(240 days)
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.
§ 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.