The Nitom Locking facebow is a type of orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. It has two catches or locks on the inner bow to prevent it accidentally coming out at night.

Device Description

The Nitom Locking facebow is a type of orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. The Nitom Facebow has two catches or locks on the inner bow to prevent it accidentally coming out at night. It is attached to extra oral traction tubes of the patients fixed orthodontic appliance on the upper first molars. It is usually worn by the patient in the evening and at night. It improves the anchorage of the upper back teeth. It is made of stainless steel.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Nitom Locking Facebow." As such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive performance data or clinical study results in the way a Class III device or a novel software-as-a-medical-device (SaMD) might.

Therefore, many of the typical acceptance criteria and study elements you've requested (like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance metrics, training set details, etc.) are not typically found or required in a 510(k) submission for a Class II mechanical device like an orthodontic facebow. The primary "study" is the comparison to the predicate device to establish equivalence.

Here's an attempt to answer your questions based on the provided text, indicating where information is not available or not applicable for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (orthodontic facebow), the "acceptance criteria" are typically met by demonstrating that the new device functions similarly and is constructed from similar materials as a legally marketed predicate device, with no new safety or effectiveness concerns. The performance is largely implied by its design and intended use, aligning with the predicate.

Acceptance Criteria Category	Specific Criteria (Inferred from 510(k) process)	Reported Device Performance / How Met (Based on submission)
Intended Use	The device's intended use should match or be very similar to a legally marketed predicate device.	Matches: "The Nitom Locking facebow is a type of orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards." This is consistent with what an orthodontic facebow does. The predicate device (K980245) is also a "Nitom Locking facebow" with the same product code and regulation number, strongly implying identical intended use.
Technological Characteristics	The fundamental design, materials, and operating principles should be substantially equivalent to a predicate device.	Substantially Equivalent: "The Nitom Facebow has two catches or locks on the inner bow to prevent it accidentally coming out at night. It is attached to extra oral traction tubes of the patients fixed orthodontic appliance on the upper first molars... It is made of stainless steel." The predicate device listed is also a "Nitom Locking facebow" (K980245) which implies the new device is either identical or has minor changes that don't raise new questions of safety or effectiveness compared to the previous version of the same device.
Safety and Effectiveness	The device should not raise new questions of safety or effectiveness compared to the predicate device.	Implied Equivalence: By being found "substantially equivalent" to the predicate, the FDA has determined that the device is as safe and effective as the predicate. No new specific risks are highlighted in the summary. The addition of "two catches or locks" is presented as a feature to "prevent it accidentally coming out at night," which could be seen as an enhancement adding to safety/patient comfort without altering the fundamental function.
Biocompatibility	Materials used (e.g., stainless steel) should be biocompatible for intended patient contact (not explicitly stated as a criterion but an underlying assumption).	Met by Material Choice: The device is made of "stainless steel," a commonly accepted biocompatible material for orthodontic appliances. No specific biocompatibility testing results are presented in this summary, but its long-standing use in medical devices means it implicitly meets this criterion.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. This 510(k) submission does not describe a clinical performance test set or study involving patient data. The "test" is primarily a comparison of the device's characteristics to a predicate device.
Data Provenance: Not applicable. No clinical data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no "test set" requiring ground truth established by experts in the context of clinical performance data for this 510(k). The regulatory review for substantial equivalence is performed by FDA reviewers, not by external experts establishing ground truth for a clinical dataset.

4. Adjudication method for the test set

Not applicable. No test set or clinical study requiring adjudication is mentioned.

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

Not applicable. This device is a mechanical orthodontic appliance, not an AI/software device. Therefore, no MRMC study or AI-assisted performance evaluation would be conducted or relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical orthodontic appliance. There is no algorithm or standalone performance characteristic to evaluate in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No clinical studies requiring ground truth were conducted or presented in this 510(k) summary. The "ground truth" for the submission is the legally marketed predicate device and its established safety and effectiveness.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a mechanical device, not a machine learning algorithm.

9. How the ground truth for the training set was established

Not applicable. As above, no training set for an algorithm is relevant here.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or justification for the Nitom Locking Facebow meeting its acceptance criteria (i.e., being safe and effective for its intended use) is based on the demonstration of substantial equivalence to a legally marketed predicate device as required by the 510(k) premarket notification pathway.

Predicate Device: The predicate device identified is K980245, which is also named "Nitom Locking facebow," with the same product code (DZB) and regulation number (872.5500). This strongly suggests the new device is either identical to a previously cleared version, or has minor modifications that do not alter the fundamental safety or effectiveness.
Comparison: The submission explicitly states the "Nitom Locking facebow" is a type of orthodontic facebow used with a neckstrap or headcap to hold or move upper back teeth backward. It highlights a specific feature: "two catches or locks on the inner bow to prevent it accidentally coming out at night." This feature is likely presented as a minor modification that enhances safety/patient experience without fundamentally changing the device's principle of operation compared to the predicate.
Conclusion of FDA Review: The FDA's letter (DEC 22, 2005) states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

In essence, the study that "proves" this device meets acceptance criteria is the regulatory comparison against a predicate device, demonstrating that its intended use, materials (stainless steel), and technological characteristics are sufficiently similar to an already cleared device that it does not pose new questions of safety or effectiveness. For Class II mechanical devices like this, detailed clinical trials with specific performance metrics are often not required for 510(k) clearance if substantial equivalence to a predicate can be adequately demonstrated through engineering, material, and functional comparisons.

Summary

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K 052553

DEC 2 2 2005

5. 510K Summary (As required by section 807.92(c))

5.1.

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Owners name and contact person (807.92 (a)(1)): Dr. Russell Henry Ashleigh Samuels.

Owners address:	7 Cricket Lane,Loughborough,Leicestershire,LE11 3PD,England, UK.
Telephone number:	01509 (0044 1509) 216480.
Summary prepared:	9th September 2005.

5.2.

Device classification name (807.92 (a)(2)): Headgear, Extraoral, Orthodontic.

Trade name of device: Nitom Locking facebow.

The common name: Orthodontic facebow.

5.3.
An identification of the legally marketed device to which the submitter claims equivalence is (807.92 (a) (3) ):

Classification Advisory committee:	Dental
Product code:	DZB.
Regulation number:	872.5500
Device name:	Nitom Locking facebow
510K number:	K980245.

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Description of The Device (807.92 (a)(4)):

ર . રાં

Statement of intended use of the device (807.92 (a)(5)).

The nitom locking facebow is used by the Dental speciality of Orthodontics in the treatment of some orthodontic patients. The patients are usually children aged 9 to 16 years of age. The device is usually worn in the evenings and at night time while asleep. It is attached to a headcap or neckstrap at one end and to the upper molar teeth at the other end. It uses the back of the head or neck to apply a backward force to the upper molar teeth to prevent them moving forward during orthodontic treatment. It is a very useful device in helping to achieve a successful outcome in some cases.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing wings or feathers.

Public Health Service

DEC 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Russell Henry Ashleigh Samuels Russell Samuels Orthodontic Design 7 Cricket Lane Loughborough, Leicestershire LE11 3PD England UNITED KINGDOM

Re: K052553

Trade/Device Name: Nitom Locking Facebow Regulation Number: 872.5500 Regulation Name: Extraoral Orthodontic Head Gear Regulatory Class: II Product Code: DZB Dated: November 22, 2005 Received: December 2, 2005

Dear Dr. Samuels:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becalen by (2) + = device is substantially equivalent (for the referenced above and have decembica the device is enatketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed predice Medical Dev indications for use stated in the cholors, to regionent date of the Medical Device interstate comments prior to way 20, 1770, as can reclassified in accordance with the provisions of Amendments, or to devices that nave obcil recisement of a premarked on the premarked the Federal Food, Drug, and Cosmetic Free/ market the device, subject to the general
approval application (PMA). You may, therefore, market the Associal of approval appreation (1 Mr.). " Tou 1107) rail controls provisions of the Act include controls provisions of the Act. The general occurrent of devices, good manufacturing practice, lequirements for anitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III if your device is classified (sec above) into ennorols. Existing major regulations affecting (PMA), it may be subject to such additional controllations, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title Andrea in the F your device can be found in the Code of Pederal Neg.
addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Samuels

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 moun that I Driving 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); good manufacturing practice and insting (21 CF reviews 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo reter mtification. The FDA finding of substantial equivalence of your device to a promaince hotel 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), r Jou don't the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj count of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syitte y. Michael Oms

Chiu Lin, Ph.D. 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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K052553

Indications for Use

510(k) Number (if known): K052553

Nitom Locking Facebow Device Name:

The Nitom Locking facebow is a type of Indications For Use: orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. It has two catches or locks on the inner bow to prevent it accidentally coming out at night.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Susan Runner

K052553

Page 1 of

Regulation Number and Section

§ 872.5500 Extraoral orthodontic headgear.

(a)
Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.(b)
Classification. Class II.