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ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.

ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system.

ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

Device Description

ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It is designed with intuitive graphical user interfaces (GUIs) and is based on Microsoft Windows® with defined hardware requirements.

Viewpoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference.

ViewPoint 6 supports both a single workstation and a client/browser - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read-only functionality.

ViewPoint 6 software is a server-based application with client-server architecture, accessed via client computers or mobile devices as well as browser-based systems. Viewpoint 6 is installed on client provided servers within a hospital network.

The software comes with features to view, annotate, measure, calculate, save and retrieve clinical data (including images via DICOM format) to support patient documentation and record keeping related to ultrasound image scans. Additionally, the software is available for patient administrative tasks such as appointment scheduling and exam billing.

This product does not control or alter any of the medical devices providing data across the hospital network.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "ViewPoint 6." This type of document focuses on demonstrating substantial equivalence to a predicate device and typically does not contain detailed primary study results with acceptance criteria and specific performance metrics as would be found in a clinical study report. It primarily outlines the scope of V&V activities and voluntary standards adhered to.

Based on the provided text, the following information can be extracted regarding the device performance and acceptance criteria:

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

The document does not provide a specific table of acceptance criteria with corresponding reported device performance values in terms of clinical accuracy (e.g., sensitivity, specificity). Instead, it states that:

"Successful completion of design verification and validation testing was performed to confirm that software and user requirements have been met."

This implies that the acceptance criteria are tied to the fulfillment of software and user requirements, which are assessed through various testing activities, but the specific numerical performance metrics are not detailed in this summary. The general statement about "Performance dependent on customer hardware but minimum hardware requirements for acceptable performance are defined in the System Requirements" suggests that performance acceptance is related to system specifications rather than clinical efficacy metrics.

2. Sample sized 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 any sample sizes for a clinical test set, nor does it provide data provenance (e.g., country of origin, retrospective or prospective nature). The V&V activities mentioned (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Performance testing, Safety testing) are typically software engineering and system-level tests and do not involve a clinical test set with patient data for performance evaluation in the context of diagnostic accuracy.

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)

No clinical test set is described, and therefore, there is no information about the number or qualifications of experts used to establish ground truth.

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

No clinical test set is described, so 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

The document states:

"The similarities and differences between the subject device and the predicate device, were determined not to have a significant impact on the device's performance, the clinical performance, and the actual use scenarios. Therefore, the subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence."

This explicitly indicates that no MRMC comparative effectiveness study, or any clinical study, was conducted or deemed necessary for this 510(k) submission. Therefore, there is no information about AI assistance or its effect size on human reader improvement.

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

The device is described as "an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data." The indications for use state it "is not intended to be used as an automated diagnosis system." This confirms it's a tool to assist clinicians, not a standalone diagnostic algorithm. No standalone algorithmic performance study was conducted or mentioned.

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

As no clinical studies were performed for diagnostic accuracy, no specific ground truth type (expert consensus, pathology, outcomes data, etc.) is mentioned. The V&V activities focused on software and system requirements.

8. The sample size for the training set

The document does not refer to any AI/ML components that would require a training set. Therefore, no training set sample size is provided.

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

Since no training set is mentioned for AI/ML, there is no information on how its ground truth would be established.

In summary:

This 510(k) submission for ViewPoint 6 primarily relies on demonstrating substantial equivalence to a predicate device (ViewPoint 6 v6.12 K203677) through software validation and verification activities, adherence to voluntary standards, and a comparison of technological characteristics. It explicitly states that clinical studies were not required because the changes from the predicate device were not deemed to have a significant impact on clinical performance. Therefore, detailed information regarding clinical performance acceptance criteria, sample sizes for test or training sets, expert adjudication, or AI performance metrics is not present in this document.

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K Number

K203677

Device Name

ViewPoint 6

Manufacturer

GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC

Date Cleared

2021-01-15

(29 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K200852,K192917

Predicate For

K241300

Intended Use

ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.

ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system. ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

Device Description

ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.

ViewPoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images, and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference. ViewPoint 6 supports both a single workstation and a client - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read - only functionality

AI/ML Overview

The document provided is a 510(k) Premarket Notification Submission for the GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC's ViewPoint 6 device (K203677). This submission primarily focuses on establishing substantial equivalence to a predicate device (ViewPoint 6, K192917) and a reference device (EchoPAC Software Only, K200852).

Based on the provided information, the 510(k) submission states that clinical studies were not required or performed to support the substantial equivalence of ViewPoint 6. Therefore, there is no detailed study data, acceptance criteria, or performance metrics within this document that would typically be associated with a clinical trial or performance evaluation study specifically proving the device meets certain acceptance criteria through direct testing.

The conclusion explicitly states:
"The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence."

"GE Healthcare considers the ViewPoint 6 to be as safe, as effective, and performance is substantially equivalent to the predicate device."

This means that the manufacturer is asserting the new ViewPoint 6 is functionally equivalent to the previously cleared ViewPoint 6 (K192917) and EchoPAC Software Only (K200852) based on its intended use, technological characteristics, and non-clinical performance (e.g., meeting voluntary standards, software development quality assurance measures).

Therefore, it is not possible to provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from the provided text, as such a study was not conducted or reported in this submission.

The document highlights the device's adherence to voluntary standards and internal quality assurance measures in lieu of clinical performance testing for this specific 510(k) submission.

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K Number

K192917

Device Name

ViewPoint 6

Manufacturer

GE Medical Systems Ultrasound and

Date Cleared

2020-01-06

(83 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K192159,K191792,K173456

Predicate For

K203677

Intended Use

ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system.

ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

Device Description

ViewPoint 6 supports both a single workstation and a client - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read - only functionality.

AI/ML Overview

This FDA 510(k) summary for GE Healthcare's ViewPoint 6 software does not contain the detailed information necessary to complete the requested table and answer the study-related questions. The document states that no clinical studies were required to support substantial equivalence (Page 6).

Therefore, I cannot provide:

A table of acceptance criteria and the reported device performance: This information is derived from clinical studies, which were not performed.
Sample size used for the test set and the data provenance: No clinical test set was described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth for a test set was established as no clinical test was conducted.
Adjudication method for the test set: Not applicable as no test set was used.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, the document explicitly states no clinical studies were required.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no algorithm performance study was described. ViewPoint 6 is described as an image archiving and reporting software, not an automated diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Based on the provided document, the ViewPoint 6 device is a Picture Archiving and Communication System (PACS) software tool. The 510(k) submission for ViewPoint 6 relied primarily on non-clinical tests and a comparison to predicate devices, rather than clinical performance studies, to demonstrate substantial equivalence.

The document states:

"The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." (Page 6)
"GE Healthcare considers the ViewPoint 6 to be as safe, as effective, and performance is substantially equivalent to the predicate devices." (Page 6)
The determination of substantial equivalence was based on "intended use, capabilities, technological characteristics, safety and effectiveness" compared to predicate devices (ViewPoint 6, K173456, and reference devices Voluson E10, K192159 and Versana Balance, K191792). (Page 5)
The summary focuses on "Non-Clinical Tests" such as compliance with voluntary standards (IEC 62366-1, IEC 62304, NEMA PS 3.1-3.20 DICOM, ISO 14971, IEC 82304-1) and quality assurance measures (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing). (Pages 5-6)

Therefore, the requested information regarding acceptance criteria and performance data from a clinical study cannot be extracted from this document, as no such study was conducted or presented in this 510(k) summary.

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K Number

K173456

Device Name

ViewPoint 6

Manufacturer

GE Medical Systems Ultrasound and Primary

Date Cleared

2018-01-05

(59 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K172342,K162743

Predicate For

K192917

Intended Use

ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system.

ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

Device Description

ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.

ViewPoint 6 supports both a single workstation and a client-server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read-only functionality.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. Instead, it is a 510(k) premarket notification for a medical device called "ViewPoint 6." This document primarily discusses the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical tests performed to ensure compliance with relevant standards.

Specifically, the document states: "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." This means that no clinical study was conducted to demonstrate the device's performance against specific acceptance criteria.

Therefore, I cannot provide the requested information, including:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts used for ground truth and their qualifications.
Adjudication method for the test set.
MRMC comparative effectiveness study results.
Standalone performance results.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

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K Number

K162743

Device Name

ViewPoint 6

Manufacturer

GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS

Date Cleared

2016-11-22

(53 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K103458

Predicate For

K173456

Intended Use

ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 provides the user the ability to include images. drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.

Device Description

ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data.

ViewPoint 6 supports both a single workstation and a clientserver setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read-only functionality.

AI/ML Overview

The provided text contains information about a 510(k) submission for the ViewPoint 6 device, which is a Picture Archiving and Communications System (PACS). However, it explicitly states, "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence."

Therefore, the document does not contain information regarding acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance. It focuses on non-clinical tests (compliance with standards, quality assurance measures).

Here's what can be extracted based on the prompt's requirements, highlighting the lack of relevant clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission states that clinical studies were not required to support substantial equivalence. Therefore, there are no reported acceptance criteria or device performance metrics from a clinical study.

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

Not applicable. No clinical test set was used as clinical studies were not required.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No clinical test set requiring ground truth established by experts was used.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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

No. A MRMC comparative effectiveness study was not performed as clinical studies were not required.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-loop Performance) was Done

Not applicable. The device is a PACS system for diagnostic interpretation and reporting, not an automated diagnosis system. The submission explicitly states: "ViewPoint 6 is not intended to be used as an automated diagnosis system." Therefore, a standalone algorithm performance study is not relevant in the context of this device.

7. The Type of Ground Truth Used

Not applicable. No clinical test set requiring ground truth was used.

8. The Sample Size for the Training Set

Not applicable. The device is a PACS software, not an AI/ML diagnostic algorithm that would typically involve a "training set" for model development.

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

Not applicable. As explained above, there is no mention of a training set or associated ground truth.

Summary of Non-Clinical Tests and Quality Assurance (as provided in the document):

The device complies with the following voluntary standards:

IEC 62366-1:2015 Medical devices Application of usability engineering to medical devices
IEC 62304:2006, Medical device software Software life cycle process
NEMA PS 3.1 - 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
ISO 14971:2012 Medical Devices Application of risk management to medical devices

Quality assurance measures applied to the development of the system include:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Final Acceptance Testing (Design Validation and Service Validation)
Performance testing (Verification)
Safety testing (Verification)

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K Number

K103458

Device Name

VIEWPOINT 6

Manufacturer

GE HEALTHCARE

Date Cleared

2011-03-04

(101 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K050943

Predicate For

K162743

Intended Use

ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint displays to the user, can be used for diagnostic purposes.

ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.

ViewPoint is not intended to operate medical devices in surgery related procedures.

Device Description

GE ViewPoint 6 is an-image-archiving and reporting software for medical practices and clinical radiological departments used for diagnostic purpose. It incorporates basic features of administration, image and data acquisition from medical devices via DICOM or proprietary interface, data transfer from third party systems, reporting of medical findings, report generation, network interfacing and archiving. Image processing and calculations capabilities are available for images.

The basis for this submission is a modification to a legally marketed device to incorporate additional features and to modify the wording of the indications for use statement for clarification purposes. The proposed indications for use statement is equivalent to the one from the predicate device. The intended use is identical to the predicate device.
The device modifications mainly consist of:

Enhancements to the User Interface for improved usability;
Additional customization capabilities;
Configurable User Interface language.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for GE Healthcare's ViewPoint 6, an image archiving and reporting software for medical practices and clinical radiological departments. The document focuses on demonstrating substantial equivalence to a predicate device (ViewPoint 5) and does not describe a study involving AI or specific acceptance criteria for a device's performance in terms of diagnostic accuracy or a similar clinical metric.

Therefore, many of the requested details, such as a table of acceptance criteria and reported device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable or not available in this document.

Here's what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable / Not available. The document states that ViewPoint 6 did not require clinical studies. The "acceptance criteria" here are related to regulatory compliance and demonstrating substantial equivalence to a predicate device, rather than specific performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI device. The study performed involved non-clinical tests to verify compliance with voluntary standards and ensure quality assurance.

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

Not applicable / Not available. As no clinical studies were performed, there is no test set in the context of diagnostic performance evaluation. The "tests" mentioned are for software verification and validation (e.g., unit, integration, performance, safety, simulated use testing).

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

Not applicable / Not available. No ground truth for diagnostic performance was established for a test set as no clinical studies were performed.

4. Adjudication Method for the Test Set:

Not applicable / Not available.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This device is an image archiving and reporting software, not an AI-powered diagnostic tool for assisting human readers. The document explicitly states it "is not intended to be used as an automated diagnosis system."

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

Not applicable. This device is software for image management and reporting, not a standalone diagnostic algorithm.

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

Not applicable. No clinical ground truth was established for diagnostic performance. The "ground truth" in the context of this submission refers to the successful completion of software development lifecycle activities and adherence to established standards and requirements for software functionality and safety.

8. The Sample Size for the Training Set:

Not applicable / Not available. This is not an AI/machine learning device that relies on a training set for model development.

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

Not applicable / Not available.

Summary of the Study and Device Information (as per document):

Device Name: ViewPoint 6
Device Type: Image archiving and reporting software for medical practices and clinical radiological departments.
Intended Use: "To accept, transfer, display, store and process medical images and data, including the ability to measure, calculate, annotate and prepare and print patient examination reports primarily for diagnostic ultrasound." It also explicitly states: "ViewPoint is not intended to be used as an automated diagnosis system."
Study Performed: Non-clinical tests were conducted to comply with voluntary standards and apply quality assurance measures to the development of the system. These included:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
Conclusion of Study: "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." The non-clinical tests were deemed sufficient to demonstrate that ViewPoint 6 is as safe, as effective, and its performance is substantially equivalent to the predicate device (ViewPoint 5).

In essence, the ViewPoint 6 submission is for a software update to an existing PACS (Picture Archiving and Communications System) type device, not for an AI diagnostic device. Its regulatory pathway leveraging substantial equivalence to a predicate device and focusing on non-clinical software testing reflects its classification and intended use as a medical image management system, not a device making diagnostic interpretations.

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K Number

K031760

Device Name

VIEWPOINT TELEMETRY SYSTEM

Manufacturer

DATASCOPE CORP.

Date Cleared

2003-10-10

(126 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K021681,K022453,K020524

Predicate For

K142601

Intended Use

The ViewPoint Central Monitoring System is intended for use in a fixed location, in the health care facility setting, as a central viewing station. The ViewPoint Central Monitoring System is not intended to be directly connected to the patient at any time, or installed in a patient's vicinity.

The ViewPoint Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.

The ViewPoint Telemetry System is intended for installation in the hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility.

Device Description

The ViewPoint Telemetry System is an expansion to the ViewPoint Central Monitoring System, previously cleared by FDA under K011540. There have been no significant changes to ViewPoint Central Monitoring System since its clearance. The standard configuration of the ViewPoint Central Monitoring System consists of the ViewPoint Central Station, network printers, displays, keyboard, speakers, universal power supply and a mouse.

The ViewPoint Telemetry System is an ambulatory monitoring system that is designed to be used in the hospital/clinical environment to acquire and transmit ECG data derived from wireless physiological monitor(s) via RF telemetry transmitter(s) and receiver(s). The ViewPoint Telemetry System consists of three components: the ViewPoint Server (Server), Access Point, and ViewPoint Telepack 2.4 (Telepack). The ViewPoint Telemetry System uses the capability of bi-directional communication with the Server, via an Access Point network installed throughout the specified coverage area. These Access Points interface with the Server through an Ethernet connection. The Server does not collect data directly from patients; rather, it receives data through the Access Point from monitors, such as a Telepack, performs ST/Arrhythmia analysis, and then forwards it to the ViewPoint Central Station.

AI/ML Overview

The provided text describes the ViewPoint Telemetry System, a cardiac arrhythmia monitor. However, it does not explicitly detail specific acceptance criteria or a dedicated study with performance metrics that directly prove the device meets particular criteria. Instead, it outlines the device's intended use, its components, and its substantial equivalence to predicate devices, supported by a general statement about completed development activities and testing.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred and note when information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from "Substantial Equivalence")	Reported Device Performance	Comments
Safety	As safe as predicate devices	Deemed "as safe"	Based on overall development activities and testing. No specific quantitative safety metrics are provided.
Effectiveness	As effective as predicate devices	Deemed "as effective"	Based on overall development activities and testing. No specific quantitative effectiveness metrics (e.g., sensitivity, specificity for arrhythmia detection) are provided.
Performance	Performs as well as predicate devices	Deemed to "perform as well"	Based on overall development activities and testing. No specific quantitative performance metrics are provided.
Physiological Monitoring	Acquire and monitor ECG	Yes	Stated as a capability.
	Monitor Heart Rate from ECG	Yes	Stated as a capability.
	Detect Lethal Arrhythmia	Yes	Stated as a capability.
	Detect Non-Lethal Arrhythmia	Yes	Stated as a capability.
	Perform ST Segment Analysis	Yes	Stated as a capability.
Networking/Communication	Bi-directional communication with Server via Access Point	Yes	Stated as a capability.
	Use 2.4 GHz ISM wireless band	Yes	Stated as a capability.
	Frequency hopping spread spectrum transmission	Yes	Stated as a capability.
Ambulatory Use	Allow for patient mobility	Yes	Stated as a design feature and intended use.

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

Sample Size for Test Set: Not specified. The document refers to "Performance testing" and "Hardware and Software validation" but does not provide details on sample sizes for any specific test sets.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

Not specified. The document does not describe the establishment of a ground truth for performance evaluation in a clinical study.

4. Adjudication method for the test set

Not specified.

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 is not mentioned. The device described appears to be a monitoring system that processes data, not an AI-assisted diagnostic tool for human readers in the context of image interpretation or similar tasks.

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

The device performs "ST/Arrhythmia analysis" and detects "various ECG arrhythmia events and select physiological parameter limit violations" autonomously. The document implies that this processing is done by the system, and then the information is displayed to clinicians. While not explicitly called a "standalone performance study," the system's ability to perform these analyses without direct human intervention suggests an inherent standalone algorithmic function. However, no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) are provided for these algorithmic detections.

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

Not specified. Given the context of a 510(k) submission and substantial equivalence for a monitoring system, it's highly likely that engineering tests and comparisons to predicate device behavior were used. Clinical ground truth (e.g., confirmed arrhythmia diagnoses by cardiologists) for performance metrics is not detailed in this summary.

8. The sample size for the training set

Not applicable. The document describes a medical device for monitoring, not an AI/ML algorithm that requires a distinct "training set" in the modern sense. The "development" process included "Hardware and software testing" and "Code design and code reviews," which would typically involve internal testing and validation against known standards and specifications, rather than machine learning training.

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

Not applicable, as there's no mention of a "training set" for an AI/ML algorithm.

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K Number

K011540

Device Name

VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07

Manufacturer

DATASCOPE CORP.

Date Cleared

2002-02-06

(264 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

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K Number

K991256

Device Name

VIEWPOINT ENT/ORTHOPEDIC OPTION

Manufacturer

PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

Date Cleared

1999-10-08

(178 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

The ViewPoint is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:

Intra-cranial surgical procedures involving space occupying lesions or malformations . (including soft tissue, vascular and osseous)
Spinal surgical procedures involving spinal stabilization, neural decompression, or . resection of spinal neoplasms.
ENT procedures. .
Orthopedic surgical procedures. .

Device Description

AI/ML Overview

This looks like a 510(k) clearance letter for a medical device called "ViewPoint ENT/Orthopedic Option," not a study or a technical report with detailed acceptance criteria and performance data.

The provided text does not include the specific details required to complete your request, such as a table of acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document primarily states:

Intended Use: "to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures."
Indications for Use: Intra-cranial, spinal, ENT, and orthopedic surgical procedures where stereotactic surgery is suitable and a rigid anatomical reference exists.
Regulatory Clearance: The device was found substantially equivalent to pre-amendment devices under a 510(k) submission. This is a regulatory pathway for market approval, not a detailed scientific study report.

Therefore, based only on the provided text, I cannot fill in the requested table and answer the study-related questions. The 510(k) summary and clearance letter typically do not contain this level of detail about specific performance studies and their methodology. These details would usually be found in a separate study report or the full 510(k) submission if it were publicly available and contained such performance data.

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K Number

K983764

Device Name

VIEWPOINT TOOLS- STERRAD

Manufacturer

PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

Date Cleared

1999-07-08

(255 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K963221,K970604

Predicate For

N/A

Intended Use

The ViewPoint is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

The ViewPoint is indicated for use in:

· Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)

· Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.

Device Description

Prior to use the ViewPoint tools must be sterilized. Testing has been completed to validate the use of the Sterrad 100 system for this process. The Guide Block (Non-Trackable and Trackable) and the Trackable Awl are three additional tools now available for the ViewPoint. The Guide Blocks guide and track the trajectory of a biopsy needle during a procedure. The Trackable Awl is a standard awl that has been adapted to include infrared emitting diodes so that the tip of the awl can be tracked similar to the standard ViewPoint Y-probe.

AI/ML Overview

The provided text describes the ViewPoint Tools - Sterrad, an Image Assisted Surgery Device. The submission is a 510(k) for new tools (Guide Blocks and Trackable Awl) and a new sterilization technique (Sterrad 100 system) for the previously cleared ViewPoint system. The document focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study on the device's diagnostic performance for its intended use.

Here's the breakdown of the acceptance criteria and the study as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily aims to demonstrate that the new ViewPoint tools (Guide Blocks and Trackable Awl) and the new sterilization technique (Sterrad 100 system) are substantially equivalent to previously cleared predicate devices and sterilization methods. The acceptance criteria are implicit in proving this equivalence, particularly regarding the existing accuracy specifications of the ViewPoint system.

Parameter	Acceptance Criteria (from Predicate Device)	Reported Device Performance (ViewPoint - Sterrad)
Tools	Y-Probe, Cable, Head Tracker, Spine Tracker, Drill Guide (Non-Trackable and Trackable)	Y-Probe, Cable, Head Tracker, Spine Tracker, Drill Guide (Non-Trackable and Trackable), Guide Block (Non-Trackable and Trackable), Trackable Awl (New tools claimed equivalent)
Material Considerations	Combination of metal and non-metal, IREDs sensitive to heat.	Same.
Lumens	Dead-end lumen in LEMO Connector for trackable tools; single-channel stainless steel lumen for drill guides.	Same.
Use limits	None specified for predicate.	Same (None).
Accuracy (Y-probe)	Repeatability/Resolution: 1mm; Distance measurement: $\pm$ 0.75 mm; 3D Localization: $\leq$ 1.57 mm; Fourth Fiducial Checkpoint: $<$ 5.0 mm	Same (Implied: the new tools/sterilization do not degrade the existing accuracy).
Sterilization Technique	Ethylene Oxide	Sterrad (New technique claimed equivalent in effectiveness and non-impact on tool function/accuracy).
Intended Use	As device for presurgical planning and intra-operative orientation/reference.	Same.
Indications for Use	Intra-cranial and Spinal surgical procedures.	Same.

Study Proving Acceptance Criteria:

The "study" described is a demonstration of substantial equivalence to predicate devices (K963221 and K970604). This is a regulatory pathway, not a traditional clinical accuracy or effectiveness study. The primary focus is on showing that the modifications (new tools and sterilization method) do not raise new questions of safety or effectiveness and perform as well as the legally marketed predicate devices.

The document states: "The use of the Sterrad 100 system adequately sterilizes the ViewPoint tools for intraoperative procedures and does not affect the accuracy or function of the tools. The Guide Blocks and the Trackable Awl described in this submission are equivalent to the tools described in the 510(k) submissions K963221 and K970604. This equivalence is demonstrated in the following table."

This suggests that:

Sterilization Validation: Testing was completed to validate the use of the Sterrad 100 system for this process. This implies a sterilization validation study was performed to ensure the Sterrad 100 achieves sterility and does not negatively impact the tools' accuracy or function.
Tool Equivalence: The new tools (Guide Blocks and Trackable Awl) are stated to be "equivalent" to the predicate tools, implying design and performance similarity where applicable, and that their addition does not change the overall system's fundamental performance characteristics (like accuracy).

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not specify a distinct "test set" in the context of a clinical performance study with a patient cohort. The submission is focused on demonstrating equivalence through technical comparisons and sterilization validation. For the sterilization validation, the sample size would refer to the number of devices or cycles tested, but this detail is not provided.
Data Provenance: Not applicable in the context of a clinical test set. The data originates from internal company testing (for sterilization validation and tool comparison) and references previously cleared predicate device characteristics.

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

This is not applicable as the submission is not a clinical effectiveness study requiring expert interpretation of results for ground truth establishment. The ground truth for tool accuracy parameters would be established by engineering measurements and metrology standards. For sterilization, ground truth is microbiological sterility testing.

4. Adjudication Method for the Test Set

Not applicable as there is no human-read test set requiring adjudication in this 510(k) submission.

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

No, an MRMC comparative effectiveness study was not done or described in this document. The submission focuses on device equivalence, not clinical effectiveness studies with human readers.

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

This device is an Image Assisted Surgery Device, implying a human-in-the-loop system. The concept of "standalone" performance for an algorithm without human intervention generally applies to diagnostic AI systems, which is not the primary focus of this submission. The accuracy parameters (e.g., repeatability, 3D localization) relate to the device itself, not a diagnostic algorithm.

7. The Type of Ground Truth Used

For Accuracy: The ground truth for the stated accuracy parameters (e.g., 3D Localization $\leq$ 1.57 mm) would be based on engineering measurement standards and metrology, verified through controlled laboratory testing.
For Sterilization: The ground truth for adequate sterilization would be established through microbiological testing (e.g., sterility testing, bioburden reduction validation) following recognized sterilization standards.
For Equivalence of Tools: The ground truth for equivalence (e.g., material considerations, lumens, form, and fit) is via design specifications, material certifications, and comparative technical analysis against the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device submission that involves a training set.

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

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

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