(140 days)
MISO Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
MISO Translucent Orthodontic Bracket is comprised of single crystal(mono clear sapphire) alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. MISO Translucent Orthodontic Bracket consists of 3parts. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placenient of an arch wire which applies the necessary force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.
The provided text describes a 510(k) submission for the MISO Translucent Orthodontic Bracket. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and study details for a medical device AI/software will not be present in this document.
Here's the breakdown of what can be extracted and what is not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify general "acceptance criteria" in the typical sense of a target performance metric for AI/software (e.g., sensitivity, specificity). Instead, it compares the technical characteristics of the proposed device with predicate devices. The key performance characteristic mentioned for the device itself is Bond Strength.
| Characteristic | Acceptance Criteria (from predicate/standard) | Reported Device Performance (MISO) |
|---|---|---|
| Bond Strength (MPa) | $5.51 \pm 1.65$ (Predicate 1 - Absolute) | |
| $19.41 \pm 5.08$ (Predicate 2 - Sapphire Ceramic Bracket) | $11.73 \pm 3.04$ | |
| Material | Alumina (mono crystal ceramic bracket) | Alumina (mono crystal ceramic bracket) |
| Translucent | Yes | Yes |
| Standards | ISO 10993, ISO 11405:2003 | ISO 10993, ISO 11405:2003 |
| Biocompatibility | Yes | Yes |
| Available Slot Sizes | 0.018/0.022 inch | 0.018/0.022 inch |
| Available Prescriptions | Roth/MBT/Edgewise | Roth/MBT/Edgewise |
Note on "Acceptance Criteria": The document implies that demonstrating comparable or superior performance (within acceptable variations) to the predicate devices, especially regarding bond strength, and adherence to relevant ISO standards, serves as the basis for establishing "substantial equivalence." The predicate device's bond strengths ($5.51 \pm 1.65$ MPa and $19.41 \pm 5.08$ MPa) could be interpreted as the "acceptance range" or reference points for demonstrating equivalence. The MISO device's bond strength ($11.73 \pm 3.04$ MPa) falls within the range of the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The study described is not a clinical AI/software validation; it's a materials testing study.
- Sample Size: Not explicitly stated for bond strength testing, other than "results are detailed in Section 12" which is not provided.
- Data Provenance: Not applicable as it's a material property test, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for material bond strength is established through laboratory measurement, not expert consensus.
4. Adjudication Method for the Test Set
Not applicable.
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 is a material properties submission, not an AI/software device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material properties submission, not an AI/software device.
7. The Type of Ground Truth Used
- Ground Truth Type: Laboratory measurements of material properties, specifically "Bond strength testing was carried out according to ISO 11405-2003(E)."
8. The Sample Size for the Training Set
Not applicable. This is a material properties submission for a physical device, not an AI model.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.