(83 days)
The Welch Allyn Reveal Intraoral Camera System is indicated for use during dental examinations and procedures when a video image is desired.
The purpose of the Welch Allyn Reveal Intraoral Camera System is to provide video images of the mouth and oral structures. Video images aid in patient education and insurance documentation. The intended use of the Welch Allyn Reveal Intraoral Camera System is to provide video images during dental examinations and procedures. The Welch Allyn Reveal Intraoral Camera System is effective in its intended use.
The provided 510(k) summary for the Welch Allyn Reveal Intraoral Camera System does not contain detailed acceptance criteria or a study proving its performance in the manner typically expected for AI/ML-based medical devices. This is because the device appears to be an intraoral camera system from 1998, a time before the widespread use of AI/ML in medical imaging, and its regulatory submission focuses on its ability to provide video images and its safety/effectiveness for that purpose.
Therefore, many of the requested elements pertaining to AI/ML device evaluation (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details, etc.) are not applicable to this document.
However, I can extract the available information and structure it to the best of my ability based on the prompt's request.
Description of Acceptance Criteria and Device Performance Study (Based on Provided 510(k) Summary for K981937)
The Welch Allyn Reveal Intraoral Camera System is a Class I medical device intended to provide video images of the mouth and oral structures during dental examinations and procedures. The 510(k) submission, dated May 27, 1998, focuses on demonstrating substantial equivalence to a predicate device (UltraCam Intraoral Camera System, K933671) and compliance with relevant safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred from Submission) | Reported Device Performance (Summary Statements) |
|---|---|
| Safety: | |
| - Compliance with Electrical Safety Standards | - Complies with IEC 601-1, EN 60601-1-2, and UL 2601. |
| - Provides safety to patient and user | - Designed to provide safety to the patient as well as the user. |
| Effectiveness/Intended Use: | |
| - Provides video images of mouth and oral structures | - "The purpose...is to provide video images of the mouth and oral structures." |
| - Aids in patient education and insurance documentation | - "Video images aid in patient education and insurance documentation." |
| - Effective in its intended use (providing video images during dental examinations and procedures) | - "The Welch Allyn Reveal Intraoral Camera System is effective in its intended use."- "The Welch Allyn Reveal Intraoral Camera System is effective for its intended use of providing video images during dental examinations and procedures." |
| Substantial Equivalence: | |
| - Technological Characteristics comparable to predicate device | - See Attachment "A" for a comparison of features and specifications with the predicate device (UltraCam Intraoral Camera System, K933671). |
Study Information (Limitations: As this is a 1998 device and not AI/ML, much of this is N/A)
This 510(k) summary does not describe a clinical study with a detailed test set, ground truth establishment, or performance metrics typically associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC). The "study" appears to be an internal assessment of compliance with performance claims and safety standards, and a comparison to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- N/A. The document does not describe a specific clinical "test set" with a defined sample size for performance evaluation in the context of diagnostic accuracy or AI/ML output. Assessment of effectiveness is based on the device's ability to produce video images and its technological characteristics compared to a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- N/A. Ground truth in the context of diagnostic accuracy or AI output is not applicable here, as the device's primary function is imaging, not automated interpretation.
4. Adjudication Method for the Test Set
- N/A. Not applicable, as there is no described test set requiring expert adjudication for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is not mentioned. This type of study is typically used to assess human reader performance, often with and without AI assistance, which is not relevant for this intraoral camera.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This device does not have an "algorithm only" component for diagnostic output; its function is to capture video images.
7. The Type of Ground Truth Used
- N/A (for AI/ML context). For the purpose of regulatory clearance, the "ground truth" for this device's effectiveness would be its ability to physically capture and display video images, which is inherently verifiable through technical specifications and direct observation, rather than external expert consensus, pathology, or outcomes data for a diagnostic prediction.
8. The Sample Size for the Training Set
- N/A. The concept of a "training set" for an AI/ML algorithm is not applicable to this device.
9. How the Ground Truth for the Training Set was Established
- N/A. Not applicable, as there is no AI/ML component requiring a training set.
Conclusion on Device Evaluation:
The Welch Allyn Reveal Intraoral Camera System's regulatory submission, typical for devices of its era and classification, relied on demonstrating its technological characteristics, adherence to safety standards, and substantial equivalence to a legally marketed predicate device. The "effectiveness" was established by its ability to perform its core function (provide video images) as stated in its intended use, rather than through complex clinical trials assessing diagnostic accuracy or AI performance.
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KA81937
"510(k) SUMMARY" Summary of Safety and Effectiveness
| Submitter's Name & Address: | Welch Allyn Inc.4619 Jordan Road, Box 187Skaneateles Falls, New York 13153-0187 |
|---|---|
| Contact Person & Telephone: | Kathy Lowther(315) 685-2897 |
| Date Summary Prepared: | May 27, 1998 |
| Device Name: | Classification Name - Unit, Operative DentalCommon/Usual Name - Intraoral CameraProprietary Name - Welch Allyn Reveal Intraoral Camera System |
UltraCam Intraoral Camera System (510(k) number K933671) Predicate Device:
Device Description, intended Use & Effectiveness:
The purpose of the Welch Allyn Reveal Intraoral Camera System is to provide video images of the mouth and oral structures. Video images aid in patient education and insurance documentation. The intended use of the Welch Allyn Reveal Intraoral Camera System is to provide video images during dental examinations and procedures. The Welch Allyn Reveal Intraoral Camera System is effective in its intended use.
Technological Characteristics:
See Attachment "A" for a comparison of the features and specifications of the Welch Allyn Reveal Intraoral Camera System and the predicate device.
Summary of Safety:
The Welch Allyn Reveal Intraoral Camera System was designed to provide safety to the patient as well as the user. The system complies with IEC 601-1, EN 60601-1-2, and UL 2601.
Summary of Effectiveness:
The Welch Allyn Reveal Intraoral Camera System is effective for its intended use of providing video images during dental examinations and procedures.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 1998
Ms. Kathy Lowther Quality Engineer Welch Allyn, Incorporated 4619 Jordan Road, Box 187 Skaneateles Falls, New York 13153-0187
Re : K981937 Welch Allyn Reveal Intraoral Camera System Trade Name: Regulatory Class: I Product Code: EIA Dated: May 29, 1998 Received: June 2, 1998
Dear Ms. Lowther:
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 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 (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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
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Page 2 - Ms. Lowther
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.
If 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) 594-4692. 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 qeneral 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/dsmamain.html".
Sincerely yours,
S. Butman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _________________
Device Name: Welch Allyn Reveal Intraoral Camera System
Indications For Use:
The Welch Allyn Reveal Intraoral Camera System is indicated for use during dental examinations and procedures when a video image is desired.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Roemer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 98192 510(k) Number
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.