(65 days)
The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelostic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.
Hyperelastic Archwire is a metallic shape memory alloy orthodontic archwire for maxillary and mandibular arches. This alloy exerts low constant forces, retains elastic properties at large strains, with low frictional binding properties.
The provided text describes a 510(k) Pre-market Notification for the "Hyperelastic Archwire." This notification focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data. Therefore, the information typically requested about acceptance criteria and clinical study results for software as a medical device (SaMD) or AI-powered devices is largely not applicable in this context.
Here's an analysis based on the provided text, addressing the requested points where possible, and indicating where information is not available or not relevant for this type of device submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Hyperelastic Archwire vs. Predicate) |
|---|---|
| Biocompatibility for intended use (Safety) | Safe for intended use |
| Tensile plateau (Mechanical Property) | Not explicitly quantified, but generally superior |
| Tensile hysteresis (Mechanical Property) | Significantly less stress hysteresis |
| Flexure hysteresis (Mechanical Property) | Not explicitly quantified, but generally superior |
| Binding (Mechanical Property) | Significant reduction in orthodontic binding friction |
| Hardness (Material Property) | Not explicitly quantified |
| Roughness (Material Property) | Not explicitly quantified |
| Set angle after 90° bend (Mechanical Property) | Not explicitly quantified |
| Elastic recovery (Mechanical Property) | Greater superelastic strain recovery |
| Fatigue (Mechanical Property) | Greater fatigue life |
| Corrosion resistance (Material Property) | Equivalent to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As this submission relies on bench testing of physical properties, traditional "test sets" of patient data are not applicable. The bench tests would have involved specific numbers of archwire samples for each test, but these details are not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as this device does not involve human interpretation of medical images or data. Ground truth here refers to the actual physical and mechanical properties measured by scientific instruments and validated methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for clinical endpoints or interpretation of ambiguous data, which is not the case for bench testing of material properties.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) interact with or are assisted by the AI. The Hyperelastic Archwire is a physical orthodontic device and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device does not contain an algorithm. The "performance" here refers to the physical and mechanical characteristics of the archwire itself, measured through bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for this device is based on objective measurements of physical and mechanical properties through standardized bench testing methods. This includes measurements of:
- Tensile characteristics (plateau, hysteresis)
- Flexure characteristics (hysteresis)
- Binding force
- Hardness
- Roughness
- Set angle
- Elastic recovery
- Fatigue life
- Biocompatibility (based on established material safety standards)
- Corrosion resistance
8. The sample size for the training set
This information is not applicable. This device is a physical product, not a software or AI model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this physical device.
§ 872.5410 Orthodontic appliance and accessories.
(a)
Identification. An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.