(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.
§ 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.