(79 days)
The Welch Allyn model #77000 Front-Line Doc™ system is intended for dictation and also enhances medical records by allowing physicians to add images to their dictated patient notes. The device is intended to be used by trained personnel within a medical or school environment.
Front-line Doc is a medical imaging and documentation system. It consists of a handheld portable instrument and software applications bundled to inhance office transcription and documentation. Software applications can be utilized on a PC to perform the transcription, review, and management tracking and reporting processes.
The provided text describes a "Dictation System with PACS" named "Welch Allyn Front-Line Doc," not a device with specific performance metrics like sensitivity, specificity, or image quality. Therefore, a table of acceptance criteria and reported device performance, as typically found for diagnostic devices, cannot be generated from this document.
The "effectiveness" of the device is described in the "Summary of Effectiveness" section, focusing on its utility as a medical imaging and documentation system, rather than quantifiable performance metrics.
Here's an analysis of the provided information based on the requested categories, highlighting what is present and what is absent:
Acceptance Criteria and Study for Welch Allyn Front-Line Doc
This summary is based on the provided 510(k) Pre-Market Notification for the "Welch Allyn Front-Line Doc" (K984215).
1. Table of Acceptance Criteria and Reported Device Performance
As this device is a dictation and imaging documentation system, not a diagnostic device that produces quantitative results, specific performance metrics like sensitivity, specificity, or accuracy are not applicable or reported in the provided document. The acceptance criteria and "performance" are framed around its functional equivalence to existing systems and meeting user needs.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: | The effectiveness of the Front-Line Doc system is the same as current dictation systems and PACS already on the market. |
| The results of the evaluations indicated that the Welch Allyn Front-Line Doc System serves the needs of the documentation procedure in an equivalent or better manner of effectiveness. | |
| Meeting Practitioner Needs: The device should satisfy the needs of practicing physicians for medical imaging and documentation. | On-site evaluations with practicing physicians indicated that the device "met all of the practitioner's needs." The evaluating practitioners were users of existing dictation or dictation and imaging devices, suggesting their needs were compared to their current tools. |
| Safety: Device must be safe for practitioner and patient. | Multiple safety areas investigated, reviewed, and deemed safe: |
- Toxicity: Not intended to contact patient; made of skin-compatible materials.
- Electrical: Agency approval based on UL 544 standards.
- Light Output: Consistent with output from safe use journal light.
- Explosion: Highly unlikely; non-explosive materials, batteries protected.
- Surface Temperature: All surfaces evaluated for practitioner contact.
- Fire Hazard: Extremely low probability; low voltage halogen lamp (max 5 watts), low voltage video/audio.
- Mechanical (Sharp Edges): All contact surfaces blended and rounded; no injury from sharp edges.
- Software: Risk Analysis, FMEA, and Verification & Validation performed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "practicing physicians" and "evaluating practitioners" but does not give a number for how many were involved in the on-site evaluations.
- Data Provenance: The evaluations were conducted "on-site" but the specific country of origin is not mentioned. Given Welch Allyn Inc. is based in Skaneateles Falls, N.Y., USA, it is highly likely the evaluations took place in the United States. The study appears to be prospective in nature, as it involved active evaluations of the developing device by physicians.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated. The evaluators are referred to as "practicing physicians," but no specific count is provided.
- Qualifications of Experts: They are described as "practicing physicians" who were "users of either an existing dictation, or other model dictation and imaging devices." No specific specialty (e.g., radiologist, general practitioner) or years of experience are mentioned.
4. Adjudication Method for the Test Set
- The document describes "on-site evaluations" and "the results of the evaluations indicated..." This suggests a qualitative assessment or consensus among the evaluating practitioners regarding the device's utility in meeting their needs. No formal adjudication method (e.g., 2+1, 3+1) is described. It appears to be a direct assessment of user satisfaction and functional equivalence.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This device is not an AI-powered diagnostic tool. The effectiveness study focused on comparing the system's overall function and user satisfaction to existing dictation and imaging devices, not on improving human reader performance with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The "Welch Allyn Front-Line Doc" is a system designed for human use and interaction (dictation, imaging, documentation). It does not have a standalone algorithm performance that would be evaluated without human involvement. Its "performance" is inherently tied to its utility for human users.
7. The Type of Ground Truth Used
- The "ground truth" for this device's effectiveness was primarily expert consensus / user satisfaction regarding its ability to meet documentation needs, and its functional equivalence to predicate dictation and PACS systems. This is based on feedback from "practicing physicians."
8. The Sample Size for the Training Set
- Not applicable / Not specified. This device does not use machine learning or AI that would require a "training set" in the traditional sense for diagnostic algorithm development. The development process involved iterative design and evaluation, but not an AI training data set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI training set, there is no ground truth established for one. The "ground truth" for the device's development was derived from understanding the "practitioner's needs" through on-site evaluations and ensuring the device's functionality matched or exceeded that of existing systems.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).