(137 days)
The Providence Molding Helmet is used for treatment of children from three (3) to eighteen (18) months with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is prescribed by a physician to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.
The Providence Molding Helmet is a cranial orthosis used to treat moderate to severe non-synostotic positional plagiocephaly in children from 3 to 18 months of age. This includes infants with plagiocephalic-, brachyecephalic-, and scaphocephalic- shaped heads. This device works by applying gentle holding pressure to the prominent regions of the infant's skull while leaving room for growth in the adjacent flattened regions. The Providence Molding Helmet consists of a 5/32 polypropylene outer shell and two (2) layers of 3/16 volara foam inner lining. The helmet is split posteriorly and an elastic Velcro strap is attached to the back of the helmet to keep it securely in place. The device allows for growth of the flattened areas of the infant's skull into the voids of the shell/foam lining, thus correcting the plagiocephaly and giving the infant's skull a more symmetrical shape. The Providence Molding Helmet is custom designed and custom fitted for each patient from a plaster mold of the infants' head.
The provided text is a 510(k) summary and FDA clearance letter for the Providence Molding Helmet. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about any specific study that proves the device meets acceptance criteria.
The 510(k) clearance process for this type of device (Class II, Cranial Orthosis) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and performance metrics as might be seen for novel high-risk devices or software.
Therefore, I cannot populate the requested table or answer most of the questions because the information is not present in the provided document.
Here's a breakdown of what can be extracted based on the input:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states "Performance Standards: None, Special Controls required". The 510(k) process for this device focused on substantial equivalence, not on specific performance metrics or acceptance criteria from a study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided. No test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No test set or adjudication is mentioned.
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. This device is a physical cranial orthosis, not an AI software. An MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Cannot be provided. No ground truth is mentioned in the context of device performance evaluation. The device corrects shape, and its effectiveness would likely be assessed by clinical observation and anthropometric measurements, but no such study is detailed here.
8. The sample size for the training set:
- Cannot be provided. No training set is mentioned as this is a physical device, not a machine learning algorithm.
9. How the ground truth for the training set was established:
- Cannot be provided. No training set or ground truth establishment is mentioned.
Summary based on the provided text:
The Providence Molding Helmet received 510(k) clearance based on its substantial equivalence to the Ballert Molding Helmet (K011433). The clearance letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the device was found to be as safe and effective as a legally marketed predicate device, and did not require new clinical performance studies with specific acceptance criteria to demonstrate its safety and effectiveness. The document lists "Performance Standards: None, Special Controls required," indicating that the regulatory pathway did not involve adherence to quantitative performance standards for clearance.
§ 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)).