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The Orthodontic Appliance is indicated for the correction of tooth malocclusion in patients with permanent dentition. The Orthodontic Appliance moves the teeth by continuous gentle force.

The Orthodontic Appliance is a series of clear, lightweight, plastic aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. The product is made of a polymer thermoplastic material (polyvinyl ester mixture) by pressing.

The doctor-prescribed Orthodontic Appliance are provided non-sterile and are customized for each patient according to the 3D printed data designed by Clear Aligner Design Software. Shandong Huge Dental Material Corporation manufactures the Orthodontic Appliance by thermoforming commercially available thermoplastic material and send them to the clinician. The clinician confirms the fit of the aligners upon delivery to the patient and monitors the patient's progress throughout treatment. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each pair of appliance is 2-3 weeks, wear the appliances for at least 20 hours every day and it is to be worn except during eating or cleaning of the oral cavity.

The type of Orthodontic Appliance is LX-A with various thickness so that the clinician can select suitable thickness based on patients' teeth micromaxillary deformity conditions. Different thickness are identical in chemical compositions, indications for use, functions, performance characteristics, operation principle and other aspects.

The provided document is a 510(k) summary for an Orthodontic Appliance. It details the device's indications for use, its description, comparison to a predicate device, and non-clinical performance testing. However, it explicitly states that no clinical testing was required or performed to support the device's clearance.

Therefore, many of the requested details regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document, as such a study was not conducted for human performance. The focus of the provided document is on demonstrating substantial equivalence to a predicate device through non-clinical means (material properties, biocompatibility, and software V&V for ordering/processing).

Here's what can be extracted based on the information provided:

Acceptance Criteria and Device Performance (Non-Clinical)

Since no clinical study was performed, the "device performance" relies on non-clinical tests and comparison to a predicate. The acceptance criteria essentially stem from demonstrating that the subject device is comparable to the predicate device in terms of performance characteristics.

Specific tested items included:Appearance and surface characteristicsDimensionspH valueElasticity variableVolume weightWater sorptionSolubilityThe comparative testing between the proposed and predicate device for these properties was conducted to demonstrate substantial equivalence. The implication is that the subject device's performance aligns with or is sufficiently similar to the predicate device and established material properties. |
| Biocompatibility (ISO 10993 Standards): | The document states: "Biocompatibility tests were performed to satisfied the ISO 10993 standards. The test results of the tests met the requirements of the study protocols..."

Specific tests conducted:Cytotoxicity (ISO 10993-5)Skin Sensitization (ISO 10993-10)Intracutaneous Reactivity (ISO 10993-10)Subchronic systemic toxicity (ISO 10993-11)Genotoxicity (ISO 10993-3)The results indicated the device met the requirements, supported by the long history of safe use of the thermoplastic material and the predicate device's information. |
| Software Verification & Validation: | The document states: "Software verification and validation testing were conducted on the software that facilitates ordering and processing of the Orthodontic Appliance to support that the device is as safe and effective as the predicates. Documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a 'moderate' level of concern." This indicates that the software was tested and verified to perform its intended functions related to device ordering and processing, meeting the requirements for its risk classification. |

Study Details (Based on the document's claims of no clinical testing required)

Many of these categories are not applicable (N/A) because the submission explicitly states:
"The performance of Orthodontic Appliance in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. Therefore, there was no clinical testing required to support Orthodontic Appliance, as the indications for use is equivalent to the predicate device."

1. Sample sizes used for the test set and the data provenance:

   • Clinical Test Set: N/A (No clinical test set was used for human performance evaluation).
   • Non-Clinical Test Set: Not specified in terms of sample numbers, but tests were performed on material samples and the device itself (e.g., for dimensions, appearance, physical/chemical properties). Data provenance is from Shandong Huge Dental Material Corporation's internal testing and material suppliers' data.
     • Biocompatibility Tests: Sample sizes for ISO 10993 tests are not explicitly mentioned in this summary, but these are standard lab tests performed on material extracts or samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No clinical ground truth was established as no clinical study was performed for this 510(k)).

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No clinical test set requiring adjudication).

4. 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: N/A (No MRMC study was performed as no clinical study was conducted, and the device is a physical appliance, not an AI-based diagnostic tool for human readers).

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (The device is a physical appliance, not an algorithm, and no standalone clinical performance was evaluated). Non-clinical standalone tests were performed as detailed in the table above (physical/mechanical properties, biocompatibility).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (No clinical ground truth as no clinical study for human performance was conducted. For non-clinical tests, "ground truth" would be the established ISO standards and material specifications).

7. The sample size for the training set: N/A (The device is a physical orthodontic appliance, not a machine learning model. Therefore, there's no "training set" in the context of an AI/ML device). The design of the appliance is based on 3D printed data generated by "Clear Aligner Design Software", but this itself is part of the manufacturing process, not a training set for an AI algorithm.

8. How the ground truth for the training set was established: N/A (No training set for an AI/ML model).

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Infants born with complete bilateral clefts of the lip and palate have an associated protrusion of the premaxillary segment. The amount of protrusion from the molar and cuspids segments (maxillary segments) varies between 8 and 18 mm. Treatment of the protruding premaxillary segment is one of the most difficult problems in orthodontics and plastic surgery. The bilateral cleft palate appliance is indicated for patients with more than about five millimeters of protrusion. It provides the most predictable and rapid method for repositioning the premaxillary segment into the normal dental arch prior to surgical correction of the lip. With the premaxillary segment repositioned it is possible to repair both sides of the lip in one operation. The lip repair can be performed without tension on the lip sutures, thus minimizing scar formation. Surgical repair of the dental alveolar process is also possible and when performed it reduces the incidence of palatal fistulas in the growing child.

Sometimes there is minimal premaxillary protrusion but the maxillary segments are constricted or collapsed. Expansion of the maxillary segments can be accomplished using the bilateral cleft palate appliance.

Infants with unilateral complete or incomplete clefts of the lip and palate usually have quite severe nasal asymmetry both laterally and in the antero-posterior This is related to malformation of the dentoalveolar maxillary dimension. segments. The cleft maxilla appears to be retruded and the noncleft premaxillary segment shows a variable degree of protrusion. If the cleft is complete there is usually a wide cleft of the alveolar process in the range of 8 to 24 mm. Surgical correction of the nasal asymmetry is extremely difficult and after the first reconstructive surgical treatment there is frequently residual nasal deformity which may persist until teenage and still be quite difficult to correct.

The unilateral cleft palate appliance is indicated for the newborn infant with a complete lip and palate cleft or one that is nearly complete. It will have the effect of treating the asymmetry of the nasal alar bases so that they are level anteroposteriorly. It will also bring the dentoalveolar segments into alignment. The correction of the dental segments is a very significant benefit because the parts of the cleft lip can be brought together and the lip reconstructed with much less tension on the repaired area. Reconstruction of the nose is very much facilitated when the asymmetry of the nasal alar bases is first eliminated. Treatment with the unilateral appliance usually provides an alignment of the dentoalveolar ridge that permits primary reconstruction of the alveolar process at the first surgical treatment.

Two appliances are the subjects in this description. They are used for improving the alignment of the dental segments in infants with cleft lip and palate. One is for the infant with bilateral clefts of the lip and palate. and the other is for the infant with unilateral cleft of the lip and palate. These will be referred to as follows:

• a) Bilateral Cleft Palate Orthodontic Appliance (ECPR)
• b) Unilateral Cleft Palate Orthodontic Appliance (DMA)

The appliances are custom mounted on a plaster cast of an infant's palate with dental acrylic resin and retained with stainless steel pins.

This 510(k) summary describes two orthodontic appliances for infants with cleft lip and palate: a Bilateral Cleft Palate Orthodontic Appliance (ECPR) and a Unilateral Cleft Palate Orthodontic Appliance (DMA).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define "acceptance criteria" in a quantitative, measurable format with specific thresholds for success. Instead, the "Safety and Effectiveness Information Summary" section (Section 9) provides a retrospective review of clinical experience as evidence of effectiveness and safety.

Given the nature of the device (orthodontic appliances for a specific medical condition), the "acceptance criteria" appear to be broadly defined by achieving desired clinical outcomes related to dental segment alignment and reduction of cleft width, with an implicit criterion of no serious safety issues.

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

• Sample Size: The submission states that "over the past 14 years the total number of these appliances of both kinds used by Dr. Latham and others is 1,153 appliances." This represents the total cohort over which experience was gathered. It is not segmented into "test set" and "training set" in the context of a typical AI/medical device study.
• Data Provenance: The data is based on clinical use by "Dr. Latham and others" over an extended period. The appliances are from "Cleft Palate Appliances Inc. 218 Commissioners Road West London, Ontario, Canada." This suggests the clinical experience is likely from Canada, although not explicitly stated. The study is retrospective, based on "Our records indicate..." (Section 9).

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

The concept of "ground truth" and "experts" for a test set, as applied in AI/imaging studies, is not present in this submission. The effectiveness and safety information is derived from the aggregated clinical experience of "Dr. Latham and others."

• Number of Experts: Not specified. It refers to "Dr. Latham and others."
• Qualifications of Experts: Dr. Latham is implied to be a practitioner involved in the use of these appliances over many years. Given the device's application, these would likely be orthodontists, possibly with a specialization in craniofacial anomalies, or other medical professionals involved in cleft palate treatment. Specific qualifications (e.g., years of experience, board certification) are not provided.

4. Adjudication Method for the Test Set

No explicit adjudication method is described. The "desired clinical result" for the unilateral appliance (and implicitly for the bilateral) is the standard against which "failure" is judged. This assessment would have been made by the treating clinicians in the course of their practice.

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 MRMC study was conducted. This device is a physical appliance, not an AI-based diagnostic or assistive software. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

This is not an algorithm or software device. It is a physical medical device. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The ground truth is based on clinical observation and desired clinical outcomes as determined by treating physicians (e.g., "judged by observing the cleft alveolar segments in good alignment with the alveolar cleft borders touching, or nearly so" - Section 4). This is essentially expert clinical assessment of treatment success or failure.

8. The Sample Size for the Training Set

No distinct "training set" is mentioned in the context of data used to "train" a device. The 1,153 appliances represent the total clinical experience that informs the safety and effectiveness summary.

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

As there is no explicit "training set" in the context of device development (e.g., for an AI model), this question is not directly applicable. The "ground truth" for the overall clinical experience (which is what informs the device's efficacy claims) was established through the professional judgment and clinical outcomes observed by Dr. Latham and other practitioners over the period of use.

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