(547 days)
The COPC Band is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants initiating treatment from three to 14 months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic patterned head shapes.
The COPC Band is a cranial orthosis used to treat abnormally shaped craniums in infants three to 14 months of age. This condition is clinically known as positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened areas of the skull into the created spaces. The COPC Band is only available through a prescription issued by a physician. The orthosis is custom designed for each patient from a modified model and measurements of the infant's head. The mold is prepared for fabrication using advanced plaster modification techniques. Each orthosis is composed of an outer shell of thermoformable plastic, an inner lining of hypoallergenic foam, and a strap for securing Optimum fit and alignment is insured and monitored by the clinical the orthosis. practitioner.
The COPC Band is a cranial orthosis designed to treat positional or deformational plagiocephaly in infants aged three to 14 months. The device works by passively holding prominent cranial regions to guide the growth of flattened areas of the skull, thereby improving cranial symmetry and/or shape.
1. Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable table format. Instead, it argues for substantial equivalence to a predicate device (DOC™ Band) based on several factors:
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Material Safety/Biocompatibility | Materials (modified polyethylene and aliplast) are safe, non-hazardous, and non-reactive with human skin under normal contact conditions. This is assessed via standard biocompatibility assessments. |
| Mechanical Safety (Pressure/Overtightening) | Incorporates a "natural corrugated stop" to prevent overtightening and harmful pressure. Pressure sensor analysis on a cranial model demonstrates intimate contact with prominent regions and no pressure in corrective voids. |
| Effectiveness (Mechanism of Action) | Passively holds prominent cranial regions in static equilibrium while guiding growth in flattened areas, analogous to the predicate device. |
| Method of Production | Very similar to the predicate device. |
| Instructions for Use | Very similar to the predicate device. |
| Basic Function | Fits the child in a similar fashion to the predicate device. |
| Indications for Use | Analogous to those of the predicate device (treatment of nonsynostotic positional plagiocephaly in infants 3-14 months). |
2. Sample Size Used for the Test Set and Data Provenance:
No explicit test set or specific sample size for a clinical study is mentioned. The safety and performance data presented relies on material biocompatibility assessments and a limited mechanical test using a cranial model.
- Data Provenance: Not explicitly stated, but the description of the pressure sensor analysis implies it was conducted in a lab setting, likely within the United States. It is an engineering/bench test, not human clinical data.
- Retrospective/Prospective: Not applicable, as this is primarily based on bench testing and material characteristics, and comparison to existing data for the predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The provided data does not describe a study involving expert assessment or ground truth establishment in a clinical context (e.g., diagnosis of plagiocephaly or assessment of treatment outcomes by human experts). The "performance data" section focuses on material safety and mechanical characteristics.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of a test set requiring adjudication in the common sense of clinical data review.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done or mentioned. The submission focuses on substantial equivalence to the predicate device based on design, materials, and safety features.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The COPC Band is a physical medical device, not an algorithm or AI-driven system. Therefore, no standalone algorithm performance study was conducted.
7. Type of Ground Truth Used:
The "ground truth" for the device's acceptable performance is primarily established through:
- Material Specifications and Biocompatibility Standards: MSDS sheets and standard biocompatibility assessments for the materials used.
- Bench Testing/Mechanical Analysis: Pressure sensor analysis on a cranial model to demonstrate pressure distribution and the function of the corrugated stop.
- Comparison to Predicate Device: The effectiveness and safety are largely inferred by demonstrating analogous characteristics to the legally marketed DOC™ Band, which already has established effectiveness.
8. Sample Size for the Training Set:
Not applicable. The COPC Band is a physical medical device; there is no "training set" in the context of machine learning or algorithms. Its design and manufacturing process are based on established practices for cranial orthoses.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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)).