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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

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.

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The O&P Bivalve Cranial Molding Helmet 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 sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic and scaphocephalic shaped heads.

O&P Bivalve 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 creating a void. As the child's head grows, the skull is slowly reshaped and rounded by growing into the open voids created in the helmet for this purpose. The finished helmet has a foam-lined interior and has rigid plastic exterior. The helmet is bivalve with the anterior section overlapping the posterior section. The helmet is secured by means of a rivet on one side and an elasticized Velcro closure on the opposite side.

The provided 510(k) summary for the O&P Bivalve Cranial Molding Helmet (K063395) describes the device's substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance data for the new device. Therefore, much of the requested information regarding acceptance criteria and a dedicated study proving performance for this specific device is not present in the provided text.

However, I can extract information related to the predicate device and the general evidence used to support the effectiveness of cranial orthoses.

1. Table of Acceptance Criteria and Reported Device Performance

As this submission relies on substantial equivalence and does not establish new acceptance criteria for the O&P Bivalve Cranial Molding Helmet, a direct table of acceptance criteria and performance for this device cannot be generated.

Instead, the submission refers to the performance of its predicate device and the general effectiveness of cranial orthoses. The "performance" in this context refers to clinical outcomes observed with similar devices.

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

• Test Set Sample Size: Not applicable. There was no specific "test set" for the O&P Bivalve Cranial Molding Helmet, as its performance was not evaluated through a new clinical study.
• Data Provenance: The submission references:
  • Retrospective clinical experience with the predicate device (Precision Prosthetics' Orthotic Molding Helmet), stating "Precision Prosthetics treated over 2,340 children with their orthotic molding helmet" over nine years. No specific country of origin is mentioned for this experience, but given the company's location (Missouri, USA), it's highly likely to be US-based.
  • Published scientific literature on cranial orthoses by Clarren et al. (1979, 1981, 1977), Persing et al. (1986), Kane et al. (1996), and especially Littlefield et al. (1998). These studies describe general findings on the effectiveness of cranial orthoses. The Littlefield et al. study described monitoring "more than 750 infants." Specific country of origin for these studies is not detailed in the summary, but given the journals and authors often published in English, they are likely from Western countries (e.g., USA).

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

Not applicable. No specific test set was created for this device where expert ground truth was established. The effectiveness claims are based on prior clinical experience with a substantially equivalent device and existing scientific literature on the general class of devices.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated test set was used for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This submission does not describe an MRMC comparative effectiveness study, as it is centered on substantial equivalence rather than a new clinical trial comparing human readers with and without AI assistance. This device is a physical medical device, not an AI/software device that would involve human readers.

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

Not applicable. This is a physical cranial orthosis, not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the effectiveness claims cited comes from:

• Clinical outcomes data: From the past 9 years of treating over 2,340 children with the predicate device, implying observed improvement in cranial shape.
• Published clinical studies: Which documented "complete or near complete correction of asymmetry" based on measurements or assessments of infants' head shapes over time (e.g., Littlefield et al. 1998 study). This would typically involve clinical assessment and anthropometric measurements by medical professionals.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. If interpreted as the "experience" pool for the predicate device, it would be "over 2,340 children" and "more than 750 infants" from the cited studies.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of an AI/ML device. For the clinical experience and studies cited, the "ground truth" (i.e., whether the treatment was effective) was established through clinical observation, anthropometric measurements, and follow-up assessments by medical professionals involved in the treatment of positional plagiocephaly.

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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.

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