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The STARband and STARlight are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

The STARband and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband and STARlight provide total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband and STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4" to 3/8" clear Surlyn. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition, optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.

The STARband Side Opening design and the STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap (1½" for STARband Side Opening and 1" for STARlight Side Opening) across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The proposed device modification is a new software component for a previously cleared shape capture method, the STARscanner™ Data Acquisition System. The new software component is the Cranial Comparison Utility (CCU). The CCU is a separate software program that is designed to present specific measurements derived from a threedimensional (3D) digital model of a patient's cranium. These features are useful to medical professionals by providing more detailed shape data that can be incorporated into the patient evaluation/assessment and for tracking cranial head shape changes.

1. A table of acceptance criteria and the reported device performance:

The document describes the Cranial Comparison Utility (CCU) as a software component for the previously cleared STARscanner™ Data Acquisition System, which is used for the fabrication of STARband and STARlight Cranial Orthoses. The acceptance criteria and performance data specifically address the CCU.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document states that the "CCU Accuracy and Capabilities Study" "Utilized a representative cranial shape that possesses a predefined shape with known dimensions." It does not specify a numerical sample size in terms of the number of unique patient scans or models. Instead, it refers to a single "representative cranial shape." This suggests a phantom or a standardized model rather than a dataset of patient scans.
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the nature of a "representative cranial shape" with "predefined shape and known dimensions," it is highly likely this refers to a synthetic or phantom model used in a controlled laboratory setting, rather than real patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not mention the number or qualifications of experts used to establish the ground truth for the CCU's test set. The ground truth was established by "predefined shape with known dimensions" and "manual measurements and 3D-CAD software." This suggests that the ground truth was derived from engineering specifications and objective measurements rather than subjective expert consensus on patient data.

4. Adjudication method for the test set:

Not applicable. The ground truth for the CCU's performance was established using objective "predefined shape with known dimensions" and comparison to "manual measurements and 3D-CAD software." There was no multi-reader or human adjudication process described.

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, an MRMC comparative effectiveness study was not done. The CCU is a software tool for measurement and analysis of 3D cranial models, not an AI-assisted diagnostic tool for human readers. It provides "more detailed shape data that can be incorporated into the patient evaluation/assessment and for tracking cranial head shape changes" by medical professionals, but it does not describe human reader performance with or without the CCU.

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

Yes, a standalone study evaluating the CCU (algorithm only) was performed. The "CCU Accuracy and Capabilities Study" assessed the accuracy of measurements and capabilities entirely of the software by comparing its output to "manual measurements and 3D-CAD software" on a "representative cranial shape."

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

The ground truth used for the CCU's accuracy and capabilities study was based on:

• "Predefined shape with known dimensions" of a representative cranial shape. This implies a precisely manufactured physical model or a digitally engineered model with exact specifications.
• Comparison to "manual measurements and 3D-CAD software." This suggests that precise reference measurements from established tools were used as the gold standard.

8. The sample size for the training set:

The document does not describe a "training set" for the CCU. This suggests that the CCU software likely relies on deterministic algorithms for geometric measurements and comparisons, rather than machine learning models that require training data.

9. How the ground truth for the training set was established:
As no training set is described for the CCU, the method for establishing its ground truth is not applicable.

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Infants. 3 - 18 months of age, with abnormally shaped craniums with no outstanding cranial abnormalities that have a RX from a physician who has assessed the child to rule out craniosynostosis.

The Static Cranioplasty Orthosis is a cranial orthosis used to treat abnormally shaped craniums in infants three to 18 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 flattenedareas of the skull into the created spaces. The Static Cranioplasty Orthosis is only available if prescribed by a physician.

The orthosis is custom designed for each patient from a cast of the infant's head or a scan using the STARscanner from Orthomerica . The mold, either plaster from the cast, or foam from the scan, is modified and prepared for fabrication by the treating practitioner using mathematical analyses and plaster modification techniques. The orthosis is then fabricated under the direction of the same practitioner. Each orthosis is composed of an outer shell of thermoformable plastic, 5-6 layers of hypoallergenic polyethylene foam and a strap for securing the orthosis. Optimum fit and alignment is insured and monitored by the same clinical practitioner.

The provided text describes a 510(k) submission for the Boston Band Cranial Remolding Orthosis. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not a study designed to prove the device meets specific acceptance criteria with reported performance metrics in the way a clinical trial for a novel AI or diagnostic device would.

Therefore, many of the requested details (like sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable or present in this type of regulatory document.

However, I can extract the information related to the device's effectiveness as established by referencing a clinical trial and comparing it to a predicate device.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria or reported device performance in a dedicated table format. Instead, it claims substantial equivalence to a predicate device and references a clinical trial to establish "effectiveness." The "acceptance criteria" here are implicitly meeting the standard of effectiveness and safety demonstrated by the predicate and supported by existing clinical literature.

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

• Sample Size for Test Set: Not explicitly stated in this document for the Boston Band. The effectiveness claim relies on a clinical trial referenced for cranial orthoses in general, not specifically for the Boston Band.
• Data Provenance: The document references a clinical trial: "Ottoto: Treatment Protocols for Plagiocephaly, Jeff Larson, CO:JPO 2004, Vol 16, Num 4s." The provenance of that study's data (country of origin, retrospective/prospective) is not provided in this 510(k) submission.

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

This information is not provided because the document references an existing clinical trial for cranial orthoses to establish effectiveness. There is no "test set" in the context of validating a new algorithm, or a process described for establishing ground truth from experts for this specific 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. The document relies on a referenced clinical trial's methodology, not a separate adjudication process described here for a specific test set.

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 is a medical device (cranial orthosis), not an AI or diagnostic imaging device that involves "human readers" or "AI assistance."

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the effectiveness claim is based on the outcomes reported in the referenced clinical trial ("Ottoto: Treatment Protocols for Plagiocephaly, Jeff Larson, CO:JPO 2004, Vol 16, Num 4s"). This would typically involve clinical outcome data (e.g., changes in cranial measurements, resolution of deformities) rather than expert consensus, pathology, or other types of ground truth used for diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no concept of a "training set" in this context.

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

Not applicable.

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The Clarren Helmet is a cranial orthosis that applies passive 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.

The Clarren Helmet is a cranial orthosis that applies passive 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. It consists of a polypropylene sheet, three-eights of an inch thick, which is vacuum formed over a plaster model of a baby's head to produce a helmet. A liner for the helmet is made of Plastizote, one-fourth of an inch in thickness. Small holes are bored in the helmet for ventilation and large holes for the child's ears A Velero chinstrap is attached to help keep the helmet in place on the baby's head. It is manufactured from a positive model, obtained via traditional manual casting methods or a three-dimensional scan of the infant's head.

The submission describes the Clarren Helmet (Orthomerica) and its use in conjunction with the STARscanner.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantifiable acceptance criteria for the Clarren Helmet or the STARscanner. Instead, it relies on substantial equivalence to previously cleared devices.

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

• Clarren Helmet (Orthomerica): No specific test set or sample size is mentioned for the Orthomerica version of the Clarren Helmet. The claim is based on its identity to the Clarren Helmet (Children's Hospital), which presumably had supporting data in its original clearance.
• STARscanner: No specific test set or sample size is mentioned for the STARscanner in this submission. It refers to its previous FDA clearance (K011350) and states that data "demonstrates more accurate results than the manual process." This implies a comparison, but details about the comparison's sample size or provenance (country of origin, retrospective/prospective) are not provided in this excerpt.

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

• Clarren Helmet (Orthomerica): Not applicable, as no dedicated test set for this specific device is described. The original Clarren Helmet's studies (if they involved expert ground truth) are referenced, but details are not here.
• STARscanner: Not applicable. The submission mentions "more accurate results" but does not detail the method of establishing ground truth or expert involvement for the STARscanner's performance evaluation.

4. Adjudication Method for the Test Set

• Clarren Helmet (Orthomerica) / STARscanner: Not applicable, as no specific test set requiring adjudication is described in this excerpt.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Clarren Helmet (Orthomerica) / STARscanner: No MRMC comparative effectiveness study is mentioned in this document. The focus for the Clarren Helmet is on substantial equivalence to a predicate, and for the STARscanner, on automation accuracy compared to manual processes.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Clarren Helmet (Orthomerica): Not applicable. The Clarren Helmet is a physical cranial orthosis, not an algorithm.
• STARscanner: The description of the STARscanner states it "yields more accurate results than the manual process," implying a standalone assessment of its automated measurement and carving capability. However, the details of how this accuracy was measured and whether it was without human intervention in the loop of the measurement phase are not provided. The previous FDA clearance (K011350) for the STARscanner likely contains these details.

7. Type of Ground Truth Used

• Clarren Helmet (Orthomerica): The references provided for the Clarren Helmet (Children's Hospital) are medical journal articles from 1979 and 1981, suggesting that the ground truth for its efficacy might have been based on clinical outcomes data (e.g., improvement in cranial symmetry/shape, as assessed by clinicians or objective measurements over time) observed in those studies.
• STARscanner: For the STARscanner, the claim of "more accurate results than the manual process" suggests the ground truth would be based on highly precise physical measurements of the infant's head model or actual head, against which both the STARscanner's output and the manual process's output are compared. The exact nature of this "ground truth" (e.g., gold standard precision measurement tools) is not specified.

8. Sample Size for the Training Set

• Clarren Helmet (Orthomerica) / STARscanner: The submission does not mention any training sets, as it is focused on demonstrating substantial equivalence and the performance of a physical device/scanner, not on a machine learning algorithm that requires a training set.

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

• Clarren Helmet (Orthomerica) / STARscanner: Not applicable, as no training set is mentioned.

Summary of the Study and Its Limitations (based on provided text):

The submission does not present a new, comprehensive study with explicit acceptance criteria for the Clarren Helmet (Orthomerica). Instead, it relies on two primary arguments:

1. Substantial Equivalence to a Predicate Device: The Clarren Helmet (Orthomerica) is deemed "safe and effective and identical" to the predicate, the Clarren Helmet (Children's Hospital), which had prior FDA clearance based on published studies (Clarren, 1979, 1981). This implies the acceptance criteria and proof of effectiveness for the Orthomerica version are derived from the prior clearance of the Children's Hospital version.
2. Previous Clearance and Demonstrated Performance of the STARscanner: The STARscanner had already received FDA clearance (K011350) when used with another cranial orthosis (STARband). The submission asserts that the STARscanner's "performance data demonstrates that the proposed automation of measuring for and carving a positive mold of the patient's head yields more accurate results than the manual process used for the predicate device."

Key Missing Information: The document lacks specific details regarding quantitative acceptance criteria, new clinical study data for the Orthomerica Clarren Helmet, or detailed technical study data for the STARscanner's accuracy (including sample sizes, ground truth establishment, or expert involvement) within this specific submission. It heavily leverages previous clearances and external publications for its justification.

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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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