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MISTI Silicone Implant is intended for the augmentation of the nasal, malar, chin, gluteal, calf and/or pectoral contour.

The MISTI Silicone Implant offers various types including Nasal, Chin, Mid-face, Forehead, Block, Temple, Gluteal, Calf and Pectoral. The Nasal, Chin, Mid-face, Forehead, Gluteal, Calf and Pectoral are used for the areas indicated in the type names. The Block type is used for various areas during plastic and reconstruction surgeries. The Temple type can be used on a juncture where four skull bones fuse together so called the temple region. It is made of implant grade silicone elastomer, and the design characteristic minimizes carving and promotes natural line.

The provided text is a 510(k) Premarket Notification from the FDA regarding the MISTI Silicone Implant. This document outlines the manufacturer's claim of substantial equivalence to existing predicate devices, primarily based on material, design, function, and performance data from non-clinical tests.

However, the document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy, which is typically what these questions relate to for AI/Software as a Medical Device (SaMD).

Therefore, I cannot provide the requested table and detailed information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these types of studies were not conducted or reported in this 510(k) submission.

This 510(k) focuses on demonstrating the physical and biological safety of the MISTI Silicone Implant by comparing its characteristics and performance in non-clinical tests (material properties, biocompatibility, sterilization) to legally marketed predicate devices, rather than on diagnostic accuracy or clinical effectiveness studies in humans with defined acceptance criteria for AI performance.

The "Performance Data (Non-Clinical)" section lists various tests performed, such as:

• Sterilization Validation
• Appearance
• Dimensional inspection
• Extraction
• Hardness (ASTM D2240 (Type A))
• Tensile strength (ASTMD412)
• Elongation (ASTM D412)
• Tear strength (ASTM D624)
• Cytotoxicity (ISO 10993-5)
• Skin Sensitization (ISO 10993-10)
• Intracutaneous Reactivity (ISO 10993-23)
• Pyrogen (ISO 10993-11)
• Acute Systemic Toxicity (ISO 10993-11)
• Subchronic Toxicity (ISO 10993-11)
• Implantation (ISO 10993-6)
• Genotoxicity (Ames) (ISO 10993-3)
• Genotoxicity (In vitro) (ISO 10993-3)

These tests are primarily focused on the safety and material properties of the implant, not on evaluating an AI algorithm's diagnostic performance.

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The FITme Customized Silicone Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The FITme Customized Silicone Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.

The FITme Customized Silicone Implant is a patient-specific medical device intended for augmentation, reconstructive and cosmetic surgery of facial region, specifically the nasal contour, the malar cheek contour, and chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant, FITme Customized Silicone Implant, is made of implant grade silicone elastomer, in a range of durometers as specified by the surgeon.

The patient's own medical imaging (e.g., Computed Tomography (CT) scan) is translated into a digital model of the patient's skull using the software, Mimics by Materialise. At the recommendation of the surgeon, the Mimics is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or to create a digital implant model as an STL file.

KEOSAN TRADING Co. manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by KEOSAN TRADING Co., using plaster molds or 3D-printed molds as appropriate. The FITme Customized Silicone Implant is manufactured from the customized molds and provided to the surgeon, non-sterile.

The provided text is a 510(k) premarket notification for a medical device (FITme Customized Silicone Implant). It asserts substantial equivalence to a predicate device, but does not describe acceptance criteria, a study proving device performance against those criteria, or any details related to AI/algorithm performance.

Therefore, I cannot provide the requested table and information based on the given document. The document describes a traditional medical device (silicone implant) and its manufacturing process, not an AI or software algorithm.

To answer your request, a document detailing the validation of an AI/software as a medical device (SaMD) or an AI-powered medical device would be required. This would typically include performance metrics like sensitivity, specificity, accuracy, and confidence intervals, along with details on test sets, ground truth establishment, and expert involvement.

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The Keos Anterior Cervical Interbody Fusion Devices (IBFDs) are in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Keos Anterior Cervical IBFD's are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autogenous bone graft. Keos Anterior Cervical IBFD's are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The subject Keos Anterior Cervical Interbody Fusion Device (IBFD) System is composed of anterior cervical spacers and associated instruments. Keos Anterior Cervical IBFD cages are manufactured from polyetheretherketone (PEEK) according to ASTM F2026, as well as Hydroxyapaetite (HA) Enhanced PEEK. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Keos Anterior Cervical IBFD cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. Additionally, the device contains six (6) tantalum marker balls per ASTM F560 to provide imaging visibility for device positioning.

The Keos Anterior Cervical Interbody Fusion Device System implants are intended for single use only. All components of the Keos Anterior Cervical IBFD System are provided non-sterile, to be sterilized by the end user.

The provided text is a 510(k) summary for the Keos Anterior Cervical Interbody Fusion Device System. This document focuses on demonstrating substantial equivalence to previously cleared devices through performance testing, rather than an AI/ML device study. Therefore, most of the requested information about acceptance criteria, study method, sample sizes, ground truth establishment, and expert involvement is not applicable or cannot be extracted from this document, as it pertains to a different type of device evaluation.

However, I can provide the information available regarding the performance testing that was conducted.

Summary of Performance Testing for Keos Anterior Cervical Interbody Fusion Device System (K212450)

This device is a physical medical implant (Interbody Fusion Device), not an AI/ML-based diagnostic or therapeutic system. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training sets) are not relevant to this submission.

The acceptance criteria and device performance are related to mechanical and biocompatibility testing of the physical implant as per relevant ASTM standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical implant testing, not an AI/ML-based study with a test set of data. The "test set" would be the number of physical devices tested according to the ASTM standards. The provenance is from bench testing in a laboratory setting. Specific numbers of devices tested are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, is established by industry standards (ASTM) and engineering principles for mechanical performance, not expert consensus interpreting medical images or data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This term relates to human interpretation/review of data, which is not part of this type of device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI/ML devices.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML devices.

7. The type of ground truth used:

• Mechanical Performance: Established by adherence to the requirements and methodologies outlined in ASTM F2077 and ASTM F2267 standards for intervertebral body fusion devices. The "ground truth" is therefore consistency with established engineering principles and performance benchmarks for such implants.

8. The sample size for the training set: Not applicable. This is for AI/ML devices.

9. How the ground truth for the training set was established: Not applicable. This is for AI/ML devices.

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The Keos Lumbar IBFD is indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) of the spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels.

These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, anterior plate systems, and rod systems.) The device(s) is intended to be used with autogenous bone graft.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. The Keos Lumbar IBFD can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF. a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provide support to the spine for a posterior surgery.

The Keos Lumbar Intervertebral Body Fusion Devices (IBFD) are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion (IBF). They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

Keos Lumbar Intervertebral Body Fusion Devices (IBFD) are made from PEEK radiolucent material and Hydroxyapatite (HA) Enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

Surgical instruments are required for implantation of the device. The accessories are manufactured from 17-4 Stainless Steel (per ASTM F899-11), 465 Stainless Steel, Silicon, 6061 Aluminum, 300 and 400 Series Stainless Steel.

I apologize, but the provided text from the FDA 510(k) clearance letter for the Keos Lumbar IBFD does not contain any information about acceptance criteria or a study proving the device meets performance criteria for an AI/software as a medical device (SaMD).

The document is a clearance letter for a physical medical device (an intervertebral body fusion device) and focuses on its substantial equivalence to a predicate physical device. It describes:

• The device name, regulation, and product code.
• The indications for use of the physical implant.
• The materials and manufacturing of the physical implant and surgical instruments.
• A statement about "Confirmatory testing, including impaction, as well as rationales were provided to demonstrate substantial equivalence." (This refers to mechanical and material testing, not AI performance).

Therefore, I cannot provide the requested table and study details as they are absent from the provided text.

If you have a different document that describes an AI/SaMD for which you need this information, please provide that text.

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Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Keos Lumbar IBFD can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF)

Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF)

Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.

The series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The series of intervertebral body fusion devices are made from the PEEK radiolucent material and HA enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

Here's an analysis of the provided text regarding the Keos Lumbar IBFD and its acceptance criteria, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not provide specific sample sizes for the mechanical tests (Static and Dynamic Compression Tests) or the material characterization tests (XRD, FTIR, XPS). It only states that these tests were performed and the device met the acceptance criteria.

The data provenance is not specified (e.g., country of origin). Since these are material and mechanical bench tests, the concept of "retrospective or prospective" data provenance, as it typically applies to clinical studies, is not directly relevant here. These are laboratory tests.

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

This information is not applicable. The "ground truth" for these tests (mechanical and material characterization) is the established standard (e.g., ASTM F2077 for compression, ISO 17665 for sterilization) and the objective measurements derived from the tests themselves, rather than expert consensus on a clinical outcome.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image interpretation where there's subjectivity and disagreement among human reviewers to establish a consensus ground truth. The tests mentioned are objective laboratory tests.

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

An MRMC study was not conducted. This device is an Intervertebral Body Fusion Device (implantable medical device), not an AI-powered diagnostic or assistive tool for human readers. No mention of AI or human reader improvement is present.

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

This information is not applicable. The device is a physical implant, not an algorithm. Therefore, no standalone algorithm performance study was performed.

7. The Type of Ground Truth Used

The ground truth used for the nonclinical tests was primarily:

• Standardized Test Methods: Adherence to established industry standards like ASTM F2077 for mechanical testing and ISO 17665 for sterilization validation.
• Objective Measurement Data: The results of the laboratory tests (e.g., force, displacement, spectral data) compared against defined pass/fail criteria within those standards.
• Material Specifications: Compliance with material standards (e.g., ASTM F2026 for PEEK-OPTIMA and ASTM F560 for tantalum x-ray markers).

8. The Sample Size for the Training Set

No training set is mentioned or applicable. This device is a physical implant for which safety and effectiveness are shown through nonclinical (bench) testing and substantial equivalence to a predicate device, not through machine learning model training.

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

This information is not applicable as there was no training set.

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Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft.

Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Keos Lumbar IBFD can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF)
Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF)
Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.

The series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The series of intervertebral body fusion devices are made from the PEEK radiolucent material and HA enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

The provided text details a 510(k) premarket notification for the "Keos Lumbar IBFD," an intervertebral body fusion device. While it describes the device's indications for use and a summary of nonclinical tests, it does not contain information about studies involving human readers, AI assistance, training sets, or expert ground truths as requested in the prompt. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through material and mechanical testing.

Therefore, many of the requested elements about acceptance criteria and studies cannot be extracted from this document, as they are not present.

Here's a breakdown of the information that can be extracted or inferred from the document regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The results of these studies showed that the Keos Lumbar IBFD met the acceptance criteria." However, it does not provide the specific numerical acceptance criteria or detailed numerical results for each test. It only confirms that the device passed.

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

• The document does not specify the sample size for the testing performed (e.g., number of devices tested for mechanical properties).
• The data provenance (country of origin, retrospective/prospective) is not mentioned, as these are non-clinical (mechanical) tests, not clinical studies.

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

• This information is not applicable and not present. The studies performed were non-clinical mechanical tests, not studies requiring expert interpretation of medical data or images.

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

• This information is not applicable and not present, as the studies performed were non-clinical mechanical tests.

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

• No MRMC or comparative effectiveness study involving human readers or AI assistance was performed or reported. The document explicitly states: "No clinical tests were performed."

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

• No standalone algorithm performance study was done. This device is a physical intervertebral body fusion device, not a software algorithm.

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

• The "ground truth" for the mechanical tests would be the established scientific and engineering principles outlined in the referenced ASTM standards (e.g., F2077, F2267) and ISO standards (e.g., 17665). The tests measure physical properties against these predefined parameters. There is no biological or expert-derived "ground truth" in this context.

8. The sample size for the training set

• This information is not applicable and not present. The device is a physical implant, not an AI model requiring a training set.

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

• This information is not applicable and not present, as there is no training set for this type of device.

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Keosys Medical Imaging Suite (KSWVWR) is intended to be used by trained medical professionals included, but not limited to, radiologists, nuclear medicine physicians and physicists.

Keosys Medical Imaging Suite is a software application intended to aid in diagnostic and evaluation of medical image data. Although this device allows the visualization of mammography images, it is not intended as a tool for primary diagnosis in mammography.

Keosys Medical Imaging Suite can be used for display, process, temporarily store, print and also create and print reports from 2D and 3D multimodal DICOM medical image data. The imaging data can be Computed Tomography (CT), Magnetic Resonance (MR), Radiography X (CR, DX, XRF, MG), Nuclear Medecine (NM) including planar imaging (Static, Whole body, Dynamic, Gated) and tomographic imaging (SPECT, Gated SPECT), Positon Emission Tomography (PT), Ultrasound (US).

Keosys Medical Imaging suite provides tools like rulers, markers or region of interests (e.g. it can be used in an oncology clinical workflow for tumor burden assessment or therapeutic response evaluation).

It is the user responsibility to check that the ambient luminosity conditions, the images compression ratio and the interpretation monitor specifications are consistent with a clinical diagnostic use of the data.

Keosys' Advanced Medical Imaging Software Suite (aka Viewer, aka KSWVWR) is a multimodality diagnostic workstation for visualization and 3D post-processing of Radiological and Nuclear Medicine medical images. It includes dedicated applications for the therapeutic response evaluation process in a multi-vendor, multi-modal and multi time-points context. The solution also includes the latest recommendations for SUV calculation.

Here's an analysis of the provided text to extract the acceptance criteria and details about the study, as requested.

Note: The provided document is a 510(k) summary for the "Advanced Medical Imaging Software Suite (KSWVWR)". It outlines the device's indications for use and compares it to predicate devices. However, it does not contain detailed acceptance criteria, specific study results, or information about sample sizes, ground truth establishment methods, or expert qualifications for a performance study. The document primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a standalone performance study report. Therefore, many of your requested points cannot be directly addressed from this text.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a study. The focus is on functionality and equivalence.

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

The document does not provide details on a specific "test set" with sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for a performance study. The testing mentioned is part of the general software development process.

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

This information is not provided in the document.

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

This information is not provided in the document.

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

The document does not describe an MRMC comparative effectiveness study where human readers used the AI. The device is a "viewer" and "software application intended to aid in diagnostic and evaluation." It provides tools but is not explicitly an "AI" in the sense of providing automated diagnostic suggestions or classifications to be compared with human performance with/without its assistance. It enables the display and manipulation of images and provides measurement tools.

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

The document describes the device as a "software application intended to aid in diagnostic and evaluation of medical image data" and that it "provides tools like rulers, markers or region of interests." It is a diagnostic workstation for visualization and 3D post-processing, and its use is by "trained medical professionals." This implies a human-in-the-loop device. There is no mention of a standalone algorithm performance study.

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

This information is not provided in the document.

8. The sample size for the training set

The document does not describe any machine learning or AI components that would historically require a "training set" in the context of supervised learning, nor does it mention a sample size for such.

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

Not applicable, as no training set is described.

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Imagys (KSNRMAVWRxx, KSNERDxx) is a medical solution for the upload, the secure transfer, the management, the viewing, the reviewing, the storage and archiving of imaging data, and the related documentations, acquired from a variety of imaging devices. Imagys can also support the management of the imaging parts of a clinical trial workflow including the following steps : quality control, data processing and audit trails. Imagys runs on any standard PC and servers compliant with the Imagys specifications. Typical end users are trained medical professionals and clinical trial actors.

The imaging data can be CT (Computed Tomography), MR (Magnetic Resonance), CR (Computed Radiography), NM (Nuclear Medecine), PET (Positon Emission Tomography), SC (Secondary Capture), US (Ultrasound), XA (Angiographic), video and more DICOM, or others imaging standards, data accepted by the Imagys solution.

It is the user responsibility to check that the ambient luminosity conditions, the images compression ratio and the interpretation monitor specifications are consistent with a clinical diagnostic use of the data.

This device is not indicated for mammography use. Lossy compressed mammography-images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Imagys is a computing and software solution designed by experts in medical imaging and telecommunications for the collection, quality control, processing, analysis and visualization of imaging data. Imagys can help to execute olinical trials with secure transfer, management, viewing, printing, storage and archiving of data.

Based on the provided text, the Keosys Imagys device is a Picture Archiving and Communication System (PACS). The 510(k) summary focuses on its functionality for managing, viewing, and archiving medical imaging data, particularly for clinical trials.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

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

The provided 510(k) summary does not explicitly state specific acceptance criteria (e.g., quantitative metrics like sensitivity, specificity, or image quality thresholds) or specific reported device performance metrics in a formal table or detailed section.

The document refers to "specifications that are documented in a Software Test Plan" and mentions "Performance and functional testing are an integral part of Keosys's software development process." However, these specifications and their outcomes are not detailed in this public summary.

Therefore, for this device (a PACS system), the "acceptance criteria" appear to be broadly focused on its ability to:

• Collect, quality control, process, analyze, and visualize imaging data.
• Securely transfer, manage, view, print, store, and archive data.
• Support clinical trial workflows (quality control, data processing, audit trails).
• Run on standard PCs and servers compliant with Imagys specifications.
• Handle various DICOM and other imaging standards data (CT, MR, CR, NM, PET, SC, US, XA, video).

The "reported device performance" is implicitly that the device meets these functional requirements as evidenced by the FDA's substantial equivalence determination to predicate devices. There are no quantitative performance metrics such as accuracy, precision, or processing speed reported in the document.

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

The document does not specify the sample size of any test set used in a performance study, nor does it provide details on the data provenance (country of origin, retrospective/prospective). It generally discusses "Performance and functional testing" without outlining the datasets used.

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)

The document does not mention the use of experts to establish ground truth for any test set, nor does it specify their number or qualifications. The device is a PACS for data management and visualization, not an AI diagnostic tool requiring expert ground truth for diagnostic accuracy.

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

The document does not describe any adjudication method as no expert evaluation requiring adjudication is mentioned for establishing ground truth on a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This is consistent with the device being a PACS system for data management, not an AI-powered diagnostic aid meant to improve human reader performance.

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

The document does not describe any standalone algorithm performance testing. The Imagys is described as a "computing and software solution" for data management and visualization, implying human interaction for its intended use, rather than a standalone AI algorithm generating diagnostic outputs.

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

Given that Imagys is a PACS system designed for data management and viewing, rather than a diagnostic tool, the concept of "ground truth" for its performance evaluation would likely relate to the integrity and accuracy of data storage, retrieval, display, and transfer. For example, ensuring that an image stored is identical to an image retrieved, or that image metadata is correctly handled. However, the document does not explicitly define the type of ground truth used for its testing, beyond stating "Imagys is tested according to the specifications that are documented in a Software Test Plan."

8. The sample size for the training set

The document does not mention a training set sample size. This device is a PACS system, which typically relies on software engineering principles and functional testing rather than machine learning training sets.

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

Since no training set is mentioned (as the device is not an AI diagnostic model), there is no information on how ground truth for a training set was established.

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Visio+ CD Viewer is a software component that is used for viewing medical images stored on a CD-ROM. This software is not meant for primary image interpretation in mammography.

Visio+ CD Viewer is located on the CD-ROM with the medical images. Visio+ CD Viewer provides tools for image review and manipulation which can only be used with the medical images present on the CD-ROM.

Typical users of Visio+ CD Viewer are trained professionals, including physicians and radiologists.

Visio+ CD Viewer is a component software which must be burned on a CD-ROM with medical images by another Medical Device.

Visio+ CD Viewer operates only on a computer that meets the following requirements: Windows 2000/XP, Pentium III 1 GHz or better, 512 Mo RAM, minimum display resolution 1024x768, a CD or DVD drive. Visio+ CD Viewer provides tools for image review and manipulation.

This submission describes the Visio+ CD Viewer, a software component designed for viewing medical images stored on a CD-ROM. The document mentions "Testing: Visio+ CD Viewer is tested according to the specifications that are documented in a Software Test Plan. Performance and functional testing are an integral part of Keosys's software development process." However, it does not provide details of specific acceptance criteria, studies, or performance results. Therefore, I cannot generate the requested table or answer most of the questions as the information is not present in the provided text.

Based on the provided text, the following information can be extracted:

7. The type of ground truth used:
Not specified, but functional and performance testing are mentioned.

8. The sample size for the training set:
Not specified, as this device is a viewer and not an AI/ML algorithm requiring a training set in the conventional sense.

9. How the ground truth for the training set was established:
Not applicable, as this device is a viewer and not an AI/ML algorithm requiring a training set in the conventional sense.

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