(435 days)
JELTRATE PLUS is used for all routine dental impressions.
JELTRATE PLUS is dust free, fast setting, and helps protect staff from infection due to cross-contamination prior to soaking the impression.
This looks like a 510(k) summary for a dental impression material, not a medical device that would typically involve a "study that proves the device meets the acceptance criteria" in the way that AI/ML devices do (e.g., with sensitivity, specificity, and ROC curves).
The document describes an "additional claim" for an existing product, Jeltrate® PLUS™ Antimicrobial Dustless Alginate Impression Material, related to its antimicrobial properties. The "study" mentioned is likely a microbiological study to validate this claim, rather than a clinical trial with human subjects and expert ground truth.
Therefore, many of the requested categories (like MRMC study, number of experts for ground truth, adjudication method, training set details) are not applicable to the information provided.
However, I can extract the relevant information regarding the acceptance criterion and the "study" that supports it:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Elimination of up to 99% of viable surface microorganisms after water rinsing impression for just 15 seconds. | JELTRATE PLUS eliminates up to 99% of viable surface microorganisms after water rinsing the impression for just 15 seconds. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified in the provided documents.
- Data Provenance: Not specified. This would typically be a laboratory-based microbiological study, rather than human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for a microbiological claim would be established through laboratory methods (e.g., colony counting) by microbiologists or lab technicians, not clinical experts for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical ground truth consensus with multiple human readers, not for microbiological testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/ML medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML medical device.
7. The Type of Ground Truth Used
The ground truth would be based on microbiological assay results (e.g., quantification of viable microorganisms before and after treatment) obtained in a laboratory setting.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning study; there is no training set mentioned.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
{0}------------------------------------------------
st College Avenue 7405-0
AUG 1 3 1996
COMPLIANCE DEPT. TELEFAX (717) 849-4343
August 8, 1996
| 301-480-3002TELEFAXED ANDEXPRESS MAIL | |||
|---|---|---|---|
| Mr. Greg Singleton (HFZ-480)Food and Drug AdministrationCenter for Devices and Radiological Health9200 Corporate BoulevardRockville, MD 20850 | FDA/CDRH9 AUG 96 | ||
| AMENDMENT #3 | K952614, Jeltrate® PLUS™ Antimicrobial Dustless AlginateImpression Material | RECEIVED |
This letter is in response to your telephone call to me this afternoon.
As you requested, attached is a revised 510(K) SUMMARY for K952614, changing the claim to read:
Jeltrate® PLUS™ eliminates up to 99% of viable surface microorganisms after water rinsing the impression for just 15 seconds.
If you have any additional questions, please don't hesitate to contact me. Thank you.
Sincerely,
I. Jeffrey Lek
P. Jeffery Lehn Associate Director Corporate Compliance
Attachment
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and closely spaced together. The overall impression is of a strong, established brand name. The image is in black and white.
DENTSPLY Internationa
570 West College Avenue
P.O. Box 872
York, PA 17405-0872
(717) 845-7511
Fax (717) 854-2943
TELEFAX (717) 849-4343
510(k) SUMMARY
NAME & ADDRESS: DENTSPLY International, 570 West College Avenue, York, PA 17404 CONTACT: P. Jeffery Lehn (717) 849-4343 (717) 845-7511 FAX: PHONE : DATE PREPARED: August 8, 1996
TRADE OR PROPRIETARY NAME: JELTRATE® PLUS™ IMPRESSION MATERIAL
COMMON OR USUAL NAME: Impression Material
Impression Material, 21 CFR, 872.3660 CLASSIFICATION NAME:
LEGALLY MARKETED DEVICE: Jeltrate PLUS Impression Material K883842
DESCRIPTION OF DEVICE: JELTRATE PLUS is dust free, fast setting, and helps protect staff from infection due to cross-contamination prior to soaking the impression.
INTENDED USE: JELTRATE PLUS is used for all routine dental impressions.
TECHNOLOGICAL CHARACTERICS: There has been no change in composition, design, material, packaging, function or manufacture of Jeltrate® PLUS™ Antimicrobial Dustless Alginate Impression Material (K883842). This submission represents only an additional claim.
We believe the conclusions of the study conducted support the additional claim that JELTRATE PLUS eliminates up to 99% of viable surface microorganisms after water rinsing the impression for just 15 seconds.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).