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.

Device Description

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.

AI/ML Overview

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.

Summary

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2/11/99

K984215

"510 (k) SUMMARY" Summary of Safety and Effectiveness

Submitter's Name & Address: Welch Allyn Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, N.Y. 13153-0220

Contact Person & Telephone: Colin Wolff (315) 685-2525

November 19, 1998 Date Summary Prepared:

Classification Name Picture Archiving and Communication System Device Name: Common/Usual Name - Dictation System with PACS Proprietary Name - Welch Allyn Front-Line Doc
model Image Vault (ref. 510(k) #K974102) Predicate Device:

Device Description, Intended Use & Effectiveness:

The effectiveness of the Front-Line Doc system is the same as current dictation systems and PACS already on the market.

Technological Characteristics:

See attachment "A" for a comparison of the Front-Line Doc to the predicate device.

Safety:

Numerous safety areas were investigated and reviewed to ensure that the Welch Allyn Front-Line Doc System is as safe, or safer than existing similar devices already in commercial distribution. The device under review is considered very safe for both practitioner and patient. It is non-contact for the patient. The procedure and technique are low risk. The specific safety areas considered are as follows:

The device is not intended to contact any patient. It is made of Toxicity materials that are skin compatible.
has agency approval based on standards from UL 544. Electrical
Light output levels are consistent with output from safe use journal Light

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Explosion	Highly unlikely; manufactured of non-explosive materials. The batteries are protected from an electrical short condition.
SurfaceTemperature	All surfaces have been evaluated for practitioner contact.
Fire Hazard	Probability extremely low; this system uses a low voltage halogenlamp, which draws a maximum of 5 watts power. The video and audioportions are also low voltage.
Mechanical -(Sharp Edges)	All contact surfaces have been blended androunded. No injury will result from sharp edges.
Software	Risk Analysis, FMEA, and Verf.& Valid. performed for software.

Summary of Effectiveness:

The determination of device effectiveness was coordinated in the following manner:

The Welch Allyn Front-Line Doc development team conducted on-site evaluations of the device with practicing physicians in an effort to determine if the device met all of the practitioner's needs. The evaluating practitioners were also users of either an existing dictaton, or other model dictation and imaging devices (all have the same intended use). 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 1999

Colin Wolff Certified Quality Engineer Welch Allyn, Inc. 4341 State Street Rd. Skaneateles Falls, NY 13153-0220 Re:

K984215 Welch Allyn Front-Line Doc Dated: November 20, 1998 Received: November 24, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Wolff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

J.J.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K984215

Device Name: Welch Allyn Front-Line Doc

Indications For Use:

The Welch Allyn model #77000 Front-Line Doc™ system is intended for dictation and r he volumentation. It also enhaoces 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Vimil le. Segpan
(Division Sign-Off)

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K984215

Regulation Number and Section

§ 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).