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The NuBrace IRO is indicated for the treatment of tooth malocclusion and for preprosthetic orthodontic cosmetic movement in patients with permanent dentition (i.e., all second molars). The NuBrace IRO is intended to position teeth by way of continuous gentle force.

The NuBrace IRO consists of dual laminated polymers that enhance patient comfort and move teeth at a longer, more gradual rate of tooth movement.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NuBrace Invisible Removable Orthodontics (IRO):

Based on the provided 510(k) summary, the device is being cleared primarily based on substantial equivalence to a predicate device, rather than explicit, quantifiable acceptance criteria from a specific clinical or performance study with defined metrics.

Here's a breakdown of the requested information, acknowledging the limitations of the provided document:

NuBrace Invisible Removable Orthodontics (IRO) Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a clinical study with human subjects. The reported in vitro testing does not specify a sample size (e.g., number of aligners, number of simulated teeth).
• Data Provenance: The study described is "In vitro testing." No information on country of origin or whether it was retrospective or prospective is applicable or provided, as it's a lab-based test.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided as part of the 510(k) summary. The "ground truth" for the in vitro testing appears to be based on the intended mechanical properties and observable tooth movement, likely evaluated by the manufacturer's internal experts or engineers, but no specifics are given.

4. Adjudication Method for the Test Set

• This information is not provided. Given the in vitro nature of the described testing, formal expert adjudication as seen in clinical trials is unlikely to have been performed or reported in this summary.

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

• No, an MRMC comparative effectiveness study was not done (or at least, not reported in this 510(k) summary). The submission relies on in vitro testing and substantial equivalence to a predicate, not a clinical trial comparing device performance with and without AI assistance (which is not applicable here as this is a physical device).

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

• Not applicable. This device is a physical orthodontic appliance, not a software algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

• For the in vitro testing: The ground truth appears to be based on the expected mechanical performance (e.g., "longer duration of action," "more patient comfort," "tooth movement observed was as expected"). This would be determined by engineering specifications and dental principles. It is not pathology, expert consensus (in a clinical sense), or outcomes data from human patients.

8. The Sample Size for the Training Set

• Not applicable. The device is a physical medical device. There is no "training set" in the context of machine learning or AI models. If "training set" refers to prototypes or iterations during development, that information is not provided.

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

• Not applicable. As there is no training set for an AI/ML model, this question is not relevant to the provided documentation for this physical device.

Summary of the Study:

The "study" cited in the 510(k) summary is comprised of in vitro testing. This testing was conducted to demonstrate:

• The effect of the dual laminated polymers on increasing the duration of action.
• The effect of the softer layer on patient comfort during wear.
• That "NulBrace IRO functioned as intended and the tooth movement observed was as expected."

The primary evidence for acceptance relies on the assertion that NuBrace IRO is substantially equivalent to the predicate device (Align Technology, Inc.'s Align System K981095) due to similar intended uses, indications, technological characteristics, and principles of operation, with the minor technological differences "raising no new issues of safety or effectiveness."

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