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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.

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