(202 days)
- A root end filling material
- For the repair of repair of root canals as an apical plug during apexification
- For repair of root perforations during root canal therapy or as a consequence of internal resorption
- As a pulp capping material
- Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations
ProRoot MTA White and ProRoot MTA Gray is a powder consisting of fine hydrophilic particles that set in the presence of moisture. Hydration of the powder creates a colloidal gel that solidifies to form a strong impermeable barrier that fully cures over a four-week period.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
The provided text is a 510(k) premarket notification for a dental device, ProRoot MTA White/Gray (Pediatric Pulpotomy). It focuses on establishing substantial equivalence to previously cleared predicate devices and adding a new indication for use: "Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations."
It's important to note that this document is not a standalone study report with explicit acceptance criteria and detailed performance metrics as one might find for a diagnostic or imaging AI/software device. Instead, it's a regulatory submission demonstrating the safety and effectiveness of expanding the indications for an existing material based on clinical literature. Therefore, the information requested will be interpreted within this context.
1. Table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative sense (e.g., "sensitivity must be >90%"). Instead, the acceptance criterion for the new indication is demonstrating safety and effectiveness for pulpotomy in pediatric patients, supported by existing clinical literature.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and effectiveness for pulpotomy in primary teeth in pediatric populations. | The device (ProRoot MTA White/Gray, which is identical to the predicate devices) has been "studied extensively in technical literature by dental professionals."Based on "completed studies (pulpotomy in 171 pediatric patients covering 408 primary teeth), it is appropriate to add pulpotomy of primary teeth as an indication for use in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations for ProRoot MTA White and ProRoot MTA Gray." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): The filing mentions "completed studies (pulpotomy in 171 pediatric patients covering 408 primary teeth)." This represents the total number of patients and teeth across the summarized clinical literature.
- Data Provenance: The data originates from "independently reviewed medical literature" and "relevant clinical data available in independently reviewed medical literature." One specific reference is provided: Srinivasan, V, et al "Mineral trioxide aggregate in paediatric dentistry" International Journal of Paediatric Dentistry, 19:34-47, 2009. The studies are retrospective as they are existing published literature. The country of origin of the data is not specified but is presumably international given the nature of scientific literature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the exact number of experts involved in establishing the ground truth for the collected literature. It refers to studies conducted by "dental professionals." The provided reference is to an "International Journal of Paediatric Dentistry," suggesting the experts involved would be pediatric dentists or dental professionals specializing in pediatric dentistry. Their specific years of experience are not detailed.
4. Adjudication method for the test set
The document does not describe a specific adjudication method (like 2+1, 3+1, none) for the clinical literature review or for establishing ground truth within those studies. The assessment relies on the conclusions and methods presented in the published scientific literature.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is not an AI/software device designed to assist human readers. It is a dental material used directly in treatment.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a dental material, not an algorithm or software. Its performance is evaluated based on its clinical outcomes after application by a dental professional.
7. The type of ground truth used
The ground truth used in the referenced clinical literature would be clinical outcomes data relevant to pulpotomy procedures, such as:
- Clinical success (e.g., absence of pain, swelling, mobility)
- Radiographic success (e.g., absence of periapical or furcal radiolucency, normal root development)
- Histological findings (if biopsies were taken, though less common for outcome assessment in pulpotomy for regulatory purposes).
- Retention rates of the teeth.
8. The sample size for the training set
N/A. This device does not use an "algorithm" in the traditional sense that requires a training set for machine learning. The clinical experience and data from the 171 pediatric patients (408 teeth) constitute the evidence base, not a training set for an algorithm.
9. How the ground truth for the training set was established
N/A. As above, there is no training set for an algorithm. The ground truth for the clinical studies (evidence base) was established through standard clinical and radiographic follow-up protocols within the individual studies published in the medical literature.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26,2015
Dentsply International Inc. Helen Lewis Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17401
Re: K142178
Trade/Device Name: Pro Root MTA Regulation Number: 21 CFR 872.3820 Regulation Name: Regulatory Class: II Product Code: KIF Dated: November 24, 2014 Received: November 28, 2014
Dear Ms. Helen Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name(s): ProRoot MTA White/Gray (Pediatric Pulpotomy)
Indications for Use:
- A root end filling material ●
- For the repair of repair of root canals as an apical plug during apexification 0
14217
- 0 For repair of root perforations during root canal therapy or as a consequence of internal resorption
- As a pulp capping material 0
- Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 0 years) pediatric patient populations
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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SECTION 5. 510(k) SUMMARY for ProRoot MTA White/Gray (Pediatric Pulpotomy)
- 5.1 Submitter Information:
DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, PA 17401
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
Date Prepared: 04 August 2014
- 5.2 Device Name:
| Proprietary Name: | ProRoot MTA WhiteProRoot MTA Gray |
|---|---|
| Classification Name: | Resin, root canal filling |
| CFR Number: | 872.3850 |
| Device Class: | II |
| Product Code: | KIF |
- 5.3 Predicate Devices:
| Predicate DeviceName | 510(k) | S.E. Date | Company Name |
|---|---|---|---|
| White MTA Material | K011009 | May 2, 2001 | DENTSPLY International, Inc. |
| MTA Material II | K981260 | July 31, 1998 | DENTSPLY International, Inc. |
- 5.4 Description of Device:
The proposed ProRoot MTA White/Gray (Pediatric Pulpotomy) is identical to the predicates White MTA Material, K011009 and MTA Material II, K981620.
ProRoot MTA White and ProRoot MTA Gray is a powder consisting of fine hydrophilic particles that set in the presence of moisture. Hydration of the powder creates a colloidal gel that solidifies to form a strong impermeable barrier that fully cures over a four-week period.
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5.5 Indications for Use:
- o A root end filling material
- For the repair of repair of root canals as an apical plug during apexification o
- For repair of root perforations during root canal therapy or as a consequence of o internal resorption
- o As a pulp capping material
- Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-0 21 years) pediatric patient populations
5.6 Substantial Equivalence:
Technological Characteristics.
| Predicate Device | Predicate Device | Proposed Device | |
|---|---|---|---|
| White MTA Material | MTA Material II | ProRoot MTA White/Gray | |
| K011009 | K981620 | (Pediatric Pulpotomy) | |
| Indicationsfor Use | • Repair of root perforation during root canal therapy (endodontic therapy), or as a consequence of internal resorption;• Repair of root canals as an apical plug during apexification;• Root end filling material; and• Pulp capping material | • A root end filling material. | • A root end filling material• For the repair of repair of root canals as an apical plug during apexification• For repair of root perforations during root canal therapy or as a consequence of internal resorption• As a pulp capping material• Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations |
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| Features | ProRoot MTA White andProRoot MTA Gray is apowder consisting of finehydrophilic particles that setin the presence of moisture.Hydration of the powdercreates a colloidal gel thatsolidifies to form a strongimpermeable barrier thatfully cures over a four-weekperiod. | ProRoot MTAWhite and ProRootMTA Gray is apowder consisting offine hydrophilicparticles that set inthe presence ofmoisture. Hydrationof the powdercreates a colloidalgel that solidifies toform a strongimpermeable barrierthat fully cures overa four-week period. | ProRoot MTA White andProRoot MTA Gray is apowder consisting of finehydrophilic particles that setin the presence of moisture.Hydration of the powdercreates a colloidal gel thatsolidifies to form a strongimpermeable barrier thatfully cures over a four-weekperiod. |
|---|---|---|---|
| ---------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
5.7 Non-Clinical Performance Data:
The quality requirements for the devices have not changed as a result of this filing. Only the proposed Indications for Use for the ProRoot MTA White/Gray (Pediatric Pulpotomy) have been modified as compared to the predicates White MTA Material, K011009 and MTA Material II, K981620. The results of performance testing and biocompatibility testing conducted for the predicate devices, White MTA Material (K011009) and MTA Material II (K981620) are valid, therefore, no additional performance testing or biocompatibility testing has been performed.
5.8 Clinical Performance Data:
ProRoot MTA White and ProRoot MTA Gray have been sold by DENTSPLY International and its predecessors since February 10, 1997 and have been in use as a dental repair material since that time. ProRoot MTA White/Gray (Pediatric Pulpotomy) have been studied extensively in technical literature by dental professionals', and based on the completed studies (pulpotomy in 171 pediatric patients covering 408 primary teeth), it is appropriate to add pulpotomy of primary teeth as an indication for use in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations for ProRoot MTA White and ProRoot MTA Gray.
Review of relevant clinical data available in independently reviewed medical literature and the consideration of clinical use is germane when assessing the safety and effectiveness of the device when adding a primary indication directed
1 Srinivasan, V, et al "Mineral trioxide aggregate in paediatric dentistry" International Journal of Paediatric Dentistry, 19:34-47, 2009.
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at the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations.
Conclusion as to Substantial Equivalence
5.9
The ProRoot MTA White and ProRoot MTA Gray material covered by this application are substantially equivalent to the predicate devices, as they are identical to the predicate devices and the purpose of this application is only to define a new indication for use for a special population of patients [child (ages >2-12 years) and adolescent (ages >12-21 years)].2
2 Guidance for Industry and FDA Staff "Premarket Assessment of Pediatric Medical Devices" March 14, 2014
Traditional 510(k)
ProRoot MTA White/Gray (Pediatric Pulpotomy)
DENTSPLY International 4
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.