not an AI/ML algorithm that requires training data in the traditional sense.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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