PROVIDENCE MOLDING HELMET by NORTHEAST ORTHOTICS AND PROTHETICS, INC.

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.

Device Description

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.

AI/ML Overview

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.

Summary

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510(k) Summary of Safety and Effectiveness

Submitter: D. Barry McCoy C.P.O. Northeast Orthotics and Prosthetics Inc. Rhode Island Hospital, 2 Dudley St, Providence, RI 02903 and Custom Composite Mfg. Inc. 170 Macklin St. Cranston, RI 02920

Contact: D. Barry McCoy C.P.O. Telephone (401) 275-2230 Fax 401-275-4901 Date: June 9, 2003

Classification: Class II I .
Common or Usual Name: cranial orthosis, cranial band, helmet, Molding helmet II.
Classification Name: Cranial Orthosis, Code MVA CFR 882.5970 III.
Predicate Device: Ballert Molding Helmet (K 011433) IV.
V. Performance Standards: None, Special Controls required
VI. Description:
- A. 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.
- B. 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.
- C. The Providence Molding Helmet is custom designed and custom fitted for each patient from a plaster mold of the infants' head.
Labels and Labeling: Labels and instructions for use are provided including VII. precautions, and materials required by the special controls to which this product is subject.
Indications for Use: The Providence Molding Helmet is intended for medical VIII. purposes to improve cranial symmetry and/or shape. This device is prescribed by a physician to treat moderate to severe non-synostotic positional plagiocephaly in children from 3 to 18 months of age.
IX. Substantial Equivalence: The Providence Molding Helmet is substantially equivalent to the Ballert Molding Helmet (K 011433)
Clinical Review and Discussion: A review of the literature was provided. X.
Indications for Use: The Providence Molding Helmet is a cranial orthosis used to XI. treat moderate to severe non-synostotic positional plagiocephaly in children from 3 to 18 months of age. This includes infants with plagiocephalic-, brach vecephalic -, and scaphocephalic - shaped heads.
Contraindications for Use: Infants with synostosis, or hydrocephalus. XII.

(End of Summary)

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2003

D. Barry McCoy, C.P.O. 170 Macklin St. Cranston, Rhode Island 02920

Re: K030669

Trade/Device Name: Providence Molding Helmet Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: June 19, 2003 Received: June 13, 2003

Dear Mr. McCoy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. D. Barry McCoy, C.P.O.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K030669

Device Name: Providence Molding Helmet

Indications for Use:

Contradictions for Use: Infants with synostosis or hydrocephalus.

Mark N Milkerso

(Division Sign-Off) Dision of General, Restorative and Neurological Devices

510(k) Number -

Regulation Number and Section

§ 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)).