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Orthodontic Facemask is used as a treatment option for Class III malocclusions.

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This is a 510(k) premarket notification for an Orthodontic Facemask, which is a physical device, not an AI/ML powered software device. Therefore, the questions related to AI/ML powered software performance, such as acceptance criteria, study details, expert consensus, ground truth, and training/test set specifics, are not applicable. The provided document focuses on regulatory approval for the physical device.

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Use as a treatment option for Class III malocclusion.

The Reverse Pull Adjustable Facemask is an extra oral device placed on the face of a patient. The subject device is provided assembled; packaged in a plastic heat sealed bag placed in a nylon pouch, to safeguard the integrity of the packaging. The device is provided non(sterile. No prior skin preparation is required to use the device. The skin contacting surfaces may require light cleaning with water between uses, depending on the patient's personal hygiene.

The subject device consists of a vertical main frame, made of 304(grade stainless steel, having adjustable supports for the patient's forehead and chin. The two supports are lined with Ethylene( Vinyl Acetate (EVA) plastic foam for patient comfort. Moreover, the forehead support has two vents to allow airflow to skin in contact with the support. Two additional EVA pads for forehead and chin supports are included for patient comfort and hygiene.

An elastic capstan crossbar made of 304 grade stainless steel, with an allen screw is present on the vertical main frame between the forehead and chin support. The crossbar is utilized by the Orthodontic practitioner as a means of anchorage support for attaching elastics to intraoral appliances. Elastics or the intraoral appliances are not provided with this device.

The provided document is a 510(k) premarket notification for a medical device called "Reverse Pull Adjustable Facemask." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) application.

Therefore, the study design and acceptance criteria outlined in your request (related to AI performance, human readers, ground truth, and comprehensive clinical trials) are not applicable to this specific document. This document focuses on demonstrating physical and material equivalence to an already approved device.

However, I can extract information related to the performance testing and comparisons made in this 510(k) submission, even though it doesn't align with a clinical or AI-driven evaluation.

Here's a breakdown of the relevant information from the document, tailored as much as possible to your request, but highlighting where your schema doesn't apply:

Acceptance Criteria and Study for Reverse Pull Adjustable Facemask

This device is a Class II medical device (Extraoral Orthodontic Headgear) seeking clearance via a 510(k) submission, which means it aims to demonstrate substantial equivalence to a predicate device, not necessarily prove novel safety and effectiveness through extensive clinical trials. The "acceptance criteria" here therefore relate to demonstrating physical and material similarity and comparable mechanical performance to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: For the tensile strength testing, the document states "Performance tests in accordance to ISO 6892-1:2016 for tensile testing of metallic materials at room temperature was conducted on the final finished device configuration as well as the predicate device." It does not specify the exact number of units tested.
• Data Provenance: This is a premarket submission by Sawbros Industries Pvt., Ltd. from India. The testing would have been conducted as part of their R&D and quality control processes. The data is retrospective in the sense that it's gathered specifically for this submission to demonstrate equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This submission is for a physical medical device (orthodontic facemask), not an AI/software device that relies on expert interpretation for "ground truth" of images or clinical outcomes. The "ground truth" here is the physical and mechanical properties of the device and its predicate.

4. Adjudication Method for the Test Set

• Not Applicable. As above, no "adjudication" in the sense of reconciling expert opinions on clinical cases is relevant. The "adjudication" is essentially the direct measurement of physical properties per ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is not an AI-assisted diagnostic or prognostic device. No MRMC study was conducted.

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

• Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Physical and Mechanical Properties: The "ground truth" for this substantial equivalence argument is derived from the established physical dimensions, material composition, and mechanical performance (e.g., tensile strength) of both the subject device and the predicate device, as measured against relevant ISO standards.
• Predicate Device Characteristics: The characteristics of the legally marketed predicate device (K000358, Multi Adjustable Facemask) serve as the primary reference for "ground truth" in terms of design and material.

8. The Sample Size for the Training Set

• Not Applicable. This is not a machine learning or AI device that requires a training set. The device is manufactured based on design specifications.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As above, no training set. The design specifications and material choices are based on engineering principles and similarity to existing, legally marketed devices.

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Protraction Face Mask and Reverse Pull Face Mask are used as a treatment option for Class III malocclusions.

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The provided document is an FDA 510(k) clearance letter for a "Protraction Face Mask / Reverse Pull Face Mask." This document explicitly states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

Typically, acceptance criteria and study results are provided for devices that rely on new technology or algorithms where performance needs to be clinically validated, such as AI/ML-based diagnostic devices.

The Protraction Face Mask / Reverse Pull Face Mask is an "Extraoral Orthodontic Headgear" (Product Code: DZB). This type of device is a physical, mechanical appliance used in orthodontics. Its performance is generally evaluated based on mechanical properties (e.g., strength, durability, biocompatibility of materials) and clinical effectiveness in applying forces for orthodontic treatment, which would be established through a comparison to existing, similar devices (predicate devices) already on the market.

Therefore, I cannot extract the requested information from this document because it describes a traditional medical device clearance, not an AI/ML or novel technology device that would typically have specific "acceptance criteria" and a "study proving the device meets acceptance criteria" in the way implied by the prompt's structured questions.

No information regarding acceptance criteria or a performance study as outlined in your prompt can be found in the provided document.

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KJ Mask is used as a treatment option for Class III malocclusions.

KJ Mask (KM 102-S, KM 201-L) is a device made of materials such as aluminum alloy, stainless steel and plastic intended to be placed on face for the purpose of orthodontics. The device is constructed of four parts, a chip cup, forehead rest, cross bar and main frame. It is intended to exert orthopedic or orthodontic forces of the maxillary arch in order to effect a change in the position of the maxilla in relation to the mandible and other facial structures.

The provided document, K103019 for the "KJ Mask", is a 510(k) Premarket Notification to the FDA. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data in the same way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain information on:

• A table of acceptance criteria and reported device performance (as defined by specific metrics like sensitivity, specificity, or accuracy).
• Sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, etc.) for a test set.
• Sample sizes for training sets or how ground truth for a training set was established.

Explanation of why this information is not present:

The 510(k) pathway, under which this device was submitted, focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparisons of:

• Indications for Use: The KJ Mask's indication is for "Class III malocclusions," which is compared to the predicate device's indication.
• Technological Characteristics: The document states, "KJ Mask and the predicate device consist of almost the same components. The similarity in design between KJ Mask and the predicate device supports the safety and effectiveness of KJ mask for the indicated use." This includes materials, design, and construction.
• Safety and Effectiveness: This is argued by drawing parallels to the predicate device, assuming the predicate's established safety and effectiveness extend to the new device due to their substantial similarity.

Since the device is an orthodontic face mask, not an AI/ML-driven diagnostic or therapeutic device, the concepts of "acceptance criteria" based on statistical performance metrics (like sensitivity, specificity), ground truth, training/test sets, MRMC studies, or standalone algorithm performance are not applicable to this 510(k) submission.

Summary based on the provided document:

The provided document describes the KJ Mask, an orthodontic face mask intended to treat Class III malocclusions. Its acceptance for marketing by the FDA was based on demonstrating substantial equivalence to a predicate device, the "ADP Face Mask by Ormco Corp. (K923556)".

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable/Not present. The submission relies on substantial equivalence to a predicate device rather than performance against predefined statistical acceptance criteria.

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

• Not applicable/Not present. No test set or clinical study data is reported for the KJ Mask itself in this 510(k) summary; the focus is on comparison to the predicate device.

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

• Not applicable/Not present. No ground truth establishment is described for a test set.

4. Adjudication method for the test set:

• Not applicable/Not present.

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/Not present. This device is not an AI-driven diagnostic system; it is a physical medical device.

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

• Not applicable/Not present.

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

• Not applicable/Not present.

8. The sample size for the training set:

• Not applicable/Not present.

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

• Not applicable/Not present.

Essentially, the "study" proving the device met the "acceptance criteria" in this context is the 510(k) submission process itself, which concluded that the KJ Mask is substantially equivalent to marketed predicate devices based on its design, materials, and intended use. The FDA's issuance of the 510(k) clearance acts as the "proof" that it meets the regulatory requirements for marketing, which, for this class of device, is substantial equivalence.

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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.

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.

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.

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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Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety. The devices are for Orthodontic Use Only, on the order of an Orthodontist.

Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety.

This document is a 510(k) clearance letter from the FDA for the "Equa Pull Constant Force Headgear." It states that the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials or detailed performance study reports with the level of detail you've asked for. While a manufacturer might conduct performance testing to support their substantial equivalence claim, the FDA's clearance letter itself typically summarizes the regulatory decision and does not provide these detailed technical specifications of the studies.

Therefore,Based on the provided text, I cannot extract the acceptance criteria or the details of a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not contain the detailed performance study information you've requested.

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The Keles protraction face mask is used in the treatment of patients with Class III The Keles profitaction facc mask is used in the neationed maxilla. The facemask is especially useful in patients with an anterior bite tendency or condition.

The Keles Facemask is an orthodontic headgear device. All components have been used in legally marketed devices or have been found to be safe for dental use.

This submission is a 510(k) premarket notification for a Class II medical device, the Keles Facemask, an orthodontic headgear. The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective. Therefore, there are no specific "acceptance criteria" in the sense of performance metrics (like sensitivity, specificity, accuracy) for an AI model or a new diagnostic technology.

Instead, the "acceptance criteria" are related to demonstrating substantial equivalence in design, materials, manufacturing, and intended use to a predicate device. The "study" that proves the device meets these criteria is the submission itself, which provides a detailed comparison to the predicate device.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

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

• Not applicable. This submission is for a physical medical device (orthodontic headgear), not a data-driven device like an AI algorithm. Therefore, there is no "test set" of patient data in the context of an AI study. The determination of substantial equivalence relies on a comparison of device characteristics, materials, and intended use.

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

• Not applicable. See point 2. The "ground truth" here is established by regulatory standards and expert opinion within Great Lakes Orthodontics regarding the safety and effectiveness of their design compared to a known safe and effective predicate device.

4. Adjudication method for the test set

• Not applicable. See point 2. The regulatory review process itself involves expert review by the FDA, who adjudicates the submitted evidence for substantial equivalence.

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 physical orthodontic device, not an AI diagnostic tool.

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

• Not applicable. This device is a physical orthodontic device, not an AI algorithm.

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

• The "ground truth" for this type of submission is the established safety and effectiveness of the legally marketed predicate device. The manufacturer asserts, and the FDA concurs, that the Keles Facemask is substantially equivalent to this predicate, implying it meets the same safety and effectiveness standards.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in this context.

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

• Not applicable. See point 8.

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The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.

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I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, sample size, ground truth establishment, or any studies conducted for the Morales Protraction Facemask. The document is an FDA 510(k) premarket notification letter, which primarily focuses on the substantial equivalence of the device to legally marketed predicate devices and administrative details like regulation numbers and contact information. It does not contain the detailed technical or clinical study data you are asking for.

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