(104 days)
The Cranial Remolding Orthosis is prescribed for use on infants between 3-18 months with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, scaphocephalic, and brachycephalic-shaped heads, by applying pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. The Cranial Remolding Orthosis is also prescribed for use following minimally invasive surgery for infants between 3-18 months with craniosynostosis who still need moderate to severe correction of plagiocephali-shaped, brachycephalic-shaped, and/or scaphocephalic-shaped heads.
The Cranial Remolding Orthosis is prescribed for use on infants between 3-18 months with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, scaphocephalic, and brachycephalic-shaped heads by applying pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. The Cranial Remolding Orthosis is also prescribed for use following minimally invasive surgery for infants between 3-18 months with craniosynostosis who still need moderate to severe correction of plagiocephali-shaped, brachycephalic-shaped, and/or scaphocephalic-shaped heads.
The device allows for growth of the flattened areas of the infant's skull into the voids within the shell and foam lining. This combination of total contact and relief allows for significant correction of the asymmetrical head shape; thereby giving the infant's skull a more symmetrical and/or proportioned shape.
The Cranial Remolding Orthosis is fabricated from a 3/16" co-polymer base plastic shell with a ½" foam interface liner. The type of material used on the foam interface liner is Pelite polvethylene foam, Plastazote, or Aliplast foam spacer fills a ½" side opening, opposite the deficit, utilizing the same material as the corresponding foam liner. The anterior inferior edge is trimmed just above the eyebrows, and the sides are trimmed above and around the ears. The posterior inferior is trimmed distally to capture the occiput. A hook and loop closure (also referred to as Velcro within the industry) is attached on the side of the deficit, bridging over the side opening, keeping the device securely in place.
The provided text for K111247 primarily focuses on establishing substantial equivalence to a predicate device, the STARband Cranial Remolding Orthosis (K082950/K011350). The FDA 510(k) submission process for this device, a Cranial Remolding Orthosis, relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo clinical studies with acceptance criteria in the same way a novel device might.
Here's an analysis of the "acceptance criteria" and "study" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: Materials used are safe for skin contact and do not cause irritation or toxic effects. | The device uses 3/16" copolymer plastic and ½" hypoallergenic polyethylene foam (Pelite, Plastazote or Aliplast). These materials are similar to the predicate device and have a "demonstrated history of use in a specified role" without adverse effects. No skin irritation or toxic effects are reported. |
| Biocompatibility: No adverse biological reactions. | "The safety of the cranial orthosis has been demonstrated through past biocompatibility assessments which revealed that this type of device is not expected to adversely affect children under intended conditions of wear/use." (Referencing ISO 10993-11 guidance). "No testing is needed if the material has a demonstrated history of use." |
| Mechanical Design/Function Equivalence: The device's design maintains pressure and redirects growth as the predicate. | The device "maintains total contact over areas of bossing or protrusion and creates voids over areas of depression or flattening to redirect cranial growth toward greater symmetry," which is identical to the stated function of the STARband. The design and production processes are considered "substantially equivalent." |
| Manufacturing Process Equivalence: The manufacturing process results in a product comparable to the predicate. | "The materials used and processes of manufacturing the device are handled in an identical manner to the predicate device, incorporating all the safety and standards of practice." |
| Imaging System Accuracy (for scanning heads): The scanning system used to create the custom mold is accurate, reproducible, and repeatable. | The OMEGA Scanner "provides a 3D digital image of the patient's head that is accurate to .5mm." Its accuracy, reproducibility, and repeatability were "evaluated by scanning three cylindrical shapes five times and downloading the files three times." The OMEGA Scanner "met the predetermined acceptable criteria." |
| Safety: No improper migration or harmful pressure levels; smooth interior poses no threat during use. | "It is designed to avoid improper migration or harmful levels of pressure. The interior of the device is smooth and poses no threat to the child during application." |
| Clinical Effectiveness (Implied by Predicate Equivalence): The device effectively improves cranial symmetry and/or shape. | The effectiveness is largely inferred from the equivalence to the predicate device, which has been "effectively used for years without complications." |
| Special Controls Compliance: Adherence to regulatory special controls for cranial orthoses (21 C.F.R. § 882.5970). | The submission states: "Special controls are required. 21 C.F.R. § 882.5970" and implies compliance through substantial equivalence. |
| Intended Use Equivalence: The Cranial Remolding Orthosis has the same intended use as the predicate device. | The "Intended Use" statement for the Cranial Remolding Orthosis is nearly identical to the described function of the STARband. |
Study Proving Acceptance Criteria:
The "study" or justification for meeting these acceptance criteria is primarily a comparative analysis against the predicate device (STARband) and reference to existing standards and literature.
- For material and biocompatibility: The documentation cites ISO 10993-11, indicating that if a material has a "demonstrated history of use in a specified role," no new testing is needed. The materials used are stated to be "identical" or "substantially equivalent" to those in the predicate, which has such a history.
- For design and manufacturing: A direct comparison (Table 5.1) is presented, highlighting the similarities in intended use, materials, product design, and production processes between the Cranial Remolding Orthosis and the STARband. The document asserts that "The materials used and processes of manufacturing the device are handled in an identical manner to the predicate device."
- For the scanning technology (OMEGA Scanner vs. STARScanner): A specific validation study was performed: "The accuracy, reproducibility, and repeatability of the STARScanner and the OMEGA scanner were evaluated by scanning three cylindrical shapes five times and downloading the files three times to the digital image. Standard measurement system statistical process control procedures were used to evaluate the scan rate of error, standard deviation, repeatability, and reproducibility of multiple scans. Both devices met the predetermined acceptable criteria." This indicates a technical performance study for the measurement component, not the orthosis itself.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For the orthosis itself: No specific test set sample size for clinical performance is mentioned in the context of this 510(k) submission, as it relies on substantial equivalence to the predicate.
- For the OMEGA Scanner validation: "scanning three cylindrical shapes five times" means 3 shapes * 5 scans = 15 total scans. The files were downloaded "three times" for each scan, suggesting repeated digital processing.
- Data Provenance: The document does not specify country of origin for the data in the OMEGA scanner validation study. The study appears to be internal validation by the manufacturer or associated entity. It is a prospective study for the OMEGA scanner's technical performance. For the orthosis, the data provenance is primarily from the known performance and history of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- For the orthosis: No experts are explicitly mentioned for establishing ground truth for a test set of the Cranial Remolding Orthosis itself, as its effectiveness is inferred from the predicate.
- For the OMEGA Scanner validation: No experts are mentioned for establishing ground truth in the technical validation of the scanner (i.e., measuring cylindrical shapes). The "ground truth" would be the known dimensions of the cylindrical shapes measured instrumentally.
4. Adjudication Method for the Test Set
- No adjudication method is described for the performance of the orthosis, as no clinical test set directly evaluating the orthosis's performance is presented in this 510(k). For the OMEGA scanner, the evaluation was against "predetermined acceptable criteria," implying a comparison to established metric values rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done or reported for the Cranial Remolding Orthosis. This type of study is typically done for diagnostic devices where human interpretation is involved.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- The device is a physical orthosis, not an algorithm. The OMEGA scanner, which is a component of the workflow, had a standalone technical validation for its accuracy, reproducibility, and repeatability in measuring physical objects (cylindrical shapes). This is an "algorithm only" type of test in the sense that the scanner's output (3D digital image) was tested for its fidelity, independent of human interpretation or intervention in the measurement process itself.
7. Type of Ground Truth Used
- For the orthosis: The ground truth for effectiveness is implicitly tied to the established clinical outcomes and safety profile of the predicate device (STARband). The clinical literature referenced (Littlefield et al., 1988) speaks to the treatment of craniofacial asymmetry with dynamic orthotic cranioplasty in general, supporting the concept of this type of device.
- For the OMEGA Scanner validation: The ground truth was the known dimensions of the "three cylindrical shapes."
8. Sample Size for the Training Set
- For the orthosis: There is no mention of a "training set" in the context of this device because it is a physical medical device manufactured based on patient-specific molds, not a machine learning model.
- For the OMEGA Scanner: No specific "training set" is mentioned for the scanner's underlying algorithms either. The scanner validation study is a performance evaluation of a pre-existing system.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set (in the context of machine learning) is described for this device or its related components.
§ 882.5970 Cranial orthosis.
(a)
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).