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Found 9 results
510(k) Data Aggregation
(111 days)
Sphere and Asphere:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the spherical and aspheric design are indicated for monthly disposable wear 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 (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the toric design is indicated for monthly disposable wear 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 (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the multifocal design is indicated for monthly disposable wear 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 lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each month, or more often, if recommended by the eye care professional.
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is a hemispherical shell with a molded base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lens is fabricated from somofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 44.0% somofilcon A and 56.0% water by weight when immersed in saline solution. The somofilcon A name has been adopted by the United States Adopted Names Council (USAN).
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens contains phthalocyanine blue (21 CFR Part 74.3045) for visibility and handling. The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >80% in the UVA range (316nm - 380nm).
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is manufactured in spherical/aspheric, toric, multifocal design configurations. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance |
|---|---|---|
| Chord Diameter | 11.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.050 mm to 0.200 mm | When ≤ 0.10 mm ±0.010 mm + 10% When > 0.10 mm ±0.015 mm + 5% |
| Base Curve | 7.0 mm to 10.0 mm | ±0.20 mm |
| Back Vertex Power (F'v) | -20.00 D to +20.00 D (in 0.25 D steps) | When 0.00 < |
| Cylinder Power (F'c) | -0.25 D to -2.25 D (in 0.25 D steps) | When 0.00 < F'c ≤ 2.00 D ±0.25 D When 2.00 < F'c ≤4.00 D±0.37 D |
| Cylinder Axis | 10° to 180° in 10° steps (in 10° steps) | When 0.00 < F'c ≤ 1.50 D ± 8° When F'c > 1.50 D± 5° |
| Multifocal Power | +0.25 D to +4.00 D (in 0.25 D steps) | ±0.25D |
| Oxygen Permeability (x 10-11 (cm2•ml O2)/(sec•ml•mmHg)) | 60 | ±20% |
| Visible Light Transmittance | >95% | ±5% |
| Ultraviolet radiation Transmittance | < 5% TUVB <20% TUVA | TUVB (280 to 315nm) < 0.05 TV TUVA (316 to 380nm) < 0.05 TV |
| Water Content | 56% | ±2% |
| Refractive Index | 1.398 | ±0.005 |
N/A
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(125 days)
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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(57 days)
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.
| Acceptance Criteria / Characteristic | Predicate Device (Viztek ViZion DR + Wireless K152279 - GOS Scintillator) | Modified Device (ViZion DR + Wireless, CSI Scintillator) | Performance vs. Predicate |
|---|---|---|---|
| Intended Use | Unchanged | Unchanged | Equivalent |
| Configuration | Unchanged | Unchanged | Equivalent |
| Digital Panel (size, pixel size) | iRay Technology Mars1417V-PSI 14" x 17", 150 µm | iRay Technology Mars1417V-TSI 14" x 17", 150 µm | Not a meaningful difference |
| Internal image storage | 200 full size images | Unchanged | Equivalent |
| Image acquisition time | < 5 Seconds | Unchanged | Equivalent |
| DICOM 3 | Yes | Yes | Equivalent |
| A/D Conversion | 14 bit | Unchanged | Equivalent |
| Scintillator | DRZ-Plus Gd2O2S:Tb (GOS) | CSI (Cesium Iodide) | Changed |
| MTF (0.5 (1/mm)) | 0.75 | 0.83 | Better (0.83 > 0.75) |
| DQE (0.5 (1/mm)) | 0.27 | 0.55 | Better (0.55 > 0.27) |
| Interface | Unchanged | Unchanged | Equivalent |
| Power source | Unchanged | Unchanged | Equivalent |
| Electrical safety and EMC | Complies with IEC 60601-1, IEC 60601-1-2, FCC Part 15 | Same | Equivalent |
| Clinical Image Quality | Predicate panel images | Modified panel images | As good as or better |
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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(29 days)
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.
| Criterion (Implied/Predicate Based) | Predicate Device Performance (Viztek ViZion + DR K123644) | Vizion DR + Wireless Performance |
|---|---|---|
| Intended Use | General radiographic examinations (skull, chest, shoulders, spine, abdomen, pelvis, extremities), excluding fluoroscopy, angiography, mammography | UNCHANGED (Same) |
| Digital Panel - Pixel size | 150 µm | 150 µm |
| Digital Panel - Pixels | 2288x2800 (6.4 million pixels) | 2304x2800 (6.4 million pixels) |
| Software Output | DICOM image | SAME as K123644 |
| DICOM 3 | Yes | YES |
| A/D Conversion | 14 bit | SAME |
| MTF (0.5 (1/mm) | 0.75 | 0.75 (Essentially the same) |
| DQE (0.5 (1/mm) | 0.23 | 0.27 (Essentially the same) |
| Scintillator | GOS scintillation screen | UNCHANGED |
| Interface | Gigabit Ethernet | Wired: Gigabit Ethernet (1000BASE-T); Wireless: IEEE802.11a/b/g/n |
| Power Source | AC Line | AC Line and/or Rechargeable Lithium Battery (3 hr run time) |
| Electrical Safety | IEC 60601-1 | SAME |
| EMC | IEC 60601-1-2 | SAME, plus complies with FCC Part 15 Rules and Regulations |
| Image Quality | Implied to be acceptable based on predicate clearance | "as good as or better than the images acquired with the predicate panel" |
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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(168 days)
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
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device (Viztek ViZion DR K112661 and ViZion + DR, K123644). | "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." (Matches predicate exactly). |
| Image Quality | Equal to or better than predicate devices. | "Clinical images collected demonstrate equal or better image quality as compared to our predicates." |
| Safety | As safe as predicate devices, meeting relevant IEC standards. | "The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate devices.""Electrical Safety per IEC-60601-1 and EMC per IEC-60601-1-2." |
| Effectiveness | As effective as predicate devices. | "The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate devices.""MTF and DQE measurements were supplied by the panel manufacturer in accordance with the FDA guidance document." |
| Technical Parameters | Digital Panel Pixel Size & Resolution: Comparable or improved to predicate panels.Software: Same. | Digital Panel: Trixell Pixium Rad 4143, 2880 (h) x 2880 (v) pixels, pitch 148 µm (h) x 148 µm (v). (Predicate K123644 panels: 139 µm, 3064x3072 pixels for 17x17; 150 µm, 2288x2800 pixels for 14x17). This indicates comparable technical specifications.Software: "SAME as K112661, outputs a DICOM image." |
| DICOM Compatibility | Yes (same as predicate). | "Yes" |
| Power Source | AC Line (same as predicate). | "AC Line" |
| Risk | Acceptable risks, analyzed per FDA guidance. | "Risk Analysis was conducted in accordance with FDA guidance documents." |
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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(46 days)
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.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Clinical Image Quality | As safe and effective as the predicate devices (Viztek ViZion DR, K112661, and Atlaim ATAL 8, K113812), specifically, image quality should be "equal or better" than the predicates. | "Clinical images were acquired and evaluated by 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." |
| Electrical Safety | Compliance with IEC 60601-1 (for electrical safety) and IEC 60601-1-2 (for EMC). | "Electrical Safety per IEC-60601-1 and EMC per IEC 60601-1-2." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | "Electrical Safety per IEC-60601-1 and EMC per IEC 60601-1-2." |
| MTF and DQE | No explicit criteria mentioned, but assumed to be comparable to or better than predicate devices, as these are standard metrics for digital imaging systems. | "MTF and DQE measurements... was conducted in accordance with FDA guidance documents." (Results not explicitly provided in the summary, but implied to be acceptable for substantial equivalence). |
| Risk Analysis | Compliance with FDA guidance documents. | "Risk Analysis... was conducted in accordance with FDA guidance documents." |
| Software Validation | Compliance with FDA guidance documents. | "Software validation was conducted in accordance with FDA guidance documents." |
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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(99 days)
The Sensititre® Vizion® is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The "Sensititre® Vizion® is an instrument that takes a digital image of a Sensitities susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for nonfastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp.
NOTE: Please refer to the Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System package insert and the YeastOne package insert for additional instructions, limitations, and references.
This 510(k) is for the addition of: "Vizion® for reading Sensititre YeastOne Plates" The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert.
The "Vizion" can be used as an alternate method where the user manually reads the MIC result on the Sensititre System.
The Sensititre® Vizion® is an instrument that takes a digital image of a Sensitities susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Sensititre® Vizion® device:
The provided document is a 510(k) clearance letter from the FDA for the Sensititre® Vizion®. It indicates that the device has been reviewed and found substantially equivalent to legally marketed predicate devices. However, the document itself DOES NOT contain the detailed acceptance criteria or the specific study data proving the device meets those criteria.
This type of FDA letter is a summary of the FDA's decision, not the full submission with all the study details. The study data and acceptance criteria would have been part of the original 510(k) submission (K112276) made by TREK Diagnostic Systems.
Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text. I can only infer some high-level information.
Here's what can be extracted and what cannot:
What can be inferred from the document:
- Device Performance: The device's primary function is to capture a digital image of a Sensititre susceptibility plate, magnify it, and project it onto a monitor to assist a user in manually reading MIC results by visually detecting color changes. The performance described is its use as an "alternate manual reading method."
- Device Use Case: It's intended for use with Sensititre MIC or BP Susceptibility Test Systems for nonfastidious Gram positive, Gram negative, and fastidious organisms (Haemophilus influenzae, Streptococci pneumoniae, Streptococci other than S. pneumoniae), and Candida spp. Specifically, this 510(k) addition is for reading "Sensititre YeastOne Plates."
- Ground Truth (for device function): The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert. This implies the "ground truth" for the device's function is the visually determined color change criterion set by the existing Sensititre/YeastOne methods itself, as interpreted by a human user.
What CANNOT be determined from the provided text:
- Specific Acceptance Criteria: The document does not list any quantitative or qualitative acceptance criteria (e.g., accuracy percentages, concordance rates, error rates) that the device had to meet.
- Reported Device Performance against specific criteria: Since criteria aren't listed, the specific reported performance in relation to those criteria is absent.
- Sample size for the test set: Not mentioned.
- Data provenance (country of origin, retrospective/prospective): Not mentioned.
- Number of experts and qualifications for ground truth: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study and effect size: No mention of such a study or human-in-the-loop performance improvement. The device explicitly states it's an "alternate manual reading method," suggesting it's an aid, but not comparing its impact on a human reader's improvement.
- Standalone (algorithm only) performance: The device requires a "user" to determine the MIC by "visually looking for the color change." This clearly indicates it's not a standalone algorithm, but a tool to assist human interpretation.
- Type of ground truth used: While the method of determining the MIC (visual color change) is described, the specific nature of the "ground truth experts" or "reference method" used for validation of the Vizion's assistance is not elaborated upon. It relies on the established protocol of the Sensititre system.
- Sample size for the training set: Not mentioned (and likely not applicable in the AI sense, as this is an image magnification and display tool, not a machine learning algorithm detecting MICs autonomously).
- How the ground truth for the training set was established: Not mentioned.
Summary Table (based on what can be inferred, with significant gaps):
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Primary Function | Not explicitly stated in the provided document. Likely implicit criteria related to clear image capture, magnification, and accurate display of color changes on Sensititre plates for manual interpretation. | The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert. It is described as an "alternate manual reading method." |
| Clinical Use | Not explicitly stated in the provided document. Likely implicit criteria related to supporting accurate manual MIC reading for the specified organisms and plate types. | "Intended for use with the Sensititre® MIC or BP Susceptibility Test System... an alternate manual reading method for the Sensititre® MIC plates for nonfastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp." Also, specifically for "reading Sensititre YeastOne Plates." |
| Safety and Effectiveness | Not explicitly stated in the provided document. FDA's clearance implies that the device was found substantially equivalent to predicate devices, meaning it is considered as safe and effective as those existing devices for its intended use as an aid for manual interpretation. | Substantially equivalent to legally marketed predicate devices. |
Other Study Information (mostly "Cannot be determined"):
- Sample size used for the test set and the data provenance: Cannot be determined from the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Cannot be determined from the document.
- Adjudication method: Cannot be determined from the document.
- 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 mentioned. The device is described as an aid for manual reading, not an AI for autonomous interpretation or a tool explicitly studying reader improvement with assistance in the way a diagnostic AI would.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, the device explicitly requires a user ("The user determines the MIC by visually looking for the color change"). It is a human-in-the-loop device.
- The type of ground truth used: The "ground truth" for the interpretation itself is the visual color change according to the existing Sensititre/YeastOne technical inserts, as interpreted by a human user. For validating the performance of the Vizion as an aid, it would likely involve concordance studies against direct visual reading or a reference method, but the details are not present.
- The sample size for the training set: Not applicable and not mentioned, as this is not an AI/machine learning algorithm in terms of training on large datasets to make diagnostic decisions. It's an imaging and display tool.
- How the ground truth for the training set was established: Not applicable for the reasons above.
To get the detailed information you are requesting, you would need to access the full 510(k) submission (K112276) documents from the FDA, which are typically much more extensive than the clearance letter.
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(37 days)
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 two cleared devices: ViZion DR, K102123 and K102587, the Samsung Digital Flat Panel. ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) (K102587, Samsung Flat-Panel X-Ray Detector), made by Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. 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 film less. environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and Samsung FPD were not changed.
This is a 510(k) premarket notification for a new version of the Viztek ViZion DR, a Digital Radiography (DR) system. The submission focuses on replacing the digital flat panel detector (FPD) with a new model while maintaining the existing software and overall functionality. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of demonstrating substantial equivalence to a predicate device, rather than proving a specific diagnostic accuracy against a clinical ground truth.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to the predicate device, specifically regarding safety and effectiveness, and the absence of new indications for use or technological differences that would raise new questions of safety or effectiveness. The reported performance is a comparison to the predicate.
| Characteristic | Acceptance Criteria (Implicitly, as per Predicate) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Same as Viztek ViZion DR K102123: Digital image capture in general radiographic examinations (excluding fluoroscopy, angiography, mammography), imaging skull, chest, shoulders, spine, abdomen, pelvis, and extremities. | SAME (Matches predicate exactly) |
| Digital Panel | Samsung LTX240AA01-A (K090742) with Pixel size 143 µm, 3072 x 3072 pixels, 9 million pixels. | Samsung LLX240AB01 (K102587) with Pixel size 143 µm, 3072 x 3072 pixels, 9 million pixels. |
| Software | Employs OPAL-RAD PACS image viewing and acquire interface software technology, K063337. | SAME (Matches predicate exactly) |
| Electrical Safety | Electrical Safety per IEC-60601. UL listed. | SAME (Matches predicate exactly) |
| Safety and Effectiveness | As safe and effective as predicate devices. | "The results of clinical image inspection, bench, and test laboratory indicates that the new device is as safe and effective as the predicate devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates." |
| Technological Differences | No new technological differences that raise new questions of safety or effectiveness. | "have few technological differences" (only change is the FPD) and "no new indications for use, thus rendering it substantially equivalent". |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical images collected demonstrate equal or better image quality as compared to our predicates." However, it does not specify the sample size for this clinical image inspection, nor does it provide details about the data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a 510(k) for a component change (the FPD), this might have been a limited comparative study rather than a large-scale clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document mentions "clinical image inspection" but does not provide any information on the number of experts involved in this inspection or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. It only mentions "clinical image inspection."
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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a digital X-ray detector system, not an AI-assisted diagnostic tool. The comparison is between the new detector and a previous detector system, with the focus on image quality and equivalence, not reader performance improvement with AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an algorithm's performance without human intervention. Since the device is a digital X-ray detector system (hardware), not a diagnostic algorithm, this concept does not apply. The "standalone performance" for this device would relate to its hardware specifications and image acquisition capabilities, which are covered by bench and laboratory testing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The available information suggests that the "ground truth" for the comparison was based on "clinical image inspection" and possibly "bench, and test laboratory" results, comparing the image quality of the new device to that of the predicate device. This implies a subjective assessment of image quality by potentially experts, but the specifics are not detailed. It is unlikely to involve pathology or outcomes data for this type of 510(k) submission.
8. The Sample Size for the Training Set
This submission is for a digital X-ray detector system, not an AI algorithm that requires a training set. Therefore, there is no training set in the context of this device.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this hardware device, this question is not applicable.
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(179 days)
ViZion DR is intended for digital image capture use in general radiographic examinations for adult and pediattic, 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 intearation of two cleared devices. ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) K090742 (Samsung Flat-Panel X-Ray Detector), Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. ViZion is designed to perform digital radiographic examinations in replacement for conventional film. This integrated platform provides the benefits of PACS with the 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 Samsung FPD were not changed.
The provided text is a 510(k) summary for the Viztek ViZion DR, a digital flat panel X-Ray detector system. It describes the device, its intended use, and states that bench and test laboratory results indicate the new device is as safe and effective as predicate devices, with clinical images demonstrating equal or better image quality.
However, the document does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment methods, information about expert involvement, adjudication methods, or MRMC study details. The 510(k) summary is a high-level comparison to predicate devices, focusing on substantial equivalence rather than a detailed performance study with quantifiable acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or stated based on the text provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Clinical images demonstrate equal or better image quality as compared to predicate devices. |
| Not specified in document | Device is as safe and effective as predicate devices. |
2. Sample sized 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 only states "Clinical images collected."
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or from which country.
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. The document does not mention the involvement of experts in establishing ground truth or evaluating the clinical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. No adjudication method is mentioned.
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 specified. The document does not mention an MRMC study or any AI assistance. The device is a digital X-ray detector system, not an AI-powered analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified. The device is a digital X-ray detector system, not an algorithm, so the concept of "standalone" performance for an algorithm isn't directly relevant in the context of this document. The document focuses on the image quality produced by the detector.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. The document only states "Clinical images collected demonstrate equal or better image quality." It does not elaborate on how "image quality" was objectively assessed or against what ground truth.
8. The sample size for the training set
- Not applicable/Not specified. This device is an imaging hardware system. It does not appear to involve machine learning models that would require a "training set" in the conventional sense. The "training" here would refer to engineering and calibration, not data-driven model training.
9. How the ground truth for the training set was established
- Not applicable/Not specified. (See point 8).
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