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Non-Sterile Zirconia Block (Model name: ARENA Star, Galaxy Star) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. All zirconia block are processed through dental laboratories or by dental professionals.

Non-Sterile Zirconia Block (Model name: ARENA Star, Galaxy Star) used to produce dental restoration to support designing computer for dental use and to process cutting as a manufacture unit, on which CAD/CAM system is applied for processing and sintering. After application, this material cannot to be reused for fabrication.

The provided FDA 510(k) clearance letter pertains to a Non-Sterile Zirconia Block used for dental restorations. This document focuses on demonstrating the substantial equivalence of the new device (ARENA Star, Galaxy Star) to a predicate device (Non-Sterile Zirconia Block, K223253) based on its material properties and chemical composition, not on an AI or software-driven diagnostic or assistive system.

Therefore, the requested information about acceptance criteria, study design for AI performance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance does not apply to this submission. This is a material science and manufacturing equivalency clearance, not a performance study for AI.

However, I can extract the acceptance criteria related to the material properties and the type of non-clinical testing performed.

Updated Information based on the provided document:

Acceptance Criteria and Device Performance for ARENA Star, Galaxy Star (Non-Sterile Zirconia Block)

The acceptance criteria for this device are based on demonstrating mechanical and biological equivalence to a predicate device and adherence to international standards for dental ceramic materials.

1. Table of Acceptance Criteria and Reported Device Performance:

The remaining information requested is typically relevant for AI/ML-based medical devices, which operate on analyzing data (e.g., images, signals) and often involve performance metrics like sensitivity, specificity, accuracy, and comparisons to human expert performance. This 510(k) submission is for a physical medical device (zirconia block), where the "study" demonstrating criteria fulfillment is primarily non-clinical bench testing and chemical analysis to confirm material properties and biocompatibility.

Therefore, for aspects like "Sample size for the test set," "Experts used to establish ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Type of ground truth," "Training set sample size," and "Ground truth for the training set" – these points are not applicable to this specific device and the information provided in the 510(k) clearance letter. The "ground truth" here is established through standardized material testing methods and chemical analysis, not through expert interpretation of data.

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The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable bronchoscope under continuous and direct control by a physician operator. The Galaxy System™ includes full procedure navigation that integrates a pre-operative computed tomography scan to display scope tip location relative to the pre-operative scan anatomy. Additionally, Galaxy integrates a tomosynthesis spin to update the scope and target position to overcome any changes in anatomy not reflected in the pre-op CT scan.

The provided document focuses on the substantial equivalence of the Noah Medical Galaxy System to a predicate device (Monarch Endoscopy Platform) and a reference device (superDimension Navigation System). It details various performance tests conducted to support this claim, but it does not explicitly define specific acceptance criteria with numerical thresholds for device performance, nor does it present a study that reports numerical device performance against such criteria.

Instead, the document broadly states that the device has been "successfully tested" and "meets the intended user needs". It also mentions a simulated use study where users were able to "navigate to within 30 mm of the lesion, complete tomosynthesis, and acquire tissue". However, this is described as a capability demonstrated rather than a performance metric achieved against a pre-defined acceptance criterion.

Therefore, I cannot fully complete the table for acceptance criteria and reported device performance as requested, as these specific numerical values and direct comparisons are not present in the provided text.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, no explicit numerical acceptance criteria or corresponding reported device performance metrics are provided in the document. The performance data section describes general testing and findings without quantifiable acceptance thresholds.

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

The document mentions "human cadaver and animal models" for "Design Validation testing" and "Simulated Use" testing. It also refers to "representative users" for "Human Factor Usability Testing."

• Test Set Sample Size: Not explicitly stated as a number. The document refers to "human cadaver and animal models" and "representative users" without specifying the quantity.
• Data Provenance: The testing was performed by Noah Medical, implying it's internal study data. The document does not specify the country of origin of the cadavers or animals, nor does it explicitly state whether the study was retrospective or prospective, though design validation and usability testing are typically prospective.

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

The document does not describe a process for establishing ground truth for a test set through expert consensus in the context of clinical performance evaluation against a specific gold standard. The focus of the performance testing described is on functional verification, safety, and usability.

• For the simulated use, "The user group included physicians who have been trained and are actively using the predicate and reference devices." The number of these physicians is not specified, and their specific role in establishing "ground truth" (as opposed to being subjects performing tasks) is not detailed.
• Qualifications of these physicians are generally described as "trained and actively using the predicate and reference devices," suggesting experience with similar bronchoscopic navigation systems.

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing focuses on functional and usability aspects rather than diagnostic or clinical accuracy requiring expert review and adjudication of findings.

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

The document does not mention a MRMC comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The performance data focuses on the device's functionality, safety, and usability, demonstrating substantial equivalence to predicate devices, not on the comparative effectiveness of AI-assisted vs. unassisted human performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not explicitly describe a standalone algorithm performance study. The Galaxy System's navigation component is integrated and described as used by physicians: "The Galaxy System enables a physician to utilize electro-mechanical articulation for precise control... By utilizing electromagnetic field-based sensors on the tip of the endoscope tip location relative to the pre-operative scan anatomy is continuously displayed." The software verification and validation section confirms that "Galaxy System software conforms to the design specifications and meets the intended use and needs of the intended users," but this is about software correctness rather than a standalone performance metric against a clinical ground truth.

7. Type of Ground Truth Used

For the simulated use testing, the "ground truth" for navigation was implicitly the ability to "successfully navigate to a peripheral lung lesion" and reach "within 30 mm of the lesion." This appears to be based on an expected outcome in the cadaver/animal models, rather than a clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This suggests the described performance testing is for validation, not for the training of a machine learning model, or if there was training, its details are not included in this summary.

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

As no information about a training set is provided, how its ground truth was established is also not available in this document.

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MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

The MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems consist of three components: a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately.

The Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter. The microcoil is the implantable segment of the device and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable).

For the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT microcoils: The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture and then formed into a secondary shape. The secondary shape may be spherical, complex, or helical.

For the GALAXY G3 Mini microcoils: The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which contains a polypropylene suture (SR) and then formed into a secondary shape. The secondary shape is complex.

For all Microcoil Delivery Systems: The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The Device Positioning Unit includes five (5) fluoro saver markers on the proximal section of the shaft. The markers are intended to indicate when the tip of the microcoil is approaching the tip of the microcatheter. When the distal-most marker reaches the proximal end of the Rotating Hemostatic Valve (RHV) on the microcatheter, the tip of the coil is approaching the tip of the microcatheter and fluoroscopy should be used to guide further coil insertion.

The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool.

The ENPOWER Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB.

The connecting cables may be one of two types: one with a remote detach button (the ENPOWER Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The ENPOWER Detachment Control Box, catalog no. DCB2000500, works with the ENPOWER Control Cable and with the standard connecting cable.

The provided text describes a 510(k) premarket notification for microcoil delivery systems, which are medical devices, not an AI/ML powered device. Therefore, a study proving an AI/ML device meets acceptance criteria is not presented in this document.

The document discusses non-clinical performance data for the microcoil delivery systems, specifically focusing on verification and validation testing of minor design modifications related to the Device Positioning Unit's core wire.

Here's the information regarding the device's acceptance criteria and the study that proves it meets them, based on the provided text, adapted for the context of a medical device rather than an AI/ML system:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "Samples" in the results, but doesn't quantify the number of units tested for each criterion.
• Data Provenance: The tests were conducted internally as "bench testing." The country of origin is not specified, but the applicant, Medos International SARL, is located in Le Locle, Switzerland. The testing is retrospective, as it's part of a 510(k) submission for an already manufactured device with minor modifications.

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

This is not applicable as the study involved non-clinical bench testing of a physical medical device, not a diagnostic or prognostic system requiring expert interpretation of data or images. The "ground truth" here is determined by the physical properties and performance measured during the tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements of physical performance and do not involve human adjudication in the typical sense of reviewing subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and no MRMC study was performed. The document explicitly states: "Clinical studies were not required as appropriate verification and validation of the minor design modifications was achieved based on the bench testing."

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was defined by objective physical measurements and engineering specifications, which determine whether the device meets its design requirements. For example, "tracking force" would have a specified maximum force for successful delivery, and "microcatheter stability" would have an acceptable range of movement.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML context.

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

Not applicable. As above, there is no AI/ML training set.

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The Akesis Galaxy RTi Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures for adults.

The Akesis Galaxy RTi, is a medical teletherapy device, which contains (30) Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimators and a blocking position. consists of a) The y-ray treatment unit, and b) interface to a stereotactic localization system, and c) kV x-ray positioning and verification system

The provided text describes a medical device, the Akesis Galaxy RTi Rotating Gamma System, which is a radionuclide radiation therapy system intended for stereotactic irradiation of human head structures in adults. The submission is a 510(k) premarket notification, indicating the device is being compared to a legally marketed predicate device (Akesis Galaxy RTx Rotating Gamma System).

Based on the provided information, the study focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria in the context of diagnostic accuracy (e.g., sensitivity, specificity) derived from a clinical study with a test set, ground truth, and expert readers.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific acceptance criteria in the form of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the device's clinical application. Instead, acceptance criteria are aligned with demonstrating substantial equivalence to a predicate device and complying with recognized standards.

Regarding the Absence of Diagnostic Performance Studies for AI/Machine Learning Devices:

It is crucial to note that this 510(k) submission is for a radionuclide radiation therapy system, which is a physical device used for treatment. It is not an AI/machine learning diagnostic device where performance is typically measured in terms of sensitivity, specificity, or AUC against a ground truth established by experts. Therefore, many of the questions regarding sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this type of device and submission.

The "study that proves the device meets the acceptance criteria" in this context refers to engineering tests, verification and validation activities, and comparisons of technical characteristics to a predicate device, rather than a clinical trial assessing a diagnostic AI algorithm.

Here's a breakdown for the N/A questions:

2. Sample size used for the test set and the data provenance: N/A (Not an AI/diagnostic device clinical study). The performance data cited are related to engineering and safety standards compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth as understood in AI/diagnostic performance studies is not applicable here).

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this device does not involve human readers interpreting images with or without AI assistance for diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a therapeutic device, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" here is compliance with engineering standards and specifications, not clinical diagnostic accuracy.

8. The sample size for the training set: N/A. (Not an AI/machine learning algorithm).

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

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The Akesis Galaxy RTx Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures.

The Akesis Galaxy RTx, is a medical teletherapy device, which contains (30) Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimators and a blocking position.

The rotating gamma system focuses the thirty beams and combining their individual doses at the target. The design of the system automates the treatment delivery by moving the target to the focal point, while the patient's head is immobilized in a headframe which has been fitted prior to the commencement of treatment. The entire system consists of a) the y-ray treatment unit, and b) the stereotactic localization system.

The provided text describes the 510(k) premarket notification for the Akesis Galaxy RTx, a radionuclide radiation therapy system. It details the device's technical characteristics, its comparison to a predicate device, and various performance data submitted in support of its substantial equivalence.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance for diagnostic or assistive functions related to image analysis or data processing. The device described is a physical radiation therapy system, and the performance data pertains to its safety, electrical compatibility, hardware/software verification, and its ability to meet specifications for radiation delivery.

Therefore, I cannot provide the requested information for an AI/ML device, as the provided text relates to a different type of medical device for radiation therapy.

If you have information about an AI/ML device and its associated acceptance criteria and study data, please provide that text.

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The Akesis Galaxy Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures

The Galaxy Rotating Gamma System is a teletherapy device which contains 30 cobalt - 60 sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built in" secondary collimator, which has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the cobalt -60 y-ray beams during treatment, 30 non overlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The v-ray treatment unit, and b) the stereotactic localization system.

Here's a breakdown of the requested information based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (Akesis Galaxy Rotating Gamma System). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical trial data or detailed performance metrics against specific acceptance criteria for diagnostic output. Therefore, many of the typical elements requested for AI/diagnostic device studies will either not be applicable or will have limited information.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, explicit "acceptance criteria" against diagnostic performance metrics (like sensitivity, specificity, accuracy) are not provided in the document. Instead, the focus is on engineering performance, safety, and equivalence to a predicate device.

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

No specific "test set" for diagnostic performance is mentioned as this device is a therapeutic radiation delivery system, not a diagnostic imaging or AI algorithm. The performance data provided relates to engineering and safety testing.

• Sample Size for Test Set: Not applicable in the context of diagnostic/AI performance testing. The "test sets" would be the units of the device itself undergoing various engineering and safety tests.
• Data Provenance: Not specified, but likely laboratory and manufacturing testing environments for engineering and safety verification.

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

Not applicable. This device does not establish a "ground truth" in the diagnostic sense, nor does it rely on human expert interpretation for its function. The "ground truth" for engineering and safety testing would be established by validated test procedures, reference standards, and regulatory requirements rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. There's no physician-based adjudication process for the engineering and safety performance of a radiation therapy system described here.

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

No. An MRMC study is typically for evaluating the diagnostic performance of an AI algorithm with and without human assistance. This device is a radiation therapy system, not a diagnostic AI tool, and thus such a study is not relevant or reported in this document.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI algorithm but a physical medical device. The "standalone performance" is implicitly covered by the engineering and safety tests described, demonstrating that the device functions according to its specifications.

7. Type of Ground Truth Used

For the engineering and safety tests, the "ground truth" consists of:

• Compliance with recognized international standards (e.g., ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 61217, 62274, 62366).
• Compliance with regulatory requirements (21 CFR §820).
• Conformance to the device's own internal design specifications and requirements.

8. Sample Size for the Training Set

Not applicable. This device is a hardware system, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no "training set."

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The device is intended to be used for the tanning of human skin.

The series of tanning bed/booths are available in four configurations. Units consist of LPI, Inc. branded and OEM tanning beds and booths.

• ESB -14, 16, 18, 24, and Oasis 36(booth)
• Solar Storm 16R, 24S, 24R, 24C, 32S, 32R, 32C, 36ST, 48ST(Booth)
• Solar Wave 16, 24
• . Sunco - 16XS, 24XS, 32XS, and 48Vertical (Booth)
  Each configuration consists of a metal structure with lamps placed equally distant horizontally (booths) and arranged in manner to provide the tanner an even tan. The user of tanning beds lies down on the bench section and pulls down the canopy cover, which is equipped with a counterweighted gas springs/shocks in order for this section of the bed to open and close. The user of a tanning booth stands within the sections of the booth. The section of the booth (door) also has gas springs/shocks and wheels to close the door. All units have electronic type ballasts that powers the lamps. Each unit is also equipped with a settable electronic timer which is controlled by a time setting of 10, 15, or 20 minutes. Timers are also equipped with an "off" button to allow user to turn off the lamps any time prior to the duration of the set timer.

This document is a 510(k) summary for tanning units (tanning beds/booths). It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device. Instead, it demonstrates substantial equivalence to predicate devices and adherence to existing regulations for sunlamp products.

Therefore, many of the requested sections about specific acceptance criteria, study sizes, expert involvement, and AI performance metrics are not applicable to this document.

Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is not available:

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

This document does not present a table of acceptance criteria for a new performance claim, nor does it report device performance in terms of metrics like sensitivity, specificity, or accuracy (which would be relevant for an AI/ML device). Instead, it confirms adherence to established standards and guidelines for sunlamp products.

The key "performance criteria" that are implicitly met are:

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

Not applicable. This is not a study involving a test set of data as for an AI/ML device. The "testing" refers to quality control and compliance checks on the physical tanning units.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth establishment by experts is not described for this type of device submission.

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

Not applicable.

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

Not applicable. This device is a tanning unit, not an AI-assisted diagnostic or interpretive system.

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

Not applicable.

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

The "ground truth" implicitly used here relates to established regulatory standards and guidance for sunlamp products (e.g., maximum UV irradiance, electrical safety standards, biocompatibility standards). These are not clinical outcomes or expert consensus on clinical data.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

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The Galaxy R Digital Radiography Upgrade is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in all general purpose diagnostic procedures. Not for mammography.

This device is medical image acquisition device. X-rays generated by X-ray generator/ tube that penetrate patient's body are converted to a digital file by the detector. After that the detector sends this digital file to a personal computer (via Ethernet) where the companion software has been installed. This software was cleared in our previous submission, K132921, and it has not been modified. A monitor displays this image. Images can then be transferred via the DICOM protocol. There are four models available, two are 14″ x 17″ and two are 17″ x 17″ (Available in either CSI or GOS scintillator versions). The user must supply the x-ray generator and tubestand to form a full system. Exposure can be Generator Synchronous, or via - AED (Auto Exposure Detection). The technology is Amorphous Silicon (a-Si) Photodiode coupled with either the Gadox or Cesium Iodide scintillators, same as in the predicate.

This document is an FDA 510(k) summary for the Galaxy R Digital Radiography Upgrade, a device intended to replace radiographic film/screen systems in general-purpose diagnostic procedures (excluding mammography). The submission aims to demonstrate substantial equivalence to the predicate device, Atlaim ATAL 8C (K113812).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" is not explicitly defined in terms of specific performance thresholds that the device must meet in a formal, quantifiable sense within this 510(k) summary. Instead, the document focuses on demonstrating substantial equivalence to a predicate device. This is primarily achieved through a comparison table highlighting technological characteristics. The "performance" is implicitly compared to the predicate, with minor differences deemed not to have a material effect on safety or effectiveness.

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

• Sample Size (Test Set): Not explicitly stated with a specific number of images. The document states "Clinical images of actual patients were submitted."
• Data Provenance: Not explicitly stated (e.g., country of origin). The images were from "actual patients," implying retrospective or prospective clinical acquisition, but the specific study design for the clinical images is not detailed.

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

• Number of Experts: Singular, "Board Certified Radiologist."
• Qualifications of Experts: "Board Certified Radiologist." No specific experience in years is mentioned.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states that the clinical images "were evaluated by Board Certified Radiologist and found to be of excellent diagnostic quality." This implies a single expert review for quality, not a consensus-based adjudication for ground truth for diagnostic accuracy.

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 upgrade to a digital radiography system, not an AI-assisted diagnostic tool.

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

Yes, in a sense. The "non-clinical tests" section describes bench testing for imaging characteristics like MTF and DQE, which are measurements of the device's technical performance independent of human interpretation. The "clinical images" were used to show the complete system works as intended, evaluated by a radiologist. This suggests standalone performance of the image acquisition hardware, with a human validating the output quality.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests (MTF, DQE), the "ground truth" is derived from physical measurements and technical standards in accordance with the FDA Guidance Document on Solid State Imaging Devices.

For the clinical images, the ground truth is expert opinion/evaluation by a single Board Certified Radiologist, who deemed them to be "of excellent diagnostic quality." This is a qualitative assessment of image quality for diagnostic purposes, not a definitive ground truth for specific pathologies or outcomes.

8. The Sample Size for the Training Set

The document does not mention any training set. This device is a digital radiography upgrade, not an AI/machine learning algorithm requiring a separate training set.

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

Not applicable, as no training set is mentioned for this type of device submission.

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The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.

Temporary stabilization of the femur, tibia and ankle in conditions and procedures, such as:

• comminuted open or closed fractures
• polytrauma patient
• damage control orthopedics for fractures with severe soft tissue injuries
• peri-prosthetic or peri-implant fractures
• joint dislocations, intra- and extra-articular injuries where spanning fixation is needed
• intra-operative fracture reduction
• intermediate stabilization in staged surgery
• infected non-union pending second stage treatment bone-loss or other reconstructive procedures.

The Galaxy UNYCO System consists of a series of sterile kits that include clamps, rods, screws and specific application tools. An external fixation system, as the subject device, is modular and so different frame configurations are possible. The Orthofix components in the Galaxy UNYCO System are not intended to replace normal healthy bone or to withstand the stresses of weight bearing. The Galaxy UNYCO System is compatible with Galaxy Fixation System and bicortical screws.

Here's an analysis of the provided text regarding acceptance criteria and studies, organized as requested.

The provided document describes the Galaxy UNYCO System, which is an external fixation device. This device is exempt from the typical AI/machine learning evaluation criteria, as it is a mechanical device, not a diagnostic algorithm. Therefore, many of the requested fields (such as effect size of human readers with AI, standalone performance, training set details, and expert ground truth establishment for AI) are not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, mechanical performance, and biocompatibility, as is typical for traditional 510(k) submissions for mechanical devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Galaxy UNYCO System are based on its mechanical performance and biocompatibility, demonstrating that it meets established standards for external skeletal fixation devices and medical-grade materials. The reported performance indicates that the device met or exceeded these requirements.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Focusing on Mechanical Device Evaluation)

As this is a mechanical device, the "study" primarily refers to bench testing and material characterization, not clinical trials or AI performance evaluations.

• Sample size used for the test set and the data provenance: Not explicitly stated in terms of a "sample size" for a test set as would be for an AI model. The evaluation involved mechanical testing of device components and biocompatibility testing of materials. The data provenance would be laboratory testing conducted by or for Orthofix Srl. No specific country of origin for this testing data is provided, but Orthofix Srl is located in Italy.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical devices is established through engineering specifications, material science, and established international standards (e.g., ASTM, ISO), not by expert consensus in diagnosing cases.
• Adjudication method for the test set: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, common in diagnostic imaging studies for AI.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
• The type of ground truth used:
  • Mechanical: Engineering specifications and performance defined by international standards (ASTM F1541-02e1, ASTM F899-12b, ASTM F543-13e1).
  • Biocompatibility: Standards for non-pyrogenicity and material safety (USP 38:2014, ANSI/AAMI ST72:2011).
• The sample size for the training set: Not applicable. This is not an AI device and does not have a "training set" in the machine learning sense. The design and material choices are based on established engineering principles and prior knowledge.
• How the ground truth for the training set was established: Not applicable.

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• 1. Direct anterior and posterior restorations (including occlusal surfaces)
• 2. Direct veneers
• 3. Correction of tooth position and tooth shape
• 4. Indirect restorations including inlays, onlays and veneers
• 5. Intraoral repairs of fractured restorations
• 6. Core build-ups
• 7. Splinting

The subject devices (Medi galaxy Flow, Medi Classic, Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior.Medi White Pearl) are visible light-cure, radiopaque restorative material (Composite) with high polishingability, excellent physical properties and are designed for anterior and posterior restorations. The subject devices formulated from multifunctional methacrylate monomer-based resin, photo initiator, silanated inorganic filler and pigments. Available in multiple shades. These restoratives provides high strength and low wear for durability. They are packaged in traditional syringes and Pre-Loaded Tips.

The provided FDA 510(k) document (K170873) is for a dental restorative material, not an AI-powered diagnostic device. Therefore, the typical acceptance criteria and study designs relating to AI performance metrics (like sensitivity, specificity, F1-score, reader studies, etc.) are not applicable here.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on physical and mechanical properties, chemical composition, and biocompatibility, as per the requirements for Class II medical devices like tooth shade resin materials.

Here's a breakdown of the relevant information provided, adapted to the context of a material rather than an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with ISO 4049:2009 for "Dentistry - Polymer-based restorative materials" and substantial equivalence to the predicate device (Clearfil Majesty ES-2) across various physical and performance properties. The "reported device performance" refers to the measured values for the subject devices and the predicate device.

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

• Sample Size: The document does not explicitly state the sample size (n-value) for each physical and mechanical property test. It provides mean values and standard deviations, which implies repeat measurements were taken, but the exact number of samples per test is not detailed.
• Data Provenance: The data is generated from non-clinical performance testing of the subject devices themselves, and for comparison, the predicate device. The country of origin for the data generation and whether it's retrospective or prospective is not specified, but it would typically be prospective laboratory testing conducted by the manufacturer or a contracted lab.

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

This question is not applicable. The "ground truth" for material properties is established through standardized laboratory testing methods (e.g., ISO 4049:2009), not through expert clinical consensus or interpretation in the way AI models are evaluated.

4. Adjudication Method for the Test Set

This question is not applicable as there is no expert adjudication for material properties. Compliance is determined by objective measurements against established international standards.

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

This question is not applicable. MRMC studies are used for evaluating diagnostic accuracy with human readers, which is not relevant for a dental restorative material.

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

This question is not applicable. This is not an AI algorithm. The performance data presented are "standalone" in the sense that they describe the intrinsic physical and chemical properties of the material itself.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements obtained through standardized laboratory testing protocols as defined by ISO 4049:2009 and comparison to the well-established performance of a legally marketed predicate device.

8. The Sample Size for the Training Set

This question is not applicable. There is no AI model, therefore, no training set.

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

This question is not applicable as there is no AI model or training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a non-clinical performance testing program based on the international standard ISO 4049:2009 (Dentistry - Polymer-based restorative materials). The manufacturer tested the physical and mechanical properties of the subject devices (Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Plus, Medi Opaque Posterior, Medi White Pearl) and compared them to a legally marketed predicate device, Clearfil Majesty ES-2, which also complies with ISO 4049:2009.

The study demonstrated that:

• The subject devices' measured physical properties (e.g., radiopacity, compressive strength, flexural strength, depth of cure, water sorption, water solubility) fall within very similar values to those of the predicate device.
• The chemical ingredients of the subject devices are all used in the predicate devices.
• The subject devices, like the predicate, comply with ISO 4049:2009.
• The biocompatibility is considered acceptable because the chemical ingredients are common to the predicate device, which has no reported post-market adverse events.

These findings support the conclusion that the subject devices are substantially equivalent in performance to the predicate device and thus meet the necessary acceptance criteria for marketing.

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