(294 days)
The i-ROOT 100 is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures
i-ROOT 100 is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main unit and lip clip, Cable assembly and 2 kinds of File holder.
The provided text, a 510(k) summary for the i-ROOT 100 Electronic Apex Locator, does not contain the detailed information necessary to fully answer all aspects of your request regarding a study that proves the device meets acceptance criteria.
The document is a premarket notification for a medical device seeking substantial equivalence to a predicate device. It primarily focuses on comparing the new device's technological characteristics to the predicate device and asserting that performance tests demonstrated safety and effectiveness. It does not present a formal clinical study with detailed methodology, results, or statistical analyses as would be expected for a comprehensive "study that proves the device meets the acceptance criteria."
Here's an attempt to extract and infer information based on the provided text, along with clear indications of what information is missing:
Acceptance Criteria and Device Performance (Based on available information and inferences):
Given that this is a 510(k) submission for substantial equivalence, the primary "acceptance criterion" is likely substantial equivalence to the predicate device (i-ROOT K100450). The performance criteria mentioned are largely those demonstrating equivalence in key functional aspects.
| Acceptance Criteria (Inferred from document) | Reported Device Performance (from F. Technological Characteristics) |
|---|---|
| Buzzer volume equivalent to predicate | Identical to predicate |
| Signal equivalent to predicate | Identical to predicate |
| Graph display equivalent to predicate | Identical to predicate |
| Intended Use equivalent to predicate | Identical to predicate |
| Frequencies used (500 Hz, 5 kHz) | 500 Hz ±0.2 Hz, 5 kHz ±0.002 kHz (Identical to predicate) |
| Patient auxiliary current (less than AC 10 µA) | Less than AC 10 µA (Identical to predicate) |
| Accuracy (±0.5mm) | ±0.5mm (Identical to predicate) |
| Power consumption (less than 0.27VA) | Less than 0.27VA (Identical to predicate) |
| Manufacturing and inspection quality standards | Follows documented procedures based on ISO 9001/ ISO 13485/ Medical Device Directives 93/42/EEC |
| Overall safety and effectiveness | "demonstrated that i-ROOT 100 is as safe, as effective and performs in a substantially equivalent manner to the predicate device" |
Missing Information/Cannot Be Determined from the Text:
The following information, which would typically be found in a detailed study report, is not present in this 510(k) summary:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "performance tests" and adherence to quality systems.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. It's unclear if any human experts were involved in a formal ground truth establishment process for performance testing, as the focus is on technical equivalence.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
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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: Not applicable. This device is a standalone measurement tool, not an AI-assisted diagnostic imaging device that would typically involve human "readers." Therefore, an MRMC study is not relevant to this type of device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a "standalone" Electronic Apex Locator. Its listed performance metrics (like accuracy ±0.5mm) imply a direct measurement capability, which is inherently algorithm/device-only performance. However, no specific study details are provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. For an apex locator, ground truth would typically refer to the actual length of the root canal determined by a reliable method (e.g., direct measurement during an extraction, micro-CT, or a gold-standard clinical method). The document only states "Accuracy(±0.5mm)" but doesn't detail how this accuracy was verified against a ground truth.
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The sample size for the training set: Not applicable. This is a measurement device, not an AI/machine learning model that typically requires a "training set."
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How the ground truth for the training set was established: Not applicable, as no training set for an AI model is mentioned.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a new device to an existing one, primarily through technological comparison and general statements of performance. It does not present the detailed methodology and results of a clinical performance study that would provide the deep dive into acceptance criteria and their proof that your request seeks. This type of information would typically be found in a more detailed test report or clinical study summary, which is not part of this 510(k) summary.
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JUN 1 9 2012
റ 510(k) Summary
[as required by 807.92(c)]
A. Applicant:
-Company name: S-Denti Co.,Ltd -Address: Rm.607,612 Byucksan Digital Valley 6, 481-4, Gasan-dong, Geumcheon-gu, Seoul, 153-803, Korea Tel : +82-2-2627-3765~7 Fax : +82-2-2627-3768web : www.s-denti.com -Contact person: Peter Chung 412-687-3976 -Date: July 7th, 2011
B. Proprietary and Established Names:
Trade Name: i-ROOT 100 Common Name:. Root Apex Locator Ragulation Name: Root Apex Locator Regulatory Classification: Unclassified, Dental, Product Code: LQY
C. Predicate device: i- ROOT(K100450)
D. Device Description
i-ROOT 100 is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main unit and lip clip, Cable assembly and 2 kinds of File holder.
E. Intended use
The i-ROOT 100 is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures
F. Technological Characteristics:
The i-ROOT 100 is identical with predicate device in the following contents;
Buzzer volume ,signal, Graph , Intended Use, Frequencies used(500 Hz ±0.2 Hz, 5 klz ±0.002 klz),
Patient auxiliary current(less than AC 10 µA), Accuracy(±0.5mm) and Power consumption (less than 0.27VA)
Difference is as follows;
Predicate device(i-ROOT) uses the built-in rechargeable Lithium-ion batteries (4.1V x 2 pcs) and i-ROOT 100 uses the alkaline disposable batteries (1.5V AA x 3 pcs).
G. Performance (Safety and Effectiveness Information)
The production and inspection is followed by our documented procedures based on our quality systems - ISO 9001/ ISO 13485/ Medical Device Directives 93/42/EEC, which have been assessed by the third party certification bodies of SGS Certification.
I. Conclusion:
The performance tests demonstrated that i-ROOT 100 is as safe, as effective and performs in a substantially equivalent manner to the predicate device
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 9 2012
Ms. Tae K. Nam - President S-Denti Company. Limited Rm 607 Byucksan Digital Valley 6. 481-4 Gasan-Dong Geumcheon-Gu Tae Kye Nam Republic of Korea 153-803
Re: K112508
Trade/Device Name: i-ROOT 100 Electronic Apex Locator Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LQY Dated: May 26, 2012 Received: June 5, 2012
Dear Ms. Nam:
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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Page 2- Ms. Nam
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 4.
Indications for Use
510(k) Number (if known): K
Electronic Apex Locator Device Name: i-ROOT 100
Indications For Use:
The i-ROOT 100 is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures
Prescription Use _ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swa Rusine
Page 1 of
(Division Sign-Off) rivision of Anesthesiology, General Hospital fection Control, Dental Devices
510(k) Number: K112508
N/A