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510(k) Data Aggregation
(41 days)
DYJ
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.
| Acceptance Criteria (Inferred from Report) | Reported Device Performance (as per Section 9) |
|---|---|
| Effectiveness: | |
| Bilateral Appliance: | |
| - Reposition premaxillary segment to normal dental arch | "provides the most predictable and rapid method for repositioning the premaxillary segment into the normal dental arch prior to surgical correction of the lip." (Section 6) |
| - Minimize scar formation during lip repair | "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." (Section 6) |
| - Reduce incidence of palatal fistulas | "Surgical repair of the dental alveolar process is also possible and when performed it reduces the incidence of palatal fistulas in the growing child." (Section 6) |
| - Expand constricted or collapsed maxillary segments | "Expansion of the maxillary segments can be accomplished using the bilateral cleft palate appliance." (Section 6) |
| Unilateral Appliance: | |
| - Treat nasal asymmetry (level alar bases anteroposteriorly) | "It will have the effect of treating the asymmetry of the nasal alar bases so that they are level anteroposteriorly." (Section 6) |
| - Align dentoalveolar segments | "It will also bring the dentoalveolar segments into alignment." (Section 6) "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." (Section 6) |
| - Facilitate lip repair with less tension | "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." (Section 6) The efficacy of the appliance depends upon retention to the palatal segments with stainless steel pins... (Section 3) "Successful use of the appliance is judged by observing the cleft alveolar segments in good alignment... touching, or nearly so." (Section 4) |
| - Facilitate nose reconstruction | "Reconstruction of the nose is very much facilitated when the asymmetry of the nasal alar bases is first eliminated." (Section 6) |
| - Overall clinical success rate | Unilateral Appliance: "about one in 40 of the unilateral cleft palate appliances fails to treat to the desired clinical result." (Section 9) This implies a success rate of approximately 97.5%. (No specific failure rate is given for the bilateral appliance, but it is stated to be used "in principle" for 23 years). |
| Safety: | |
| - Absence of safety-related problems | "In the experience noted above, there has been no report of a safety-related problem." (Section 9) |
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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