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Sphere/Asphere:
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the spherical/aspheric design are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

Toric:
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the toric design are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

Multifocal:
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the multifocal design are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use. The VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are tinted to enhance or alter the apparent color of the eye.

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from mififilcon A. which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lenses consist of 40.0% mififilcon A and 60.0% water by weight when immersed in saline solution. The mififilcon A name has been adopted by the United States Adopted Names Council (USAN).

The VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens contains phthalocyanine blue (21 CFR Part 74.3045) for visibility and handling. The VizionFocus Color (miffilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green, Mica.

When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >80% in the UVA range (316mm - 380mm). The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are manufactured in spherical/aspheric, toric, and multifocal design configurations.

The provided text describes the 510(k) submission for VizionFocus contact lenses, demonstrating their substantial equivalence to predicate devices. However, this submission does not contain acceptance criteria or study details for an AI/ML powered medical device. The document pertains to contact lenses, which are physical medical devices, not software-based AI/ML devices. Therefore, a table of acceptance criteria and study proving an AI device meets acceptance criteria cannot be extracted from this text.

The information provided describes:

• Device Type: VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens. These are physical contact lenses, not an AI/ML powered device.
• Study Purpose: To demonstrate the safety and effectiveness of the contact lenses by comparing them to legally marketed predicate devices, establishing substantial equivalence. This is a typical regulatory pathway for physical medical devices.
• Studies Conducted: Non-clinical performance testing (biocompatibility/toxicology, shelf life, bench tests like refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, and polymerization residuals) and a clinical study.
• Clinical Study Design: Multi-center, single-masked (examiner), bilateral, randomized concurrent-control study with 91-day treatment follow-up.
• Clinical Study Sample Size: 120 subjects enrolled (60 test, 60 control), 117 completed.
• Clinical Study Data Provenance: Not explicitly stated, but typically clinical trials for FDA submissions are conducted in the US or in compliance with international standards that are accepted by the FDA. The indication of a multi-center study implies diverse geographic recruitment within the study's operational regions.
• Ground Truth: For the clinical study, the ground truth was established through biomicroscopy findings, symptoms, adverse reactions, and vision safety measures (keratometry changes, refractive changes, best corrected visual acuity) observed and recorded by examiners. There is no mention of expert consensus, pathology, or outcomes data in the context of establishing ground truth for an AI model.

The prompt specifically asks for details around an AI/ML powered medical device's acceptance criteria and study, which are not present in the provided text.

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The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.

Avascular necrosis of the femoral head.

Acute traumatic fracture of the femoral head or neck.

Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, surface replacement arthroplasty, or total hip replacement.

The M-Vizion Monobloc is a range extension to the already cleared M-Vizion Femoral Revision System (K201471, K191816 and K170690).

The M-VIZION Monobloc Stem is a monobloc cementless stem intended to be used for hip arthroplasty, in primary or revision surgeries. It shows a fluted tapered distal portion made of forged Ti-6Al-7Nb alloy according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6- Aluminium 7-Niobium Alloy coated with a titanium coating. TiGrowth®-C (Medacta commercial name: Mectagrip); a proximal portion coated with Titanium Ti ASTM F 1580 and it is sandblasted distally.

The available size are:

• Length L190 mm ø12-26 mm STD/LAT; .
• Length L240 mm ø12-26 mm STD/LAT;
• Length L290 mm ø12-26 mm STD/LAT. ●

The two versions STD/LAT have the following geometrical details:

• STD: CCD angle 132°, offset 37 mm; .
• LAT: CCD angle 132°, offset 43 mm. ●

The M-VIZION Monobloc Stem is a range extension of the M-VIZION Modular Stem, from which it leverages most of the geometrical features such as the stem taper angle, the flutes design, the shape of the neck and proximal portion, and the Ti coating. Differently from the M-VIZION Monobloc Stem, the M- VIZION Modular Stem includes also a Locking Screw to fix the two parts.

The provided text is a 510(k) summary for the M-Vizion Monobloc hip prosthesis. It describes the device, its indications for use, comparison to predicate devices, and performance data. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/algorithm performance.

The document states: "No clinical studies were conducted." and focuses on non-clinical performance tests (Range of motion, FEM analysis) and biocompatibility for the physical implant. It is a submission for a medical device, not an AI/algorithm-driven product where acceptance criteria and performance metrics (like sensitivity, specificity, etc.) for an AI would be relevant.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here is a breakdown of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not available. The document is for a physical hip prosthesis, and the "performance data" refers to mechanical properties and biocompatibility, not AI performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. There is no AI test set mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no AI ground truth establishment mentioned.
4. Adjudication method: Not applicable. No expert adjudication is mentioned relevant to AI performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "No clinical studies were conducted."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used: Not applicable. No AI ground truth is mentioned.
8. The sample size for the training set: Not applicable. No AI training set is mentioned.
9. How the ground truth for the training set was established: Not applicable. No AI training set ground truth is mentioned.

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The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.

Hip Replacement is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.

• · Avascular necrosis of the femoral head.
  · Acute traumatic fracture of the femoral head or neck.

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The M-Vizion Femoral Revision System Extension implants are a range extension to the already cleared M-Vizion Femoral Revision System (K191816 and K170690). The range extension includes proximal bodies with holes and distal stems 4°.

The M-Vizion Femoral Revision System a is modular cementless stem intended to be used for hip arthroplasty, primary or revision. The system is composed of proximal body, distal stem and locking screw. The proximal body and the distal stem are intended to be assembled together on a conical coupling and tightened by the locking screw.

The locking screw provided with the subject proximal bodies is the same component cleared with the predicate devices. M-Vizion Femoral Revision System K191816 and K170690.

The proximal body is made of titanium alloy (Ti6A17Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy and coated with a titanium coating, TiGrowth®-C (Medacta commercial name: Mectagrip). The distal stem is made of titanium alloy while the locking screw is made of titanium alloy and coated with TiNbN.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "M-Vizion Femoral Revision System Extension." It is for a hip prosthesis.

The provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device. This document is for a traditional medical device (hip prosthesis) and focuses on demonstrating substantial equivalence to previously cleared predicate devices through materials, design, and mechanical testing, rather than algorithmic performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size used for the test set and data provenance.
3. Number of experts to establish ground truth and qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The "Performance Data" section explicitly states:

• "No clinical studies were conducted."
• Performance data provided is related to "DESIGN VALIDATION and CHARACTERIZATION TESTING" for mechanical properties (e.g., fatigue tests) and "PYROGENICITY" testing, not AI/ML model performance.

This document clearly pertains to a physical orthopedic implant, not a software-driven device requiring performance evaluation based on AI/ML metrics.

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The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.

Hip Replacement is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.

• · Avascular necrosis of the femoral head.
  · Acute traumatic fracture of the femoral head or neck.

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The M-Vizion Femoral Revision System is modular cementless stem intended to be used for hip arthroplasty, primary or revision. The system is composed of proximal body, distal stem and locking screw. The proximal body and the distal stem are intended to be assembled together on a conical coupling and tightened by the locking screw.

The proximal body is made of titanium alloy (Ti6Al7Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy and coated with a titanium coating, TiGrowth®-C (Medacta commercial name: Mectagrip). The distal stem is a straight stem made of titanium alloy and the principal feature consists of shard fins that potentially increase the rotation stability. The locking screw is made of titanium alloy and coated with TiNbN.

This is a 510(k) summary for the Medacta M-Vizion Femoral Revision System Extension, which is a medical device and not an AI/ML product. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not applicable to this document.

The document discusses the substantial equivalence of the new device extensions to previously cleared predicate devices based on non-clinical performance data (engineering rationale and mechanical testing) to ensure safety and effectiveness. No clinical studies were conducted as the new sizes were determined not to represent a new worst-case scenario.

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The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.

Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The M-Vizion Femoral Revision System is a modular cementless stem intended to be used for hip arthroplasty in primary or revision surgery. The system is composed of the proximal body, the distal stem, and the locking screw. The proximal body and the distal stem are intended to be assembled together on a conical coupling and tightened by the locking screw.

The proximal body is made of titanium alloy and coated with a titanium coating, TiGrowth -C (Medacta commercial name: Mectagrip). The distal stem is a straight stem made of titanium alloy and the principal feature consists of shard fins that potentially increase the rotation stability. The locking screw is made of titanium alloy and coated with TiNbN.

The provided text describes the M-Vizion Femoral Revision System, a medical device, and its demonstrated substantial equivalence to predicate devices. However, it does not include specific acceptance criteria with numerical values for performance, nor does it detail a standalone study that directly proves the device meets such criteria in a comparative effectiveness manner with effect sizes or human reader performance.

The document primarily focuses on non-clinical performance tests performed to demonstrate substantial equivalence, rather than establishing acceptance criteria or reporting performance against them in a table format.

Therefore, much of the requested information cannot be extracted directly from the provided text. Below, I will present the information that can be inferred or directly stated, and clearly indicate what is not available.

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

The document lists performance tests conducted but does not specify the numerical acceptance criteria for these tests or provide specific reported numerical performance values. It only states that the tests "met the acceptance criteria that were based on standards."

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Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion DR + Wireless allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

The ViZion DR + Wireless system represents the straightforward integration of a modified digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K152279 wherein we have changed the panel scintillator to Cesium Iodide in addition to having the GOS scintillator available. Changing the scintillator is the only modification.

ViZion DR + Wireless is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD). ViZion DR + Wireless is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vizion DR + Wireless device, presented in the requested format:

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

The document describes a modification to an existing device (K152279) where the scintillator material was changed from Gadolinium Oxysulfide (GOS) to Cesium Iodide (CSI). The primary acceptance criteria for equivalence appear to be related to imaging performance metrics (MTF and DQE) and clinical image quality.

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 for Test Set: Not explicitly stated for either the quantitative (MTF/DQE) or clinical image evaluation. For the clinical images, it states "Clinical images were acquired," implying a set of images, but no number is given.
• Data Provenance: Not explicitly stated. The document is from the US FDA, and the company address is in North Carolina, USA, suggesting the study was likely conducted in the USA, but this is not confirmed. It is implied to be prospective or specifically acquired for this evaluation, as it mentions "Clinical images were acquired and evaluated..."

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)

• Number of Experts: One
• Qualifications of Experts: "a board certified radiologist" (no mention of years of experience).

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

• Adjudication Method: None. A single board-certified radiologist performed the evaluation.

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. The study described is a comparison of two imaging technologies (different scintillators), not an AI-assisted reading study. The device is a digital X-ray receptor, not an AI diagnostic tool.

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

• Standalone Performance: Not applicable. This device is an imaging acquisition system, not an AI algorithm. The performance evaluation focuses on the image quality produced by the system itself before interpretation. The quantitative metrics (MTF, DQE) are "standalone" in the sense that they measure the physical performance of the sensor, but this is not an AI algorithm.

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

• Type of Ground Truth:
  • For MTF and DQE: These are objective physical measurements of image quality, not dependent on a "ground truth" derived from patient data in the same way clinical diagnostics are. They are measured against known physical standards.
  • For Clinical Image Quality: The "ground truth" for clinical image quality comparison was the subjective opinion of a board-certified radiologist, who evaluated whether images from the modified panel were "as good as or better than" images from the predicate panel. This is a form of expert opinion/subjective evaluation rather than an objective clinical endpoint like pathology.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. The Vizion DR + Wireless is a hardware device (digital X-ray detector) and associated software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software" was previously cleared and confirmation testing was performed after the hardware modification.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.

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Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion DR + Wireless allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

The ViZion DR + Wireless system represents the straightforward integration of a modified digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K123644 wherein we have changed panel to a wireless version of the previously cleared panel/software combination. Going wireless (with batterv operation possible) are the ONLY modifications.

ViZion DR + Wireless is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD). ViZion DR + Wireless is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed. Our predicate is ViZion DR +, K123644. We do not supply the router, but any router meeting the IEEE 802.11 a/b/g/n specifications will work. With the advent of AED (automatic exposure detection) by the panel, integration with or connection to specific generators is no longer required. If the user decides NOT to use AED, wired synchronization with Sedecal Series SHF generators is known to work.

Here's a breakdown of the acceptance criteria and study information for the Viztek ViZion DR + Wireless device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provided does not explicitly state formal "acceptance criteria" in a quantitative, measurable sense for the device, beyond equivalence to a predicate device. Instead, it focuses on demonstrating substantial equivalence through a comparison of technical specifications and performance characteristics, some of which could be considered de-facto acceptance criteria derived from the predicate's performance.

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

• Sample Size for Test Set: The document simply states "Clinical images were acquired" and "bench, and test laboratory results." It does not specify the number of clinical images or cases used for evaluation.
• Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the U.S. FDA, it is likely that the clinical image acquisition was performed in the U.S. The study appears to be prospective in the sense that new images were acquired specifically for this evaluation.

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

• Number of Experts: One board-certified radiologist.
• Qualifications: "board certified radiologist." No specific tenure or experience level is mentioned beyond board certification.

4. Adjudication Method for the Test Set

• Adjudication Method: None mentioned. A single radiologist evaluated the images.

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

• No, a MRMC comparative effectiveness study was not done. The evaluation was based on a single radiologist's assessment of clinical images from the new panel compared to the predicate, and bench testing.

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

• Not applicable / not a software-only algorithm. The device is a digital X-ray receptor panel (hardware) with associated software. The "performance" being evaluated is of the integrated system and its ability to produce diagnostic images. The comparison focuses on the image quality produced by the device, which is inherently designed for human interpretation.

7. Type of Ground Truth Used

• Expert Consensus / Expert Interpretation: The ground truth for image quality was established by the interpretation of a single board-certified radiologist. There is no mention of pathology, outcomes data, or other objective measures for ground truth.

8. Sample Size for the Training Set

• Not applicable / Not explicitly a machine learning model requiring a training set. The device is primarily a hardware modification (wireless panel) to an existing cleared system. While there's "software," the document states "Since no software modifications were required, confirmation testing was performed." This suggests the software itself was not re-trained or developed with a new dataset for this specific submission, but rather integrated with the new wireless panel.

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

• Not applicable. As stated above, a distinct "training set" for a machine learning model isn't indicated as part of this device's submission or the testing described.

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ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

The ViZion Ultra system represents the straightforward integration of a new digital x-ray receptor panel (K110849) and our previously cleared software. This is a MODIFICATION of our clearances K112661 and K123644 wherein we have changed the supplier of the panel. Therefore a special 510(k) has been submitted. The ViZion Ultra is compatible with Sedecal SHF generators. Some manufacturers rebrand the Sedecal SHF generators, and these generators are compatible as well.

ViZion Ultra is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) ViZion Ultra is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advartages of digital radiography for a filmless environment and improves cost effectiveness. The major funciple of operation of the Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion + DR, K123644, wherein we combined our OPAL-RAD software with two new digital panels.

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

Key Takeaway: This 510(k) submission is for a modification to an existing digital X-ray system, specifically changing the supplier of the digital receptor panel. Therefore, the "study" primarily focuses on demonstrating that the new panel performs as well as or better than the previously cleared predicate device, rather than establishing de novo efficacy. The acceptance criteria are implicitly met by achieving substantial equivalence to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a numerical sample size for the clinical images used in the evaluation. It only states that "Clinical images were acquired."
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) for a minor modification (panel change), it's likely these were prospectively acquired images for comparison purposes, but this is not definitively stated.

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

• Number of Experts: "a board certified radiologist" (singular, implies one).
• Qualifications of Experts: "board certified radiologist." Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

• The document states that "a board certified radiologist... concluded the images from the new panel are as good as the images acquired with the predicate panel." This indicates a single-reader assessment rather than a multi-reader adjudication method (like 2+1 or 3+1). There was no additional adjudication process described.

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

• No, an MRMC comparative effectiveness study was not done. The evaluation described involves a single radiologist comparing images from the new panel to those from the predicate panel. The focus was on demonstrating non-inferiority (equal or better image quality) rather than quantifying an improvement in human reader performance with AI assistance. This device is a digital X-ray receptor, not an AI-powered diagnostic aid.

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

• This question is not applicable in the context of this device. The ViZion Ultra is a digital X-ray receptor panel and associated software for image acquisition. It is not an algorithm designed for interpretation or diagnosis that would typically undergo a standalone performance study in the way AI algorithms are evaluated. Its "performance" is inherently tied to the image it produces for a human reader. The technical parameters like MTF and DQE (mentioned as being supplied by the manufacturer) represent objective standalone measures of the detector's physical performance.

7. Type of Ground Truth Used

• The ground truth for the clinical images was implicitly established by expert consensus/opinion (from the single board-certified radiologist) that the images produced by the new panel were "as good as" those from the predicate panel. There is no mention of pathology, outcomes data, or other objective measures of disease presence as ground truth, as the study's purpose was image quality comparison for substantial equivalence, not diagnostic accuracy.

8. Sample Size for the Training Set

• Not applicable / Not provided. The device described is a hardware component (digital X-ray detector) and associated software for image acquisition and viewing. It is not an AI/Machine Learning algorithm that typically requires a distinct "training set" in the conventional sense for its function. The software is noted as "SAME as K112661," implying that its functionality is established.

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

• Not applicable. As stated above, this is not an AI/ML device that requires a training set with established ground truth for learning.

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ViZion + DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion + allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

The ViZion + DR system represents the straightforward integration of a new digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K112661 wherein we have changed the supplier of the panel. ViZion + DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) ViZion + is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion DR, K112661, wherein we combined our OPAL-RAD software with a new digital panel. We now also offer two sizes of panels: 14" x 17" and 17" x 17" panels.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Viztek ViZion + DR device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K123644) does not outline specific numerical acceptance criteria for image quality metrics. Instead, it relies on a qualitative assessment for substantial equivalence.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical images were acquired," implying a set of images, but the exact number is not provided.
• Data Provenance: The document does not specify the country of origin of the data. It is implied to be retrospective or a limited prospective acquisition for the purpose of the 510(k) submission, as it involves comparison to existing predicate devices. The study is described as a clinical image evaluation, not a large-scale clinical trial.

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

• Number of Experts: "a board certified radiologist" (singular).
• Qualifications: "board certified radiologist." No further details on years of experience are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: "a board certified radiologist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel." This indicates a single reader assessment, not a multi-reader adjudication method (like 2+1 or 3+1).

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The evaluation was performed by a single board-certified radiologist.
• Effect Size: Not applicable, as no MRMC study was conducted.

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

• This device is a digital flat panel X-ray detector system, not an AI algorithm. Therefore, a standalone performance study in the context of an AI algorithm is not applicable. The device itself is the imaging system, and its performance is assessed directly (both technically and clinically).

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical image evaluation was expert opinion/consensus, specifically the judgment of a single board-certified radiologist comparing the new panel's images to those from predicate panels. There is no mention of pathology or outcomes data for establishing ground truth in this submission.

8. The Sample Size for the Training Set

• This submission describes a hardware modification (a new digital panel combined with existing software) and its equivalence to predicate devices, not the development or training of a new AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable, as there is no training set for an AI algorithm.

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