(181 days)
The AccessPoint™ software is intended to translate different medical image formats into a single format suitable for display on a standard Personal Computer.
Generally speaking, AccessPoint is a software product designed to provide the translation of different medical image formats into a form compatible to be displayed on a standard PC. Connection between sites including hospitals, out reach clinics, physician home and office are provided through the use of e-mail. The images and reports (patient studies) may be transported via e-mail in a secure manor (encryption of data) following standards used by the Internet and local LAN (Intranet), transport systems. A description of the various elements follow:
The AccessPoint™ software conforms to DICOM V3 service classes in the role of Service Class Reader.
Please note that the provided text is a "Safety and Effectiveness Summary" for a 510(k) submission, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report as would be found in a full efficacy study. As such, some of the requested information (like specific acceptance criteria values, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC study details, and detailed ground truth methodology for training sets) is not explicitly stated or derivable from the provided document.
However, I can extract the available information and highlight what is missing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define a table of "acceptance criteria" with quantitative targets that the AccessPoint™ device must meet (e.g., a specific accuracy percentage, sensitivity, or specificity). Instead, it describes the device's functional capabilities and compares them to a predicate device to establish substantial equivalence.
The "performance" described is largely functional equivalence and compatibility rather than clinical performance metrics. The table provided in the document is a "Substantial Equivalence Table" comparing features.
Substantial Equivalence Table (from document)
| Feature | Access Point™ Performance |
|---|---|
| Real-Time Image Playback | Yes |
| Slow Motion or Frame by Frame Review | Yes |
| Image Zoom | Variable from .5 to SVGA size |
| Study Comparison | Windows 95, NT facilities |
| ECG Synchronized Playback | Yes |
| ECG Display | Yes |
| Patient Demographics Display | Window contains age, heart rate, BP, study type and date |
| Modem Transmission | Windows 95 Windows NT standard |
| Windows Messaging, Exchange, SMTP | |
| Network Support | Windows 95, Windows NT TCP/IP standard |
| Comprehensive Image Serial Study Review | DICOM V3.0, TomTec, Microsonics, HP, Esaote/Biosound acquired |
| Different Modalities Review | DICOM US, NM |
| Audio Capture & Playback | Windows 95, NT facilities |
| Patient Data Storage | DICOM Version 310 Lossy |
| Compression | JPEG baseline, Lossless REL Lossless JPEG baseline |
| Acquisition of Ultrasound Images | Does not acquire images from analog composite video sources. Reads images formatted and acquired by other systems, i.e., TomTec P90, Nova Microsonics, DICOM, AU3, AU4, HP |
| Integration Into Ultrasound System | No |
| Proprietary Hardware | None |
| General Functional Performance Summary: | The AccessPoint™ software is intended to translate different medical image formats into a single format suitable for display on a standard Personal Computer. It conforms to DICOM V3 service classes as a reader. Supports various communication, storage, and image formats, including standard compression techniques. It displays compression ratios and notes lossy compression on screen. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly mentioned in the document.
- Data Provenance: Not explicitly mentioned. The device is software designed to work with various existing imaging systems (Biosound/Esaote, Hewlett Packard, TomTec, MicroSonics, DICOM US, NM), implying it would be used with data potentially originating from different sources and countries where these systems are used. The document does not specify if a specific dataset (retrospective or prospective) was used for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. A "Safety and Effectiveness Summary" for a 510(k) usually focuses on technical equivalence and functional performance rather than clinical ground truth validation with experts.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, there is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study, nor an effect size for human readers improving with or without AI assistance. This type of study is not typically part of a 510(k) submission focused on image viewing and transport software. The device itself is described as "Medical Image Reading and Transport Software," not an AI diagnostic aid for interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: The document describes the software's standalone functionalities (e.g., its ability to translate image formats, display images, handle compression). It is inherently a "standalone" software product in that it performs its functions without direct human intervention in the processing of the image data, but its purpose is to present data to a human for interpretation. It is not an AI algorithm that makes diagnostic claims independently. The "performance" assessment is functional and comparative to existing predicate devices based on features.
7. The Type of Ground Truth Used
- Given the nature of the device (image translation and display software) and the context of a 510(k) summary focused on substantial equivalence to a predicate device, clinical "ground truth" (like pathology or outcome data) in the diagnostic sense is not applicable or mentioned. The "ground truth" for this device's performance would be whether it correctly translates and displays the various image formats as intended, and whether its features are comparable to the predicate device. This would likely be assessed through technical verification and validation, not clinical ground truth.
8. The Sample Size for the Training Set
- This information is not provided. The AccessPoint™ device is described as "Medical Image Reading and Transport Software" and is not an AI/ML model that is "trained" on a dataset in the conventional sense of machine learning for diagnostic inference. It is software that adheres to standards and handles various image formats.
9. How the Ground Truth for the Training Set was Established
- As explained in point 8, the concept of a "training set" and "ground truth" for a training set in the context of an AI/ML model does not directly apply to this type of medical image viewing and transport software as described in the document. The software is developed based on programming standards (e.g., DICOM V3, Windows operating systems, internet protocols) and compatibility with existing commercial ultrasound image formats. Its "correctness" is established through engineering and software validation against these specifications, not via a human-labeled training set for diagnostic purposes.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the text "K963936/" above the words "BIOSOUND ESAOTE". The text "BIOSOUND" is in a bold, sans-serif font, while "ESAOTE" is in a similar font but with a lined design. The text "K963936/" is handwritten and appears to be a serial number or code.
Safety and Effectiveness Summary AccessPoint™ Biosound, Inc.
MAR 31 1997
Biosound, Inc. 8000 Castleway Drive Indianapolis. IN 46250 317 849.1793 800 428.4374 tax 317 841.8616 http://www.biosound.com/
HA oo Ol IZ
Safety and Effectiveness Summary
The following safety and effectiveness summary has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR 1807.92(a).
807.92(a)(1)
Submitter Information
Wayne Nethercutt Director, Regulatory Affairs 8000 Castleway Drive Indianapolis, IN 46250 Phone: (317) 849-1793 Facsimile: (317) 841-8616 Contact Person: Wayne Nethercutt Date: 09/27/96
Our mission is to enhance the quality of life lis providing diagnostic medical equipment and services of superior quality and value for the early detection and management of disease.
{1}------------------------------------------------
K963936/A1
Safety and Effectiveness Summarv AccessPointM Biosound, Inc.
807.92(a)(2)
Trade Name: AccessPoint ™ Med E-mail DICOM Reader
Common Name: Medical Image Reading and Transport Software
Classification Name(s): Diagnostic Ultrasound 90ITX .
807.92(a)(3)
Predicate Device(s)
- TomTec P90 K950279 .
Additional Substantial Equivalence information is provided in the attached Substantial Equivalence Comparison Table.
807.92(a)(4)
Device Description
- Generally speaking, AccessPoint is a software product designed to provide the translation of different medical image formats into a form compatible to be displayed on a standard PC. Connection between sites including hospitals, out reach clinics, physician home and office are provided through the use of e-mail. The images and reports (patient studies) may be transported via e-mail in a secure manor (encryption of data) following standards used by the Internet and local LAN (Intranet), transport systems. A description of the various elements follow:
The AccessPoint™ software conforms to DICOM V3 service classes in the role of Service Class Reader.
{2}------------------------------------------------
Safety and Effectiveness Summary AccessPoint™ Biosound. Inc.
Communications
Modems supported by Microsoft windows 95 and Windows NT Network communications utilizing TCP/IP Internet Protocol definitions E-mail utilizing POP3 and SMTP (simple mail transfer protocol) standard as implemented in the Microsoft Windows 95, and windows NT operating system Telecommunications standard Integrated Services Digital Network (ISDN) Internet Service access through TCP/IP connection.
Storage
Floppy disk, hard disk, tape, and optical storage supported by Windows 95 or NT operating system.
Image Formats
AccessPoint™ supports the requirement in the Ultrasound Application Profile (APL-US) in the role of file set - Reader as incorporated in the DICOM version 3 definition.
- Commercial Ultrasound Image Formats:
Biosound/Esaote AU3 and AU4 digital formats Hewlett Packard DSR Tiff format TomTec version 5 and P90 versions MicroSonics DSR, DataVue, ImageVue formats
Data Compression
Standard compression techniques used include:
Run Length encoding as published in DICOM V3 supplement 5 also referred to as Tiff Pack bits compression.
ISO/IEC 10918-1 JPEG baseline lossy, and Baseline lossless Compression Audio compression ADPCM adaptive pulse code modulation supplied standard in Windows 95 and Windows NT.
The compression ratio is displayed on the status bar of each window showing the operator and reader that the images displayed have been compressed.
Lossy compression is noted on each display screen.
{3}------------------------------------------------
Safety and Effectiveness Summary AccessPoint™ Biosound, Inc.
Workstation
Monitor
Standard SVGA monitors are used which comply with the requirements of the Radiation Control and Health and Safety Act.
Processors and Storage
No special image processing hardware is required. Storage requirements vary based on the source of the image data as follows:
With Biosound/Esaote AU3 Ultrasound System, 128/230 MB Magneto optical 3.5" disk drive (internal)
With Tom Tec version 5 acquisition systems, one compatible disk drive 128/230 MB Magneto optical 3.5" disk drive (internal) SCSI controller compatible with Windows 95 or 650/1.3 MB Magneto optical disk drive SCSI controller compatible with Windows 95.
With MicroSonics DSR acquisition, one compatible disk drive 230 MB Magneto optical 3.5" disk drive (internal) SCSI controller compatible with Windows 95 or 650/1.3 MB Magneto optical disk drive, SCSI controller compatible with Windows વેરું.
With Hewlett Packard DSR acquisition, one compatible disk drive, 650 MB Magneto optical disk drive, SCSI controller compatible with Windows 95.
Operator Interface
Standard input devices supported by Microsoft Windows 95, and Windows NT 3.51. No special devices are required. Common implementation includes a keyboard and MS compatible mouse.
Software
1
The workstation uses: Microsoft Office Professional Edition Microsoft Windows 95, windows NT 3.51 or greater Microsoft Plus Pack Microsoft Internet Explorer 3.0
807.92(a)(5)
Intended Use(s)
The AccessPoint™ software is intended to translate different medical image formats into a single format suitable for display on a standard Personal Computer.
{4}------------------------------------------------
Safety and Effectiveness Summary AccessPointM Biosound. Inc. 807.92(a)(6)
Substantial Equivalence Table
Feature
Access Point™
TomTec P90 K950279
| Real-Time Image Playback | Yes | Yes |
|---|---|---|
| Slow Motion or Frame by FrameReview | Yes | Yes |
| Image Zoom | Variable from .5 to SVGA size | 2X only |
| Study Comparison | Windows 95, NT facilities | Windows 3.11 Facilities |
| ECG Synchronized Playback | Yes | Yes |
| ECG Display | Yes | Yes |
| Patient Demographics Display | Window contains age, heartrate, BP, study type and date | Heart rate, BP, studyphase |
| Modem Transmission | Windows 95 Windows NTstandard | Custom software |
| Windows Messaging,Exchange, SMTP | No | |
| Network Support | Windows 95, Windows NTTCP/IP standard | Windows 3.11 |
| Comprehensive Image SerialStudy Review | DICOM V3.0, TomTec,Microsonics, HP,Esaote/Biosound acquired | TomTec, MicroSonicsacquired |
| Different Modalities Review | DICOM US, NM | Proprietary format withDICOM support |
| Audio Capture & Playback | Windows 95, NT facilities | Windows |
| Patient Data Storage | DICOM Version 310 Lossy | Proprietary patient roster |
| Compression | JPEG baseline, Lossless RELLossless JPEG baseline | JPEG lossy, JPEGlossless |
Differences
ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
| Feature | Access Point™ | TomTec P90 |
|---|---|---|
| Acquisition of Ultrasound Images | Does not acquire images fromanalog composite videosources. Reads imagesformatted and acquired byother systems, i.e., TomTecP90, Nova Microsonics,DICOM, AU3, AU4, HP | Analog composite videoNTSC/PAL, SVHS, RGB |
| Integration Into UltrasoundSystem | No | All manufacturersultrasound systems |
| Proprietary Hardware | None | Digital Echo Bus™ |
§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.