Search Results

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 sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.

O&P Cranial Molding Helmets are custom made at the direction of a physician's prescription. Helmets are made by hand for each infant by taking a cast of the baby's head. The cast is filled with plaster and a positive mold of the infant's head is created. The flattened areas of the positive mold (corresponding to the flattened areas of the infants head) are then built up and made round. The finished helmet has a hard middle layer with a padded inner and outer laver. There are ventilation holes in the top of the helmet is held in place with a chinstrap.

O&P Cranial Molding Helmets work in two ways. The first way is that the helmet fits close to the head where the head sticks out, and loosely over the flattened area. The skull will grow into the loose area of the helmet, allowing the flattened parts of the head to "catch up" with the prominent areas. This type of helmet is known as a "passive" or "Clarren style" helmet. The second way the helmet is effective is by providing a rounded surface for the infant's head to lie on, removing the worry about proper positioning.

The provided text does not contain detailed acceptance criteria and a specific study proving the device meets those criteria in the format typically used for medical device validation (e.g., sensitivity, specificity, accuracy metrics with statistical significance).

Instead, the document is a 510(k) Summary for the O&P Cranial Molding Helmet, asserting substantial equivalence to a predicate device (Orthomerica's STARband K011350). The "performance data" section primarily relies on:

• Substantial Equivalence: Claiming that since the O&P Cranial Molding Helmet is substantially equivalent to the STARband (which itself claimed substantial equivalence to the OPI Band), it meets the same standards of performance.
• Historical Use: Stating that an area hospital department in St. Louis has used O&P Cranial Molding Helmets effectively and safely for 19 years, treating an estimated 4,256 infants.
• Literature Review: Citing several published studies and a "comprehensive assessment" of cranial orthoses to support the effectiveness of such devices in correcting abnormal head shape.

Therefore, many of the requested items (sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not explicitly addressed in this 510(k) summary as it is not a direct study report for the O&P Cranial Molding Helmet's performance metrics against a predefined acceptance criterion.

However, based on the provided text, here's an attempt to answer the questions, indicating where information is not present or inferred from the context of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics (e.g., "must achieve X% improvement in CVA"). The implicit acceptance criterion is that the device is "safe and effective for its intended use" and "substantially equivalent" to predicate devices. This implies meeting the performance standards previously accepted for the predicate.
• Reported Device Performance:
  • Effectiveness: Corrects abnormal head shape, with evidence of relapse following treatment (from cited literature on similar devices).
  • Safety: Used effectively and safely for 19 years with 4,256 infants treated.
  • Specific Metrics: No specific quantitative performance metrics (e.g., average reduction in cranial vault asymmetry index) are provided for the O&P Cranial Molding Helmet itself. The document references a study (Littlefield et al., 1988) that documented "complete or near complete correction of asymmetry for a wide variety of head shapes" for cranial orthoses in general, but not specifically for the O&P device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable/Not specified for the O&P Cranial Molding Helmet as a direct test. The document refers to:
  • Over 4,256 infants treated with O&P Cranial Molding Helmets over 19 years, but this is historical use, not a controlled test set to establish performance metrics against predefined criteria for this submission.
  • One cited study (Littlefield et al., 1988) monitored over 750 infants for cranial orthoses in general.
• Data Provenance:
  • Historical Use of O&P Helmets: An area hospital department in St. Louis (inferred to be US-based, given the submission in the US). This data appears retrospective, gathered over 19 years.
  • Cited Literature: Various studies published in journals (e.g., Journal of Pediatrics, Journal of Craniofacial Surgery). The geographical origin and whether they were retrospective or prospective are specific to each cited paper and not detailed here. The "comprehensive assessment" by Littlefield et al. monitored patients over 10 years, suggesting it was a prospective or long-term observational study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not applicable. This information is not provided. The approach is substantial equivalence and reference to existing literature rather than a new controlled study with an explicit ground truth establishment process by experts for the test set of the O&P Cranial Molding Helmet.

4. Adjudication Method for the Test Set

• Not applicable. This information is not provided.

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

• Not applicable. This device is a physical orthotic device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and "human readers" or "AI assistance" are not relevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a physical orthotic device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Implicitly based on clinical outcomes and expert judgment as documented in the cited literature for cranial orthoses. For the historical use of the O&P device, "effectiveness and safety" were determined by the hospital's long-term experience, which would involve physician assessment of infant head shape improvement (clinical outcome). The cited literature similarly relies on clinical assessments of head shape correction.

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. As above, this is not a machine learning model.

Ask a specific question about this device