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510(k) Data Aggregation
(42 days)
Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside of hospital, in a variety of procedures of the skull, spinal column, extremities, and at the discretion of the medical professional the device may be used for other imaging applications on all pediatric patients (birth to 21 years) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications
The Virtual C DRF-NEO system is a mobile imaging system that acquire, process and display both static radiographic images and dynamic radiographic images such as photo-spot and fluoroscopy. Dynamic image acquisition is performed without the limitation of a mechanical linkage between the x-ray source and the x-ray detector. The mechanical linkage typical in existing dynamic imaging systems is either a c-arm or u-arm that ensures the alignment of the imaging components during image acquisition. The Virtual C DRF-NEO System features a novel collimator with built-in x-ray source to detector alignment software (Machine-Vision Collimator (MVC), combine they provide the technology for a "virtual c-arm" system. The novel MVC utilized four independent shutter to automatically position the radiation beam, so the area of exposure always remains within the confines of the active area of the detector. In addition, the angle and inclination of x-ray source is displayed to the operator. A visual display provides real time video images of the patient and a shaded area within the video images represent the location and size of the radiation beam with respect to the patient.
The provided text describes a 510(k) premarket notification for the "Virtual C DRF-NEO Digital Imaging System." This document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technical specifications and summaries of non-clinical testing. It explicitly states that "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification."
Therefore, based on the provided text, there is no study that proves the device meets specific acceptance criteria related to its performance in a clinical or standalone setting. The submission relies on establishing substantial equivalence to a predicate device, and thus, does not include information on acceptance criteria based on clinical performance metrics or studies involving human readers or ground truth.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not define specific clinical acceptance criteria for the "Virtual C DRF-NEO Digital Imaging System" or present a study comparing its performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not defined in the document for clinical or standalone performance. | Not applicable as no such study was presented. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical test set was used, as "No clinical data is necessary to evaluate safety or effectiveness." The assessment was based on non-clinical bench testing and comparison to technical specifications of a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set was used, and therefore, no experts were involved in establishing ground truth for clinical performance.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
Not applicable. No MRMC comparative effectiveness study was conducted. The device is a digital imaging system, not an AI-assisted diagnostic tool that would typically involve a multi-reader study to evaluate improvement with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. No standalone performance study was conducted. The assessment was based on demonstrating substantial equivalence to a predicate device.
7. The Type of Ground Truth Used
Not applicable. For the purpose of this 510(k) submission, the ground truth was effectively the technical specifications and validated performance of the predicate device and the digital panel component (DRTECH EVS 2430W with K171137 clearance), against which the proposed device's characteristics were compared for substantial equivalence. No clinical ground truth (e.g., pathology, outcomes data) was used for evaluating the new device's performance in a clinical context.
8. The Sample Size for the Training Set
Not applicable. No training set was involved, as this submission is not for an AI/ML algorithm requiring a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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(64 days)
Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside and outside of hospital, in a variety of procedures of the skull, spinal column, extremities, and at the discretion of the medical professional the device may be used for other imaging applications on all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications
The Virtual C DRF system is a mobile imaging system that acquire, process and display both static radiographic images and dynamic radiographic images such as multi-rad and fluoroscopy. Dynamic image acquisition is performed without the limitation of a mechanical linkage between the x-ray source and the x-ray detector. The mechanical linkage typical in existing dynamic imaging systems is either a c-arm or u-arm that ensures the alignment of the imaging components during image acquisition. The Virtual C DRF System features a novel collimator with built-in x-ray source to detector alignment software (Machine-Vision Collimator (MVC), combine they provide the technology for a "virtual c-arm" system. The novel MVC utilized four independent shutter to automatically position the radiation beam, so the area of exposure always remains within the confines of the active area of the detector. In addition, the angle and inclination of x-ray source is displayed to the operator. A visual display provides real time video images of the patient and a shaded area within the video images represent the location and size of the radiation beam with respect to the patient. As compared to our predicate device, there are three main changes: The digital receptor panel become a DRTECH brand panel, the generator changes from Sedecal to Source-ray, and and the collimator is changed from Colimar to a PortaVision "Machine Vision" collimator. An initial report was submitted for that collimator.
The provided document is a 510(k) Premarket Notification for the "Virtual C DRF Digital Imaging System." It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with an AI algorithm.
Therefore, the document does not contain the information requested regarding acceptance criteria for an AI-powered device, a study proving it meets these criteria, or details about expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily discusses non-clinical testing (bench testing, electrical safety, EMC, software validation, cybersecurity) and a comparison of the new device's technical specifications and intended use against a predicate device. It explicitly states: "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification."
In summary, none of the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance) for an AI-powered device is present in this medical device submission.
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(102 days)
A software system used with the Microsoft Kinect intended to support repetitive task practice for rehabilitation of adults under supervision of a medical professional in a clinical or home setting. The system includes simulated activities of daily living (ADLs) for the upper extremity with audio-visual feedback & graphic movement representations for patients as well as patient performance metrics for the medical professional. Patient assessment, exercise guidance, and approval by the medical professional is required prior to use.
The VOTA software system comprises a VOTA patient-facing and a provider-facing Provider Dashboard. The VOTA patient-facing application supports repetitive task practice exercises for the upper extremity that are consistent with Standard of Care for physical rehabilitation of adults. The software runs on a personal computer under the Windows 8.1 operating system (or later) and uses a Microsoft Xbox One Kinect Sensor (hereafter referred to as Kinect Sensor) to track patient arm movements. These arm movements are translated into equivalent movements of a graphical avatar that represents the patient in a virtual environment. The patient is thus able to practice activities of daily living (ADLs) that involve meaningful tasks and evoke functional movements with graduated levels of difficulty. The activities are organized into a virtual "Road to Recovery" that traverses a series of four islands, each organized around a central theme. There is no physical contact between the patient and the device during exercises, and thus no energy is directed to the patient assessment by a medical professional, and selection of exercise and settings, is required prior to use.
The provider-facing VOTA Provider Dashboard application enables the medical professional to view patient performance metrics and participation history using data produced by the VOTA patient-facing application. The application runs on the same personal computer and operating system as the patientfacing application.
All hardware associated with VOTA are commercial-of-the-shelf, consumer hardware items. The VOTA system ships with the following:
- Microsoft Xbox One Kinect Sensor and Kinect power supply;
- Microsoft Xbox Kinect Adapter for Xbox One ;
- Kinect TV Mount for Xbox One;
- Personal computer (preloaded with VOTA software) and computer power supply;
- Wireless keyboard;
- HDMI cable;
- Getting Started Guide; and
- Third-party Labeling Package
The provided text describes the 510(k) premarket notification for the Virtual Occupational Therapy Application (VOTA). However, it does not contain a specific table of acceptance criteria nor a detailed study that proves the device meets specific acceptance criteria in the way typically seen for a new AI/ML drug or device submission with quantifiable performance metrics (e.g., sensitivity, specificity, accuracy).
The document focuses on demonstrating substantial equivalence to a predicate device (Jintronix Rehabilitation System (JRS)) by comparing intended use, technological characteristics, and safety characteristics, rather than establishing quantifiable performance acceptance criteria for VOTA itself. The clinical testing described is primarily to show effectiveness for rehabilitation, not to meet pre-defined, quantitative performance metrics for a diagnostic or assistive AI system.
Therefore, I will extract and synthesize the information available in the document regarding the device's performance, the type of testing conducted, and the evidence provided to support its safety and effectiveness relative to its intended use and predicate device. I will then explain why some requested information (like specific quantitative acceptance criteria and AI-specific study details) is not present in this type of submission.
Here's the closest representation of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy, as would be typical for an AI/ML diagnostic or predictive device. Instead, the "acceptance criteria" are implied through the demonstration of substantial equivalence to a predicate device and clinical usability/effectiveness for its intended rehabilitative purpose.
The "performance" is primarily assessed in terms of clinical effectiveness for rehabilitation and safety.
| Implied "Acceptance Criteria" Category | Description / Reported Performance |
|---|---|
| Functional Gain / Clinical Effectiveness | Acceptance Implied by: Demonstration of clinically significant improvement in upper extremity (UE) motor performance. Reported Performance: Stroke patients (n=15) using VOTA for ~1 hour, 3 times/week, over 8 weeks (24 total sessions) achieved an average Fugl-Meyer UE (FMUE) improvement of 6 points. This was measured pre- and post-intervention using the FMUE, a widely-recognized and clinically-relevant measure. |
| Safety | Acceptance Implied by: Absence of adverse events, compliance with safety standards, and no unique safety concerns compared to predicate. Reported Performance: No adverse incidents or injuries were reported over the entire period of actual VOTA use by stroke patients in the clinical testing, spanning 240 total sessions of approximately 1 hour each. The device also complies with consumer electrical safety standards (e.g., UL) and laser Class 1 standard (IEC 60825-1:2007) for the Kinect sensor. The risk analysis (ISO 14971) indicated a "Moderate Level of Concern" due to a small, non-zero risk of minor injury from overexertion if incorrectly used, which is mitigated by medical professional supervision as stipulated in the Indications for Use. |
| Usability | Acceptance Implied by: Assessment using a widely-accepted instrument and systematic comparison to Standard of Care by licensed therapists. Reported Performance: Clinical testing included "assessment of usability using a widely-accepted instrument" and "systematic comparison of VOTA to Standard of Care by licensed therapists." (Specific scores or detailed results are not provided in this summary). |
| Accuracy of Tracking | Acceptance Implied by: Sufficiency of Kinect-based tracking for intended application and established literature. Reported Performance: Clinical testing "demonstrated that VOTA's Kinect-based upper extremity tracking produces valid results for the intended application." The Kinect-based tracking solution was found to be "sufficient, both to permit patients to successfully perform virtual ADL exercises and to support derivation of speed-based motor performance metrics." References were provided for existing literature demonstrating the accuracy of Kinect-based upper extremity tracking. |
| Functional Equivalence | Acceptance Implied by: Demonstration that core functionality aligns with predicate and supports Indications for Use. Reported Performance: Bench testing validated "the core functionality of the software system" and established "substantial equivalency to the Predicate." Traceability was provided between Indications for Use, system-level requirements, test plans, and documented test results showing success criteria are met. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 15 stroke survivors with upper extremity impairment participated in the clinical testing.
- Data Provenance: The clinical testing was conducted by the University of Virginia (UVa) Department of Physical Medicine and Rehabilitation and the UVa HealthSouth Rehabilitation Hospital under the approval and governance of the UVa Institutional Review Board for Human Subject Research (IRB-HSR). This indicates prospective data collection from a specific clinical setting in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not explicitly stated as a distinct "ground truth" expert panel in the document. The clinical study involved:
- Licensed occupational therapists who supervised the sessions.
- Experienced therapists who assessed safety (over 200 hours of actual patient contact time using the VOTA system).
- Qualifications of Experts: Licensed occupational therapists; experienced therapists (implied clinical background). The Fugl-Meyer UE assessment (FMUE) is a gold-standard, clinician-administered test, meaning the scores collected by the trained therapists serve as the "ground truth" for motor performance.
4. Adjudication method for the test set
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the test set. For the FMUE assessment, it is a standardized clinical measure typically administered by a single trained therapist for each assessment. Inter-rater reliability (if multiple therapists assessed the same patient) or a consensus process is not 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
- No, an MRMC comparative effectiveness study, as typically understood for evaluating AI assistance for human readers/clinicians, was not performed. This device is a direct patient-facing rehabilitation tool with a clinician supervising, not a diagnostic AI system assisting human interpretation of images or other data. The study was a clinical trial evaluating the therapeutic effect of the device on patients.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is not a standalone diagnostic algorithm. It is a patient-facing application that requires human-in-the-loop (medical professional supervision) as stated in its Indications for Use: "under supervision of a medical professional" and "Patient assessment, exercise guidance, and approval by the medical professional is required prior to use."
- The "standalone" performance closest to what might be considered is the accuracy of the Kinect-based tracking (which is an algorithm within the system). The document states this tracking "produces valid results for the intended application" and was "sufficient" for performing exercises and deriving metrics, citing clinical testing and existing literature. This implies an internal validation of the tracking component, but not as a separately defined "standalone" study in the context of an AI-only performance claim.
7. The type of ground truth used
- The primary "ground truth" for evaluating the device's effectiveness was clinical outcomes data – specifically, pre- and post-intervention scores from the Fugl-Meyer UE (FMUE) assessment. This is a clinician-administered, standardized functional outcome measure.
- For safety, the "ground truth" was observation of adverse events/injuries by supervising therapists.
- For tracking accuracy, the ground truth was implied by the ability of patients to successfully perform virtual activities and the feasibility of deriving motor performance metrics, supported by existing literature on Kinect accuracy.
8. The sample size for the training set
- The document does not specify a sample size for a training set for the VOTA software. This type of submission (for a device like VOTA based on existing technology like Kinect and established rehabilitation principles) is focused on demonstrating substantial equivalence and clinical effectiveness, not on detailing the dataset used to train a novel AI/ML algorithm from scratch. While VOTA is software, it's not described as a deep learning or AI model requiring a large training dataset in the typical sense of current AI medical devices. It utilizes an off-the-shelf sensor (Kinect) whose core tracking algorithms were developed by Microsoft.
9. How the ground truth for the training set was established
- Since a "training set" for a novel AI/ML algorithm is not described, the method for establishing its ground truth is also not applicable/not provided in this document. The "ground truth" relevant to VOTA's performance is established in its clinical test set, as described in point 7.
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(412 days)
The VS800 system is an automated digital slide creation, management, and viewing system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape.
The VS800HER2 Manual Read (MR) of digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2 by manual examination of the digital slide of formalin-fixed, paraffin-embedded and neoplastic tissue IHC stained for HER2 receptors on a computer monitor. HER2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer.
The VS800HER2 MR of digital slide application is intended for use as an accessory to the DakoHercepTest to aid the pathologist in the detection and semi-quantitative measurement of HER2 by manual examination of the digital slide of formalin-fixed, paraffin-embedded and neoplastic tissue immunohistochemically stained for HER2 receptors on a computer monitor. When used with the Dako Hercep Test, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered.
Note: The actual correlation of the Dako Hercep Test to the Herceptin® clinical outcome has not been established.
The VS800 System is an automated digital slide creation, management and viewing system. The VS800 System components consist of an automated digital microscope slide scanner (VS800-SS) which include a computer, keyboard and mouse, operating monitor (VS800-MTR) and VS Viewer software (VS2-ASW-IDB). The system capabilities include digitizing microscope slides at high resolution, storing and managing the resulting digital slide images, retrieving and displaying digital slides, including support for remote access over wide-area networks, providing facilities for annotating digital slides and editing metadata associated with digital slides, and facilities for image analysis of digital slides. The remote digital slide viewing capabilities of the system support reading digital slides on a computer monitor, enabling Pathologists to make clinically relevant decisions analogous to those they make using a conventional microscope. Specifically, the system supports the pathologist in the detection of HER2/neu by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER2 receptors on a computer monitor.
The VS800-SS (an automated digital microscope slide scanner) creates high resolution, color digital slide images of entire glass slides in a matter of minutes. High numeric aperture 20x objectives, specially designed for VS800-SS optical system and real time contrast auto focus system (AF) are used to produce high-quality images. VS800-SS employs a 2D CCD imager for fine image acquisition which is same technologies used in conventional microscope imaging system. VS800-SS captured image is as same as conventional microscope image.
The VS-ASW-IDB (VS Viewer software) is a full-featured digital pathology information management system. The software runs on a server computer, which stores digital slide images on disk storage such as a RAID array, and which hosts an SQL database that contains digital slide metadata. The VS-ASW-IDB includes a web application and services which encapsulate database and digital slide image access for other computers. The VS-ASW-IDB also includes support for locally or remotely connected Image Server, which run digital slide viewing software provided as part of VS-ASW-IDB.
The laboratory technician or operator of VS800-SS loads glass microscope slides into a specially designed slide carrier with a capacity up to 100 slides per carrier (300 total). The scanning process begins when the operator starts the VS800-SS scanner and finishes when the scanner has completed scanning of all loaded slides. As each glass slide is processed, the system automatically stores stitched images as a single digital slide image, which represents a histological reconstruction of the entire tissue section. When the slide scanning finished, then operator of scanner will confirms the image quality and records to the database. When the images are recorded, pathologists or authorized parsons can observe these images to access the VS-ASW-IDB.
Here's a summary of the acceptance criteria and study details for the Olympus VS800HER2 MR Application, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (Mean %) | Reported Device Performance (Range %) |
|---|---|---|---|
| Agreement with Manual Microscopy Reads (Trichotomous HER2 Scores: 0,1+; 2+; 3+) | (Individual Pathologist % Agreements are shown in the tables below.) | ||
| Site 1, Pathologist 1 | |||
| HER2 0, 1+ | N/A (Comparison study, not a specific threshold for acceptance) | 90.91% | (75.67%, 98.08%) CI |
| HER2 2+ | N/A | 88.24% | (72.55%, 96.70%) CI |
| HER2 3+ | N/A | 96.97% | (84.24%, 99.92%) CI |
| Site 1, Pathologist 2 | |||
| HER2 0, 1+ | N/A | 91.18% | (76.32%, 98.14%) CI |
| HER2 2+ | N/A | 90.91% | (75.67%, 98.08%) CI |
| HER2 3+ | N/A | 96.97% | (84.24%, 99.92%) CI |
| Site 1, Pathologist 3 | |||
| HER2 0, 1+ | N/A | 60.00% | (38.67%, 78.87%) CI |
| HER2 2+ | N/A | 97.22% | (85.47%, 99.93%) CI |
| HER2 3+ | N/A | 87.18% | (72.57%, 95.70%) CI |
| Site 2, Pathologist 1 | |||
| HER2 0, 1+ | N/A | 85.19% | (66.27%, 95.81%) CI |
| HER2 2+ | N/A | 80.95% | (65.88%, 91.40%) CI |
| HER2 3+ | N/A | 100% | (88.78%, 100%) CI |
| Site 2, Pathologist 2 | |||
| HER2 0, 1+ | N/A | 96.67% | (82.78%, 99.92%) CI |
| HER2 2+ | N/A | 78.38% | (61.79%, 90.17%) CI |
| HER2 3+ | N/A | 100% | (89.42%, 100%) CI |
| Site 2, Pathologist 3 | |||
| HER2 0, 1+ | N/A | 63.89% | (46.22%, 79.18%) CI |
| HER2 2+ | N/A | 80.65% | (62.53%, 92.55%) CI |
| HER2 3+ | N/A | 93.94% | (79.77%, 99.26%) CI |
| Precision Study (Overall Agreements for Manual Digital Reads) | |||
| Intra-Instrument (Intra-Pathologist) | N/A (Comparison study, not a specific threshold for acceptance) | 100% | (95.98%, 100%) CI |
| Inter-Instruments (Intra-Pathologist) | N/A | 95.6% | (89.01%, 98.78%) CI |
Note: The study describes percentages of agreement without predefined acceptance thresholds for substantial equivalence in the document. The statistical analysis is presented as Percent Agreement (PA) with a 95% Confidence Interval (CI) between manual microscopy reads and manual digital reads, and for precision studies.
Study Details for the Olympus VS800HER2 MR Application
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 100 slides per clinical site, so a total of 200 slides were used for the comparison study (100 slides at Site 1, 100 slides at Site 2).
- For the precision study, a subset of 30 slides from the comparison study was used.
- Data Provenance: Retrospective. The slides were "selected from archive." The country of origin is not explicitly stated, but the study was conducted at "two clinical sites," implying local (likely within the US, given FDA submission context) data.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Six pathologists in total for the comparison study (three at each of two clinical sites). One pathologist for the precision study (who repeated reads).
- Qualifications of Experts: Described as "Pathologists." Specific years of experience or sub-specialty certifications are not provided in the summary.
-
Adjudication Method for the Test Set:
- Adjudication Method: None for establishing a single "ground truth." The study compared each pathologist's "manual digital reads" against their own "manual microscopy reads." This is a paired comparison, where the conventional microscopy read by the same pathologist is considered the reference for that pathologist's digital read. The summary doesn't describe an external or consensus ground truth for the comparison study itself; rather, it assesses agreement between two reading methods by the same individual.
- For the precision study, there was also no external adjudication; it assessed agreement of repeated reads by a single pathologist.
-
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:
- This was a Multi-Reader Multi-Case (MRMC) comparative effectiveness study of digital pathology reads vs. conventional microscopy reads, but without AI assistance. The VS800HER2 MR Application is a "Manual Read" application, meaning the pathologist manually interprets the digital image.
- Therefore, there is no AI component, and no effect size regarding human readers improving with AI assistance is reported or applicable to this specific application. The study focuses on the agreement between conventional microscopy and manual reading of digital slides.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm-only performance study was done. The device (VS800HER2 MR Application) is explicitly described as for "Manual Read (MR) of digital slide application," intended "as an aid to the pathologist in the detection and semi-quantitative measurement of HER2 by manual examination of the digital slide." It is a display and management system for pathologists to manually review digital slides, not an automated AI-driven diagnostic algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the comparison study: The "ground truth" or reference standard for each pathologist's digital read was their own prior manual microscopy read of the physical glass slide. This is a paired comparison, where the same pathologist acts as their own control.
- For the precision study: The reference was the pathologist's own repeated manual digital reads from the same or different instruments.
-
The sample size for the training set:
- The 510(k) summary does not mention a training set for an algorithm, as the VS800HER2 MR Application is a manual read application. The study described is entirely a clinical validation/test set.
-
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set or an algorithm being developed (which would typically require a training set with established ground truth). The device acts as a digital visualization and management system for manual pathologist interpretation.
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(73 days)
EndoClear™ Laparoscopes Accessory is intended to be used by qualified physicians to provide endoscope lens cleaning for uninterrupted visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic procedures.
The Virtual Ports EndoClear™ system is a sterile, single patient use system consisting of: EndoClear™ Lens Cleaner and the EndoClear™ Introducer. The EndoClear Lens Cleaner is an internally anchored hands-free, laparoscope lens cleaning device which is attached to the internal abdominal cavity wall and remains in position until completion of the surgery, enabling the surgeon to effectively clean the lens of blood, fat, fog, and secretions without removing it from the cavity. The Virtual Ports EndoClear™ Lens Cleaner is introduced via a cannula using the EndoClear™ Introducer, which also removes the EndoClear™ Lens Cleaner at the end of the surgical procedure.
The Virtual Ports EndoClear™ system is a sterile, single-patient use system designed to clean the lens of a laparoscope internally during surgery without removing it from the abdominal cavity. This allows for uninterrupted visualization of internal structures during diagnostic and therapeutic laparoscopic procedures.
Here's an analysis of the acceptance criteria and study data based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device performs safely. Materials in contact with the human body are biocompatible. | The animal study demonstrated that "no safety and effectiveness questions were raised." All materials in contact with the human body are biocompatible in accordance with ISO 10993-1. |
| Effectiveness: Device effectively cleans the laparoscope lens of blood, fat, fog, and secretions without removal from the cavity, enabling uninterrupted visualization. | Bench tests and an animal study were performed. The document states: "All testing results demonstrated satisfactory performance." The animal study showed that "the EndoClear™ system performs as intended." The overall conclusion is that "the device performs safely and efficiently in accordance with its intended use." |
| Substantial Equivalence: Device is substantially equivalent to predicate devices. | Preclinical and bench performance data were supplied to demonstrate that the EndoClear™ meets its labeled performance claims and to establish substantial equivalence to the predicate devices (Laparoscope and Monopolar laparoscopic instruments; Instrumed International, Inc. K040855 and g-Lix™ Tissue Grasper; USGI Medical K061268). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Bench Tests: The document does not specify a numerical sample size for the bench tests. It states "Series of bench tests were performed."
- Animal Study: The document does not specify a numerical sample size (e.g., number of animals) for the animal study. It just states "An animal study was performed."
- Data Provenance: The document does not explicitly state the country of origin for the studies. Given the applicant's address (Israel), it's highly probable the studies were conducted in Israel or a location collaborating with the applicant. The studies described are prospective in nature, as they involve testing the device to evaluate its performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information regarding the number of experts, their qualifications, or the method used to establish ground truth for the test set in either the bench tests or the animal study. The evaluation of performance in the animal study would typically involve veterinary surgeons or researchers, but this is not detailed.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned or conducted, as this device is a physical tool for cleaning a laparoscope lens, not an imaging or diagnostic algorithm used by multiple human readers.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was conducted. The EndoClear™ system is a physical medical device, not an algorithm, and it is intended for human-in-the-loop use by a surgeon during laparoscopic procedures.
7. Type of Ground Truth Used
- Bench Tests: The ground truth for bench tests would be defined by pre-established engineering specifications or performance metrics for lens cleaning effectiveness (e.g., clarity measurements after cleaning, removal of specific contaminants).
- Animal Study: The ground truth for the animal study would likely be a combination of direct observation by the surgical team/researchers on the safety (e.g., lack of device-related injury) and effectiveness (e.g., visual clarity through the endoscope, ability to complete the intended surgical task). The document implies a qualitative assessment ("performs as intended," "no safety and effectiveness questions were raised").
8. Sample Size for the Training Set
This information is not applicable as the EndoClear™ system is a physical device and does not involve a "training set" in the context of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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(108 days)
Intended to be used for making accurate dental impressions. The resulting impressions are used to make plaster models of the teeth.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental impression material named "Virtual 380". This document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria typically found in a clinical study report or a more comprehensive premarket submission.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.
The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the approval is based on demonstrating equivalence, not necessarily on a new clinical study with specific acceptance criteria as you've outlined.
To answer your questions, one would need to review the actual 510(k) submission document (K060891) itself, which is not provided here.
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(44 days)
This device employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and pre-planning of dental implant surgery.
Virtual Implant Placement, or simply VIP, is a software program that will allow dental implant clinicians to pre-plan their implant surgeries and/or to design surgical appliances that will be used during surgery. The program will presents the clinician with various reformatted CT images of their patient's jaw(s), allow the placement and manipulation of virtual implants, and provide measurement and other tools to assist the clinician. In typical usage a dentist evaluating a patient for dental implant surgery will often refer the patient for a CT scan to better visualize the patient's anatomy, and check the amount and density of the bone for its suitability for placing implants. The CT scan site will return the axial images from the CT scan on a CD in industry-standard DICOM format. Upon receipt of the CD, the doctor will "process" the case using VIP. Axial images are well-known to radiologists, but foreign to dentists. Processing involves the removal of unnecessary images which are outside the region of interest, and drawing a curve which will be used for the later reformatting of the data to produce images more familiar to dentists. After opening a disk of images, VIP will display the axial images and thumbnails of these, along with a scout view and a checklist of stops to follow in processing the case. After the case has been processed, the axial data will be processed to make panoramic images, which are parallel to the curve that was drawn during processing, and cross-sectional images, which are perpendicular to the panoramic image. Both types of images are normally generated by the Panorex machines dentists are familiar with. Since the primary purpose of VIP is to aid in the planning of implant surgeries, VIP will allow the surgeon to place simulated implants on the image and to gauge their size and position relative to the surrounding anatomy. The simulated implants will be generic models of standard dental implants, which range from cylindrical to conical. When the data becomes available from various implant manufacturers, VIP will allow the user to pick from specific, currently-manufactured implants to approximately model any of their favorite implants.
The provided text is a 510(k) summary for the Virtual Implant Placement™ (VIP) Dental Implant Surgery Planning Software. It details the device's intended use and compares it to legally marketed predicate devices to establish substantial equivalence.
Based on the provided text, here's an analysis of the requested information:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in a quantitative, measurable form for the device's performance. Instead, it focuses on establishing substantial equivalence to predicate devices through a qualitative comparison of features and intended use. The device's performance is implicitly judged by its ability to perform similar functions as the predicate devices.
| Feature / Criterion | Predicate Device 1: SimPlant system, K033849 (Materialise.) | Predicate Device 2: ImplantMaster K042212 (I-Dent Ltd.) | Virtual Implant Placement™ (VIP) - Reported Performance |
|---|---|---|---|
| Image Source | CT Scanner | DICOM CT | DICOM CT |
| Main Indication / Purpose | Medical front-end software for visualizing gray value images, image segmentation, transfer of imaging information, planning and simulation for dental implant placement and surgical treatment. | Uses DICOM CT data for visualization, diagnosis, and treatment planning for dental implant surgery. | Employs previously scanned DICOM CT images as an aid to visualizing and pre-planning of dental implant surgery. |
| Tools | Visualization, Implant placement, measurement of distances, angles, and density. | Visualization, Implant placement. | Visualization, Implant placement, Distance measurement, Angle measurement, Rectangular measurement, Elliptical measurement. |
| Conclusion of Equivalence | N/A (Predicate) | N/A (Predicate) | "In all important respects, the VIP is substantially equivalent to one or more predicate systems." |
No specific quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity) or corresponding acceptance criteria are provided in this document. The "device performance" is described through its functionalities and comparison to existing devices.
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 mention any specific sample size for a test set or the provenance of any data used for testing. The submission is focused on establishing substantial equivalence based on a comparison of features and indications for use.
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 a test set. No details are provided regarding any clinical validation studies with expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Since no test set or expert ground truth establishment is mentioned, there is no information on adjudication methods.
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 indicate that an MRMC comparative effectiveness study was done. The device itself is described as a "software tool which serves as an aid," implying human-in-the-loop, but no data on human performance improvement with or without the software is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is explicitly described as "an aid to visualizing and pre-planning," meaning it's intended to be used with human involvement. Therefore, a standalone (algorithm only) performance assessment would not be directly relevant to its intended use, and no mention of such a study is made.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not describe the type of ground truth used because it does not refer to any formal performance study that would require ground truth. The basis for substantial equivalence is primarily a functional and indications-for-use comparison with predicate devices.
8. The sample size for the training set:
The document does not mention any sample size for a training set. As the application describes software for planning based on existing DICOM CT images, it's not clear if a machine learning model requiring a traditional "training set" (in the AI/ML sense) was used or if it's primarily rule-based or image processing software.
9. How the ground truth for the training set was established:
Since no training set is mentioned, no information is provided on how ground truth for a training set was established.
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(13 days)
The VT 3000 is designed to conduct a range of tests including Nerve Conduction Studies (NCS) and Evoked Potentials (EP).
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This document appears to be an FDA 510(k) clearance letter for a medical device (Virtual Medical Systems VT 3000, a nerve conduction velocity measurement device). It does not contain the kind of detailed study information (acceptance criteria, performance data tables, sample sizes, ground truth establishment, expert qualifications, etc.) that would be part of a submission to demonstrate clinical effectiveness or safety as you've requested.
The document primarily focuses on:
- Confirming substantial equivalence to a predicate device.
- Indications for use (Nerve Conduction Studies and Evoked Potentials).
- Regulatory classification (Class II).
- General regulatory requirements for the manufacturer.
Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study proving the device meets them. The information you've requested typically comes from the detailed technical sections of the 510(k) submission itself, which are not included here.
The provided text does not contain any of the following information:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone performance analysis was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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