(350 days)
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
| Acceptance Criteria (based on predicate equivalence) | Reported Device Performance and Basis for Acceptance |
|---|---|
| Indications for Use: Same as predicate | Met: "Use as a treatment option for Class III malocclusion." (Identical to predicate) |
| Principle of Operation: Same as predicate | Met: "Extra oral anchorage support for elastics from intra oral appliances." (Identical to predicate) |
| Anatomical Location of Use: Same as predicate | Met: "Face of patient." (Identical to predicate) |
| Patient Contact: Same as predicate | Met: "Forehead and chin." (Identical to predicate) |
| Main Frame Material: Same as predicate | Met: "304 Stainless Steel." (Identical to predicate) |
| Main Frame Cross Section: Comparable to predicate | Met: Subject device: 0.146"x0.116" vs. Predicate: 0.140"x0.115". Deemed substantially equivalent. |
| Mobilization Screw on Chin Cup: Same as predicate | Met: "Allen Screw M3 length 4mm Present." (Identical to predicate) |
| Chin Cup Support Material: Same as predicate | Met: "EVA Plastic foam." (Identical to predicate) |
| Chin Cup Mobility: Same as predicate | Met: "Immobile during use." (Identical to predicate) |
| Forehead Support Material: Same as predicate | Met: "EVA Plastic foam." (Identical to predicate) |
| Air Vents in Forehead Support: Same as predicate | Met: "Present." (Identical to predicate) |
| Crossbar Construction: Same as predicate | Met: "Capstan circular." (Identical to predicate) |
| Crossbar Material: Predicate uses ABS Plastic; Subject uses 304 Stainless Steel | Met (Difference Justified): Subject device uses "304 Stainless Steel." This material difference is not highlighted as problematic for substantial equivalence, likely indicating it does not raise new safety/effectiveness concerns or might even be considered an improvement in strength. |
| Protection Buttons end of Main Frame: Same as predicate | Met: "Present." (Identical to predicate) |
| Appliance Weight: Comparable to predicate | Met: Subject device: 1.86 oz vs. Predicate: 1.90 oz. Deemed substantially equivalent. |
| Screw Type: Same as predicate | Met: "Allen Screw M3 length 4mm." (Identical to predicate) |
| Time-Dependent Degradation: Low likelihood, same as predicate | Met: "Low likelihood." (Identical to predicate) |
| Tensile Strength: Comparable to predicate | Met: "The subject device has a similar tensile strength as the predicate and is therefore substantially similar to the predicate." |
| Biocompatibility: Evaluated and acceptable | Met: "Biocompatibility was evaluated by preparing a risk assessment as per ISO 14971." |
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.
§ 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.